I would like to welcome all of you to our next installment of our AUG's virtual forum web-based lecture series. This is a series of presentations by experts in our subspecialty from across the country focused on topics based on the FPMRS learning objectives as well as relevant practice-related topics. The virtual format also provides AUG's members the opportunity to interact with the speakers in real-time. This presentation will then be captured and made available for view at any time on the AUG's website. Upon completion of this program, you will be given the opportunity to provide some feedback, which we value greatly. For this evening's presentation, we are so pleased to have Colleen Mellon with us. She is a clinical nurse specialist and an APRN in the Urogynecology Division at Hartford Hospital. She and Kate O'Dell, who is a retired certified nurse midwife and nurse practitioner who used to practice at the University of Massachusetts Memorial Medical Center, they put together this presentation prior to Kate's retiring. Then Colleen is joining us live to answer any questions and make any clarifications as needed. Their presentation today will be Pessary Fitting, Follow-up, and Management of Complications. Thank you, Colleen, for being with us today. Thank you. The title of this webinar is Pessary Fitting, Follow-up, and Management of Complications. Speakers will be Colleen Mellon, APRN, Urogynecology Division at Hartford Hospital in Hartford, Connecticut, and Katherine O'Dell, Women's Health Nurse Practitioner, Associate Professor of OBGYN at the UMass Memorial Medical Center, Urogynecology Division in Worcester, Massachusetts. Thank you for allowing us to present this FPMRS webinar. This program will be accessible for future viewing through the AUGS Education Portal. Kate and I are members of the AUGS Advanced Practice Physical Therapy and Allied Health SIG and the SIG's Education Workgroup. This program is appropriate for all AUGS members, including fellows, urogynecology physicians, and advanced practice providers. The purpose of this program is to discuss the role of vaginal pessary as a non-surgical treatment option for vaginal prolapse and urinary incontinence in urogynecology practice. Due to time constraints, pessary insertion and removal may be covered in a series of videos available through the Education Portal video library. By completion of this presentation, participants will be able to discuss the indications for pessary use, identify types of pessaries, discuss the principles for selection of pessary, demonstrate pessary fitting, insertion, and removal techniques, describe pessary follow-up and routine maintenance, and discuss evidence-based management of common adverse effects and severe complications of pessary. Both pelvic organ prolapse and stress urinary incontinence are common benign conditions in women, which are often amenable to treatment using a vaginal support pessary. Other treatment options to improve symptoms resulting from these conditions include behavioral modifications, physical therapy to improve muscle strength and coordination, and surgeries. However, vaginal support pessaries are widely considered a first-line option, as they can be highly effective, patient-friendly, minimally invasive, and relatively low-risk. Patient acceptance for choice of pessary is high, based on appropriate counseling and positive encouragement from their provider. While patient preferences vary between individuals at any age, several studies suggest that women who decline or discontinue pessary use after shorter periods of time are more likely to be nulliparous, younger, have severe prolapse or urinary incontinence, have had prior surgery, and or have symptoms related to bowel evacuation. One group published a review of the literature addressing outcomes of 41 studies regarding pessary treatment for prolapse and health-related quality of life. Summary findings included 86% gynecologists and 98% urogynecologists use pessary in daily practice. Gellhorn and ring with support are most frequently used and appear equally effective. 85% successful pessary fitting rates were reported. Risk factors for unsuccessful pessary fitting are short vaginal length, large genital hiatus, prior hysterectomy, and prior prolapse surgery. Based on their review, they concluded that compartment and stage of prolapse does not influence success of pessary fitting. Continuation rates for pessary use in the short term range from 50 to 80% over the first three to four months, and after one year, remained at 50 to 80% continuation rate. An independent factor for continued pessary use is age greater than 65 years. They also concluded that there may be a decrease in genital hiatus with continued pessary use. There may be improvement in prolapse stage after one year. However, it is not known if this is a transient versus sustained effect. If hormone replacement therapy is prescribed, local estrogen replacement therapy is sufficient and increases initial success of fitting. Common side effects are bleeding, vaginal discharge, constipation, and odor. In addition, 56% of women report at least one side effect with long-term pessary use. Major complications of fistula, fecal impaction, hydronephrosis, and urosepsis are rare and associated with neglect of care. Sexual activity or degree of prolapse are not contraindications of pessary use. Indications for pessary use include patient preference for nonsurgical treatment, surgical risk due to medical comorbidity, recurrent prolapse or stress incontinence in a woman desiring no further surgery, to heal vaginal ulcerations prior to surgery, in pregnancy to manage prolapse and cervical insufficiency, desire for future childbearing, to treat an acute episode of urinary retention or discomfort related to prolapse, and comfort while awaiting surgery. Pessaries are also used to predict occult stress incontinence or to predict surgical outcomes for prolapse symptom relief. Therefore, a trial of pessary can be offered to all women with prolapse or stress incontinence regardless of patient characteristics. At least one urogynecology provider in each practice, often an advanced practice provider, should have expertise in pessary fitting and management. Pessary use is contraindicated in women with local or pelvic infection. This should be treated first. Exposed mesh or graft material should be addressed first. Latex sensitivity is generally not a problem because most pessaries are made of medical-grade silicone. Patient nonadherence to follow-up schedule is a contradiction and sexually active women who are not able to learn pessary self-management but wish to remain sexually active. Infections are generally low and will be discussed later in the presentation. Patient education and counseling are key factors for successful pessary fitting and continued pessary use. The patient's personal goals for pessary use including desire to avoid surgery due to personal preference, career, or family obligations, desire for pessary self-management, and sexual activity should be discussed before the fitting. The women's exam findings should be reviewed using diagrams, teaching models, or use of a mirror for patient self-examination as the concept of vaginal prolapse and placement of pessary are difficult to visualize. Additional education regarding risk factors, choice of pessary, follow-up planning, menstruation if applicable, and expectation that it may take more than one visit to determine best pessary size or type. Vaginal preparation may include treatment of follow-vaginal atrophy using standard regimens at or before the fitting visit and establishing a plan to prevent or treat constipation before pessary fitting. The remainder of my portion of the program will be primarily based on expert opinion. There are no evidence-based decision algorithms for choosing the right pessary for the right patient or for pessary follow-up and management regimens. There is little agreement as to what constitutes a successful pessary fitting. There are several ways to categorize pessaries, but they are typically divided into two types. One way is to think of them as two-dimensional support pessaries or three-dimensional space-filling pessaries. The space-filling pessaries are used typically with more advanced prolapse or in women with insufficient entroital support. Two forms of these three-dimensional pessaries are the gale horn or shelf pessary and the cube pessaries. They have concavities that provide a self-retaining quality. The vaginal tissue fills the concavities, helping to hold the pessary in place, a mechanism sometimes referred to as suction. Support pessaries include variations of ring pessary with and without an internal support membrane, as well as other shapes that we don't have time to review today. These include the gay rung, shots, and lever pessaries like the Smith-Hodge. Most of these are also available with a urethral support knob to treat stress urinary incontinence. The self-retaining pessaries include those with a stem and base like the gale horn or shelf pessary and cube pessaries, which are usually used with drainage holes, and the tandem cube, which is a variation less commonly used. Self-retaining pessaries like the donut inflatable, which is made of latex rubber, and the newer silicone inflatable donut may aid in supporting very lax vaginal walls, but still need some entroital support to be retained. Pessaries have been made of various materials over the millennia, including stones, strings, fruit, and latex rubber, but current pessaries marketed in the U.S. are predominantly made of medical-grade silicone and include drainage holes. The advantages of this material are longer use life, they can be autoclaved, and manufacturer's recommendations for sterilization should be followed. They do not absorb secretions and odors as easily as latex, and they are less likely to stimulate allergic response as it is an inert material. Most busy high-volume urogynecology practices will keep an inventory of multiple pessary types and sizes in stock in their office so that women can be fit with a pessary and go home with it the same day. More volume offices may use a fitting kit or sample size re-sterilized pessaries to predict optimum size and type, and then write a prescription for the device to be obtained through a pharmacy or medical distributor. The woman then brings her pessary to the office for insertion and teaching. This may become expensive as refitting is common. Many experienced providers evaluate for pessary size by manual measurement of the vaginal length from posterior fornix to pubic notch and width by finger breaths across. This exam also gives the provider the opportunity to assess genital hiatus, integrity of the entritis, assess for narrow or low-lying pubic arch, and assess strength and tenderness of the vaginal musculature, which all affect choice of size and type of pessary. When fitting self-retaining pessaries like the gellhorn or cube, the diameter of the apex in mid-vaginal space should be assessed to obtain a mental impression of the correct size for the upper shelf of the gellhorn or the diameter of the cube. General fitting guidelines include allowing about one hour for the pessary fitting appointment, estimating fit by manual measurement, start with the smallest pessary you think will be comfortable and retained, then work up in size if necessary. Trial the pessary in the office, making sure the woman understands that a size change may occur at the next visit, and remembering that not every woman can be fit with a pessary with about 15% failure rates reported. Another fitting decision system is based on entroital integrity and presence of new onset stress incontinence rather than stage of prolapse. Number one, those patients with entroital integrity with two to three finger-breadth widths, any variation of the ring pessary in the top row in this picture could be tried first. If that pessary falls out or if the patient has three or more finger-breadths across at the vaginal entroitis, a self-retaining pessary may be fitted first. If the patient has new onset stress urinary incontinence when a ring pessary is placed, try an incontinence-type device with a urethral knob. The two most common pessaries used in urogynecology practice are the ring pessary with support and the flexible gale horn. And the most common sizes, as you see here, should be stocked in the office. Now we will return to pessary insertion and removal techniques for the ring with support, the gale horn, and the cube pessaries. The ring pessary is inserted by pressing the small drainage holes together to fold. The folding line is between the two large drainage holes. The ring pessary is folded and inserted into the vaginal canal. The ring with support pessary is removed by grasping the large drainage hole so that the pessary folds on itself as it passes through the entroitis. Some providers may use the ring forceps or tenaculum to grasp the pessary rim or the large drainage hole. The ring pessary does not fit over the cervix like a cervical cap, as often portrayed in diagrams. It does not need to be fitted behind the pubic symphysis in order to be effective. It rests in the long axis of the vagina from the posterior fornix to just above the vaginal opening, as you see in the right side of this picture. One tip is that if the ring pessary slips only when the patient is strongly bearing down but otherwise fits well, teach the patient to rotate the pessary one quarter turn once it's inserted. This makes the pessary rigid and less likely to slip. The patient or the provider must remember to rotate the pessary back so that the large drainage hole is facing anteriorly before removal. For those patients who have complaint of lateral tenderness or rectal pressure when walking or sitting with the ring pessary, you may try the Schatz pessary, which has a thinner rim, the oval pessary, which is softer and flexible, or the cube pessary, which is retained with a smaller diameter. For the patient who wishes to remain sexually active but ring pessary does not support the prolapse, the cube with drainage holes, the gueron, which requires integrity of the pubic synthesis to hold this pessary in place, or others like the regular or silicone inflatable donut pessary can be tried. For the patient determined to use the ring pessary, she can be taught to splint the pessary with fingertip when pushing for defecation. For the difficult-to-fit patient due to wide genital hiatus or cavernous vaginal vault, a cube with drainage holes, tandem cube, for which I would personally cut drainage holes into the pessary, may be tried. In some cases, a double pessary using either a donut or ring support pessary placed against the apex or cervix, then with the gale horn placed distally, might be effective. For the patient who cannot remove their own pessary but desires self-management, a loop of dental tape, which is stronger than dental floss, can be placed through the drainage holes to help guide out the pessary. The patient is taught to place a new loop of dental floss each time pessary is removed for cleaning. No evidence of infection from this commonly used option has been reported. In addition, for some women, their willing family member or support person can help them remove the pessary. The knob or hump of the incontinence pessary is fit under the UVJ, per manufacturer's recommendations. I personally find that if the patient still leaks urine with a knob placed under the UVJ, it might be more effective to use an incontinence pessary large enough so that the knob fits under the mid-urethra, similar to the mid-urethral sling. Many women report use of vaginal menstrual tampons to help decrease stress urinary incontinence with or without their pessary. Recently, more patient-directed products are coming to the market that may better meet this need. Non-absorbent vaginal support inserts avoid the vaginal drying, irritation, and infection potential of absorption fibers of regular tampons in non-menstruating women. I also find that for patients who would like to use this over-the-counter vaginal insert for stress incontinence, but are confused on how the fitting kit works, I offer them the opportunity to come to the office with a full bladder, and I help them to determine which size will be most effective. The Gellhorn pessary is used for women with more advanced stage prolapse and insufficient introidal support. The cervix or cuff rests behind the disc portion of the pessary, and only the stem is visible at the vaginal opening when the patient does valsalva maneuver. It is available in two lengths to accommodate short and standard vaginal lengths. This is how the Gellhorn is positioned in the vagina with the disc portion of the pessary suctioned against the cervix or apex. One technique for Gellhorn insertion is to fold the two sides of the disc in toward the center, insert through the introidus, then the disc is rotated so that it is pushed flat against the cervix or apex. To remove the Gellhorn pessary, an instrument is usually needed. A ring forceps or tenaculum is clasped onto the knob of the stem. Use fingertip from the other hand to reach behind the disc to break suction. Fold the disc toward the stem to guide the pessary out on the diagonal to avoid urethral trauma. And this is another picture of that. The cube pessary is used for advanced stage prolapse and lack of vaginal tonicity. It supports the prolapse and vaginal walls by suction action of six concavities. Manufacturer's recommendations state that the cube pessary should be removed by the patient nightly and left out overnight. The package insert does not address the cube with drainage holes. Cube and tandem cube without drainage holes create an occlusive anaerobic environment with no area for drainage. We advise use of the cube with drainage holes. Anecdotally, providers report inserting cube with drainage holes in patients who are not able to self-manage pessary and then follow the patient at routine intervals without serious adverse effects. The tail on the cube pessary is not meant to dangle out of the vagina or for pulling out pessary. It can be tucked up or cut off to avoid fecal contamination. If the patient is self-managing the cube pessary, she will need instruction and practice on breaking suction to remove the pessary. The cube is inserted by compressing the pessary between the thumb and forefingers with lubrication on the leading edge. Fingers of the second hand spread the labia and the cube is guided into the vagina. It should be inserted to at least the mid-vagina in order to support the prolapse. For cube pessary removal, the suction on vaginal walls must be broken to remove the cube pessary. Work the fingertips between the vaginal walls and the pessary. Compress the cube between the thumb and forefinger and remove. A pessary hook or tenaculum can be used to assist with cube removal, reducing the risk of damage to vaginal tissue. To summarize pessary fitting, manual exam is used to estimate size. The provider then decides on pessary type and size and inserts the pessary. It's also recommended that fit be checked by determining that there is about one finger breadth space around the perimeter of the pessary. Have the patient cough and bear down in the supine and standing positions to check for fit and that the pessary is retained. Ask the patient to sit, stand, do daily type movements, bear down as if for bowel movement, and empty the bladder before leaving. All of these motions to determine if the pessary is comfortable and will stay in place. Re-examine the patient before she leaves while standing in order to check if the pessary has slipped, changed position, or if the prolapse is bulging beyond the pessary. Pessary maintenance for the patient who will self-manage her own pessary includes teaching regarding removal and insertion. This should be practiced in the office. Many women find that it is easiest to insert the pessary while in the supine or reclining position and easiest to remove while standing or bearing down. Training also includes pessary removal and cleaning schedule. Providers often recommend pessary self-removal about once weekly and before sexual relations. For some patients, they prefer to leave the pessary in place for sexual relations and this should be discussed. Pessary is washed with soap and water and self-management regimen may be individualized with provider guidance. Disuse of lubricants, acidifying gels, and or vaginal estrogen as needed. This picture shows different positions for self-insertion or removal of pessary. We want to emphasize that lots of positive reinforcement is helpful for the patient and of course provide her with contact information so that the patient can call with questions or concerns. Pessary safety measures include review of warning signs for which the patient should call the office to report such as pain, voiding or defecatory difficulty, vaginal bleeding, abnormal discharge, or if the pessary falls out. Some providers use a written pessary consent form which details pessary information and patient responsibilities that is signed by both the patient and the provider. A patient follow-up reminder system should be in place so that patients are not lost to follow-up. A medical device alert bracelet may be indicated, especially in patients with declining cognitive function. I will now turn the program over to Kate O'Dell who will discuss the management of pessary-related follow-up and complications. Once an appropriate pessary is identified and the woman begins to feel comfortable with her choice of either removing the pessary herself intermittently or of leaving it in place, an ongoing management plan should be established with her. As we've already discussed, most pessary care is guided by expert opinion in lieu of research. In this webinar, we've tried to include what is available as evidence including two recent state-of-practice studies, an online survey and a Delphi study that assessed current pessary care practices and the recommendations of the participants, many of whom were members of the OGS Advanced Practice Special Interest Group. While various types of pessaries are used widely throughout the world, the number of overall users is unknown, so complication rates cannot be established. It's clear that while pessaries are generally low-risk for most users, life-threatening complications can and do occur. Pessary reviews summarizing serious pessary-related complications most often report pessary impactions, vaginal perforations and fistulae, and acute urinary and bowel obstruction or injury. Typically, these are seen in women who are not in regular follow-up, but serious complications have also been reported in women receiving regular quarterly care. Affective women often have factors predisposing them to poor tissue quality, such as advanced age, prior pelvic radiation, poorly controlled diabetes, or long-term steroid use. And all types of pessaries have been implicated in serious side effects. To prevent serious complications, providers generally schedule routine surveillance appointments to assess early signs of problems, like spotting, introidal stenosis, or mild mechanical irritation. There is not much evidence to support a standard recommended interval. In response to pessary practice surveys, nurse providers reported requiring women who cannot perform self-removal of their pessary to return it anywhere from one- to six-month intervals, with 70 percent recommending three-month intervals, regardless of the type of pessary used. An OGS physician expert panel recently chose at least six-month return visits as a quality of care indicator. Obviously, the length of this interval plays an important role in assessing the cost of effectiveness of pessary care. Another concern for pessary care providers is the potential for loss to follow-up. To try to avoid this, many providers report use of some type of follow-up monitoring, like a log, missed appointment tracking, and reminders, or some similar system to assure that pessary users continue in care. This is particularly important when women have progressive cognitive decline. Many of them can be lost to follow-up, especially at times of transition, such as when they or a caregiver decline and change residence. Examples of a return visit generally involve at least an interval review of current pelvic floor symptoms, self-care practices, and changes in quality of life. In the survey of pessary providers, the majority of providers reported that their routine surveillance visits include a vulvar and external genital exam for irritation, legions, or symptomatic bulge past the pessary, and a vaginal speculum examination, even in asymptomatic women, to identify and modify early signs of mechanical irritation. The removed pessary was most often cleaned with soap and water, and no routine vaginal cleansing was performed. However, a few providers reported that they do routinely do vaginal cleansing, usually with a water irrigation, and they do routinely apply topical treatments, such as acidifying gels or antimicrobial creams, and or some reported that they reserve speculum examination only for women with visible bleeding. Many providers report performing careful inspection, especially of the cervical fornices, aided by tissue support with a proctoswab, to help identify early mechanical pressure ulcers that otherwise might remain hidden. Most providers reported identifying posterior and lateral wall pressure ulcers most commonly, and no providers reported identifying anterior wall injury. However, it's important to note that most of the case studies of fistulae actually involve the anterior wall. As the anterior wall may be more difficult to examine in a lathotomy position, providers should remain aware of this potential risk of missing an early anterior injury. In some women, digital manipulation may be all it takes to remove any type of vaginal pessary, whether this removal is done by the provider or the woman herself. However, if removal is more difficult, there are lots of tips and tricks for aiding removal. For one thing, a woman with a pliant, well-lubricated entroitis will likely be more comfortable with insertion and removal, so using a water-soluble lubricant and estrogenizing atrophic tissue may help women be more likely to be satisfied with a pessary in the long term. For women who still have significant discomfort with removal, some providers prescribe lidocaine gel to apply it five minutes prior to removal. For self-removal, many people use a loop of dental floss to help them reach and remove the pessary. When self-removal is difficult, some resourceful women have reported using household implements like crochet hooks to help reach their pessary, although many fear, of course, the potential for self-injury. Other reported tricks to aid a woman's self-removal and insertion of her pessary include a well-timed cough or Valsalva effort, or pessary rotating motion, or a trial of different positions, usually standing or seated on the toilet, although semi-followers might help for people who have a large prolapse at the time of the—when they are in the upright position. There are times when a provider might also be unable to remove a pessary digitally without undue discomfort to the woman. Contributing factors might be entroidal atrophy, stenosis, or vulvar dermatosis, obesity, migration of the pessary into a cavernous or stenotic apex, and in some cases just typical use of a self-retaining pessary like an appropriately fit gelhorn or cube. If more than one to two fingers would be needed in the vagina to effectively remove a pessary, providers often do report using instrumentation to facilitate removal and improve patient comfort, and instruments used include the pessary hook shown here on the left and different types of forceps. Some people use ring, kelly, or tenaculum. Each type of forceps has an advantage and disadvantage. For example, the ring forceps is unlikely to damage the pessary but may pop off and pinch the patient. A tenaculum makes a small hole in the pessary but is much more secure for a very difficult removal, and a kelly can be slipped into the hole of the gelhorn stem securely to avoid pop-off risk but not have an adequate grip. As a provider, you'll need to practice to see what type of aid you would use most safely and effectively. Remember, difficult-to-remove pessaries are fairly common, especially in high-volume urogynecology offices, and many women report a great deal of anguish related to past experiences of painful removals by inexpert providers. As a final note, some providers suggest installation of warmed, sterile water via a syringe or small catheter through the stem hole of the gelhorn pessary if it is difficult to remove, and report that this eases detachment. This may be another adjunct to have in your tool of potential care methods. These return visits, both those that are scheduled for surveillance and problem visits, are meant to allow early intervention to avoid more serious problems. For the remainder of this section of our webinar, we'll discuss management of complications, including vaginal discharge, odor, bleeding, and erosions, concluding with a brief overview of evaluation of fistulae and management of impaction. First and foremost, because it's most common, is discharge odor and vulvar skin irritation. When increased vaginal discharge does occur in new users, in the absence of problems like irritation or odor, women can usually be reassured that the increase may be a simple reactive process that may decrease spontaneously over time. However, if odor or irritation also occur, several options might help. First, rule out erosion, as blood makes a great growth medium for fragrant microbes. Also make sure the pessary has unplugged holes for normal vaginal drainage. More frequent pessary removal and cleaning may be helpful, either by the woman or the provider, and women who once thought they could never, ever remove their own pessary may become very motivated and capable in the presence of symptoms like odor. Vaginal cleaning can also be performed. After all, many of the problems reported with douching in reproductive-age women don't actually apply to postmenopausal women, when women already have an altered pH and often have a stenotic cervical ost that would preclude upward migration of vaginal flora. So some women do report that a saline or one to four vinegar and water douche weekly or monthly does resolve their symptoms. Diluted providine iodine and chlorhexidine have been used in the past for routine vaginal cleaning with pessaries. However, they do have a higher potential for de novo vaginal irritation and are no longer commonly used. Acidifying gels like Trimazan, which come with some pessaries, are also meant to acidify the vagina, provide a lubricant and control odor, but there's really very little evidence to support their role in management of odor. Some providers report that individual women have had less reaction to one manufacturer's product than another. So if a woman did have continued discharge, a trial of a different manufacturer's pessary might be helpful, even though they're both made out of medical-grade silicone. But for many women, the real source of their discharge and odor problems may be vaginal atrophy. Vaginal atrophy is associated with epithelial thinning, loss of vaginal rugae and tissue pallor and petechiae related to impaired circulation. The thickness of this stratified squamous epithelium is highly estrogen-dependent, of course, and estrogen-dependent bacteria play a role in inhibiting their odor-producing cousins. So pessary-related mechanical irritation may result in just the right mix of red blood cells and increased transidate to support odor-producing microbes. In the past, postmenopausal women have used pessaries and were often diagnosed and treated for bacterial vaginosis and given antimicrobials. However, more recent evidence suggests that pessary use does not change the vaginal microenvironment, suggesting that repeated courses of common bacterial vaginosis treatments are unlikely to be the solution to odor and discharge. Several related professional organizations, such as the North American Menopause Society, the American Congress of OBGYN, and the U.S. Endocrine Society have evidence-based position statements supporting the use of vaginal estrogen as the optimal treatment for genital atrophy when the goal is limiting systemic effect and exposure to progesterone. Vaginal estrogen has excellent absorption through the vaginal epithelium, bypasses the first-pass liver metabolism, and can have the lowest effect on serum estradiol levels. Women who refer to use compounded hormone products should be aware that these products are not regulated by the Federal Drug Administration and that they generally have not undergone rigorous clinical testing for safety, effectiveness, purity, or potency. ACOG supports the wisdom of consultation with a woman's oncologist prior to initiation of vaginal estrogen when the woman has a history of breast or genital cancer. Vaginal estrogens are probably the most likely to successfully control symptoms of vaginal atrophy and improve pessary tolerance in postmenopausal women with minor mechanical injury. However, many women still loathe to use estrogen products. These women might want to try a lubricant or moisturizer to improve their pessary comfort. In the Nurse Pessary Provider Survey, over 75% of providers reported prescribing vaginal estrogens to pessary users, with approximately 25% of them prescribing this treatment routinely to asymptomatic postmenopausal women based on their clinical observations. Since good quality evidence to support this is lacking, but still, two recent studies have attempted to better understand the effectiveness of vaginal estrogen use in preventing mechanical irritation from pessaries. And both of these noted that there was no decrease in mechanical injury in estrogen users. However, they both had serious limitations, especially in that women self-selected estrogen use. And both groups of authors agreed that adequately powered randomized control trials are necessary to better inform our practice. Meanwhile, vaginal estrogen is commonly used with alternate agents coming more often to the market. For instance, estrogen agonists and antagonists are currently being marketed. And there's a hope that they might be safer, effective, and affordable alternatives for treatment of vaginal atrophy at some point. Ospenafine is one of those newer agents. It's not yet clear, however, whether these options have a role in improving the risk of mechanical irritation with pessaries or that they will be safer for high-risk women, such as those who have a breast cancer history. Also, new agents currently cost more and may be prohibitively expensive for some women. Finally, when women using pessaries report irritation with or without vaginal discharge or odor, it's important to consider other potential contributing diagnoses, like irritation from de novo candidal infections promoted by vaginal estrogen use, contact or incontinence-associated dermatitis, or vulvar dermatoses like this lichen sclerosis, seen incidentally in an archival image of pessary removal. Some women will experience bleeding during the course of their pessary use. It could be from an abrasion, as with the removal and insertion through an atrophic introitus, or incidentally from an endometrial, vaginal, or cervical cancer, or from mechanical irritation from a correctly or a poorly fit pessary. This section will assume that other etiologies have been excluded and consider only chronic mechanical irritation of the vaginal epithelium. Images of pessaries in situ are often misleading. Artists' conceptions often show the pessary looking more like a cervical cap than like a full-length vaginal support. The radiographic images that we see show pessaries in situ, but they are often obtained on women who are supine or prone and then flipped 90 degrees for viewing. So the woman appears to be standing, but does not have the interabdominal pressure and gravity that would typically actually flatten the vaginal apex. So it's hard to know really where the pessary is likely to put the most pressure, making it even more important to look carefully for all the potential sources of reported bleeding. Erosions can be hidden deep in the cervical fornices or in the redundant vaginal folds seen in women with prolapse. It's also important to note that there is a body of knowledge about mucosal pressure ulcers that covers diverse disciplines. A mucosal pressure ulcer, like a cutaneous pressure ulcer, is caused by ischemia, but the mucosal ulcers are, by definition, caused by mechanical injury predominantly from medical devices like pessaries. They can't be staged like cutaneous ulcers as they are on moist surfaces and the depth is difficult to ascertain. Clots are often confused for slough, and there is no potential, of course, for exposure of muscle or bone. All of those are elements of staging cutaneous pressure ulcers. For this reason, mucosal pressure ulcers are typically described by location and size and the presence of friability or activity as well as description by unusual findings like discharge that's unusual or associated atypical, persistent, or raised lesions. Remember that the woman post-hysterectomy has a very thin apex. Often it can be as thin as 2 millimeters, so ulcerations don't have to be very deep to result in perforation. The first fine treatment for mucosal pressure ulcers is temporary removal of the pessary for a few weeks. The reason for the quotation marks on the easiest is that this is not always easy for the woman herself. Whether or not the pessary is removed, vaginal estrogen can be considered. The possibility of refitting or resizing the pessary at re-injection may be considered. The possibility of refitting or resizing the pessary at re-insertion can be considered, and then an application of vaginal estrogen at the apex at the time of insertion may provide a temporary cushion. We may be able to identify better options for care if we collaborate with our GI and dental colleagues who also have patients suffering from mucosal pressure ulcers. Hypergranulation tissue, on the other hand, is another type of mechanical injury seen with pessary use. This term is used to describe an abnormal buildup of epithelial membrane in response to mechanical injury, a buildup of non-functional, non-healing granulation tissue that is sometimes very friable. Another common example of this is seen in the friable granulation tissue that builds up around ostomies domas. This tissue may be slower to resolve spontaneously and may not resolve within the two to four weeks of temporary pessary removal typically sufficient for healing of mucosal pressure ulcers. Sometimes chemical cautery is used to promote timely resolution by removing the atypical granulation tissue. So for hypergranulation tissue, if it's friable and bleeding, the options are similar to the treatment for pressure ulcers, but with the added option of chemical cautery to remove the abnormal tissue and promote quicker healing. But this should be done very carefully, remembering the possibility of a very thin vaginal wall. When lesions are seen coincidentally in a surveillance visit, it may be difficult to identify visually what the lesion actually is, and a culture or biopsy may be indicated. Some pessary users may have a very patchless external cervical os with exposed columnar epithelium, which may be easily injured by pessary placement. But this is not a serious adverse event unless there is significant bleeding. However, cervical cytology should be up to date, of course, and endometrial evaluation is important if there is any question of the source of the bleeding. In addition, the stem of an abnormally rotated gellhorn pessary may enter into the patchless os of the cervix. So don't mistake this for perforation. Removal is typically possible in the office setting, and follow-up involves observation and refitting to find a pessary that will stay in place better. There are pessary users who suffer a great deal if their pessary has to be removed for two to four weeks. They may have extreme discomfort without their pessary, acute urine retention, worsening ulceration or an inability to do normal activities as their prolapse recurs. When women do have mechanical irritation from a pessary, it may be possible to relieve the ischemia produced by the pressure and still support the prolapse by using an alternate shape of pessary. For example, women with a gellhorn or ring pessary, which both rest in the posterior fornix, may be able to alternate to a cube pessary, which may be fit well into the mid-vagina. Of course, remember, it's important to be sure the ulceration or the hypergranulation tissue resolve and that biopsy is not required and that a malignant lesion is not ignored. Pessary placement can result in de novo symptoms as obviously pain or pressure can occur and women should know that this is not normal or something that they have to live with. In the first 24 hours post-fitting, someone would report a dull pressure or cramping and the surgeons are readjusting their position. But discomfort that keeps a woman awake should be reported. Interestingly, some providers have reported that their office has a policy to never fit pessaries in the late afternoon or on Fridays to avoid unnecessary emergency department visits. Pessaries can also cause de novo changes in bladder and bowel function. For example, we expect the pessary to support the anterior wall of a woman with a Cystocele, which can unkink the urethra to improve urine flow and bladder emptying. But this can also unmask occult stress incontinence. A paper towel test at the time of fitting can help identify this problem before the woman leaves from her fitting appointment. When occult stress incontinence is identified, refitting of a pessary with a urethral support knob can resolve the problem. The treatment of incontinence pessary users were satisfied with that treatment. A second study provided objective evidence of improved urethral resistance and an improved position with the incontinence pessary in place, but also a potential for urethral obstruction. Remember that it's important at any pessary fitting to confirm that the woman is able to retain the pessary when she's on the commode and also to empty her bladder. This is especially true when the person is trying an incontinence modification. If the incontinence knob does not resolve the de novo stress incontinence, but the woman is otherwise very happy with the support pessary, physical therapy may be helpful to her or she might want to consider the option of pessary use in the addition to a bulking agent or a midurethral sling. We often expect a woman's bladder will empty more effectively with a pessary in place, but as in this ring pessary user, if her distal anterior wall slips past the pessary, her urethral may actually be occluded, impeding emptying. Women with underlying marginal detrusor contractility may also have increased trouble emptying with pessary support. While we did not find evidence of a risk for UTI with pessary use. Anecdotally, pessary users appear to be at risk for unnecessary antibiotic use as they are often treated in emergency departments or primary care for positive urine dipstick testing, indicating white or red blood cells, but then later on culture showing vaginal contaminants. Many urogynecology providers report obtaining catheterized specimens for analysis when UTI is suspected to limit overexposure to antibiotics. In one small prospective study of women reported change in bowel function with pessary use, bowel symptoms tended to improve over a year of use, as did symptom related quality of life. However, some women do report increased trouble defecating with their pessary in place, and refitting of the upper shelf or changing to a different shape of pessary may be helpful. All pessary users should be counseled to avoid constipation and straining with defecation as much as possible with active management of diet and supplements as needed. Using the smallest effective pessary means that some women may need to digitally support the pessary with defecation, and discussing this option at fitting may help avoid spontaneous pessary expulsion. In addition, as with anterior slippage, the distal posterior vaginal wall is often below and poorly supported by the pessary. This distal rectocele may be asymptomatic, or if stool trapping does occur, it may be resolved by management of stool consistency, or the woman can empty the distal pouch digitally from the vaginal side of the rectovaginal septum. If the problem cannot be remedied by these simple treatments, the woman may want to reconsider a surgical option. So fistulae have been reported with all types of pessaries. In a systematic review published by Abdelaziz et al. in 2015, galehorn and shelf pessaries were most often implicated in both anterior and posterior fistulae, possibly due to the risk of the stem resulting in undue pressure if the pessary shifts position in vivo, although the edge of the flat shelf may also be a problem. The apparent culpability of the galehorn type pessary, however, is mitigated by the fact that they are most often used by higher risk women with more fragile, less supported tissue. Still, women or their caregivers should be educated to check that the tip of the stem of the pessary is palpable just inside the introitus, and that the thinner edge of the top shelf is not presenting. This image shows a full perforation of the posterior wall by a misaligned galehorn pessary in a woman referred to our Center for Surgical Treatment. When pessaries are forgotten or neglected and then cannot be removed in the office setting due to impaction, even if they have been in place for 30 years with no problems, it's generally advisable to remove them to avoid further risk of perforation. Options include re-estrogenation of the introitus and vagina to promote elasticity if the problem is not acute. This may take up to three months of treatment and observation. Otherwise, an exam under anesthesia is performed either to deconstruct the pessary in the vagina for removal or a surgical incision of the perineum must be done. But these techniques are beyond the scope of this webinar. So in summary, many women report their pessaries have dramatically changed their life for the better and go on to use a pessary happily for decades. Invented thousands of years ago, pessaries remain a low-risk, first-line treatment for prolapse and stress incontinence. But complications do occur and providers should understand options for management. In addition, despite this long history of use, there's much we don't know about optimal pessary care. And there are many areas of potential research and collaboration. For example, women often want to know if their pessaries prevent progression from prolapse, and we really don't know. Optimal management for prevention and management of alterations or hypergranulation have also not been identified. We don't know what role biofilms on pessaries may play in vaginal health, urinary symptoms, or adverse mechanical injury. And of course, there may be better pessary shapes and materials to avoid ischemia. These might also improve the removal and comfort with pessary use. So now briefly before we take any questions, we're going to go back to Colleen for a brief discussion of some of the issues that providers face when trying to build a pessary business model. Part three of our presentation discusses other considerations, pessaries and imaging, ordering and stocking pessaries, billing and coding. With regards to pessaries and MRI imaging, the pessary only needs to be removed if it contains a metal cord. This would include the lever pessaries, such as the Hodge, Reiser, and Smith, the Gay-Rung pessary, the Gay-Rung with knob, the Regula, the inflatable due to its metal valve, and incontinence ring. I also learned in preparation for this webinar that the ring with support in the large sizes, sizes 11 through 13, also have a metal cord in them. In terms of pessary and colonoscopy, in most cases the pessary can be left in place. The patient should contact their GI or colorectal specialist for confirmation. If the specialist requires that the pessary be removed before colonoscopy, an appointment can be scheduled in your office to do so and replaced afterwards. Patients often ask if their pessary will set off the metal detector at the airport. Manufacturers state that the pessary does not have enough metal in to set off the metal detector. However, with the onset of the use of body imaging scanners at the airport, the pessary may be visible. I suggest providing the patient with a wallet size card for travel, which provides written confirmation that there is a vaginal device in place with your business card stapled to it. I have not had the experience of having any of my patients stopped by the TSA agents after being through the body scanner, and I suggest that my patients don't offer that they have a vaginal device unless asked. In terms of the business of pessary management, there are two manufacturers that make pessaries. Hooper Surgical, which manufactures and distributes Mylex pessaries, which are also known as the pink ones, and the Pantech Corporation, which is distributed by many distributors in the United States, and these are known as the white ones. This picture shows some well-coordinated stocking and inventory systems that could be used in large and small offices. If you have a large-volume ordering office, you may be able to negotiate fitting kits without charge by your local representative, and these are the options from the different companies. Pessary ordering and stocking I would contact your local representative and negotiate the best pricing based on volume. You can check the manufacturer's website for listing of the most commonly used pessaries so that you keep these sizes in stock. Most will indicate which pessaries will fit about 85 percent of the women, and you should develop an inventory system or a just-in-time purchasing system to keep pessaries stocked in your office or offices with your office manager or purchasing agent. You don't want to keep too much inventory in your office, but you want to have all necessary sizes ready to go. In terms of pessary coding and billing, pessary fitting is a procedure code and should not be combined with an E&M office visit code. Cost of the pessary is bundled into the pessary fitting procedure code in my region. This may be different in different parts of the country. Follow-up visits are billed as an E&M visit based on level of service or time spent with the patient. There are ICD-10 codes for the different types of prolapse or incontinence that you may be using a pessary for, and there are also codes for vaginal erosion secondary to pessary use, atrophic vaginitis, granulation tissues, and others that you may want to use to characterize patient condition. In my region, vaginal irrigation can only be billed if there is documentation of vaginal infection by WETPREP. In my region, some insurance carriers would reject the pessary fitting code when it is just associated with an incontinence ICD-10 code and not a prolapse code also. Some colleagues report that they can only use a pessary fitting code once per year. I have not found this to be an issue in my region, and I bill for a pessary fitting procedure code each time pessary fitting is needed. In terms of pessary coding and billing, pessary fitting is a procedure code and should not be combined with an E&M office visit code. Cost of the pessary is bundled into the pessary fitting procedure code in my region. This may differ in different parts of the country. Follow-up visits are billed as E&M visits based on level of service or time spent with the patient. There are ICD-10 codes for each of the different types of prolapse as well as incontinence and additional codes for vaginal erosion secondary to pessary use, atrophic vaginitis, granulation tissue of the vagina, and others that may be used to characterize patient condition noted during office visit. In my region, vaginal irrigation can only be billed if there is documentation of vaginal infection via wet prep. In my region, some insurance carriers reject the pessary fitting code when it is just associated with an incontinence ICD-10 code and not also a prolapse code. Some colleagues report that they can only use a pessary fitting code once per year. I have not found this to be an issue in my region and I bill for pessary fitting each time refitting is needed. In conclusion, we want to thank AUGS for providing this forum for discussion between new and experienced pessary providers to help us improve our current practice and build future collaborations for research. Before opening it up for questions, I just want to mention that the advanced practice SIG does keep a list of pessary mentors around the country, so if there are new providers that would like to work with someone or have someone to consult with as they're learning pessary fitting and management, this could be available through that SIG. Now we'll open things up for questions. We are a little bit over right now, so if anybody has any questions, I would go ahead and you can type them into the Q&A box now. I do want to thank both Colleen Mellon and Catherine Odell for putting together that great presentation. As always, we learn so much and I think a lot of practical tips were gained from today's presentation. If I don't see any questions, since we are over time, I'm going to go ahead and wrap it up. In addition to Colleen and Kate, I also wanted to thank our participants also for carving out time in your day to participate in this virtual forum with our speaker and with each other. Again, upon completion of this program, you will be prompted to provide feedback, so please do share your thoughts and impressions with us, and also be on the lookout for the exact day and time for November's session, as that's still being arranged. And also, from one of our participants, no questions, but wanted to just thank you all for the presentation. I think this was really helpful, and I want everybody to remember, too, that this will be archived on the AUG's website, so if anybody wants to go back and look at certain parts of it again or get some of the references, you can look for it on the AUG's site as well, and it'll live there for eternity. So thanks again to everybody, and have a good evening.

virtual forum

Pessary Fitting

Follow-up

Complications

vaginal prolapse

urinary incontinence

pessary types

maintenance

evidence-based management

healthcare providers