Vol. 12 •Issue 10 • Page 47
The Vaginal Pessary
An Effective Yet Underused Tool for Incontinence and Prolapse
The baby boomers are aging and sagging. As a result, stress incontinence is becoming more prevalent in this age group. Stress incontinence is the involuntary loss of urine at inappropriate times. Simply put, it occurs when pressure in the bladder exceeds the intraurethral pressure necessary to retain urine. A major cause of stress incontinence is the loss of anatomic support for the urethra, bladder and urethrovesical junction. This loss of support allows displacement of the urethrovesicular junction and, as intra-abdominal pressures increase during physical activities, urine loss occurs.
Although surgery is an option, many women are interested in a more conservative approach to the management of pelvic floor and bladder dysfunction. Use of the vaginal support pessary offers such an alternative, but it is often overlooked because of patient and provider discomfort with its application. Pessaries can be extremely effective at restoring continence. They stabilize the urethra and urethrovesical junction to allow proper pressure transmission, which increases urethral resistance and helps overcome the forces of abdominal pressure.1
Background
Pessary use is not widespread for two reasons: Women are reluctant to use a pessary because they are not familiar with it, and providers are reluctant to recommend a pessary because they don’t know how to fit it properly. Table 1 outlines other common deterrents.
Pessary fitting is more art than science. It requires technical skill, and although education and background information are certainly needed, proficient management requires hands-on practice. Beginning learners may have to persevere through some fumbling inefficiencies to complete the learning curve, but it is short-lived. The process involves trial and error on the part of both patient and provider. You are already equipped with some beginning skills if you know how to fit a diaphragm. The same principles can be applied to fitting pessaries.
History
The vaginal pessary was first used thousands of years ago as a treatment for pelvic prolapse.2 Figure 1 shows examples of early versions of the device. Cleopatra is believed to have been treated for prolapse with the vaginal application of a ball soaked in an astringent. Other treatments for prolapse involved even more fascinating approaches. The simplest is probably the use of the pomegranate as a pessary, while a more bizarre strategy is the suspension of a woman by her feet so that she could be shaken until the bladder returned to its proper position. Fortunately, the use of vaginal pessaries has been refined in the last century. Today’s pessaries allow easier insertion and removal with greater efficacy, all of which make them more acceptable to providers and patients.
Role of the Modern Pessary
Today’s pessary has many applications. It can be used as a temporary measure for relief of symptoms while a patient delays urologic surgery until a more opportune time, or until she decides whether to have surgery at all. It can also be used as a permanent alternative to surgery, particularly in elderly women who want to avoid surgical risks. The proper management of a pessary is less expensive and safer than its surgical alternative.
The pessary can also be used as a diagnostic aid to predict which patients will be helped by surgical correction. If realignment of the pelvic organs to the normal anatomical position provides relief of symptoms, there is an increased likelihood that surgical correction will be successful.3 Additionally, use of a pessary may uncover a hidden incontinence problem that would require further urethrovesical neck suspension as part of the surgical treatment. It may be that prolapse had provided continence because the abnormal angle of the bladder neck (resulting from the prolapse) caused a kink that obstructed the urethra.
The pessary also has expanding uses in obstetrics. For example, it resolves an incompetent cervix by relieving pressure on the cervix and repositioning the weight of the growing fetus a strategy that can help prevent miscarriage. It may also help hasten postpartum involution and retroversion.
Physiologic Considerations
The pelvic floor is comprised of two muscle groups, the levator ani and the ischiococcygeous. The levator group is made up of the puborectalis, pubococcygeus and iliococcygeus. These muscles form the “sling” that supports the pelvic floor. They play a critical role in maintaining both urinary and fecal continence and stabilize the joints of the pelvis. The pessary supports these muscle groups and places pelvic organs in close alignment to their proper anatomic position. It also helps patients who are undergoing pelvic floor rehabilitation by repositioning pelvic structures to enhance muscle strengthening. The goal is to promote continence by stabilizing the bladder base.
Stress incontinence is often associated with a cystocele, which occurs when the tissues between the bladder and vagina weaken, leading to herniation of the bladder. This herniation causes a bulge in the anterior vaginal wall. If the cystocele descends into the vaginal space, the bladder may have to empty uphill, causing urinary retention and urgency. Overactive bladder may occur. Atrophism causes further thinning of the vaginal wall separating the bladder anteriorly and the rectum posteriorly, weakening the support even more. Pessaries work well in the treatment of urinary incontinence by compressing the urethra against the upper posterior portion of the symphasis pubis, elevating and stabilizing the bladder neck. This increases outflow resistance and may correct the angle between the bladder and the urethra.
Pessary Features
The pessary is an FDA-approved medical device that is inserted into the vagina to treat a variety of urogynecologic conditions. Most pessaries are made of a non-toxic, medical-grade silicone. The silicone is pliable, making the pessary comfortable to wear. Pessaries do not absorb vaginal secretions or odors. They are biologically inert, rarely causing allergic reactions. Pessaries used for fitting purposes can be autoclaved, boiled or soaked in Cidex. The pessary is safe and is not associated with an increased risk of cancer.
Pessaries are available in many sizes and shapes, and are designed to support various anatomical defects (Figure 2). The pessary’s outside diameter is measured in inches, with a range from 1 inch to 4 inches. At least three companies manufacture pessaries: Bioteque, Mentor and Milex. You can order the devices from each company’s sales representatives or Web site (www.bioteque.com, www.milexproducts.com, www.mentorcorp.com). Pessaries typically include instructional sheets with recommendations for use and fitting instructions for each specific pessary. Table 2 outlines indications for selection.
Selection
When selecting a pessary, you may be overwhelmed by the choices in size and style and wonder which to choose for which condition. Each woman’s anatomy is unique. For some, the initial fitting may be accomplished in one visit with excellent control of symptoms and comfort. In other cases, such as when laxity is more pronounced, a series of visits may be required. As stated earlier, there certainly is a learning curve, but it does get easier with experience. Even after 15 years of fitting pessaries, I often have to try three or four before determining the best fit for a patient.
Selection of the proper pessary mainly depends on the patient’s comfort level as well as the pessary’s ability to correct the diagnosed problem. Pessary fitting is unique in that its selection is also influenced by the provider’s ability to insert a certain pessary and the patient’s comfort in accepting it. Many providers become adept at fitting a certain kind of pessary and tend to use it frequently to treat a variety of conditions. This seems to work well. Pessaries that are difficult to insert and remove are less likely to be used. An exception is the Gellhorn, which works well and is used often but is difficult to remove. While a manufacturer may recommend a certain pessary for a particular condition, many pessaries are appropriate for a variety of conditions.
It is not necessary to have a full supply of potential pessaries, but you should have a representative selection readily available in your office. My advice is to have three or four sizes of three to four of the most commonly used pessaries (Table 3). If the majority of your population is older, you might consider sizes 0 through 3; if they tend to be younger, sizes 3 through 6 might be more useful.
A pessary known as the ring is an excellent choice for the treatment of urinary incontinence and is available as a simple ring or as a ring with a knob (shown in Figure 2). The knob exerts direct pressure on the urethra, pushing it against the pubic bone, stabilizing the bladder neck and decreasing incontinence. It is also available with a support membrane, which is beneficial for supporting a mild cystocele. I do not have much experience with the Marland, but it has the potential to work well in supporting the bladder neck and is easy to insert and remove. The patient is often able to care for it herself. For the inexperienced provider, both the Marland and the ring can be fit in a similar manner to the vaginal diaphragm, so they are less intimidating to use in your first fittings.
Considerations
Sexual activity is an important consideration when using the pessary. Ask about the woman’s sexual relationships — never assume that she is not sexually active simply because she is older. Coitus is possible with many pessaries that are not vaginally occlusive. For example, intercourse is not possible with the Gellhorn or donut, but the ring is fine. To use an occlusive pessary, the woman must have the dexterity to remove and reinsert the pessary for intercourse.
Another important consideration is the future gynecologic care a woman will be receiving. For example, she may have an upcoming routine physical exam with her primary care provider, who may be unfamiliar with pessary removal and reinsertion. A pessary needs to be removed prior to a Pap smear but can stay in place for a colonoscopy.
General Fitting Principles
The goals of pessary fitting are to achieve proper fit and correct the incontinence problem while avoiding patient discomfort.4 Pessaries are generally fit by trial and error. Fittings may require many attempts with pessaries of different sizes and shapes. Do not let this deter you! It is part of the normal fitting process. As you try the different pessaries, note and record the various pessaries used so you have an accurate record of which ones didn’t work. Pessaries used during the fitting process can be resterilized and reused.
Inform each patient that the fitting process may take a while and that three to four pessaries may be tried before the proper fit is achieved. Do not attempt to fit any more than four during a single session. Bring in a box of the pessaries you would like to try first. It is disrupting to have to repeatedly leave the room in search of the correct pessary. Always show the patient the pessary before you insert it. Have her hold it and bend it to feel its size, shape and consistency.
The patient should arrive with her rectum as empty as possible. Nothing interferes with the fitting of the pessary more than a rectum that is full of stool. She should also empty her bladder immediately prior to insertion. If she has a cystocele and does not completely empty her bladder, perform a straight catheterization to drain any residual. Prior to insertion, reduce any prolapse.
Once the patient has an empty bladder, perform a bimanual exam to rule out any pathology and to assess the size and shape of the vaginal vault and the position of the uterus, if present. Perform a wet mount since a pessary is contraindicated in the presence of an active vaginal or cervical infection.
Next, approximate size by using your fingers to measure the vaginal opening (Figure 3). It is interesting to note that the widest diameter of the vaginal opening is neither parallel nor perpendicular, but rather oblique. The opening may seem quite small, but remember that the vaginal tissue is compliant and can stretch larger than its measured distance. The exception is the woman who has vaginal atrophism; her vaginal tissue may tear and bleed when stretched.
It is impossible to describe each device and its particular characteristics for fitting within a single article. Since the ring pessary with or without knob or support is the most common initial choice for stress incontinence, I will use this device as an example for the insertion process. The ring with support has two large holes and two smaller holes for the drainage of any vaginal secretions and menses. The size is written on the rim. Next to the larger holes are two indentations on the inner aspect of the ring. This is the point where the pessary flexes in half for insertion.
The fitting process is not typically uncomfortable. I sometimes mix equal parts of K-Y Jelly and xylocaine 2% gel and spread it around the vaginal introitus prior to a fitting session. The patient may be tense, since the concept of pessary use is foreign to her and she is not quite sure what to expect. The vagina is a pouch, so it is not possible to push it into a place where it does not belong. Most women tolerate the process very well. Lubricate the vaginal opening for ease of insertion using your non-dominant hand. The leading edge of the pessary may also be lubricated. Avoid getting lubricant on the hand holding the pessary or it will be difficult to fold and insert because it will be slippery.
A properly fitting pessary should take up redundant vaginal tissue, forming a sling that will support and elevate the uterus and flatten and support a cystocele.
Try to use the smallest pessary that can control the incontinence or reduce the prolapse, so that it can be easily removed and reinserted.5 Achieving the easiest possible removal is worth the risk of having a few pessaries fall out in the beginning. Unfortunately, the smaller pessaries tend to be the easiest expelled.
For insertion, separate the labia minor at the posterior introitus and the leading edge of the pessary. With the folded concavity facing downward, insert the pessary by curving it posteriorly (Figure 4). Once inside the vagina, release the ring and the pessary springs open. Make a quarter turn to secure its position, rotating the hinge of the pessary away from the introitus so it is less likely to fall out. When the ring pessary is in proper position, it should be parallel to the vaginal axis. The pubic bone is an important landmark. Push the pessary deep into the vagina and tuck it behind the pubic bone. The pessary should fit snugly behind it. The cervix can also act as an anchor, but many women with stress incontinence have had a hysterectomy. If a cervix is present, tuck the pessary in the posterior fornix below the cervix.
You should be able to sweep your fingers around the edge of the pessary, as with a diaphragm. This helps ensure that the pessary is not pressing too tightly against the vaginal epithelium, potentially causing erosions and ulcerations. It should also be possible to easily slide the ring of the pessary up and down along the vaginal sidewall. If the ring is properly placed, it will take up redundant vaginal tissue, forming a sling that will then support and elevate the cystocele.6 The pessary should always be comfortable. In fact, the woman should not feel the pessary at all.
Once the pessary is inserted, perform a series of checks and balances to assess proper fit. Separate the labia and ask the woman to bear down. Inform her that many women normally pass gas during this exercise, so that she will not be embarrassed by it. As she bears down, observe the introitus for any sign of the white pessary. A well-supported pessary should not be visible. A slight descent may occur, but it should retract back up into position when she has stopped pushing. If the pessary descends to the introitus and stays or slips out, try a larger ring pessary or a different shape. Also observe for the bulge of a cystocele or rectocele around the pessary. Next, have the woman stand in front of you and spread her legs. Have her hold onto your shoulders for stability. (This position may feel awkward for her.) Once again, feel inside the vagina as she bears down, noting any descent of the pessary.
If the pessary remains tucked comfortably inside the vagina, instruct her to walk around the room and sit down a couple of times. Ask whether she feels any pressure or discomfort from the pessary as she performs these maneuvers. Differentiate between true discomfort or pressure and the expected vaginal tenderness from the fitting process, particularly if three or four different sized have been tried.
Re-examine the woman one more time in the lithotomy position to ascertain whether the pessary has slipped or rotated its position. If not, you are on your way to a proper fit! Initial fitting is considered a success if the patient does not feel the pessary coming down and the examination confirms that it is comfortably staying in position.
Although these post-fitting maneuvers sound complicated and time consuming, they are well worth it. They require only a few minutes and can save the woman a trip from the parking lot back to the office with pessary in hand. In rare cases, the pessary may put too much pressure on the urethra, making urination impossible. It is a good idea to have the woman urinate before she leaves the office. This is not always possible, however. Some providers send the woman out shopping for an hour or so and have her return to be checked again, but this is probably not necessary. I have requested it on occasion when I was not quite sure of the fit. The biggest test of all is how well the pessary remains in place during straining at stool when the patient returns home.
Instruct the patient to call you if the pessary is uncomfortable or if urination or defecation is difficult. Sometimes a pessary that is too large can exert too much pressure against the urethra. Defecation may also be affected. The patient may feel some lower back pain from the pessary. Since the rectum is only separated from the vagina by a few millimeters of tissue, the pessary can potentially exert rectal pressure, particularly with a large amount of stool in the rectum.
First Return Visit
The woman should return for a pessary check 1 to 3 days after a fitting. One day is best if you are unsure about the fit. At 3 days, any tenderness from the insertion process will have been resolved and any potential discomfort from the pessary will not be confused with it. It also takes a few days for the vaginal tissues to “settle in” around the pessary. Advise patients not to worry if the pessary falls out. It most typically falls out while a woman is sitting on the toilet. The patient should retrieve it, wash it with soap and water, place it in a plastic bag and return with it to the office. It is important to ask about any discomfort or problem with elimination. If a woman complains of this, remove the pessary and perform a speculum examination to observe for any local tissue reaction such as discharge, irritation or ulceration.
Estrogen Status
Assessment of estrogen status and treatment of vaginal atrophism are vital when a woman has a pessary. I perform a maturation index prior to insertion and repeat it every 2 months to assess response to vaginal estrogen. Most older women with a pessary need vaginal estrogen to maintain mucosal integrity. I usually show them the applicators for Premarin cream and the tablet Vagifem. The cream works best with severe atrophism, since the pill needs moisture to absorb and the applicator may be difficult to insert in a dry vagina. A good choice, particularly for elderly women, is the Estring. It remains in for 3 months, just like the pessary. I insert the ring first and tuck the pessary in right after.
Self-Care
Once inserted, the pessary needs to be maintained. When possible, encourage women to care for their own pessaries. A younger woman is more apt to assume this responsibility, particularly if she has prior experience with using a diaphragm. The elderly are more inclined to turn the care over to a provider. They often have little experience in inserting objects into their vagina, and most have never even used a tampon. Dexterity can be an issue since many older women have arthritis in their hands. These women are willing to return every 2 to 3 months. The cleaning schedule should be based on personal preference and the response of vaginal tissue to the presence of the pessary.
Table 4 lists some complications associated with pessary use. These are usually minor. Sometimes the pessary slips down toward the vaginal opening during a particularly hard bowel movement and the patient feels that the device has moved. If displacement occurs, she should lie flat in bed with one leg elevated and tuck the pessary deep behind her pubic bone. Most women are able to do this.
After the first return visit, a patient should return every 8 to 12 weeks. Although the pessary is non-toxic, vaginal tissues have varying responses to the presence of the pessary. Pessaries tend to trap vaginal secretions and obstruct their normal discharge. These accumulated secretions can break down and cause odor. There may be a slight increase in vaginal discharge, which is usually creamy in color. This is normal. If the discharge has any color, perform a wet mount of the secretions. Collect a vaginal culture if there is a strong odor or copious discharge. It is interesting to note that some women with a pessary have only a little discharge while other women have increased discharge, even with proper care. In the latter case, recommend cleaning at more frequent intervals.
Removal
Pessaries must be diligently maintained and removed every 2 to 3 months. Most pessaries can be collapsed and halved to facilitate insertion, but removal is more challenging. It is difficult to fold the pessary in half to remove it because it is within the small confines of the vagina. The normal discharge within the vagina also makes the pessary slippery and difficult to grasp. In some instances, the pessary simply has to be pulled out. I inform the woman of the need for this technique, which can feel abrupt. It can be accomplished in a second or two.
A wonderful device is the pessary remover (Figure 5), which has greatly enhanced the removal process. I sometimes wonder how I ever got along without it! For pessaries with a hole in the support, such as the ring or the plain ring, slide the instrument through the hole or rim, rotate it using the non-dominant hand, and quickly slip it through the introitus with the application of traction.
If you do not have a pessary remover, insert the index fingers of both hands into the vagina and grasp the leading edge of the pessary. Apply traction toward the vaginal opening as you rotate it perpendicular to the introitus. Once visible at the introitus, release the non-dominant hand, grasp the rim between the thumb and forefinger of the dominant hand and pull the pessary out. Sometimes a slight tearing of the delicate vaginal tissue may occur. Bleeding usually stops within a few minutes with the application of pressure.
At each visit, remove the pessary for cleaning and inspect the vagina. This is important since there are limited nerve endings in the vagina and the patient may not be able to sense the presence of any ulcerations or irritation. A slight discoloration of the pessary may occur, but if it is still intact, it can be cleaned and reinserted
Once you have removed the pessary and inspected the vagina, irrigate and cleanse the vagina with a mild solution of betadine or hydrogen peroxide. Insert a lubricated 20-cc syringe into the vagina (10 cc for a small introitus) and irrigate until clear (usually 40 cc to 60 cc). Be sure to document the type and amount of solution used.
Clean the pessary in soap and water and reinsert it. You may need to switch to a larger size since the vagina may stretch with the pessary in place. If a larger-sized ring is not effective, try a different type. A Gellhorn with drainage holes is often a good second choice.
Advise patients to call you if they experience any vaginal bleeding. It is imperative to carefully assess the source, since pessary placement may interfere with signs of endometrial hyperplasia. The pessary may irritate the friable atrophic vagina. If erosion or abrasions to the vaginal epithelium occur, remove the pessary for 1 to 2 weeks and allow the area to heal. Schedule a follow-up visit for 1 to 3 months later.
Most women are very satisfied with their pessaries and experience no complications that would deter them. Still, some women decided to discontinue using a pessary. The most common reasons are listed in Table 5.
A Precautionary Note
It is imperative that you maintain a list of all of your patients with pessaries, along with a schedule for their follow-up care. Since many women with pessaries are elderly, their physical or mental status may change suddenly. A woman may have a stroke or require hospitalization. The staff there may have no idea that she has a pessary in place. A forgotten pessary can be dangerous if it isn’t cleaned for a long time.7 It can erode into the bladder or become impacted in the vagina. A pessary should not be used in a woman who is unable to care for herself. If a patient has a condition such as Alzheimer’s disease, her caregivers need to know that the pessary is in place and follow the requirements for maintenance.
Reimbursement
Pessaries are now directly reimbursed by Medicare, which pays between $44 and $53 for each. The actual fitting procedure (CPT code 57160) is reimbursed at an average of $59 for the session. If a lot of time is spent at the fitting session, a level II visit (99213 to 99215 for an established patient, or 99293 to 99295 for a new patient) can be billed based on time and counseling. The follow-up visits can be billed as a level 99213 or 99214, depending on the complexity of the visit. If vaginal irrigation is performed, it can be billed as 57150 but cannot be billed along with an E and M visit unless there is a separate diagnosis and modifier 25 is used. When assessment of vaginal atrophism is performed, a level II visit (usually 99213) can be added to the procedure code, again with the separate diagnosis of vaginal atrophism and use of modifier 25.
The Test of Time
Many baby boomers are entering their postmenopausal years, a time when problems of pelvic support and urinary incontinence are more likely to occur. The vaginal pessary offers women an excellent choice as a short-term adjunct while deciding about surgery, as a diagnostic modality to decide on the type and effectiveness of surgery, or as a long-term solution to urinary incontinence without surgery. The pessary offers women a chance to lead normal lives unencumbered by the burden of incontinence.
References
1. Deger RB, Menzin AW, Mikuta JJ. The vaginal pessary: past and present. Postgraduate Obstetrics & Gynecology. 1993;13(18):1125-1129.
2. Emge LA, Durfee RB. Pelvic organ prolapse: four thousand years of treatment. Clin Obstet Gynecol. 1966;9:997.
3. Bergman A, Bhatia NN. The pessary test in women with urinary incontinence. Obstet Gynecol. 1985;65:220.
4. Sulak PJ, Kuehl TJ, Shull BL. Vaginal pessaries and their use in pelvic relaxation. Journal of Reproductive Medicine. 1993;38:12.
5. Vierea A, Larkins-Pettigrew M. Practical use of the pessary. Am Fam Physician. 2000;61:2719.
6. Miller DS. Contemporary use of the pessary. In: Sciarra JJ, Droegemueller W, eds. Gynecology and Obstetrics. Philadelphia, Pa.: J.B. Lippincott; 1992:1-12.
7. Wu V, Farrell SA, Baskett TF, et al. A simplified protocol for pessary management. Obstet Gynecol. 1997;90:992.
Helen Carcio is a women’s health nurse practitioner at Pioneer Women’s Health in Greenfield, Mass., where she specializes in the treatment of incontinence, infertility, vulvovaginitis and menopause. She created and operates two continence treatment centers, one at Pioneer Women’s Health and another at Grace Urological in Brattleboro, Vt. Carcio, who is a member of the ADVANCE for Nurse Practitioners editorial advisory board, is also an adjunct graduate nursing professor at the University of Massachusetts and is nearing completion of her PhD.
