POP (Pelvic Organ Prolapse) includes cystocele (or dropped bladder), rectocele (or dropped rectum), uterine prolapse (or dropped uterus) or enterocele.
The symptoms consist of a bulging in the vagina, or the sense that something in the vagina is lower than it was before. Sometimes it can present with the sensation of incomplete emptying of the bladder or bowels.
Why does this occur?
The reasons are multi-factorial and likely include: childbirth, hormonal status, body mass index and anything that increases intra-abdominal pressure (e.g. straining with chronic constipation, chronic cough or bronchitis, COPD, frequent vomiting, heavy lifting) and a lifetime of high impact activities (running, jumping or dancing) often it is during vigorous activities that a bulging sensation is appreciated (for example bump skiing, trampoline). Most commonly a women will first notice POP in the bathroom during a constipated bowel movement (because staining pushes the prolapse out) or when wiping after urinating. Even after prolapse is successfully treated, the continuation of any of these activities or factors after an attempted surgical repair may contribute surgical failure. There is also some evidence that there may be genetic component to pelvic prolapse, and it stands to reason that strength of supportive tissues, like ligaments, may be inheritable.
ALWAYS TRY THE NON-SURGICAL OPTION FIRST
The best first option for pelvic organ prolapse (that is too bothersome to live with conservatively) is to try a pessary. A pessary, very much like a diaphram is a rubber device that, when it fits right is easily placed in the vagina to hold up the prolapse. Some patients with early prolapse may choose to put in themselves before going tot he gym, or if they know they will be on their feet all day. Alternatively – if the pessary fits well, you may not even know it is in the vagina because it is usually comfortable and often cannot even be felt. That are many different pessaries each with many different sizes. Finding the right one is a lost art in gynecology. A pessary may be left in the vagina for up to 4-5 months without requiring removal and cleaning. Some patients are more comfortable having their gynecologist remove and clean the pessary to that the vaginal walls can be inspected. Monitoring by your gynecologist to ensure that there is not vaginal irritation or erosion being caused by the pessary is prudent.
At the right is displayed the wide variety of pessary shapes and styles
On the left is how the pessary fits in the vagina and how it hilds up dropped pelvic organs
Though the pessary is not for everybody – when it works, it is as good or better than any surgery - including the gold standard surgery the sacrocolpopexy.
Vaginal pessary treatment of prolapse and incontinence
Author
Jeffrey L Clemons, MD, LTC, FACOG
Section Editor
Linda Brubaker, MD, FACS, FACOG
Deputy Editor
Sandy J Falk, MD
Last literature review version 18.3: September 2010 |This topic last updated: May 28, 2010
INTRODUCTION — Pelvic organ prolapse (POP) and stress urinary incontinence (SUI) are common conditions, with prevalence rates of 25 to 65 and 20 to 55 percent, respectively [1-6]. Surgical repair is one approach to treatment: approximately 200,000 women undergo surgery for POP and 135,000 women undergo surgery for SUI annually in the United States [7,8], and approximately 11 percent of women undergo surgery for POP or SUI by age 80; 30 percent of these women will have repeat surgery because of persistent or recurrent symptoms [9]. (See “An overview of the epidemiology, risk factors, clinical manifestations, and management of pelvic organ prolapse in women” and “Treatment of urinary incontinence”.)
Vaginal pessaries are an alternative treatment option for women with these conditions.
INDICATIONS — A pessary trial can be offered to all women with POP or SUI, regardless of patient characteristics. Clinical settings where pessary use should be considered include:
Patient preference for nonsurgical treatment.
Presence of severe medical comorbidities that make the patient a poor surgical candidate.
Need to delay surgery for several weeks or months.
Recurrent POP or SUI and patient preference for avoidance of repeat surgery. However, prior prolapse surgery and prior hysterectomy are risk factors for failure to fit a pessary (see ‘Risk factors for an inability to fit a pessary’ below).
Vaginal ulcerations caused by severe POP. Reduction of POP through use of a pessary and application of vaginal estrogen cream both promote healing of the ulcers within three to six weeks, which is useful prior to surgical repair.
Current pregnancy, to manage POP and cervical insufficiency.
Desire for future childbearing. The benefit of surgical repair of POP may be nullified by subsequent pregnancy and childbirth.
PATIENT ACCEPTANCE — Patient acceptance of pessaries varies from 42 to 100 percent [10-12], and is related to appropriate counseling and encouragement from the provider. Patients who decline a pessary trial are more likely to be nulliparous [11], younger [12], or have severe prolapse and incontinence [12]. This was illustrated in a study of treatment choices among women with POP that found older women were more likely than younger women to choose a pessary, whereas women with prior prolapse surgery and more severe prolapse were more likely to choose surgical treatment [13].
CONTRAINDICATIONS — Contraindications to pessary use are rarely encountered. Potential contraindications include:
Local infection — Active infections of the vagina or pelvis, such as vaginitis or pelvic inflammatory disease, preclude the use of a pessary until the infection has been resolved.
Latex sensitivity — The Inflatoball pessary is made of latex; therefore, it is contraindicated in women with latex allergies. The other pessaries discussed below are nonallergenic.
Noncompliance — Noncompliance with follow-up could be harmful since an undetected and untreated erosion could put the patient at risk of developing a fistula.
Sexually active women who are unable to remove and reinsert the pessary — Inability to manage the pessary around coital activity could be discouraging.
TYPES OF PESSARIES — Pessaries come in several different shapes and sizes (picture 1). Most are made of silicone, which is nonallergenic, durable, autoclavable, and does not retain odors. A few are made of other materials, such as latex or polycarbonate. Pessaries are available from: Milex™, Cooper Surgical, Trumbull, CT; Bioteque America, Inc, Langhorne, PA; Artisan Medical, Medford, NJ; and Marina Medical, Sunrise, FL. There are also a few incontinence pessaries, designed specifically for the treatment of SUI.
Support versus space filling pessaries — Pessaries can be classified into essentially two categories: support and space-filling. The support pessary is used to treat all stages of POP and SUI, whereas the space-filling pessary is mostly used for severe POP. Both types are held in place proximally by the uterus (or the vaginal apex following hysterectomy), laterally by the levator muscles, and distally by the pubic bone and the vaginal introitus. Space-filling pessaries and larger size pessaries are often needed for severe prolapse (stage III or IV), as vaginal capacity can increase significantly as a result of levator atrophy and an enlarged vaginal introitus can allow a support pessary to rotate and be expelled.
Surveys of gynecologists [14] and urogynecologists [15] showed that the ring pessary (support type pessary) was the most commonly used pessary. A prospective observational study reported that most women with stage II and III prolapse (100 and 71 percent, respectively) were successfully fitted with ring pessaries, whereas women with stage IV prolapse usually required a Gellhorn pessary (space-filling pessary) (64 percent) [10]. A randomized crossover trial compared the ‘ring with support’ to Gellhorn pessary in women with stage II-IV prolapse and showed significant improvement in prolapse, urinary, and rectal symptoms with both, and no difference in symptom response between pessaries [16].
I suggest initial use of a support pessary, rather than a space-filling pessary, because support pessaries are:
More easily removed and inserted by the patient
Allow intercourse while in place
Are often more comfortable.
I routinely use the ‘ring with support’ or Gellhorn pessary, as most women with prolapse can be managed with ring sizes 3, 4, and 5 and Gellhorn sizes 2.5, 2.75, and 3 inches [10], and, as discussed above, they are equally effective for the treatment of prolapse [16].
In unusual cases of prolapse, a double pessary may be used [17,18].
Support pessaries — Support pessaries are essentially two-dimensional, and sit in the long axis of the vagina. Types of support pessaries include the ring (with or without a support diaphragm), the lever, the Gehrung, the Shaatz, and the incontinence ring or dish pessaries. Most women can remove and reinsert support pessaries. Sexual intercourse is still possible when they are left in place.
Ring pessaries are the only support pessaries that I use, as use of only one type of support pessary is practical and the lever, Gehrung, and Shaatz pessaries have minimal added benefit.
Ring pessaries — The ring pessary, as in Letters F, G and L in the picture (picture 1), will fit 70 percent of women. It is the most commonly used pessary, as it can treat all stages of POP, as well as SUI [10,14,15]. Additionally, it is comfortable, easily removed and inserted by the patient, and sexual intercourse is possible when left in place. A string may be attached to the ring to aid in removal; this string should be tucked into the vagina to avoid soiling with urine and feces. However, the ring can usually be removed easily without a string.
The ‘ring with support’ pessary has a thin diaphragm across the ring, and is especially useful for women with uterine prolapse and/or cystocele, but may also be used to treat rectocele and vaginal vault prolapse. Although the ring pessary is available in sizes 0 to 9, most women can be managed with sizes 3, 4, and 5 [10].
The ring pessary is inserted by folding it in half like a taco, and then inserting it with the curved side up (figure 1). The ring will then open to its circular shape. The lower rim of the pessary should rest behind the pubic symphysis (figure 2). The ring should then be turned one-quarter turn, so that it will not easily fold onto itself and be expelled.
The ‘ring without support’ pessary is useful in younger women, as they have less atrophy of the levator muscles, and a more oval contour to the vagina. The absence of the support diaphragm allows this pessary to take an oval shape and conform to the shape of the vagina.
The incontinence ring pessary has a knob that is placed beneath the urethra to increase urethral pressure when treating SUI (figure 3).
Lever pessaries — The Smith, Hodge, and Risser pessaries, as in Letters A, B, C, and E in the picture (picture 1), are collectively referred to as lever pessaries. These devices were originally intended to treat uterine retroversion. They may be used for uterine prolapse and cystocele, and case reports have described use in pregnancies complicated by cervical insufficiency. They are no longer commonly used.
When inserting a lever pessary, the uterus is manually anteverted if it has been retrodisplaced. The pessary is then folded and inserted into the vagina. The index finger is placed against the posterior bar until it rests posterior to the cervix. The anterior bar should rest posteriorly to the pubic symphysis (figure 4).
Gehrung pessary — The Gehrung pessary is designed to treat cystocele and/or rectocele. It has a U-shaped flexible rim with a rubber diaphragm, as in Letter D in the picture (picture 1). When inserted properly, the two bases rest on the posterior vagina against the lateral levator muscles, and the concave surface and diaphragm support the anterior vagina. There are no studies of this pessary.
Shaatz pessary — The Shaatz pessary is a rigid ring pessary, and essentially the same as the Gellhorn pessary without the stem (ie, just the base of the Gellhorn), as in Letter I in the picture (picture 1). It does not fold, so must be inserted vertically and then rotated to a horizontal position.
Space-filling pessaries — Space-filling pessaries are essentially three-dimensional, and differ from the support pessaries in that they have a large base that supports the vaginal apex (or cervix). They include the Gellhorn, donut, cube, inflatoball, and Colpexin sphere pessaries. They are often needed in women with severe (stage III or IV) POP, especially post-hysterectomy vaginal vault prolapse, but offer no advantage in the treatment of SUI. Space-filling pessaries are often difficult for patients to remove, and sexual intercourse is not possible when they are in place. To simplify office management, I mostly use the flexible Gellhorn pessaries, but occasionally use the other space-filling pessaries.
Gellhorn pessary — The Gellhorn pessary has a broad, firm, circular base with a stem protruding from the center, as in Letter K in the picture (picture 1). The broad base provides support to the vaginal apex, and the stem sits on the long axis of the vagina. The stem keeps the circular base from rotating into the long axis of the vagina and being expelled (figure 5). The base is slightly concave, allowing suction to form against the vagina, which helps hold the pessary in place, but can make it difficult to remove manually. There are small holes in the base to allow drainage, as well as a hole in the stem (picture 2). The Gellhorn sizes reflect the diameter of the base and are available in 1.5 to 3.5 inch sizes, in one-quarter-inch increments. Most women can be managed with the 2.5, 2.75, and 3-inch sizes [10].
The Gellhorn pessary is inserted by first holding the stem and partially folding one side of the base up to the stem, so that the base of the pessary is vertical and at a 90-degree angle to the introitus. (Folding the base up to the stem gives the Gellhorn more of a two-dimensional shape). A finger from the opposite hand separates the introitus and depresses the perineal body. The leading edge of the base is placed into the vagina until it reaches the apex, then rotated so that the base supports the apex and the stem is in the long axis of the vagina.
A Kelly clamp can be used to grasp the stem to assist with removal (one jaw of the clamp is inserted into the hole and the other jaw grasps the outside of the stem). The flexible Gellhorn is better than the rigid Gellhorn, as placement is easier. A string may be attached to the stem to aid in removal. This string should be tucked into the vagina to avoid soiling with urine and feces.
Donut pessary — The donut pessary is similar to a ring pessary, but the ring is thick and hollow, as in Letter N in the picture (picture 1). The thick, hollow ring fills the larger space associated with advanced prolapse and levator atrophy. The donut pessary is available in diameter sizes similar to the Gellhorn, ranging from 1- to 3-inch sizes, in one-quarter-inch increments. Most women needing a donut pessary can be managed with the 2.5, 2.75, and 3-inch sizes.
The donut pessary is inserted by holding it vertically (figure 6) and then rotating it to a horizontal position during placement. A Kelly clamp may be required for pessary removal.
Cube pessary — The Cube pessary has six concave sides, as in Letter H in the first picture (picture 1 and picture 3), which allow the Cube to hold the vaginal walls with suction, thereby preventing prolapse (figure 7). Although the Cube is highly effective in correcting prolapse, many consider it to be the pessary of last resort because even short-term use is associated with a profound malodorous discharge and vaginal erosions. To minimize occurrence of these problems, the Cube pessary should be removed nightly, cleaned, and not reinserted until the next morning.
The Cube pessary is inserted by squeezing the flexible rubber sides together and then placing the device at the vaginal apex. It is available in sizes 0 to 7, with diameters ranging from 1 to 2.25 inches.
Inflatable pessary — The Inflatoball pessary was designed to facilitate removal and insertion by the patient, as in Letter M in the picture (picture 1). It has an air-filled ball and a stem with a port; a bulb is attached to the port to inflate or deflate the pessary, which makes the device less bulky during insertion and removal. However, the stem protrudes from the vagina and may cause unacceptable discomfort. Additionally, the pessary is made of latex, not silicone, so it cannot be used in women with latex allergy.
The Inflatoball is placed in a similar manner as the donut pessary. The bulb is then attached, a ball-bearing within the stem is moved to a lateral projection on the side of the stem, the pessary is inflated, the ball-bearing is moved back into position to keep the pessary inflated, and the bulb is removed (figure 8). The Inflatoball pessary is available in diameter sizes of 2 to 2.75 inches, in one-quarter-inch increments.
Spherical pessary — The Colpexin® Sphere (Adamed, Warsaw, Poland) is a newer pessary designed to make removal and insertion easier, improve comfort (because of its smaller size and spherical shape), and allow the patient to perform concomitant pelvic floor muscle exercises (figure 9). It is made of polycarbonate, with an attached braided nylon string for ease of removal, and is available in six sizes, from 28 mm to 44 mm.
Incontinence pessaries — There are a few pessaries designed specifically for SUI. They include incontinence ring and incontinence dish pessaries, the Uresta™ incontinence pessary, the Contiform™ intravaginal device, the Cook® Continence Ring, the Introl® bladder neck support prosthesis, and the ConTIPI disposable intravaginal device.
When fitted properly, an incontinence pessary compresses the urethra against the upper posterior portion of the symphysis pubis, causing an increase in urethral resistance that prevents leakage associated with sudden increases in abdominal pressure (ie, cough or valsalva).
Incontinence ring and dish — The incontinence ring pessary, as in Letter L in the picture (picture 1), has a knob that is placed beneath the urethra to increase urethral pressure to treat stress incontinence (figure 3). The incontinence dish is more rigid and shaped like a dish, but has minimal added benefit.
Bell-shaped incontinence pessary — The Uresta™ incontinence pessary is a bell-shaped pessary with a handle at its base for easy removal and insertion. It has a narrow, rounded tip that allows easy insertion into the vaginal introitus. When properly positioned, the wide base supports the urethra. It is made of a medical grade rubber that has been extensively tested for biocompatibility and safety, and available in sizes 3, 4, and 5 (small, medium, and large).
Cylindrical intravaginal device — The Contiform™ intravaginal device is shaped like a large, hollow tampon made of Santoprene™, a nonallergenic thermoplastic rubber. The device sits behind the pubic bone and supports the urethra during episodes of increased intraabdominal pressure. Its tampon-like shape was partly designed to facilitate self-insertion/removal by patients. This pessary can be ordered only in or from Australia or New Zealand [19].
Continence Ring — The Cook® Continence Ring (Spencer, IN) is only available from the manufacturer with a doctor’s letter. It is a flexible ring pessary with an inflatable balloon that lies under the urethrovesical junction. The balloon obstructs the flow of urine during rest and episodes of physical stress. When the patient experiences an urge to void, or when a specified time interval on a voiding schedule has passed, the balloon is deflated to allow voiding.
Disposable intravaginal device — The ConTIPI disposable intravaginal device is made of a flexible resin core with a cover made of soft nylon mesh, which provides support to the urethra whenever abdominal pressure is transferred to the pelvic floor. The device is inserted with an applicator, similar to a tampon, and a cotton string is attached to the mesh cover for removal. Among 60 women with severe SUI, 85 percent were markedly improved [20].
PESSARY FITTING TRIAL
Fitting the pessary — Women to be fitted for a pessary are first examined with an empty bladder in the dorsal lithotomy position. Post-void urine residual is assessed and urine is sent for urinalysis. A split speculum exam using the pelvic organ prolapse quantitation system (POP-Q) is used to stage the prolapse [21] and assess vaginal atrophy. Pelvic floor muscle strength (Kegel squeeze) is also evaluated. (See “Pelvic organ prolapse in women: Diagnostic evaluation”.)
Vaginal introitus size, vaginal length, and prolapse stage are used to guide selection of pessary type and size. However, pessary fitting is mostly a trial and error process, and several pessaries may be needed to obtain an adequate fit. Ultimately, the largest pessary that is comfortable is prescribed.
The type of pessary likely to be needed is determined by measuring prolapse stage and the size of the vaginal introitus, the latter is gauged by the number of fingerbreadths accommodated across the posterior fourchette (this is typically 1 to 4 fingers) [10]. If the vaginal introitus size is 1 to 2 fingerbreadths and the prolapse stage is II-III, a ring pessary is likely to be successful, whereas with a 3 to 4 fingerbreadth introitus or stage IV prolapse, a Gellhorn pessary is more likely to be successful [10]. Next, the size of the pessary that will be needed is estimated by inserting two fingers to measure the width and length of the vagina (figure 10). It is important to get an overall estimate of the vaginal length and vaginal width together. If the vaginal length has been shortened by a prior hysterectomy, or if the vaginal width has been narrowed by a prior prolapse surgery, then only smaller size pessaries will fit.
Pessaries are inserted into the vagina with the dominant hand, while the nondominant hand separates the introitus and depresses the perineal body. A nonlubricated glove is used, and a small amount of lubricant is applied to the leading edge of the pessary; if too much lubricant is used, the pessary will be too slippery to control. After the pessary is inserted into the vagina, the woman is asked to strain and cough repeatedly on the examination table, ambulate in the office, and void and strain while sitting on a toilet. This “office trial” helps determine if she will be able to retain the pessary and void when she returns home, and if bothersome urinary incontinence will develop. She should have a negative cough stress test following pessary placement, as she is unlikely to be satisfied if there are significant SUI symptoms.
Women should be reassured that it is not an emergency if the pessary is expelled; they should just bring the pessary back to the office and a different type or size of pessary will likely be effective.
Follow-up — A follow-up visit is scheduled one to two weeks later. The patient is asked if there were any side effects, such as discomfort, expulsion, persistent bulge or pressure symptoms, persistent or de novo stress or urge urinary incontinence, difficulty with urination or bowel movements, or vaginal bleeding or discharge.
The pessary is removed and cleaned with soap and water, and the vagina is examined for erosions. If the pessary fits well and there were no side effects, motivated and able patients are taught how to remove, clean, and reinsert their pessary at least once per week, with follow-up in one to two months, and every 6 to 12 months thereafter. If the patient cannot, or chooses not, to remove and reinsert her pessary, then she returns for follow-up in one to two months, and every three to four months thereafter for pessary cleaning and assessment by the provider.
I offer most women low-dose estrogen vaginal cream (0.25 to 0.5 g applicator, two to three nights per week) to treat co-existing vaginal atrophy and dryness from estrogen deficiency.
In some women, the width of the introitus may decrease in size after several weeks of pessary use. In such women, a new smaller size pessary is prescribed to allow for easier removal and insertion.
Management of side effects — If bothersome side effects occur, then pessary use is either discontinued, or the patient is fit with a different size or type of pessary and asked to return again in one to two weeks, or medical therapy is prescribed, if appropriate [22].
Vaginal erosions and ulcers are reported in 3 to 24 percent of women (weighted mean 10 percent) [10,12,23,24]. Other common side effects include vaginal bleeding, development of a foul vaginal discharge, and irritative symptoms. These minor complications usually occur in the setting of vaginal atrophy, and can be treated or prevented with medical therapy.
If vaginal atrophy and discharge are the main problems, I offer treatment with low dose vaginal estrogen cream (0.25 to 0.5 g applicator, two to three nights a week) or Trimo-San vaginal cream (Milex™, Cooper Surgical, Trumbull, CT). However, if vaginal atrophy is severe or vaginal erosions are present, I use a higher dose of vaginal estrogen (0.5 to 1 g applicator nightly) and continue pessary use, with follow-up examinations every one to two weeks until the vagina heals.
Other common side effects from pessary use include de novo (occult) SUI, interference with sexual intercourse, and difficulty with bowel movements. Urinary tract infections have been reported in 13 percent of pessary users, and bacterial vaginosis in up to 32 percent [12,23,25,26]. Some women may need to stop pessary use temporarily, or be fitted with another size or type of pessary, or consider surgical treatment of their POP/SUI.
Duration of use and replacement — Pessary use may be continued indefinitely. A change in the pessary type or size may be needed as a woman ages. The pessary does not need to be replaced if it becomes discolored, but a new pessary should be given if it becomes cracked or loses its shape and strength.
OUTCOME
Pessary fitting trials — Several cohort studies were reviewed to determine the outcome of pessary fitting trials in women with prolapse and urinary incontinence. Eight studies were prospective [10,16,24,27-31] and 10 were retrospective [11,23,25,32-38]. They varied in the types of pessaries used (support only, space-filling only, or both), prolapse severity, indication for pessary (prolapse only, incontinence only, or both), time to first follow-up visit (one to four weeks), and study site (urogynecology practice or nurse pessary clinic) [10,11,16,23-25,27-38].
Outcomes were reported using one or more of three denominators: (1) all women offered a pessary (intention-to-treat), (2) only women who were fitted with a pessary at the first visit, or (3) women with a successful pessary fitting trial (ie, woman is fitted (or refitted) with a pessary and decides at the follow-up visit to continue use). Weighted averages and ranges were calculated for several outcomes, and the main findings are described below:
At the first visit, 85 percent (range 71 to 94 percent) of women were fitted with a pessary [10,11,16,23,24,27,28,32-35]. On average, two to three pessaries were tried before obtaining an adequate fit [10,11,23].
For women with prolapse, ring pessaries (sizes 3,4,5) were used in 70 to 74 percent, and space-filling pessaries (Gellhorn and donut) were used in 26 to 29 percent [10,24,35].
Refitting with a new pessary at the first follow-up visit was necessary in 29 to 40 percent of women, and was successful in 76 to 85 percent [10,16,33,37].
For women with incontinence, incontinence ring or dish pessaries were used in 78 to 80 percent, and ring pessaries were used in 11 to 20 percent [11,23]; in two studies, the Introl and Uresta incontinence pessaries were used [27,28].
A successful pessary fitting trial was achieved in 62 percent (range 41 to 86 percent) of all women (intention-to-treat, includes women initially unable to be fitted) [10,11,16,23-25,27,28,30,32,33,35,38], and 71 percent (range 24 to 95 percent) of women initially fitted with a pessary [10,11,16,23,24,27-34,37].
Women with prolapse were as likely as women with incontinence to have a successful pessary fitting trial (71 and 74 percent, respectively). Common reasons for an unsuccessful pessary fitting trial were discomfort, expulsion, inadequate relief of prolapse symptoms, worsening or persistent urinary incontinence, de novo difficulty with voiding or defecation, and inconvenience.
Risk factors for an inability to fit a pessary — The most common predictors of an unsuccessful pessary fitting trial are prior prolapse surgery [11,23,25,32,33], prior hysterectomy [11,29,32,33], and concurrent POP and SUI [12,24,25,30]. Related risk factors include short vaginal length (<6 cm) and a wide vaginal introitus (over 4 fingerbreadths) [10]. Prolapse surgery and hysterectomy alter the vaginal anatomy, potentially resulting in a shortened or narrowed vagina. Concurrent SUI may be difficult to treat when fitting a pessary for POP, as the pessary type and size that best treat the prolapse may fail to provide adequate support for the urethra.
Less common risk factors for an unsuccessful pessary fitting trial include younger age [24], higher parity [30], and obesity [25]. Sexual activity does not appear to be a risk factor for failure [10,30,33,34]. Additionally, the following POP-Q exam parameters have been evaluated and found not to be risk factors for pessary failure: prolapse stage or grade (ie, severity) [10,12,24,25,32,33], the leading vaginal compartment of the prolapse (ie, anterior, apical, or posterior) [10,32], and genital hiatus [10,11,32]. Unfortunately, the POP-Q examination fails to address introital width, vaginal caliber, atrophy of pelvic floor muscles, and shape of the pelvic bones, all of which may influence pessary success.
Treatment of prolapse trials — Only short-term and medium-term outcomes of pessary treatment of POP have been published.
Satisfaction and continued use — In observational studies, short-term (two to six months) satisfaction and continued use was 81 percent (range 63 to 92 percent) for women with a successful pessary fitting trial, and 59 percent (range 40 to 77 percent) by intention-to-treat [16,24,25,33,35,39]. Medium-term (one to two years) satisfaction and continued use was 61 percent (range 53 to 83 percent) for women with a successful pessary fitting trial, and 40 percent (range 30 to 63 percent) by intention-to-treat [12,16,24,25,35,36,40,41].
Symptom improvement — A single randomized trial that compared the ‘ring with support’ and Gellhorn pessary found similar improvement in symptoms after three months of use for both devices [16].
In observational studies, after two to four months of pessary use: 70 to 90 percent of prolapse symptoms resolved (bulge, pressure, splinting) [16,29,39], 40 to 50 percent of associated urinary symptoms resolved (stress and urge incontinence and voiding difficulty) [16,24,30,39], 30 to 50 percent of associated bowel symptoms resolved (anal incontinence, anal urgency, and obstructive symptoms) [16,30], and 40 to 60 percent of women reported increased sexual frequency and satisfaction [30].
Validated questionnaires — Two studies have demonstrated that Pelvic Floor Distress Inventory (PFDI) improved in women successfully treated with a pessary for POP, notably the urinary and prolapse scales, but not the colorectal scale [42,43]. Interestingly, the Pelvic Floor Impact Questionnaire (PFIQ) did not change with pessary use. Of note, one study also evaluated women treated with surgery for POP, and all six scales of the PFDI and PFIQ improved.
Anatomic changes — There are limited data on the anatomic changes following pessary use. One study reported a decrease in size of the genital hiatus (GH) after three months of pessary use, from 4.8 cm to 3.9 cm [44]. Another study reported an improvement in POP-Q stage in 21 percent of women after one year of use [35].
Therefore, it appears that correction of the vaginal prolapse with a vaginal pessary not only restores the vagina, bladder, and rectum to their normal positions to improve prolapse symptoms, but also improves many of the associated urinary, bowel, and sexual dysfunction symptoms.
Risk factors for discontinuing pessary use — Risk factors for discontinuing pessary use in women with a successful pessary fitting trial for POP include: severe posterior vaginal prolapse [33,40], development of occult SUI [39], and desire for surgery at first visit [40]. Although several studies have shown that prolapse stage or grade (ie, severity of POP) is not a risk factor for discontinued pessary use [24,25,36,40], a rectocele in a woman with severe posterior vaginal prolapse may be less well supported by a pessary than a cystocele or vaginal vault prolapse, leading to dissatisfaction and discontinuation. Occult SUI (ie, de novo SUI that occurs with reduction of POP with the pessary) is a difficult problem to overcome, so women with this problem often prefer surgery (to correct both the POP and SUI) or expectant management to using a pessary.
Conversely, the following have been identified as strong predictors of continued pessary use: age greater than 65 years [40], women whose baseline PFDI-20 score decreased by 50 percent after two months of use [43], and women who attain self-determined goals (ie, goals related to bladder function, physical activity, and general health) [45].
Responses to a 1997 survey of American Urogynecologic Society members on contraindications to pessary treatment of prolapse included prior hysterectomy (42 percent), current sexual activity (45 percent), and hypoestrogenism (64 percent) [15]. Interestingly, most studies have not excluded women with these conditions [10,12,16,23-25,30,32-36]. Prior hysterectomy is not a risk factor for discontinued use [24,25,33,40], although it has been identified as a risk factor for failure to fit a pessary [11,30,32,33]. Sexual activity is not a risk factor for failure to fit [10,30,33,34] or discontinued use [33,34,40]. In fact, sexual activity predicted continued pessary use in one study [34], and another reported that 90 percent of sexually active women using a pessary were able to remain sexually active [39]. Three studies recommended treatment of vaginal atrophy or erosions with more frequent use of estrogen cream (nightly), and weekly follow-up until the vagina healed, rather than excluding women with hypoestrogenism [10,12,24].
Treatment of urinary incontinence trials — The mechanism of action of vaginal pessaries for urinary incontinence is related to improved urethral function. Urodynamic studies of women treated with a pessary for SUI have shown increases in functional urethral length [46] and urethral closure pressure [46-48], absence of urethral obstruction to flow [46], and resolution of detrusor instability in women with severe prolapse and detrusor instability [49]. Anatomically, pessaries improve urethral support, as there is a reduction in the straining Q-tip angle [47], and dynamic magnetic resonance imaging studies show a decreased posterior urethrovesical angle, elevation of the bladder neck, and increased urethral lengths [48].
Management of stress incontinence with a pessary appears to be less successful than pelvic floor muscle training during the first few months of therapy; however, long-term use of either strategy is associated with similar outcomes. The highest quality data regarding this issue are from the Ambulatory Treatment for Leakage Associated with Stress Incontinence (ATLAS) randomized trial of 446 women with stress incontinence who were assigned to one of three treatment groups: continence pessary; behavioral therapy (pelvic floor muscle training and other strategies); or combined use of a pessary and behavioral therapy [50]. At three months, significantly fewer women in the pessary versus behavioral or combined groups reported a complete absence of bothersome incontinence symptoms (pessary: 33 percent; behavioral: 49 percent; combined: 44 percent) and treatment satisfaction (63; 75; 79 percent); these outcomes did not differ significantly between the behavioral and combined groups. At 12 months, there were no significant differences among the pessary, behavioral, and combined groups in the proportion of women who reported an absence of incontinence symptoms (35; 40; 33 percent) or patient satisfaction (50; 54; 54 percent).
Observational studies have reported short-term efficacy (one month or less) of pessaries for stress and mixed urinary incontinence, with improvements in pad testing, bladder diaries, and quality of life [40,51-53]. A literature review reported a subjective cured/improved rate of 63 percent after one month [54]. Medium-term (6 to 13 months) satisfaction and continued use was 59 percent (range 39 to 76 percent) for women with a successful pessary fitting trial, and 43 percent (range 16 to 59 percent) by intention-to-treat [11,27,28,37,47].
In the ATLAS trial described above, women discontinued treatment in both the pessary and behavioral groups at similar rates at both three months (18 and 15 percent) and 12 months (27 and 32 percent); these rates exclude women who withdrew from the pessary group due to a failed pessary fitting.
Other studies have reported that most women who chose not to continue using a pessary discontinued use within one to two months. The most common reasons given were persistent incontinence, resolution of incontinence with pelvic floor muscle exercises, and pessary discomfort or expulsion. Prior incontinence surgery was a risk factor for discontinued pessary use [27,37].
Continence pessaries or pelvic floor muscle training are typically used for women with stress incontinence who decline or are not candidates for more effective surgical treatments. Pelvic muscle floor training requires more time for a patient than pessary use. In contrast, exercises have no associated adverse effects, while pessary use may be accompanied by vaginal erosions and malodorous vaginal discharge. Given these clinical considerations and the ATLAS trial data, we suggest pelvic floor muscle training rather than continence pessary use for women with stress urinary incontinence who do not otherwise have a preference for one of these nonsurgical modalities. (See “Stress urinary incontinence in women: Choosing a primary surgical procedure”.)
For prediction of surgical outcome
Urinary incontinence — Occult SUI has been reported in 27 to 68 percent of women with severe prolapse [55-58]. A pessary placed during urodynamic evaluation of women with POP can diagnose occult (potential) SUI and predict whether anti-incontinence surgery will be therapeutic. This was illustrated in a study of women with POP who underwent pessary placement as part of their preoperative evaluation [58]. Among those with a positive test for occult SUI, urinary incontinence occurred postoperatively in 65 percent of women who did not undergo a tension-free vaginal tape (TVT) procedure at the time of prolapse surgery, but in only 9 percent of those who did undergo TVT. By comparison, 0/30 women with a negative pessary test developed symptomatic SUI postoperatively. These observations are similar to those from another study which reported a 64 percent rate of postoperative SUI when prolapse surgery alone was performed in women with occult SUI [59].
The Colpopexy and Urinary Reduction Efforts (CARE) trial randomized women with severe prolapse and absence of SUI to undergo abdominal sacrocolpopexy with or without concomitant Burch colposuspension [60]. Women who received a Burch colposuspension had significantly fewer postoperative SUI symptoms, regardless of whether preoperative prolapse reduction testing demonstrated occult SUI. Whether this applies to other vaginal vault suspension or anti-incontinence surgeries is unknown.
Relief of urinary obstruction — In another study, pessary reduction in women with severe anterior vaginal prolapse and urinary retention (post-void residual >100 ml) predicted cure of urinary retention by prolapse surgery: 79 percent were cured by surgery, and the pessary was 89 percent sensitive [61]. A similar study found urethral obstruction on urodynamic evaluation in 72 percent of women with grade 3 or 4 cystocele, with resolution of the obstruction in 94 percent following pessary insertion [62].
COMPLICATIONS — Serious complications from vaginal pessary use are rare. A few case reports have described pessary incarceration, fistula from the bladder or rectum, urinary or colonic obstruction, and vaginal cancer in women with “neglected” pessaries [63-67]. At risk patients are elderly women with cognitive difficulties who are unable to inform health care workers that they have a vaginal pessary in place. Such complications are usually avoidable with routine care and follow-up, although there is one report of a vesicovaginal fistula from a “well-cared-for” pessary [68], and one report of an undiagnosed vaginal cancer [69]. Communication with the patient’s family or caretakers is important to ensure that follow-up will be accomplished. Minor side effects are relatively common. (See ‘Management of side effects’ above.)
INFORMATION FOR PATIENTS — Educational materials on this topic are available for patients. (See “Patient information: Urinary incontinence in women” and “Patient information: Urinary incontinence treatments for women”.) We encourage you to print or e-mail these topics, or to refer patients to our public web site www.uptodate.com/patients, which includes these and other topics.
SUMMARY AND RECOMMENDATIONS — Treatment of pelvic organ prolapse or stress urinary incontinence with a pessary is inexpensive, effective, and safe; contraindication to use and serious complications are rare.
A pessary trial can be offered to most women with prolapse or urinary incontinence, regardless of patient characteristics. An exception is women with exposed foreign body following surgery for prolapse or urinary incontinence. (See ‘Indications’ above.)
There are two basic types of pessaries: support pessaries (eg, ring) and space-filling pessaries (eg, Gellhorn). There are also a few pessaries designed specifically for urinary incontinence. (See ‘Types of pessaries’ above.)
The ring with support and Gellhorn pessaries are equally effective for the treatment of prolapse. (See ‘Support versus space filling pessaries’ above.)
The ring pessary will fit 70 percent of women. We suggest ring pessaries for most women, because they are comfortable, easily removed and inserted by the patient, and sexual intercourse is possible with the pessary left in place (Grade 2C). (See ‘Ring pessaries’ above.)
Pessary fitting is done by trial and error; the largest pessary comfortable for the patient is used. We suggest a ring pessary if the vaginal introitus size is 1 to 2 fingerbreadths and the prolapse stage is II-III. We suggest a Gellhorn pessary if the vaginal introitus is 3 to 4 fingerbreadths or there is stage IV prolapse (Grade 2C). (See ‘Fitting the pessary’ above.)
At the initial visit, approximately 85 percent of women with pelvic organ prolapse can be fitted with a pessary; two to three different pessaries may be needed before finding the best one. (See ‘Pessary fitting trials’ above.)
At the follow-up visit one to two weeks later, women are asked if there are side effects such as discomfort, expulsion, persistent bulge or pressure symptoms, persistent or de novo stress or urge urinary incontinence, difficulty with urination or bowel movements, or vaginal bleeding or discharge. In the absence of bothersome side effects, pessary use may be continued indefinitely. A change in the pessary type or size may be needed as a woman ages. (See ‘Follow-up’ above.)
Low dose estrogen vaginal cream may be used to treat co-existing vaginal atrophy or erosions. (See ‘Management of side effects’ above.)
A successful pessary fitting occurs in approximately 70 percent of women fitted with a pessary. (See ‘Pessary fitting trials’ above.)
Risk factors for failure to fit a pessary include prior prolapse surgery, prior hysterectomy, and concurrent pelvic organ prolapse and stress urinary incontinence. Related risk factors are a short vaginal length (≤6 cm) and a wide vaginal introitus (over 4 fingerbreadths). Prolapse severity and sexual activity are not risk factors for failure to fit a pessary. (See ‘Risk factors for an inability to fit a pessary’ above.)
After a successful pessary fitting trial for prolapse, short-term (two to six months) satisfaction and continued use is approximately 80 percent, and medium-term (one to two years) satisfaction and continued use is approximately 60 percent. (See ‘Treatment of prolapse trials’ above.)
Approximately 80 percent of prolapse symptoms resolve (bulge, pressure, splinting), 50 percent of urinary symptoms resolve (stress and urge incontinence and voiding difficulty), 40 percent of bowel symptoms resolve (anal incontinence, anal urgency, and obstructive symptoms), and 50 percent report increased sexual frequency and satisfaction. (See ‘Treatment of prolapse trials’ above.)
Anatomically, the genital hiatus will decrease in size. (See ‘Treatment of prolapse trials’ above.)
Risk factors for discontinued pessary use are severe posterior vaginal prolapse, the development of occult stress urinary incontinence, and desire for surgery. Prolapse severity and desire for sexual activity are not risk factors for discontinued pessary use. (See ‘Risk factors for discontinuing pessary use’ above.)
For women with urinary incontinence, short-term (three-month) efficacy is approximately 50 percent. Twelve-month satisfaction is approximately 50 percent. (See ‘Treatment of urinary incontinence trials’ above.)
For women with stress urinary incontinence who desire nonsurgical therapy, we suggest pelvic floor muscle training over use of a continence pessary (Grade 2C). (See ‘Treatment of urinary incontinence trials’ above.)
Pessaries have been used in women with pelvic organ prolapse to diagnose occult stress urinary incontinence and to predict postoperative cure of urinary retention after prolapse surgery. (See ‘For prediction of surgical outcome’ above.)
Major complications are rare. Side effects include vaginal erosions, vaginal bleeding, and vaginal discharge. They usually occur in the setting of vaginal atrophy, and low-dose estrogen vaginal cream can treat or prevent these symptoms. (See ‘Complications’ above and ‘Management of side effects’ above.)
Acknowledgment: The opinions or assertions contained herein are the private views of the author and are not to be construed as official or as reflecting the views of the Department of the Army or the Department of Defense.
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