Nonsurgical Management of Pelvic Organ Prolapse: The Use of Vaginal Pessaries and Pelvic Floor Muscle Training
Chi Chiung Grace Chen
Jaime B. Long
DEFINITIONS
Occult and de novo stress urinary incontinence—Although occult incontinence refers to preexisting incontinence that only becomes symptomatic after prolapse reduction and de novo incontinence refers to new incontinence symptoms that develops after an intervention, these terms are often used interchangeably in the literature.
Pelvic organ prolapse—Descent/herniation of the anterior vaginal compartment (cystocele, urethrocele), apical compartment (uterine or vaginal vault prolapse), and/or posterior compartment (rectocele, sigmoidocele, perineocele, enterocele).
Pelvic floor muscle training—Exercises aimed to improve the strength and function of the pelvic floor muscles. Pelvic Organ Prolapse-Quantification (POP-Q) system— Validated and widely accepted standardized scoring system used to measure the degree and type of pelvic organ prolapse; includes an assessment of vaginal length, genital hiatus, and perineal body; see Chapter 36.
Pessary—Device inserted into the vagina for reduction of pelvic organ prolapse.
Stress urinary incontinence—Involuntary urinary leakage with effort or exertion or with sneezing or coughing as defined by the International Consultation on Incontinence.
Urge urinary incontinence—Involuntary urinary leakage accompanied by or immediately preceded by urgency as defined by the International Consultation on Incontinence.
Vaginal splinting—Digital reduction of prolapse tissue to facilitate urination and/or defecation.
Pelvic floor disorders such as pelvic organ prolapse (POP) are common and costly conditions that will be encountered by any practitioner who cares for women, especially older women. From the 2005 to 2006 National Health and Nutrition Examination Survey of 1961 nonpregnant women, Nygaard et al. reported that the prevalence of symptomatic POP was noted to be 2.87% (3.3 million). Wu et al. in 2009 reported that Due to the aging population, the prevalence of symptomatic prolapse is estimated to increase 46% (4.9 million) by 2050.
According to Olsen et al., in the United States it is currently estimated that by the age of 80, women have an 11% chance of undergoing surgery for POP or urinary incontinence with a reoperation rate of 30%. Subak et al. estimated that over 1 billion dollars are spent and over 300,000 procedures are performed annually to surgically treat prolapse; however, surgery is just one approach, and providers caring for women with this condition should be familiar with conservative options. In comparing the prevalence estimates and the number of surgeries that are performed, it is clear that many women with prolapse either choose conservative strategies or go without treatment. This observation, coupled with the high rates of surgical failure and reoperation, underscores the importance of understanding conservative management options for prolapse and discussing these options with patients. This chapter reviews the available data and recommendations on pessary use and pelvic floor muscle training (PFMT) for POP.
Pessaries have been in use for thousands of years, and although vigorous scientific trials regarding their use are only beginning to emerge, years of expert opinion and experience continue to support and guide clinical decisions. Pessaries are also utilized for urinary incontinence, uterine retroversion, and obstetric indications such as cervical insufficiency; however, this chapter focuses specifically on their use for POP.
PFMT involves exercises aimed to improve the strength and function of the pelvic floor muscles. These exercises are often performed with a physical therapist and may also involve education on lifestyle modifications such as weight loss and avoidance of heavy lifting. Although these interventions are well researched and considered first-line treatment in other pelvic floor disorders such as stress, urge, and mixed urinary incontinence, this chapter focuses specifically on the use of PFMT for POP.
HISTORY OF PESSARY
The term “pessary” is derived from the Greek word “pessós,” which is an oval stone used in certain games. This term was originally used to describe oval stones that were inserted into the uteri of camels for contraception and later was used to describe other intrauterine devices.
Throughout history and into modern times, there has been a clear consensus that the ideal conservative treatment for prolapse involves reducing the prolapse with a lubricating substance followed by placement of an object inside the vagina to prevent reprolapse. What has changed are the methods and materials involved in this process. According to Shah and colleagues and Oliver and colleagues, the first reference of uterine/vaginal prolapse and “remedies to allow the womb of a woman to slip into its place” was from the Ebers papyrus, which dates back to as early as 1550 BC. Some of these remedies include the use of honey and petroleum to reduce the prolapse as well as the use of fumes and astringents to penetrate the uterine cavity so that it would revert back into the body.
At the time of Hippocrates (400 BC), many physicians prescribed succussion therapy, which involved hanging the patient upside down from her feet and moving her up and down as to return the prolapsed organ back into the body. Various agents were used to facilitate this process, including hot oil. Earliest pessaries were fashioned from a variety of materials such as an astringent-soaked plug of wool and half a pomegranate soaked in wine. Several methods were described to hold the prolapse and/or pessary in place, including leg binding and bed rest with the foot raised above the level of the head.
In addition to the above methods, Soranus of Ephesus (98 AD) in his treatise Gynaecology believed that placing herbs that emit pleasant odors around the patient’s head would entice the prolapse to ascend. This was coupled with placing astringents that emit foul odors around the vagina to force the prolapse back into the body. He recommended that surgery not be performed unless the uterus was gangrenous. In the Middle Ages, other methods reported included frightening the prolapse with hot iron so that it would retreat back into the body. Cupping has also been advocated for prolapse reduction.
Until the 16th century, most of the materials used for pessaries were naturally occurring materials or objects that had been repurposed. It was not until the end of the 16th century that devices were purposely made to address prolapse. Notably, Ambrose Pare, a royal surgeon in the French court, made oval-shaped pessaries from materials such as brass or cork covered in wax. These pessaries were often held in place with a belt-like device worn across the waist. Hendrik van Roonhuyse (1625-1672), the Dutch gynecologist who is credited with writing one of the earliest textbooks of operative gynecology, devised a pessary made of cork with a hole in it to allow for passage of discharge. The late 17th century saw a considerable number of medical therapies and pharmaceutical concoctions promoted for the treatment of genital prolapse, which persisted even into the 18th century. Specifically, soft rubber pessaries that resembled contraceptive diaphragms with a perforated gold tip to allow for the escape of discharge were devised to address prolapse and the issue of vaginal wall injuries, which were a common result of metal pessaries. In the mid-19th century, the American Medical Association documented 123 different pessaries. Hugh Lennox Hodge (1796-1873) recommended metal, glass, and porcelain pessaries instead of wood, cork, or sponge due to his belief that the harm attributable to pessaries stems from the material, the form, and the size. Modern pessaries are primarily made of silicone and are rarely made of latex, rubber, or acrylic. These materials have completely replaced the hard plastic and polystyrene used previously. Silicone is advantageous because it is flexible yet sturdy, durable, hypoallergenic, and noncarcinogenic. It is also inert, does not absorb secretions or odors, and can be repeatedly cleaned and autoclaved, if needed for resterilization.
INDICATIONS AND THERAPEUTIC BENEFITS OF PESSARY
Pessaries are used to alleviate the symptoms of prolapse and delay or eliminate the need for surgery. As discussed below, there may also be some evidence that pessaries may retard prolapse progression. In recent surveys of gynecologists and female pelvic medicine and reconstructive surgeons/urogynecologists in the United States and United Kingdom, 86% to 98% of respondents prescribe pessaries in their practice. Cundiff et al. reported that specifically, among members of the American Urogynecologic Society (AUGS), 77% of respondents used pessaries as first-line therapy for prolapse, whereas 12% offered them only to women who are not considered good surgical candidates. Ninety-two percent believed that pessaries alleviated prolapse symptoms while 48% believed that pessaries also improved pelvic support.
The 2004 Cochrane Review concluded that there are no published randomized controlled trials addressing pessary use for POP. Although there is still no consensus on the indication for use, the use of different types of pessaries, or the ideal follow-up regimen, as discussed below, there is at least one randomized controlled trial (by Cundiff et al.) comparing the use of two different pessaries for prolapse. It is also important not to discount findings from numerous published series and experience from thousands of years of pessary use.
As most women with prolapse do not tend to experience symptoms until the prolapse extends beyond the vaginal introitus, the primary goal of pessary placement is to prevent the vaginal prolapse from extending beyond the vaginal opening. Although pessary can be offered as a treatment option to most patients with prolapse, managing the patient’s expectations regarding the likelihood of successful placement, continued use, alleviation of symptoms, and improvement of quality of life is important and may save both the provider and patient time and frustration. Pessary placement is associated with improvements in vaginal and bladder symptoms. Clemons et al. reported that compared with symptoms at baseline, pessary users were significantly less likely to experience sensation of vaginal bulge (90% to 3%), pressure (49% to 3%), presence of vaginal discharge (12% to 0%), and vaginal splinting (14% to 0%). Pessary placement has also been associated with improvement of bowel symptoms, although this was not a consistent finding in all studies. In addition to overall improvements in quality of life, body image and sexual function are also improved after pessary placement.
Because women with severe prolapse may have voiding dysfunction from the prolapse kinking the urethra leading to bladder neck obstruction, by correcting the vaginal axis, pessaries may improve obstructive and urinary urgency symptoms. In one study by Fernando et al., after pessary placement, fewer women reported difficulty voiding (77% to 48%), urinary urgency (93% to 58%), and urge incontinence (84% to 65%). Similarly, in a small retrospective review of 24 women with prolapse and elevated postvoid residuals (>100 mL) who planned to undergo surgery, Lazarou et al. reported that 75% of women had normal postvoid residuals after pessary placement. Of these women, only 1 had persistence of elevated postvoid residuals after surgery. However, due to the “unkinking” of the urethrovesical angle, pessary placement has also been associated with de novo/occult stress urinary incontinence. One prospective study by Clemons et al. found occult/de novo stress incontinence to occur in 21% of women with symptomatic prolapse fitted with a pessary.
In addition to pessary use for ongoing management of prolapse, pessary placement may also have a diagnostic role in women who desire surgery for prolapse but whose symptoms, such as pelvic or back pain, may not directly result from prolapse. In this group of women, symptom improvement during a trial of pessary may aid the clinician in counseling the patient regarding symptom improvement after surgery.
Although it is beyond the scope of this chapter to discuss pessary placement for obstetric indications such as cervical insufficiency, it is pertinent to mention that pessaries can be used for vaginal prolapse during pregnancy. In this setting, pessary use can result in similar benefits seen in nonpregnant women, such as decreased vaginal bulge symptoms and improved voiding. Although there are no data on the prevalence of prolapse during pregnancy, some experts postulate that pregnant women, may be less likely to experience prolapse later in pregnancy due to the displacement of the gravid uterus outside of the pelvis, while others hypothesize that prolapse may become more severe with pregnancy progression due to the weight of the uterus.
In addition to the symptomatic benefits of pessary use, there are some data by Handa and Jones, Matsubara and Ohki, and Jones et al. to suggest that pessary use may lead to improvement of prolapse stage and decrease in the size of genital hiatus. However, it is unclear if the observed benefit is durable or merely a more transient effect of pessary placement. It is also not evident if the change in anatomy is correlated with a significant change in symptom. These case series were limited by small sample size with short follow-up periods, and most of the observed changes were modest. What is equally or more significant is that pessary use does not appear to be associated with an increase in the severity of prolapse.
Pessary use has also been compared to surgery with mixed results. In one prospective study by Abdool et al. that compared a cohort of women who chose surgery to women who chose pessary, there were similar improvements in urinary, bowel, and sexual function, and quality of life. In a study by Barber et al. addressing the responsiveness of two condition-specific quality-of-life questionnaires (Pelvic Floor Distress Inventory [PFDI] and Pelvic Floor Impact Questionnaire [PFIQ]), women who underwent vaginal reconstructive surgery experienced significantly greater improvement in the above scales than did women enrolled in a pessary trial. Although women in the pessary trial experienced significant improvement in the prolapse and urinary subscales of the PFDI after pessary placement, there were no significant changes in the colorectal subscale of the PFDI or any of the PFIQ subscales (prolapse, urinary, colorectal). As of this publication, there are no randomized controlled trials comparing pessary and surgery in patients with POP. There is one cost-effective analysis, by Hullfish et al., that demonstrated pessary use may be more cost-effective than vaginal reconstructive surgery or expectant management in women with posthysterectomy POP.
PATIENT CONSIDERATIONS AND SELECTION FOR PESSARY USE
A pessary trial is a low-risk option for women experiencing symptomatic POP and should be considered and offered routinely. According to Pott-Grinstein and Newcomer, a 1998 survey of randomly selected members of the American College of Obstetricians and Gynecologists showed that although 86% of respondents prescribed pessaries, most felt that they underwent minimal to no training during residency. Learning the skills necessary to successfully fit and manage pessaries is fortunately not difficult and improves rapidly with experience.
Research by Heit et al., Kapoor et al., and Chan et al. shows that 30% to 60% of women diagnosed with POP will initially choose conservative management. Patients who were more likely to choose pessary tended to be older; patients with greater degree of prolapse, impairment in sexual activity, stress urinary incontinence, difficulty with bowel emptying, or previous prolapse surgery were more likely to select surgery. Additionally, those who previously encountered complications related to pessary use were more likely to choose surgery.
Research by Clemons et al., Hanson et al., Maito et al., Cundiff et al., and Komesu et al. shows that most patients (73% to 92%) can be successfully fitted with a pessary with rates of continued pessary use ranging from 16% to 89% at 6 months to 1 year. Patient characteristics that have consistently been associated with unsuccessful fitting include short vaginal length (<6 cm) and wide introitus (>4 fingerbreadths) and previous hysterectomy or reconstructive surgery (Table 40.1). Systemic and local hormone replacement therapy prior to fitting may improve the ability to successfully fit a pessary. Degree or predominant compartment of prolapse was not found to negatively impact the ability to successfully fit a pessary in most studies, but one small study did demonstrate that posterior vaginal wall prolapse was associated with increased fitting failure. Being sexually active also does not impact pessary fitting.
Long-term pessary use is related to the degree that the pessary corrects bothersome symptoms without creating new symptoms. According to Clemons et al., Komesu et al., and Friedman et al., after one year, most women (56% to 77%) will continue pessary use. Older age (>65 years) is the greatest predictor of continued use. Discontinuation of pessary use was associated with preexisting and de novo stress urinary incontinence, previous prolapse surgery, desire for surgery at first visit, and severe posterior vaginal prolapse. Being sexually active does not preclude long-term pessary use.
Pessary use is associated with few complications, and as such, there are few contraindications for usage. The most important contraindication is noncompliance with follow-up, as this can result in severe complications as described below. It is important to consider any medical condition or social situation that may predispose a patient to noncompliance, such as dementia or difficulty accessing health care routinely. Additionally, pessary use should be delayed in women with active pelvic/vaginal infection until these issues are treated and resolved. Patients with latex allergy should not use Inflatoball pessary (CooperSurgical, Inc., Trumbull, CT), but this is the only commonly available pessary made with latex. In the 1997 survey of AUGS members, although 64%, 42%, and 45% of respondents believed hypoestrogenism, prior hysterectomy, or sexual activity, respectively, to be contraindications for pessary placement/use, we do not believe that any of these factors prohibit a trial of pessary based on the existing literature and our experience.
TABLE 40.1 Patient Factors Impacting Pessary Fitting and Long-Term Use | |||||||||||||||
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PESSARY SELECTION AND FITTING
Although more than 100 pessaries have been described, 13 styles are most commonly used, each with many different sizes (Fig. 40.1). Pessaries used for prolapse can be broadly classified as support pessaries, such as the ring with or without support or space-filling pessaries such as Gellhorn or Donut (Table 40.2). Support pessaries theoretically use a spring mechanism and are thought to rest between the pubic symphysis and posterior vaginal fornix; however, in actuality, with the patient upright, these pessaries rest just inside the introitus (Fig. 40.2). Space-filling pessaries either occupy the space within the vagina or create suction and adhere to the vaginal tissue. In the standing patient, these pessaries also sit just inside the vaginal introitus (Fig. 40.3).
In the 1997 survey of AUGS members, the most commonly used pessaries were the ring and Gellhorn; 22% of respondents reported using the same pessary, usually a ring pessary, for all vaginal prolapse; 78% tailored the pessary to the prolapse and were more likely to use support pessaries for anterior and apical vaginal prolapse, and space-filling pessaries for posterior vaginal prolapse and total prolapse/complete procidentia. In studies addressing pessaries used to treat prolapse, most analyses examined ring and/or Gellhorn pessaries. In a multicenter, randomized crossover trial comparing Gellhorn with ring to support pessaries, Cundiff et al. reported that both pessaries were found to be similar in decreasing prolapse symptoms as well as associated urinary and bowel symptoms. Pessary fitting is a trial and error process and involves selecting
the ideal type of pessary as well as the correct size. In our experience, it is reasonable to start with a ring (with or without support) pessary, as this is generally the easiest for the patient to manage herself. If the patient cannot retain a ring pessary, we recommend a Gellhorn pessary followed by the Donut or cube pessary.
the ideal type of pessary as well as the correct size. In our experience, it is reasonable to start with a ring (with or without support) pessary, as this is generally the easiest for the patient to manage herself. If the patient cannot retain a ring pessary, we recommend a Gellhorn pessary followed by the Donut or cube pessary.