Treating POP and SUI with pessaries

Figure 1

Figure 2

Introduction
Pessaries have been used for thousands of years in various forms to treat pelvic organ prolapse (POP). There is evidence that points to vaginal pessary use as early as 1550 BC with linen or wool soaked in various solutions.¹ Over time, cork and brass were used to construct more modern-day pessaries, and as technology advanced, these materials were replaced by rubber.² Today, pessaries often are made of medical-grade non-reactive silicone, rubber, latex, or a combination thereof, and are shaped in various configurations and sizes to suit individual anatomy. They can be a permanent solution for women who do not desire surgery or who are not surgical candidates for other medical reasons. They can also be used as a temporizing step for women who wish to complete childbearing or to delay surgical treatment.

Indications and contraindications
A pessary fitting can be attempted for the majority of women with POP, stress urinary incontinence (SUI), or both. While there are few true contraindications, relative contraindications do exist. For example, a pessary should not be placed in a patient with evidence of active pelvic or vaginal infection, severe ulceration, or allergies to silicone, latex, or rubber. Caution is also advised to avoid placing pessaries in patients who are noncompliant or unlikely to follow up, as this may lead to long-term retained pessary complications such as infection, severe ulceration, or even fistula.³ 

Pessary fitting
It is helpful to have a fitting kit (separate from pessaries dispensed to patients), which consists of a variety of pessaries, each with a range of sizes. These fitting pessaries are made of silicone and can be sterilized with an autoclave between fittings for different patients. There are two main types of pessaries: support and space-filling. Support pessaries use leverage against firm or bony structures. They include rings, rings with support, dishes, and Shaatz pessaries. Ring and dish pessaries are commonly available with incontinence knobs. In our practice, support pessaries typically are used more commonly for patients with stages 2 and 3 prolapse. In our experience, they are more comfortable and easier to place and remove than other types of pessaries (Figure 1).

Space-filling pessaries occupy the vaginal vault and include Gellhorn, cube, and donut type devices (Figure 2). In our practice, typically these pessaries are used more commonly for patients with stages 3 and 4 prolapse, or when support-type pessaries fail. In our experience, space-filling pessaries are more challenging and uncomfortable for patients to place and remove. 

To fit a pessary, the provider inserts a finger into the vaginal posterior fornix posterior to the cervix, and the distance between the posterior fornix and the pubic notch is measured using the finger length. With that rough guide, the diameter of the pessary should match, but generally, not exceed the vaginal measurement. The leading, apical edge of the pessary is then placed (bending along the flexible axis to accommodate the vaginal introitus if a ring pessary, for example) posterior to the cervix and the following (last to be inserted) edge is placed behind the pubic notch. The largest size that fits comfortably should be used. Pressure points are identified digitally after the pessary is in place. As a rule of thumb, the provider’s finger should be able to be placed between the pessary and the vagina circumferentially around the pessary. If a pressure point is identified, a smaller size or different type of pessary should be used.⁴

To further assess if the pessary is the correct size and shape, the patient is instructed to Valsalva with it in place, then ambulate, jump, and sit to simulate normal activities. In addition, she should be able to void spontaneously with the pessary in place, or else be able to remove the pessary herself to void. In our practice, the provider would then examine the patient again to ensure that the pessary has not slid out of place or shifted. If the fitting pessary is comfortable, a personal pessary can then be dispensed to the patient new from the package or ordered from the manufacturer. 

Self-care versus follow-up care
Typical follow-up after pessary fitting involves a return visit to the outpatient office to evaluate the patient’s satisfaction with pessary management and determine whether the patient wants to self-direct her care, including removing, replacing, and cleaning the pessary or follow up with her provider in the outpatient office.  Whichever the patient chooses, the pessary should be removed and cleaned regularly with soap and water.⁴ If the patient elects for self-care, the pessary may be removed as frequently as daily. In our practice, we recommend doing so at least every 3 months, but there are limited data on which to base this recommendation. In a study about the vaginal microenvironment and its relation to frequency of pessary removal, of 137 women, 25% removed their pessary daily, 39% at least weekly, and 36% less often than weekly.⁵ Women who were older and using more vaginal hormonal therapy tended to remove the pessary less often than once weekly.⁵ Patients should be counseled that the longer the interval between cleaning the more likely they will experience an odor and/or vaginal discharge. If the patient elects outpatient follow-up care, after removal, the vaginal epithelium should be thoroughly examined for erosions or signs of infection. Some pessaries may be difficult to remove, so if this is the case, the patient will likely proceed with in-office care and management. For example, grasping the stem of a Gellhorn pessary with a ring forceps to aid in traction, then breaking the suction of the disc portion of the pessary using a finger in the vagina may be helpful.⁴ A reasonable interval for in-office follow up is 3 to 6 months, and if the patient elects self-care, intervals between visits can be increased to up to 1 year.⁴

Complications and discontinuation
Although most women can be successfully fitted for a pessary, discontinuation is common secondary to side effects including vaginal discharge, infections, and ulcerations.⁶ Some side effects of pessary use are difficult to avoid. For instance, bacterial vaginosis (BV) is three times more common in pessary users compared to the general population.⁷ However, commonly used TrimoSan gel was shown not to decrease incidence of BV in pessary users in a randomized clinical trial.⁸ Other predicting factors for discontinuation include age < 65, stage 3 or greater prolapse, posterior wall prolapse, and initial desire for surgery.⁹ Vaginal estrogen can help with some of these complications, and women who used it exhibited a significantly higher rate of continuation of pessary use (70.4% vs 41.5%, P < 0.001) and a lower rate of bothersome vaginal discharge (hazard ratio 0.31).¹⁰ Severe complications are rare, but include incarceration of the pessary as well as vesicovaginal and rectovaginal fistula formation; 91% of these complications stemmed from neglected pessaries.^4,11 If erosion occurs, the pessary should be removed and discontinued, and vaginal estrogen should be prescribed. If the ulcer is non-healing or is suspicious for malignancy, a biopsy should be considered.¹²

Pessary and POP
The International Continence Society (ICS) definition for female POP is “the descent of the anterior and/or posterior vaginal wall or vaginal apex (uterus or vaginal apex) in women after a hysterectomy.”¹³  The true prevalence of POP is uncertain, given factors such as barriers to care-seeking and patient embarrassment, but studies have found that pelvic floor disorders affect 23.7% of US women, and prolapse affects 2.9% of women aged 20 and older.¹⁴ One aspect of this recent epidemiologic study found that lifetime risk for surgical intervention for POP by age 80 was 12.6%.¹⁴

Effectiveness for prolapse symptoms and QOL
Pelvic floor symptom and quality of life improvements are particularly important with regard to POP therapy because prolapse, while not typically a life-threatening issue, can be a persistent and debilitating condition that significantly impacts patients’ quality of life. The Pelvic Floor Distress Inventory (PFDI-20) and the Pelvic Floor Impact Questionnaire (PFIQ) are two commonly used validated questionnaires to assess pelvic floor symptoms. Several studies using these questionnaires have demonstrated that pessaries are able to achieve a statistically significant improvement in patient-reported pelvic floor symptoms as well as general quality of life.^6,15-17 In addition, patients fit with a pessary had a nearly 50% improvement in body image scores using validated questionnaires as well.¹⁵ Patients who are successfully fit with pessaries can be expected to be satisfied with their use. In fact, Clemons and colleagues reported that overall, 92% of women are satisfied with a pessary if fitted successfully.¹⁸ However, the rate of discontinuation over time is high. In Cundiff’s examination of Ring and Gellhorn pessaries in a crossover comparison, the combined continuation rate was 60% for the first 3-month trial and 57% for the second 3-month trial.¹⁷

Common Types of pessaries for prolapse
The most commonly used pessary models are the ring, which is for support, and the Gellhorn, which is a space-filling device.^6,17 Abdool, et al. studied 359 patients who opted for pessary care for POP and of them, 83% were fitted with a ring pessary and 14% with a Gellhorn pessary with very few fitted with a cube or donut (0.03% and 0.02%, respectively).¹ The ring is widely used because of ease of insertion and vaginal comfort, and it allows for sexual activity without removal.¹⁹ It is also associated with the fewest complications compared to other pessaries.^15,17 In the same crossover trial of ring pessary and Gellhorn pessary, Cundiff et al. showed that the Gellhorn was associated with better effectiveness, but also with more complications such as erosion and vaginal discharge.¹⁷ The cube pessary is used much less often, likely secondary to its adherence to the vaginal mucosa and subsequent development of ulceration.²⁰ 

Sexual function
Data are limited on the topic of sexual function in pessary patients overall. From the data available, it appears that sexual activity is not associated with pessary discontinuation.⁹ However, most women appear to remove their pessary before sexual intercourse. In a study of both sexually active and inactive women using pessaries for pelvic floor disorders, 70% of women removed their pessary for sex, citing “partner can feel during sex” (31%) and “pessary is uncomfortable during sex” (20%).²¹ While women who use pessaries maintain sexual activity, data on sexual function are mixed. One study used the validated Female Sexual Function Index (FSFI), while another used the Pelvic Organ

Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12), and both found that pessary use improved sexual function on their respective indices.^16,20 In a study comparing a pessary and surgery, after 1 year, there was no improvement in sexual function symptoms after use of a pessary, while surgery did show a significant improvement in sexual function. These results are likely skewed given that women who used a Gellhorn pessary in this study were not sexually active at baseline.²²  While it appears that pessary use does not affect sexual activity and may improve sexual function, more high-quality studies are needed to better characterize these outcomes.

Pessaries versus surgery
Multiple trials have shown that, overall, younger women prefer surgical treatment, and older women prefer to use a pessary.^1,17,20 In Lone’s 2015 prospective cohort study of all patients referred to a urogynecology practice for POP undergoing primary treatment for an 18-month period, 46% of patients opted for a pessary with an average age of 67±14.1 years, while patients who elected for surgery were on average 59±11.9 years.²² In this same cohort of patients, both surgery and pessary use improved vaginal bulge and bowel symptoms, with no significant difference between the two.²² In contrast, a recent prospective cohort study performed in Scandinavia revealed that in patients with stage 2 prolapse or greater, prolapse symptoms were significantly less severe in postsurgical patients than in those who opted for a pessary.²³ 

Pessaries and SUI
Incontinence pessaries, like those for POP, are made of silicone or rubber and are placed vaginally. Pessaries for SUI, like those for POP, represent a conservative option as opposed to surgery. In contrast to pessaries for POP, these devices are designed to support the urethra and provide partial compression of it against the pubic bone. The goal is to reduce leakage with activity.^24,25 In US women, prevalence of urinary incontinence is estimated to be 17.1% and 43.1% in women over 40 years of age.¹⁴ This same epidemiological study found that lifetime risk of surgery for SUI by 80 years of age was 13.6%.¹⁴

Types of pessaries for SUI
There are a few factors that influence the type of pessary most suitable for a patient with SUI including severity of incontinence, presence of prolapse, and baseline sexual activity. In addition, if a patient has POP, a device that addresses both pathologies is optimal. Pessaries specific for SUI include the incontinence ring, incontinence ring with support, and the incontinence dish. Often pessaries for SUI have a small knob built into their structure that rests behind the urethra to aid in stabilization and increased urethral resistance to urine flow. The incontinence ring is best for patients who desire sexual activity with the pessary in place, while the incontinence dish or incontinence ring with support may be better for those patients with concomitant POP or who are not sexually active.⁶

Effectiveness for SUI symptoms and QOL
Data to support the effectiveness of pessaries for SUI are mixed. Some studies report improvement of SUI symptoms, with one trial demonstrating 58% of patients experiencing improved SUI symptoms with a pessary.²⁶ Others showed mixed performance of continence pessaries with over half (58%) of patients who were successfully fit eventually discontinuing use of the devices secondary to persistence of incontinence.²⁷ However, one multicenter randomized controlled trial compared pessary use to behavioral therapy and showed no significant difference in pelvic symptom bother and quality of life questionnaires after 3 months of treatment; specifically the aspects of the questionnaires designed to test SUI symptoms showed a non-significant 8.9% difference in scores.²⁸ 

Concomitant treatment for POP and SUI using a pessary can likewise be effective. A prospective study found that 2 months after a successful pessary fitting in those women with both prolapse and SUI, 92% of women were satisfied with therapy, however, their urinary symptoms had only decreased by 50%.¹⁸

Factors predicting success of a pessary for SUI include milder severity of stress incontinence symptoms at baseline, < 14 weekly episodes of incontinence, at least college education, and lack of previous anti-incontinence surgery.²⁹ 

Pessary Vs surgery for SUI: patient characteristics
Younger and sexually active women, as well as those with more severe incontinence symptoms, tended to choose surgical management at the beginning of their treatment course, or eventually escalate to surgical therapy as opposed to continuing to use a pessary.³⁰ Women who desired surgery at the beginning of their treatment course were 59±11.7 versus 64.5±13.5 years of age, and 67% of those who desired surgery were sexually active, while only 44% of those who desired conservative therapy were sexually active.³⁰ 

Sexual function
As with pessary use for POP, data are variable on sexual function and incontinence pessaries. One study found more improvement in sexual function in women with SUI who were treated with behavioral therapy or combined behavioral therapy and a pessary as opposed to those who were treated with a pessary alone.³¹ This improvement was measured using the PISQ-12 survey, and the degree of difference, although statistically significant, may not be clinically significant.³¹ In addition, in a separate study examining only pessary therapy, there was a 17% reported increase in frequency of sexual encounters and 11% reported improvement in sexual satisfaction.³² It appears that although adding treatment to pessary use may have a greater impact on sexual function, from these limited data, pessaries tend to improve sexual function in women who have SUI.

Conclusions
The population of the United States is aging, and the prevalence of women with at least one pelvic floor disorder is increasing, predicted to be 43.8 million by 2050.¹⁴ Estimated surgical rates for SUI or POP are likewise predicted to rise by 42.7% by 2050.¹⁴ Surgery is not an ideal option for all patients, and is associated with risks as well as risk of recurrence with need for reoperation. Women with pelvic floor disorders may present with complicated medical histories and serious comorbidities, which may render surgical therapy unsafe. Pessaries have few contraindications, and typically milder associated complications compared with those related to surgical intervention. Patient satisfaction with pessary therapy for either prolapse or SUI is generally high, and use of the devices can improve quality of life, body image, and sexual function.¹ Therefore, pessaries should be offered as an effective, safe, and nonsurgical option for treatment of pelvic floor disorders.<

Disclosures:

Dr. Rockefeller reports no conflicts. Dr. Ninivaggio receives research support from Cook MyoSite®.

References:

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