Vaginal Creams for Reduction of Vaginal Discharge and Erosion in Patients Using Ring With Support or Gellhorn Pessaries to Reduce Pelvic Organ Prolapse

Pelvic organ prolapse (POP) is a health concern for millions of women worldwide. Patients have a variety of symptoms from POP including: vaginal bulging, vaginal pressure, constipation and urinary incontinence (1). It is estimated that the lifetime risk of undergoing surgery for prolapse or incontinence is 11%. The lifetime risk for recurrence of POP after surgery is 10-20% (2). Treatment options for POP include kegel exercises, pessaries or surgical management. Due to lifestyle, timing or inability to undergo surgery secondary to medical comorbidities the pessary can be a very reasonable alternative to surgical management of POP.

There are two categories of pessaries: support and space occupying. Support pessaries are usually recommended for early stage of prolapse with adequate perineal support and include the ring pessary, Gehrung, Hodge and Shaatz. While space-occupying pessaries such as the Donut, Gellhorn, Cube and Inflataball are used for advanced stage prolapse with less perineal support and a wide genital hiatus (3). As the ring and the Gellhorn pessary are the most commonly used pessaries and can be inserted for all stages of prolapse, our study will focus on the use of the ring with support and the Gellhorn for treatment of POP (4).

After menopause, estrogen levels decline. This may allow postmenopausal vaginal pH to increase to the range of 5.0-7.5. At these higher pH levels, lactobacillus survival is hindered, and vaginal colonization by other bacterial species predisposes women to symptomatic vaginitis (5). Discontinuation of pessary use is often due to discomfort, expulsion, urinary retention bothersome vaginal discharge and vaginal erosion (6). Common complications with pessary use are erosions (8.9%), or vaginal infections (2.5%) (7). Some studies have shown an erosion rate as high as 21% (6). Patients often complain of vaginal discharge with pessary use that is malodorous and bothersome. Local estrogen can help to restore the vaginal pH and help reduce vaginal discharge. The moisturizing properties of vaginal lubricants and creams may help reduce vaginal erosion in pessary users. We would like to compare Estrace ® to a placebo. The placebo will be the hormone replacement therapy (HRT) base cream in Estrace ® without the estradiol.

No randomized control trials (RCT) have been performed showing if application of local hormone (Estrace) is superior to application of local nonhormonal vaginal cream for reduction of the bothersome symptom of vaginal discharge and subsequently erosion. We would like to compare vaginal estrogen against placebo as a mechanism to prevent bothersome discharge and prevention of vaginal erosion in women fitted with pessaries for pelvic organ prolapse.

Study Population In general, the study population will be patients of the Urogynecology practice of North Shore-Long Island Jewish Health System who present to the clinic for their initial pessary fitting. Patients will be fitted with either a ring with support or Gellhorn pessary and will return at intervals of 2, 6 and 12 weeks for follow up.