Clinical trial NCT01092624: Clinical Trial of Solifenacin Versus Placebo Plus Pessary for Women With Vaginal Prolapse
Official title: A Randomized, Placebo-Controlled Parallel-Design Trial of the Effect of Solifenacin Treatment for Overactive Bladder in Women With Anterior Vaginal Wall Prolapse Managed With a Pessary (the "PESSARY" Study)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pelvic Organ Prolapse
Keywords: voiding dysfunction
defecatory dysfunction
vaginal bulge symptoms
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Inc
First posted: 2010-03-25
Enrollment: 94
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effect of pessary therapy, with and without Solifenacin (Vesicare), on symptoms of over active bladder and bladder function in women with overactive bladder symptoms and pelvic organ prolapse.

Study Hypotheses:

Null hypothesis, HO: Reduction of anterior vaginal wall prolapse and treatment with solifenacin does not improve overactive bladder symptoms more than reduction of anterior vaginal wall prolapse and placebo.

Alternate hypothesis, HA: Reduction of anterior vaginal wall prolapse and treatment with solifenacin does improve overactive bladder symptoms more than reduction of anterior vaginal wall prolapse and placebo.

Detailed description: Pelvic organ prolapse (POP) affects approximately half of all women over age 501. The most common type of POP is anterior vaginal wall prolapse. Symptoms associated with POP include: voiding dysfunction, defecatory dysfunction and vaginal bulge symptoms. Treatments for pelvic organ prolapse include among other options, vaginal pessary or surgery. Several studies have documented improved vaginal bulge symptoms in women treated with a pessary2,3,4; however, data are sparse regarding the effect of pessaries on lower urinary tract symptoms, specifically with regard to over active bladder symptoms.

Overactive bladder, observed in approximately 40% of women 50 years of age or older, is very common in women with pelvic organ prolapse. Two retrospective studies have shown improvement in women with overactive bladder symptoms following treatment with a vaginal pessary. One study (using a non-validated questionnaire) found that, at two month follow-up, patients successfully fitted with a pessary experienced a reduction in slightly less than half of their urge incontinence symptoms.5 A second study (using the Sheffield pelvic organ prolapse symptom questionnaire), revealed that 4 months after insertion of a pessary, 38% of patients experienced reduced urinary urgency, and 29% experienced reduced urge urinary incontinence6. Despite these data, many women stop using a pessary secondary to complaints of increased urine incontinence. More information is needed on pessary therapy impact on bladder function.

Specific Aim(s):

This study will prospectively evaluate women with pelvic organ prolapse and overactive bladder symptoms treated with either

1. a pessary and solifenacin, or
2. a pessary and placebo. We will assess the effects of these therapies on overactive bladder symptoms over the course of the 14-week study.

Eligibility criteria: Inclusion Criteria:

* Female
* Age ≥ 18 years
* Have experienced symptoms of overactive bladder (e.g., urinary urgency, frequency, or urge incontinence) for at least 3 months. Specifically women must average 8 or more voids in 24 hours and have 3 or more episodes of urinary urgency or urge incontinence over the 72 hours when the diary is being completed.
* A practitioner trained in the pelvic organ prolapse quantification examination will evaluate each woman's pelvic organ support and vaginal dimensions. Women with a stage 1 or greater vaginal prolapse will be eligible for the study.

Exclusion Criteria:

* The presence of factors that would contraindicate use of antimuscarinic medications (e.g. urine retention, narrow angle glaucoma, uncontrolled constipation, dementia)
* An existing condition that would contraindicate use of a vaginal pessary (e.g., patient's vaginal length \<6 cm)
* Patient is currently using a vaginal pessary.
* Patient is unable to tolerate an object in vagina
* Patient has a history of cervical, vaginal or endometrial cancer
* Patient is not able to speak English
* Patient is currently using an anticholinergic medication, or has used one in the past 30 days
* Patients with mixed urine incontinence that is predominantly stress urine incontinence (determined by their baseline PFDI)
* Patients with a known allergy to solifenacin.
* Patients with severe hepatic impairment.

Primary outcomes:
measure: The Effect of These Therapies on Over-Active Bladder Symptoms
timeFrame: 14-Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
Study officials:
affiliation: Hartford Hospital, Women's Specialty Services
name: Paul Tulikangas, MD
role: PRINCIPAL_INVESTIGATOR
References: