BOTOX® at the Time of Prolapse Surgery for OAB

Walter Reed National Military Medical Center138 enrolled

Overview

The purpose of the study will be to assess the efficacy and safety of bladder BOTOX® for overactive bladder symptoms, such as urinary urgency and frequency, given at the time of prolapse surgery.

After being informed about the study and the potential risks, women scheduled for prolapse surgery will be screened for bothersome overactive bladder symptoms. Those that qualify and choose to enroll will be randomized to receive either bladder BOTOX® or a placebo at the time of their surgery. Neither the patient nor the investigators will know if the patient receives BOTOX® or a placebo. Subjects will complete questionnaires and bladder diaries both before and after surgery to determine efficacy and patient satisfaction. Potential adverse events, such as urinary tract infections and urinary retention, will be monitored throughout the study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

138

Conditions

Urinary Bladder, Overactive Pelvic Organ Prolapse

Interventions

OnabotulinumtoxinA 100 UNTDRUG

Intravesical injection

Injectable salineOTHER

Intravesical injection

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Women scheduled for prolapse surgery * Bothersome OAB symptoms determined by a score of \>20 on the OAB-q SF * Willingness to perform clean intermittent catheterization (CIC) * Ability to follow study instructions and complete required follow up Exclusion Criteria: * Contraindications or allergy to Onabotulinumtoxin A * Intravesical Onabotulinumtoxin A within 3 months of the planned surgery date * Total body Onabotulinumtoxin A dose of ≥ 400 Units in the 3 months prior to the scheduled surgery date. * Inability or unwillingness to self-catheterize * Post-void residual ≥ 200mL * Neurogenic bladder or other neurological diseases that may cause voiding dysfunction * Concurrent use of other pharmacological treatment for the treatment of OAB symptoms at the time of prolapse repair surgery. * Females who are pregnant, think they may be pregnant at the start of the study, planning a pregnancy during the active treatment phase of the study, or who are unwilling or unable to use a reliable form of contraception during the active treatment phase of the study. * Inability to speak or read English

Locations (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

RECRUITING

Outcomes

Primary Outcomes

Change from baseline to postoperative weeks 6 to 12 in Overactive Bladder bother short form (OAB-q SF) questionnaire looking for a decrease of 10 points, which is the minimally important difference.

The OAB-q SF is a validated 6 item questionnaire that is scored and reported on a 0 to 100 point scale with increasing scores indicating more bother.

Time frame: From baseline (time of enrollment) to 6-12 weeks postoperatively

Secondary Outcomes

Change from baseline to postoperative weeks 6 to 12 in the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form (PISQ-12).

The PISQ-12 is a 12 item validated questionnaire that evaluates sexual function in women with urinary incontinence and/or pelvic organ prolapse. It is reported on a scale of 0-48, with a higher score indicating worse sexual function.

Time frame: From baseline (time of enrollment) to 6-12 weeks postoperatively

Change from baseline to postoperative weeks 6 to 12 in Patient Global Impression of Severity Scale (PGI-S).

The PGI-S is a 7 point Likert scale, ranging from 1 to 7, with an increasing score indicating greater severity.

Time frame: From baseline (time of enrollment) to 6-12 weeks postoperatively

Patient Global Impression of Improvement Scale (PGI-I) at 6 to 12 weeks postoperatively.

The PGI-I is a 7 point Likert scale, ranging from 1 to 7, with an increasing score indicating less improvement.

Time frame: At 6-12 weeks postoperatively

Urinary tract infection

Rate of urinary tract infections based on clinical suspicion and urine culture results

Time frame: From time of treatment to 12 weeks postoperative

Urinary retention

Central Contacts

Joy E Wheat, MD

CONTACT

201-710-5109 joy.e.wheat.mil@mail.mil

Christine Vaccaro, DO

CONTACT

301-400-2468 christine.m.vaccaro.mil@mail.mil

Data from ClinicalTrials.gov

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