BOTOX® at the Time of Prolapse Surgery for OAB

Walter Reed National Military Medical Center

Status and phase: Unknown; Phase 4

Conditions: Urinary Bladder, Overactive; Pelvic Organ Prolapse

Treatments: Drug: OnabotulinumtoxinA 100 UNT; Other: Injectable saline

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT04807920

3-2021

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 138 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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138 participants in 2 patient groups, including a placebo group

Intravesical OnabotulinumtoxinA

Experimental group

Description:

The treatment group will receive 100 units of BOTOX® reconstituted in 10mL of injectable preservative-free normal saline at the time of cystoscopy. An injection cystoscopy needle will be set to 3mm and used to inject 0.5mL reconstituted OnabotulinumtoxinA at each injection site, approximately 1cm apart along the posterior bladder wall, for a total of 20 injection sites (4 rows of 5 injection sites). This will be the only treatment.

Treatment:

Drug: OnabotulinumtoxinA 100 UNT

Placebo

Placebo Comparator group

Description:

Subjects randomized to the placebo group will undergo the same procedure but will only receive 10mL of injectable preservative-free normal saline. This will be the only treatment.

Treatment:

Other: Injectable saline