BOTOX® at the Time of Prolapse Surgery for OAB

NCT04807920 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: 3-2021
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urinary Bladder, Overactive; Pelvic Organ Prolapse

Keywords

Botulinum Toxins, Type A; Mixed Urinary Incontinence; Urgency urinary incontinence

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (5)

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

  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).

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

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

  At 6-12 weeks postoperatively

• Urinary tract infection

  From time of treatment to 12 weeks postoperative

• Urinary retention

  From 2 weeks postoperatively to 12 weeks postoperatively

Study Arms (2)

Intravesical OnabotulinumtoxinA

EXPERIMENTAL

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.

Drug: OnabotulinumtoxinA 100 UNT

Placebo

PLACEBO COMPARATOR

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.

Other: Injectable saline

Interventions

OnabotulinumtoxinA 100 UNT DRUG

Intravesical injection

Intravesical OnabotulinumtoxinA

Injectable saline OTHER

Intravesical injection

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Walter Reed National Military Medical Center: lead

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889-560, United States

RECRUITING

Related Publications (30)

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MeSH Terms

Conditions

Urinary Bladder, Overactive; Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Prolapse; Pathological Conditions, Anatomical

Central Study 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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 19, 2021
• Study Start: September 23, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: October 14, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)