Evaluation of Botulinum Toxin A Alone Versus Botulinum Toxin A With Hydrodistension for Treatment of Overactive Bladder

NCT ID: NCT02995967

Last Updated: 2019-03-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2017-12-31

Brief Summary

The specific aim of this trial is to determine if hydrodistention at the time of intradetrusor injection of botulinum toxin A has additional benefit in patients with refractory overactive bladder (OAB) and urgency symptoms compared to intradetrusor injection of botulinum toxin A alone.

Consented patients will be randomized to hydrodistention at a pressure of 80 cm H2O for 5 minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A (hydrodistention group) or intradetrusor injection of 100 units of botulinum toxin A alone (botulinum toxin A alone group).

The primary aim will be subjective improvement measured as change from baseline at 12 weeks using the OAB-q bother subscale.

Conditions

Overactive Bladder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Botulinum toxin A alone group

Just the intradetrusor injection of 100 units of botulinum toxin A alone

Group Type: ACTIVE_COMPARATOR

Botulinum toxin-A

Intervention Type: DRUG

Intradetrusor injection of 100 units of botulinum toxin a

Hydrodistention group

Hydrodistention at a pressure of 80 cm H2O for 5 minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A

Group Type: EXPERIMENTAL

Hydrodistention

Intervention Type: PROCEDURE

The hydrodistention will then be performed with the bladder filled at a pressure of 80 cm H2O and noted to be full as evidenced by no further influx of water into the bladder. This volume will be held in the bladder for 5 minutes.

Interventions

Hydrodistention

The hydrodistention will then be performed with the bladder filled at a pressure of 80 cm H2O and noted to be full as evidenced by no further influx of water into the bladder. This volume will be held in the bladder for 5 minutes.

Intervention Type: PROCEDURE

Botulinum toxin-A

Intradetrusor injection of 100 units of botulinum toxin a

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Women with refractory overactive bladder symptoms, failing a credible behavioral therapy intervention and medical therapy or not tolerating medical therapy. Patients who are on medical therapy will stop the medical therapy for at least 2 weeks prior to botulinum toxin A treatment in the study
• Female ≥ 18 years old
• Desires further treatment for OAB symptoms.
• Express understanding and ability to perform clean intermittent self-catheterization (CISC) if required.
• Ability to consent
• Ability to complete all study related items and interviews

Exclusion Criteria

• Post void residual urine volume > 150 mL as assessed by catheter or ultrasound
• History of intradetrusor botulinum toxin A injection
• History of or current cancer of the genitourinary or gynecology tract
• Neurogenic bladder
• Interstitial cystitis
• Current urinary tract infection (can be treated and re-considered for study)
• Current active sacral neuromodulation device
• Non-English speaking
• History of chronic pelvic pain
• Hematuria not previously evaluated

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Joseph Malek

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Alabama Birmingham Hospital

Birmingham, Alabama, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

F160629005

Identifier Type: -

Identifier Source: org_study_id