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

NCT02995967 | Terminated Results DMC

• 1 other identifier: F160629005
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Symptom Bother

  The primary outcome will be measured as change from baseline at 12 weeks using the OAB-q bother subscale which consists of eight questions assessing symptom bother with a possible score from 0 to 100 with a higher score indicating greater symptom bother.

  12 weeks

Secondary Outcomes (9)

• Urge Urinary Incontinence Episodes

  12 weeks

• Total Number of Voids

  12 weeks

• Subjects Requiring Clean Intermittent Self-catheterization

  2 weeks

• Post Void Residual Volume

  2 weeks

• Rate of UTI

  2 weeks

Study Arms (2)

Botulinum toxin A alone group

ACTIVE COMPARATOR

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

Drug: Botulinum toxin-A

Hydrodistention group

EXPERIMENTAL

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

Procedure: Hydrodistention

Interventions

Hydrodistention 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.

Hydrodistention group

Botulinum toxin-A DRUG

Intradetrusor injection of 100 units of botulinum toxin a

Botulinum toxin A alone group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama Birmingham Hospital

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Botulinum Toxins, Type A

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

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Joseph Malek
• Organization: UAB

jmalek@uabmc.edu

2059965466

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 9, 2016
• First Posted: December 19, 2016
• Study Start: November 1, 2016
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: March 13, 2019
• Results First Posted: December 12, 2018

Record last verified: 2019-02

Locations

US (1)