Anticholinergic vs. Botox Comparison Study (ABC)

April 30, 2018 updated by: NICHD Pelvic Floor Disorders Network

Efficacy and Impact of Botulinum Toxin A Versus Anticholinergic Therapy for the Treatment of Bothersome Urge Urinary Incontinence

Urinary incontinence is a prevalent condition that markedly impacts quality of life and disproportionately affects women. Overactive Bladder syndrome (OAB) is defined as symptoms of urgency and frequency with urge urinary incontinence (OAB-wet) and without urge incontinence (OAB-dry). Conservative first line treatments for urge incontinence combined with other OAB symptoms (OAB-wet) include behavioral therapy, pelvic floor training +/- biofeedback, or the use of anticholinergic medications. These treatment modalities may not result in total continence and often drug therapy is discontinued because of lack of efficacy, side effects and cost or because of not wanting to take a pill. Behavioral therapy and pelvic muscle exercises require consistent, active intervention by the patient which is often not sustained. Thus, the objective of the Anticholinergic vs Botox Comparison Study (ABC) is to determine whether a single intra-detrusor injection of botulinum toxin A (Botox A®) is more effective than a standardized regimen of oral anticholinergics in reducing urge urinary incontinence. The null hypothesis is that there is no difference in the change from baseline in average number of urge urinary incontinence episodes over 6 months between groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a 6-month double-blind randomized trial comparing intra-detrusor botulinum toxin A (Botox A®) and anticholinergic therapy in women without neurologic disease with urge incontinence. Subjects will be followed up to an additional six months off study drug to determine duration of treatment effect.

The primary aim is to compare the change in urge incontinence episodes over 6 months between women receiving a single intra-detrusor injection of 100 unit of botulinum toxin A (Botox A®) plus daily oral placebo tablets versus women receiving a single intra-detrusor injection of saline plus daily anticholinergic therapy.

Study Type

Interventional

Enrollment (Actual)

249

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • The University of Alabama at Birmingham
    • California
      • La Jolla, California, United States, 92037
        • USCD Medical Center
      • San Diego, California, United States, 92037
        • Kaiser Permanente
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
    • Michigan
      • Dearborn, Michigan, United States, 48124
        • Oakwood Hospital
      • Royal Oak, Michigan, United States, 48073
        • Beaumont Hospital
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Magee-Women's Hospital
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Subject has signed informed consent.
  • Females at least 21 years of age
  • Five or more urge urinary incontinence episodes on a three-day voiding diary. Urge incontinence episodes will be determined based on voiding diary and subject indication of coincident urge symptoms, allowing self-characterization of incontinence type.
  • Urge predominant (urge >50% of total incontinent episodes) urinary incontinence based on self-reported characterization of incontinent episodes on diary.
  • Demonstrated ability (or have caregiver demonstrate ability) to perform clean intermittent self-catheterization in the event that this would be required.
  • Request for treatment for urge urinary incontinence. The patient may have tried other non-pharmacologic treatments for urge incontinence, such as supervised behavioral therapy, supervised physical therapy, unsupervised physical therapy, supervised biofeedback, and transvaginal electrical stimulation.
  • Subject has undergone 3-week washout period if subject were on anticholinergic therapy prior to enrollment.
  • Subject is able to complete all study related items and interviews.

Exclusion Criteria:

  • Any previous therapy with trospium chloride, solifenacin, or darifenacin
  • Failed three or more anticholinergic drugs.
  • Contraindication to anticholinergic therapy, specifically with solifenacin or trospium.
  • Current symptomatic urinary tract infection that has not resolved prior to randomization.
  • Uncontrolled narrow-angle glaucoma
  • Gastric retention
  • Baseline need for intermittent self catheterization
  • PVR >150ml on 2 occasions with void(s) of greater than 150ml
  • Surgical treatment for stress incontinence (sling, Burch or urethral injection) or pelvic organ prolapse recommended or planned at enrollment by study investigator(s).
  • Any prior intra-detrusor botulinum toxin A injections
  • Previous or currently implanted neuromodulation (sacral or tibial).
  • Surgically altered detrusor muscle, such as augmentation cystoplasty.
  • Known allergy to botulinum toxin A.
  • Women with known neurologic disease believed to potentially affect urinary function (Multiple sclerosis, spinal cord injuries, myasthenia gravis, Charcot-Marie-Tooth disease).
  • Known allergy to lidocaine.
  • Currently pregnant or lactating patients or patients planning pregnancy within the next year.
  • Sexually active premenopausal women with a uterus who have either not had a tubal ligation or are not on a medically approved form of contraception for at least 3 months prior to and throughout the duration of the study.
  • Cystoscopic findings that preclude injection, in the opinion of the investigator.
  • Current or prior bladder malignancy.
  • In the opinion of the investigator, inability to understand diary instructions and complete 3-day voiding diary.
  • Subjects who are on anticoagulant therapy,excluding aspirin
  • Subject has been previously diagnosed with interstitial cystitis or chronic pelvic pain syndrome.
  • Subjects with hematuria who have not undergone a clinically appropriate evaluation.
  • Subjects taking aminoglycosides at the time of injection.
  • Serum creatinine level greater than twice the upper limit of normal within the previous year.
  • Two or more hospitalizations for medical conditions in the previous year.
  • Plans to move out of area in the next 6 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Botox A
A single intradetrusor injection of 100U botulinum toxin A (Botox A®) plus daily oral placebo tablets
Drug: Botulinum toxin A (Botox A®)
A single intradetrusor injection of 100U botulinum toxin A in 10 mL plus 0.1 mL of indigo carmine administered during cytoscopy. Between 100 and 200ml of saline is instilled into the bladder prior to injection to allow adequate visualization of the entire bladder urothelium. The treating physician will inject a total of 10.1 mL of the masked substance into approximately 15 to 20 different detrusor muscle sites under direct visualization using disposable needles. Injections will be spread out to equally cover the posterior bladder wall and dome, but spare the bladder trigone and ureteral orifices.
Other Names:
  • (Botox A®)
Active Comparator: Standardized Anticholinergic Regimen
A standardized 3-step anticholinergic regimen of daily oral solifenacin 5mg, solifenacin 10mg, and/or trospium chloride XR 60mg, as well as a single intradetrusor injection of saline (placebo). All subjects will begin on solifenacin 5 mg for 2 mo. If a subject's symptoms are not adequately controlled at 2 mo, she will be escalated to solifenacin 10mg, and similarly at 4 mo to trospium XR 60mg. If a subject's symptoms are adequately controlled on solifenacin 5 mg, she may continue that study medication for the entirety of the study (6 mo). Additionally, if a subject is dose-escalated to solifenacin 10mg at study mo 2 or 4, and her symptoms are adequately controlled, she may continue the solifenacin 10mg dose for the remainder of the study.
Drug: Solifenacin 5mg
Oral Solifenacin 5mg once a day for up to 6 months
Other Names:
  • Vesicare
Drug: Solifenacin 10mg
Oral Solifenacin 10mg once a day for up to 4 months
Other Names:
  • Vesicare
Drug: Trospium chloride
Oral Trospium chloride XR 60mg once a day for up to 2 months
Other Names:
  • Sanctura

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Urge Urinary Incontinence (UUI) Episodes
Time Frame: Baseline through 6 months
Change from baseline in mean number of UUI episodes over 6 month double-blind period.
Baseline through 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Score on OABq-SF
Time Frame: Baseline through 6 months
Values for the Overactive Bladder Questionnaire Short Form (OABq-SF) are changes from baseline in the adjusted mean scores for months 1 to 6. Scores on the OABq-SF range from 0 to 100, with higher scores on the symptom-severity scale indicating greater severity of symptoms and higher scores on the quality-of-life scale indicating better quality of life. Data were available for 123 participants in the Standardized Anticholinergic Regimen group and 119 in the Botox A A group.
Baseline through 6 months
Efficacy
Time Frame: 6 months
Efficacy outcomes assessed reduction and resolution of incontinence, including urgency urinary incontinence (UUI).
6 months
Change in PFDI-SF and PFIQ-SF Total Scores
Time Frame: Baseline through 6 months
Values for Pelvic Floor Distress Inventory Short Form (PFDI-SF) are changes from baseline in the adjusted mean scores for months 3 to 6. Scores on the PFDI-SF range from 0 to 300, with higher scores indicating more symptoms and more bothersome symptoms. Values for the Pelvic Floor Impact Questionnaire Short Form (PFIQ-SF) are changes from baseline in the adjusted mean scores for months 3 to 6. Scores on the PFIQ-SF range from 0 to 300, with higher scores indicating a more negative effect on activities, relationships, and feelings.
Baseline through 6 months
Patient Global Impression of Improvement
Time Frame: 3 and 6 months
The Patient Global Impression of Improvement (PGI-I) is a patient-reported measure of perceived improvement with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse). Included here are participants who had adequate improvement, defined as a rating of 1 or 2 (much better).
3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NICHD Pelvic Floor Disorders Network

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Study Chair: Anthony Visco, MD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

July 19, 2010

First Submitted That Met QC Criteria

July 19, 2010

First Posted (Estimate)

July 21, 2010

Study Record Updates

Last Update Posted (Actual)

May 2, 2018

Last Update Submitted That Met QC Criteria

April 30, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PFDN 17
  • 2U10HD041261 (U.S. NIH Grant/Contract)
  • 2U10HD041267 (U.S. NIH Grant/Contract)
  • 2U01HD041249 (U.S. NIH Grant/Contract)
  • 2U10HD041250 (U.S. NIH Grant/Contract)
  • 1U10HD054136 (U.S. NIH Grant/Contract)
  • 1U10HD054214 (U.S. NIH Grant/Contract)
  • 1U10HD054215 (U.S. NIH Grant/Contract)
  • 1U10HD054241 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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