Anticholinergic vs. Botox Comparison Study (ABC)
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|ClinicalTrials.gov Identifier: NCT01166438|
Recruitment Status : Completed
First Posted : July 21, 2010
Results First Posted : December 6, 2017
Last Update Posted : May 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Urge Urinary Incontinence Overactive Bladder||Drug: Botulinum toxin A (Botox A®) Drug: Solifenacin 5mg Drug: Solifenacin 10mg Drug: Trospium chloride||Phase 3|
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 (Clinical Trial)|
|Actual Enrollment :||249 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Efficacy and Impact of Botulinum Toxin A Versus Anticholinergic Therapy for the Treatment of Bothersome Urge Urinary Incontinence|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
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 Name: (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 Name: Vesicare
Drug: Solifenacin 10mg
Oral Solifenacin 10mg once a day for up to 4 months
Other Name: Vesicare
Drug: Trospium chloride
Oral Trospium chloride XR 60mg once a day for up to 2 months
Other Name: Sanctura
- 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.
- 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.
- Efficacy [ Time Frame: 6 months ]Efficacy outcomes assessed reduction and resolution of incontinence, including urgency urinary incontinence (UUI).
- 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.
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01166438
|United States, Alabama|
|The University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35249|
|United States, California|
|USCD Medical Center|
|La Jolla, California, United States, 92037|
|San Diego, California, United States, 92037|
|United States, Illinois|
|Loyola University Medical Center|
|Maywood, Illinois, United States, 60153|
|United States, Michigan|
|Dearborn, Michigan, United States, 48124|
|Royal Oak, Michigan, United States, 48073|
|United States, North Carolina|
|Durham, North Carolina, United States, 27710|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|United States, Pennsylvania|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, Texas|
|University of Texas Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|United States, Utah|
|University of Utah|
|Salt Lake City, Utah, United States, 84132|
|Study Chair:||Anthony Visco, MD||Duke University|