Anticholinergic vs. Botox Comparison Study

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01166438
Study type	Interventional
Source	NICHD Pelvic Floor Disorders Network
Contact
Status	Completed
Phase	Phase 3
Start date	March 2010
Completion date	May 2012

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04578899` - "The Effectiveness of Transvertebral Magnetic Neuromodulation in Patients With Detrusor Overactivity"	N/A
Active, not recruiting	`NCT03556891` - Pivotal Study of eCoin for Overactive Bladder With Urgency Urinary Incontinence	N/A
Not yet recruiting	`NCT05977634` - Transcutaneous Tibial Nerve Stimulation for Idiopathic Overactive Bladder	N/A
Completed	`NCT01955408` - Severity of Overactive Bladder Symptoms in Patients After Synergo Treatment	N/A
Recruiting	`NCT06201013` - Efficacy and Safety of Vitamin D in the Treatment of OAB-wet in Children	N/A
Recruiting	`NCT03727711` - TPTNS: Home vs Hospital Treatment for Overactive Bladder	N/A
Completed	`NCT00768521` - A Study to Test the Effects of Tolterodine Tartrate in Patients With Overactive Bladder (0000-107)	Phase 1
Completed	`NCT03625843` - Mindfulness Exercises to Reduce Anxiety and Pain During Urodynamic Testing	N/A
Completed	`NCT02211846` - A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron OCAS (Oral Controlled Absorption System) in Pediatric Subjects With Neurogenic Detrusor Overactivity or Overactive Bladder	Phase 1
Completed	`NCT02835846` - Investigation of the Effect of the Female Urinary Microbiome on Incontinence	Phase 4
Completed	`NCT02857816` - PRospective Study to Evaluate EffectivenesS With the NURO™ PErcutaneous Tibial Neuromodulation System in Patients With OAB	N/A
Withdrawn	`NCT02320201` - Foot Neuromodulation for Overactive Bladder in Children	N/A
Completed	`NCT02202031` - Controlling Urgency Through Relaxation Exercises	N/A
Not yet recruiting	`NCT01409512` - Evaluation of Autonomic System Before and After Anticholinergic Treatment in Women With Overactive Bladder	N/A
Completed	`NCT01437670` - Observational Study to Estimate the Dry Mouth in OAB Patients With Solifenacin	N/A
Completed	`NCT01458197` - A Phase 2 Study to Compare the Efficacy and Tolerability of Tarafenacin 0.2 mg and Tarafenacin 0.4 mg to Placebo in Patients Suffering From Overactive Bladder.	Phase 2
Not yet recruiting	`NCT01423838` - Comparison of Solifenacin and Oxybutynin in the Treatment of Overactive Bladder	Phase 4
Terminated	`NCT01758848` - Physical Therapy for Overactive Bladder	N/A
Withdrawn	`NCT01210859` - Effects of Antimuscarinic Drugs on Overactive Bladder (OAB) Symptoms After Insertion of Ureteral Stents	N/A
Completed	`NCT00928070` - A Study Of Efficacy And Safety Of Fesoterodine In Vulnerable Elderly Subjects With Overactive Bladder	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Anticholinergic vs. Botox Comparison Study — ABC

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms