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| Sponsor: | Mayo Clinic |
|---|---|
| Information provided by: | Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00667095 |
Purpose
The purpose of this study is to determine whether women with overactive bladder (OAB) who receive direct instillation via a catheter of a Botulinum-A Toxin (Botox) with Dimethyl Sulfoxide (DMSO) solution experience significantly better improvement of their OAB symptoms when compared to a similar group of women with OAB who receive instillation of DMSO only.
| Condition | Intervention | Phase |
|---|---|---|
|
Overactive Bladder Urinary Urge Incontinence Urinary Incontinence Detrusor Hyperreflexia Urge Incontinence |
Procedure: Botox Instillation Procedure: Placebo Instillation |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study |
| Official Title: | Evaluation of the Efficacy of Botulinum-A Toxin/DMSO Instillation in the Treatment of Women With Over Active Bladder (OAB) Syndrome and/or Urinary Urge Incontinence |
| Estimated Enrollment: | 70 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | June 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Botulinum-A Toxin (Botox)/Dimethyl Sulfoxide (DMSO) Solution
|
Procedure: Botox Instillation
1 bladder instillation of 50cc of Botox/DMSO solution
|
|
2: Placebo Comparator
Dimethyl Sulfoxide (DMSO) solution
|
Procedure: Placebo Instillation
1 bladder instillation of 50cc Dimethyl Sulfoxide (DMSO) solution
|
The primary objective of this study is to evaluate the efficacy of catheter-based instillation of a solution of Botox/DMSO as a novel method for treating women with overactive bladder (OAB) and secondary urinary incontinence who have failed oral pharmacologic therapy. This study will test the broad hypothesis that administration of Botox/DMSO instillations into the bladder with a urethral catheter can significantly improve symptoms and quality of life in patients with OAB when compared to DMSO installations alone. Explicitly, we hypothesize that scores on the validated Incontinence Quality of Life (I-QOL) questionnaire of women with OAB who receive Botox/DMSO instillation will be much improved at three-month follow-up compared to similar women receiving DMSO instillation alone. Our long-term goal is to offer women with detrusor hyperreflexia or OAB a less invasive alternative to surgery and an alternative to anticholenergic by mouth medications. In support of this effort, we are proposing a randomized, double-blind, placebo controlled clinical trial to be conducted in the Department of Urology at Mayo Clinic Jacksonville.
This study will have 2 groups assigned: initial and re-treat. The initial group will be randomized (as a flip of a coin) to either Botox/DMSO or DMSO instillation and will be followed for 3 months. Patients who received DMSO only instillation during the initial group will be entered into the re-treat group to receive Botox/DMSO instillation and will be followed for 3 months also. Patients who received Botox/DMSO instillation in the initial group will not be entered in the re-treat group - they will be complete from study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Study Hotline | 904-953-0473 | |
| Contact: Yvette Phillips | 904-953-2255 |
| United States, Florida | |
| Mayo Clinic | Recruiting |
| Jacksonville, Florida, United States, 32224 | |
| Contact: Study Hotline 904-953-0473 | |
| Contact: Yvette Phillips 904-953-2255 | |
| Principal Investigator: Steven P Petrou, MD | |
| Principal Investigator: | Steven P Petrou, MD | Mayo Clinic |
More Information
| Responsible Party: | Mayo Clinic ( Steven P. Petrou, MD ) |
| Study ID Numbers: | 07-007399 |
| Study First Received: | April 23, 2008 |
| Last Updated: | April 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00667095 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
OAB Over Active Bladder overactive bladder Urinary Urge Incontinence Urinary Incontinence Botox |
DMSO bladder instillation instillation detrusor hyperreflexia urge incontinence |
|
Urinary Bladder, Overactive Antioxidants Molecular Mechanisms of Pharmacological Action Urination Disorders Physiological Effects of Drugs Nervous System Diseases Urinary Bladder Diseases Neuromuscular Agents Protective Agents Cryoprotective Agents Pharmacologic Actions |
Urological Manifestations Signs and Symptoms Dimethyl Sulfoxide Urologic Diseases Free Radical Scavengers Neurologic Manifestations Urinary Incontinence Reflex, Abnormal Peripheral Nervous System Agents Urinary Incontinence, Urge Botulinum Toxin Type A |