Clinical Trial: Over Active Bladder Instillation Study - Botox

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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 anticholinergic 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, Florida.

Note: The study was terminated early in July of 2011 due to an extended medical absence of the Principal Investigator.

Current Primary Outcome: Change in Incontinence Quality of Life (I-QoL) Score [ Time Frame: Baseline, 1 month, 3 months ]

Original Primary Outcome: To evaluate the efficacy of Botox/DMSO instillations compared to DMSO instillations alone for the treatment of OAB by assessing changes in incontinence quality of life scores [ Time Frame: 3 month follow-up ]

Current Secondary Outcome:

• Change in Incontinence Impact Questionnaire Short Form (IIQ-7) [ Time Frame: baseline, 1 month, 3 months ]
  The IIQ-7 measures the effect of urinary incontinence on quality of life. It is comprised of 7 items, each with the response scale from "0=Not at all" to "3=Greatly." The scores can range from 0 to 21; a low score indicates less impact of incontinence on quality of life.
• Change in International Consultation on Incontinence Questionnaire - Short Form Score (ICIQ-SF) [ Time Frame: baseline, 1 month, 3 months ]
  The ICIQ-SF provides a brief and robust measure to assess the impact of symptoms of incontinence on quality of life and outcome of treatment. The questionnaire has 4 items and the score can range from 0 to 21, with greater values indicating increased severity of symptoms and lower quality of life.
• Change in Urogenital Distress Inventory (UDI-6) [ Time Frame: baseline, 1 month, 3 months ]
  The UDI-6 measures the effect of urinary incontinence on quality of life. It consists of 6 items, each with the response scale from "0=Not at all" to "3=Greatly." The scores can range from 0 to 18; a low score indicates less impact of incontinence on quality of life.
• Number of Participants With Decrease in Blaivas-Groutz Anti-Incontinence Score at 1 Month and 3 Months [ Time Frame: baseline, 1 month, 3 months ]
  The Blaivas-Groutz Anti-incontinence scale was used as a measure of urinary incontinence. This scale combines information on the number of incontinent episodes in a 24-hour period, 24-hour pad weights, and a qualitative rating by the patient into a single score ranging from 0 to 6. this score is then used to categorize incontinence as none (0), mild (1-2), moderate (3-4), or severe (5-6).
• Number of Participants With a Decrease in Urinary Urgency at 1 Month and 3 Months [ Time Frame: Baseline, 1 month, 3 months ]
  Urinary urgency was measured by the Indevus Urgency Severity Scale (IUSS). The IUSS asks patients to assess the severity of 'urgency' at each void. The scale employs the following wording: "Degree of urgency is meant to describe your urge to urinate. Sometimes you may feel a very strong urge to urinate and at other times, you may feel a milder urge prior to the onset of a toilet void. Rate this feeling by circling 0, 1, 2, or 3, defined as: 0: NONE - no urgency, 1: MILD - awareness of urgency, but it is easily tolerated and you can continue with your usual activity or tasks, 2: MODERATE - enough urgency discomfort that it interferes with or shortens your usual activity or tasks, 3: SEVERE - extreme urgency discomfort that abruptly stops all activity or tasks."

Original Secondary Outcome: To compare Botox/DMSO instillation and DMSO instillation by validated urinary incontinence quality of life questionnaires and measurement tools used for summarizing the frequency and severity of urinary incontinence. [ Time Frame: 1 and 3 month follow-up ]

Information By: Mayo Clinic

Dates:
Date Received: April 23, 2008
Date Started: April 2008
Date Completion:
Last Updated: July 10, 2014
Last Verified: July 2014