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
Overview
- Phase
- Phase 3
- Intervention
- Botox Instillation
- Conditions
- Overactive Bladder
- Sponsor
- Mayo Clinic
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Change in Incontinence Quality of Life (I-QoL) Score
- Status
- Terminated
- Last Updated
- 11 years ago
Overview
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 Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Female patient aged 18 years or older
- •No evidence of stress urinary incontinence on physical examination or urodynamics
- •Patients who have failed prior drug therapy for overactive bladder or detrusor hyperreflexia
- •Patients with symptoms and signs of OAB, detrusor hyperreflexia, urinary urgency, urinary urge incontinence.
- •Patient who is mentally competent with the ability to understand and comply with the requirements of the study
- •Patient who agrees to be available for the follow-up evaluations as required by the protocol
- •Patient who has given signed informed consent
Exclusion Criteria
- •Patient with Post-Void Residual Urine (PVRU) greater than 100 ml on repeated measures. (Patient with a single PVRU of \>100 ml and followed by two consecutive PVRU measurements of \<100 ml may be included in the study)
- •Patient with greater than vesicoureteral reflux grade 1, interstitial cystitis, genitourinary fistulae
- •Patient with pelvic organ prolapse stage III or IV, i.e. the most distal part of the prolapse protruding more than 1 cm beyond the hymen (\>+1), at straining
- •Patient with un-investigated hematuria
- •Patient with lower tract genitourinary malignancies
- •Patient on current medication for stress urinary incontinence, such as alpha-adrenergic agonists or duloxetine, within three weeks prior to completing the baseline Bladder Diary (estrogen therapy on a stable dose for at least two months prior to study start is allowed)
- •Patient with ongoing complications of prior anti-incontinence surgery
- •Patient who is pregnant, lactating, or planning to become pregnant within the study period
- •Patient who has received pelvic radiation
- •Patient with any condition, which could lead to significant postoperative complications, including current infection and uncontrolled diabetes.
Arms & Interventions
Botox and DMSO instillation
Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution
Intervention: Botox Instillation
Botox and DMSO instillation
Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution
Intervention: DMSO Instillation
DMSO instillation
Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters
Intervention: DMSO Instillation
Outcomes
Primary Outcomes
Change in Incontinence Quality of Life (I-QoL) Score
Time Frame: Baseline, 1 month, 3 months
The I-QoL measures the effect of urinary incontinence on quality of life. It is divided into 3 subscales: 1) avoidance and limiting behavior, 2) psychosocial impact, and 3) social embarrassment. The I-QOL is comprised of 22 items, each with the response scale from '1= Extremely' to '5= Not at all'. A mean score for each subscale is calculated (averaging the scores for the items in each subscale) as well as a total score for all 22 items (sum of all subscale scores). The scores are then transformed to a 'Scale score' ranging from 0-100 points for ease of interpretation: Scale score = (sum of the items - lowest possible score)/possible raw score range X 100. Higher scores indicate less impact of incontinence on quality of life.
Secondary Outcomes
- Change in Incontinence Impact Questionnaire Short Form (IIQ-7)(baseline, 1 month, 3 months)
- Change in International Consultation on Incontinence Questionnaire - Short Form Score (ICIQ-SF)(baseline, 1 month, 3 months)
- Change in Urogenital Distress Inventory (UDI-6)(baseline, 1 month, 3 months)
- Number of Participants With Decrease in Blaivas-Groutz Anti-Incontinence Score at 1 Month and 3 Months(baseline, 1 month, 3 months)
- Number of Participants With a Decrease in Urinary Urgency at 1 Month and 3 Months(Baseline, 1 month, 3 months)