Over Active Bladder Instillation Study - Botox

Condition(s) targeted: Overactive Bladder; Urinary Urge Incontinence; Urinary Incontinence; Detrusor Hyperreflexia; Urge Incontinence

Intervention: Botox Instillation (Procedure); Placebo Instillation (Procedure)

Phase: Phase 3

Status: Recruiting

Sponsored by: Mayo Clinic

Official(s) and/or principal investigator(s):
Steven P Petrou, MD, Principal Investigator, Affiliation: Mayo Clinic

Overall contact:
Study Hotline, Phone: 904-953-0473

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.

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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study

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

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.

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 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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.

- Patient who is morbidly obese (defined as BMI > 40 Kg/m2)

- Patient who is bedridden, institutionalized or in such physical condition that she

cannot move to the closest bathroom without assistance from another person

- Patient with current or acute urinary tract infection, including cystitis or

urethritis. (Patient with such infections should be treated with antibiotics, with subsequent urinalysis tests confirming the absence of such infection before study inclusion)

- Patient with any condition that would preclude treatment due to contraindications

and/or warnings in the study product's labeling

- Patient on immunomodulatory therapy (suppressive or stimulatory)

- Patient with known lidocaine hypersensitivity or hypersensitivity to any anesthetics

to be used during the treatment session/surgical procedure

- Patient with a concurrent use of another study product within two weeks prior to

study start, or who concurrently participate in any other clinical study

- Any disease that in the opinion of the Investigator would make the patient unsuitable

for the study

- Patient with a life expectancy of less than 12 months

Study Hotline, Phone: 904-953-0473

Mayo Clinic, Jacksonville, Florida 32224, United States; Recruiting
Study Hotline, Phone: 904-953-0473
Yvette Phillips, Phone: 904-953-2255
Steven P Petrou, MD, Principal Investigator

Mayo Clinic Clinical Trials

Starting date: April 2008
Ending date: June 2010
Last updated: April 2, 2009