Over Active Bladder Instillation Study - Botox

NCT ID: NCT00667095

Last Updated: 2014-07-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2012-01-31

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.

Conditions

Overactive Bladder; Urinary Urge Incontinence; Urinary Incontinence; Detrusor Hyperreflexia; Urge Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Botox and DMSO instillation

Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution

Group Type: EXPERIMENTAL

Botox Instillation

Intervention Type: DRUG

Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.

DMSO Instillation

Intervention Type: DRUG

DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided.

DMSO instillation

Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters

Group Type: PLACEBO_COMPARATOR

DMSO Instillation

Intervention Type: DRUG

DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided.

Interventions

Botox Instillation

Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided.

Intervention Type: DRUG

DMSO Instillation

DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided.

Intervention Type: DRUG

Other Intervention Names

Botulinum-A Toxin; Botox; Dimethyl Sulfoxide; DMSO

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.
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Mayo Clinic

Principal Investigators

Steven P Petrou, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Jacksonville, Florida, United States

Countries

United States

References

Petrou SP, Parker AS, Crook JE, Rogers A, Metz-Kudashick D, Thiel DD. Botulinum a toxin/dimethyl sulfoxide bladder instillations for women with refractory idiopathic detrusor overactivity: a phase 1/2 study. Mayo Clin Proc. 2009 Aug;84(8):702-6. doi: 10.4065/84.8.702.

Reference Type: BACKGROUND

PMID: 19648387 (View on PubMed)

Other Identifiers

07-007399

Identifier Type: -

Identifier Source: org_study_id