Clinical trial NCT00667095: Over Active Bladder Instillation Study - Botox
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Overactive Bladder
Urinary Urge Incontinence
Urinary Incontinence
Detrusor Hyperreflexia
Urge Incontinence
Keywords: OAB
Over Active Bladder
overactive bladder
Urinary Urge Incontinence
Urinary Incontinence
Botox
DMSO
bladder instillation
instillation
detrusor hyperreflexia
urge incontinence
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2008-04-25
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Incontinence Quality of Life (I-QoL) Score
timeFrame: Baseline, 1 month, 3 months
Secondary outcomes:
measure: Change in Incontinence Impact Questionnaire Short Form (IIQ-7)
timeFrame: baseline, 1 month, 3 months
measure: Change in International Consultation on Incontinence Questionnaire - Short Form Score (ICIQ-SF)
timeFrame: baseline, 1 month, 3 months
measure: Change in Urogenital Distress Inventory (UDI-6)
timeFrame: baseline, 1 month, 3 months
measure: Number of Participants With Decrease in Blaivas-Groutz Anti-Incontinence Score at 1 Month and 3 Months
timeFrame: baseline, 1 month, 3 months
measure: Number of Participants With a Decrease in Urinary Urgency at 1 Month and 3 Months
timeFrame: Baseline, 1 month, 3 months
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Steven P Petrou, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.