Botulin-A Toxin Instillations and Overactive Bladder

Completed · Phase 1/Phase 2

Conditions studied: Overactive Bladder, Detrusor Instability, Detrusor Hyperreflexia

In brief

The primary objective of this pilot study is to evaluate the safety and efficacy of direct instillations of Botulinum-A toxin/DMSO into the bladder via a catheter system as a means of treating women with symptoms of overactive bladder and secondary urinary incontinence. In doing so, we will focus on estimating the percentage of women who experience an improvement in their urinary incontinence symptoms at one month and three months following this novel instillation technique.

Key facts

Study ID

NCT00583219

Run by

Mayo Clinic

People needed

25

Starts

2006-03-01

Expected to finish

2008-05-01

Last updated by the study team

2014-04-21

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female patient aged 18 years or older
• Patient with a history of stress urinary incontinence for at least 12 months
• Patient with Intrinsic Sphincter Deficiency who demonstrate an abdominal leak point pressure of less than 100 cm of water on urodynamic evaluation
• Patient with urinary incontinence verified by the Provocation test: a mean urinary leakage of 10 g on screening and baseline visits
• Patient with positive stress test and/or urodynamic stress incontinence
• Patient who has failed prior non-invasive treatment (e.g. behavior modification, pelvic floor exercises, biofeedback, electrical stimulation and/or drug therapy)
• Patient with negative Contigen skin test during screening.
• 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

You may not qualify if…

• Patient with Q-tip angle greater than 30 degrees
• Patient with Functional Bladder capacity <200 ml as recorded in the baseline Bladder Diary
• 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 vesicoureteral reflux, interstitial cystitis, genitourinary fistulae
• Patient with predominant urge incontinence
• Patient with detrusor overactivity on filling cystometry
• 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 urinary incontinence due to neurological disease that is known to affect urinary tract infection
• Patient with uninvestigated hematuria
• Patient with 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 who has had bulking therapy for stress urinary incontinence
• 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 > 32 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 concomitant medication with anticoagulant properties (e.g., Warfarin, Heparin, Aspirin, Nonsteroidal anti-inflammatory drugs (NSAIDs), except for cox-2 inhibitors) within two weeks prior to treatment
• Patient on immunomodulatory therapy (suppressive or stimulatory)
• Patient with a known allergy to bovine collagen
• 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

Where it is running

• Mayo Clinic Jacksonville — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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