Botulin-A Toxin Instillations and Overactive Bladder
United States25 participantsStarted 2006-03
Plain-language summary
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.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Female patient aged 18 years or older
ā. Patient with a history of stress urinary incontinence for at least 12 months
ā. Patient with Intrinsic Sphincter Deficiency who demonstrate an abdominal leak point pressure of less than 100 cm of water on urodynamic evaluation
ā. Patient with urinary incontinence verified by the Provocation test: a mean urinary leakage of 10 g on screening and baseline visits
ā. Patient with positive stress test and/or urodynamic stress incontinence
ā. Patient who has failed prior non-invasive treatment (e.g. behavior modification, pelvic floor exercises, biofeedback, electrical stimulation and/or drug therapy)
ā. Patient with negative Contigen skin test during screening.
ā. Patient who is mentally competent with the ability to understand and comply with the requirements of the study
Exclusion criteria
ā. Patient with Q-tip angle greater than 30 degrees
ā. Patient with Functional Bladder capacity \<200 ml as recorded in the baseline Bladder Diary
ā. 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)
What they're measuring
1
Median Number of Incontinent Episodes During 24 Hours
. Patient with vesicoureteral reflux, interstitial cystitis, genitourinary fistulae
ā. Patient with predominant urge incontinence
ā. Patient with detrusor overactivity on filling cystometry
ā. 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
ā. Patient with urinary incontinence due to neurological disease that is known to affect urinary tract infection