Over Active Bladder Instillation Study - Botox (NCT00667095) | Clinical Trial Compass
TerminatedPhase 3
Over Active Bladder Instillation Study - Botox
Stopped: Study terminated early due to PI's extended medical leave.
United States25 participantsStarted 2008-04
Plain-language 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.
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:
* 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 ong…
What they're measuring
1
Change in Incontinence Quality of Life (I-QoL) Score