Abstract | OBJECTIVE: METHODS: We conducted a six-month, randomized, double-blind controlled trial involving women with urinary urge incontinence. Participants received intradetrusor injections of either botulinum toxin (100U in 10 mL) via cystoscopy or a placebo control (saline injection). The primary outcome was maximum bladder capacity at cystoscopy. Secondary outcomes included quality-of-life measures, 24-hour leakage rate, patients' subjective assessment, and safety data. RESULTS: There were 21 participants: 11 in the botulinum toxin (treated) group and 10 in the placebo (control) group. There were no significant differences between the groups at baseline. After six months the mean maximum bladder capacity at cystoscopy was 161.6 mL greater in the treated group than in the control group (P = 0.018). There were no differences in diary data or quality-of-life measures. The 24-hour pad test (a measure of leakage) after three months showed significant improvement in the treated group (difference 272.12g, P = 0.016); treated subjects also showed subjective benefit at three months (difference 1.29, P = 0.007) and at six months (difference 1.16, P = 0.01). There was no significant difference in rates of urinary tract infection between groups. There was one serious adverse event (a perioperative cardiac event) in the botulinum toxin group. CONCLUSION:
|
Authors | Corrine Jabs, Erica Carleton |
Journal | Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC
(J Obstet Gynaecol Can)
Vol. 35
Issue 1
Pg. 53-60
(Jan 2013)
ISSN: 1701-2163 [Print] Netherlands |
PMID | 23343798
(Publication Type: Journal Article, Randomized Controlled Trial)
|
Chemical References |
- Placebos
- Botulinum Toxins, Type A
|
Topics |
- Aged
- Botulinum Toxins, Type A
(administration & dosage, adverse effects)
- Double-Blind Method
- Female
- Humans
- Middle Aged
- Placebos
- Quality of Life
- Treatment Outcome
- Urinary Bladder, Overactive
(complications, drug therapy)
- Urinary Incontinence, Urge
(complications, drug therapy)
|