Abstract | OBJECTIVES: To examine the efficacy and tolerability of antimuscarinic therapy in women with urge-predominant mixed incontinence. METHODS: This was a double-blind, randomized, placebo-controlled trial comprising 854 women with urge-predominant mixed incontinence, including urge incontinence (five or more episodes per week), urinary frequency (eight or more micturitions on average in 24 hours), and urgency in combination with stress incontinence. Women received 8 weeks of treatment with tolterodine tartrate extended-release (ER) 4 mg or placebo once daily. The outcome measures included urge incontinence episodes per week, stress incontinence episodes per week, micturition frequency per 24 hours, urgency episodes per 24 hours, volume voided per micturition, patient perception of bladder condition, and assessment of treatment benefit. RESULTS: After 8 weeks, tolterodine ER produced a statistically significant decrease in the weekly urge incontinence episodes compared with placebo (-12.3 versus -8.0; P <0.0001). Other micturition variables improved significantly more with tolterodine ER. No difference was found between treatment groups regarding the change in the number of stress incontinence episodes. A significantly greater proportion of patients receiving tolterodine ER than those receiving placebo reported improvement in bladder condition (61% versus 46%; P <0.001) and treatment benefit (76% versus 55%; P <0.001). After 8 weeks, the tolterodine ER group had experienced statistically significant improvements compared with the placebo group in 9 of 10 quality-of-life domains. The frequency of adverse events was similar between treatment groups. CONCLUSIONS:
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Authors | Vik Khullar, Simon Hill, Karl-Ulrich Laval, Hjalmar A Schiøtz, Udo Jonas, Eboo Versi |
Journal | Urology
(Urology)
Vol. 64
Issue 2
Pg. 269-74; discussion 274-5
(Aug 2004)
ISSN: 1527-9995 [Electronic] United States |
PMID | 15302476
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Benzhydryl Compounds
- Cresols
- Delayed-Action Preparations
- Muscarinic Antagonists
- Phenylpropanolamine
- Tolterodine Tartrate
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Topics |
- Adult
- Aged
- Benzhydryl Compounds
(administration & dosage, adverse effects, pharmacology, therapeutic use)
- Cresols
(administration & dosage, adverse effects, pharmacology, therapeutic use)
- Delayed-Action Preparations
- Diuresis
(drug effects)
- Double-Blind Method
- Female
- Humans
- Middle Aged
- Muscarinic Antagonists
(administration & dosage, adverse effects, pharmacology, therapeutic use)
- Patient Acceptance of Health Care
- Phenylpropanolamine
(administration & dosage, adverse effects, pharmacology, therapeutic use)
- Quality of Life
- Tolterodine Tartrate
- Treatment Outcome
- Urinary Incontinence
(drug therapy, psychology)
- Urinary Incontinence, Stress
(drug therapy, psychology)
- Urination
(drug effects)
- Xerostomia
(chemically induced)
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