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A prospective randomized trial comparing the use of tolterodine or weighted vaginal cones in women with overactive bladder syndrome
Yuce T, Dokmeci F, Cetinkaya SE
European Journal of Obstetrics, Gynecology, and Reproductive Biology 2016 Feb;197:91-97
clinical trial
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVE: To compare the efficacy of pelvic floor muscle exercises (PFME) using weighted vaginal cones (WVC) on the symptoms, clinical findings, urodynamic findings and quality of life (QoL) in overactive bladder (OAB) patients with tolterodine. STUDY DESIGN: Thirty-nine patients with urinary frequency (> 8/day), nocturia (> 2/night), urgency and a total score of > 8 to the overactive bladder-awareness tool (OAB-V8) were diagnosed as OAB and were randomized into two treatment groups; WVC and extended release tolterodine (tolterodine ER) 4 mg/day for 8 weeks. Results of the clinical findings, 3-day urinary diary, validated questionnaires for symptom bother and QoL (Urinary distress inventory (UDI-6), incontinence impact questionnaire (IIQ-7), OAB-V8, Wagner questionnaire) and urodynamic examination before and after treatment were compared. RESULTS: A reduction of frequency, nocturia and urinary incontinence was observed in WVC group (p = 0.006, p = 0.034 and p = 0.008, respectively) and in tolterodine group (p < 0.001, p = 0.002 and p = 0.035, respectively). 24-h dry pad test results were improved significantly in both groups (p = 0.003 and p = 0.001, respectively). Pelvic muscle strength was significantly improved in WVC group but not in tolterodine group (p = 0.010 and p = 0.180, respectively). UDI-6, IIQ-7, OAB-V8 scores were improved significantly in both groups. Improvements in Wagner questionnaire were observed in WVC group but not in tolterodine group (p = 0.002 and p = 0.591, respectively). First sensation of bladder filling was significantly improved after WVC treatment but not in tolterodine group (p = 0.035 and p = 0.550, respectively). After treatment, detrusor overactivity (DO) resolved in 8 patients in the WVC group (p = 0.003) and in 2 patients in the tolterodine group (p = 0.426). CONCLUSIONS: WVC treatment seems to be an efficacious therapeutic option for the improvement of overactive bladder syndrome (OABS).
With permission from Excerpta Medica Inc.

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