OBJECTIVES: The aim of our study was to conduct a prospective randomized trial to compare the effectiveness of peripheral tibial neurostimulation (PTNS) (Urgent PC®) versus Tolterodine (Detrol®) in the treatment of women with urge urinary incontinence and urge symptoms.
MATERIALS AND METHODS: Between June 2004 and July 2006 we included 31 patients (≥ 18 years) in our study. Sixteen patients were randomized into the neurostimulation arm, fifteen patients into the drug arm. Exclusion criteria: Contraindications against anticholinergics, pregnancy, tolterodine before. Major study endpoints: Micturitions in 24 hours, patient’s quality of life. Minor study endpoints: Incontinence episodes in 24 hours, side effects of both therapies. Duration of therapy: Twelve weeks in each study group (PTNS once a week for 30 minutes, 2 times 2mg Tolterodine administered orally per day). Follow-up-intervals: 3, 6 and 12 months after starting the therapy. Full urodynamic workup at visit 0 and visit 2 (after 12 weeks).
RESULTS: Mean age of patients: 59.4 ± 10.9 years (range 26-85 years). Postmenopausal: 96.6%. BMI: 28.7 ± 5.6 (21.3-41). Hysterectomized: 13.9%. Parity: 1.6 ± 0.9 children (range 0-4 children). Caesarean section: 13.8%. Incontinence-Operation: 20.7%. Smokers: 20.7%. More than three medications daily: 65.6%. The following data represent the factor of change in absolute numbers of the studied variable in both therapy arms: The number of micturitions remained in both groups the same between first visit and end of therapy (0.1 [CI 95%, -3.3-3.6] vs. 0.7 [CI 95%, -2.3-3.7], p=0.77), the patient’s quality of life improved in both groups (4.4 [CI 95%, 1.7-7.1] vs. 4.6 [CI 95% 2.1-7.0], p=0.93). In both groups the number of incontinence episodes declined (1.3 [CI 95%, 0.6-3.2] vs. 2.6 [CI 95%, 0.1-5.3], p=0.4), as well as the number of urge episodes (9.3 [CI 95%, 7.0-11.7] vs. 9.5 [CI 95%, 6.3-12.7], p=0.92). Side effects: 1 patient (3.4%) in the PTNS group and 6 patients (20.7%) in the drug group. Drop outs: 3 patients (10.3%) in the PTNS group and 2 patients (6.9%) in the drug group.
CONCLUSION: There was no statistical significant difference between the both groups of therapy regarding the chosen major study endpoints and minor study endpoints. A distinct lower rate of side effects in the PTNS group (3.4 vs. 20.7%, p=0.051) has been shown to be an obvious advantage of PTNS as non-medical treatment in a group of patients with a number of co-morbidities and therefore high drug load (65.9%).
Source: Uroplasty summary of original poster