| SUFU 2007 - A Multicentric, Prospective, Randomized Clinical Trial Comparing Tension-Free Vaginal Tape Surgery and No Treatment for the Management of Stress Urinary Incontinence in Elderly Women |
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| Thursday, 01 March 2007 | ||
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Campeau L *, Tu LM **, Lemieux MC *, Naud A ***, Karsenty G *, Corcos J * * Department of Urology,
Materials and Methods: This multicentric, prospective, randomized controlled trial enrolled a total of 69 women aged over 70 years who initially consented to be randomized to either undergo immediate TVT surgery or to wait for 6 months before submitting to the same surgery (control group). The main outcomes measured at every encounter (pre-randomization, 8-12 weeks and 6 months) consisted of the Incontinence-Quality of Life (I-QOL) Questionnaire, the Patient Satisfaction Questionnaire and the Urinary Problems Self-assessment Questionnaire, among others. Results: The analysis included 31 patients in the immediate surgery group and 27 subjects in the control group. Peri-operative complications in the immediate surgery group were bladder perforation (22.6%), urinary retention (12.9%), urinary tract infection (3.2%) and de novo urgency (3.2%). At 6 months, the mean I-QOL scores for the TVT and control groups were respectively 96.5±15.5 and 61.6±19.8 (p<0.0001); mean Patient Satisfaction scores were respectively 8.0±2.7 and 2.0±2.4 (p<0.0001); and mean Urinary Problems scores were respectively 4.5±4.3 and 11.6±3.5 (p<0.0001). Conclusion: At 6 months post-randomization, the group of elderly women who underwent immediate TVT surgery showed a significant improvement in QOL, patient satisfaction and less urinary problems compared to the group of women waiting for the same surgery. Funded by Gynecare and Fonds de la recherche en santé du Quebec (FRSQ). UroToday.com Coverage of SUFU 2007
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