A multicenter, prospective, randomized clinical trial comparing tension-free vaginal tape surgery and no treatment for the management of stress urinary incontinence in elderly women

Abstract

Aims: The aim of our study was to test the hypothesis that elderly women undergoing tension-free vaginal tape surgery (TVT) will have a better quality of life (QOL) and satisfaction compared to non-treated women despite age-and technique-related potential morbidity. Methods: This multicenter, 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 visit (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 Editorial CommentThe authors provide a study with the primary goal of deciding whether elderly women who underwent surgery with its attendant risks would have an improved quality of life and satisfaction than those patients who deferred surgery and merely continued on in their state of incontinence or in simpler terms: should an elderly woman have surgery or just live with her symptoms. The population studied included patients that either refused or failed conservative therapy and were on no medication for bladder dysfunction (including overactive bladder or urinary tract infection). The patients had no evidence of detrusor overactivity and had normal compliance on cystometrogram. The patient population was randomized to either having surgery immediately or waiting six months and being reevaluated and then having their surgery at that time. The metrics for both groups were quantified at baseline and again at 6 months and then compared. The tools that were utilized to assess the patient's quality of life included the IQOL Questionnaire; Patient Satisfaction scores; in addition to a Urinary Problems quantification. The authors found that patients who had the surgery had improvement in the measured parameters over those practicing watchful waiting thus supporting their hypothesis that surgery was worthwhile over watchful waiting in the elderly population. This is an excellent pape...