None listed
Conditions
Brief summary
Genital prolapse is a common condition with at least 1 woman in 10 undergoing surgery for this condition. It may be associated with urinary stress incontinence. Paradoxically, women suffering of severe genital prolapse may be continent. By reducing the prolapse during urodynamic assessment (barrier test), one can unmask urinary stress incontinence, called occult stress incontinence (OSI). Reducing the prolapse during urodynamic testing aims at mimicking the postoperative state. It is however unclear from the literature whether a positive barrier test is an indication for anti-incontinence surgery performed at the same time as prolapse surgery. Tensionfree Vaginal Tape (TVT) is an efficient anti-incontinence procedure and can be easily performed at the same time as prolapse surgery. Our study intends to randomise patients undergoing surgery for severe prolapse in two groups, one with usual prolapse surgery without any anti-incontinence procedure, the second with prolapse surgery and TVT. Urodynamics studies on patients with severe prolapse describe 36 to 80% of OSI. Our hypothesis is that 50% of patients operated for prolapse with a positive barrier test will develop urinary stress incontinence. TVT cures or improves stress incontinence in about 90% of patients. Combining TVT with prolapse surgery may therefore reduce the post-operative rate of stress incontinence from 50% to 10%. However, systematic use of TVT may expose patients to complications like voiding difficulties or de novo detrusor instability. The other option is to operate patients for prolapse and perform TVT under local anaesthesia only in those who develop distressing stress incontinence post-operatively.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
pelvic organ prolapse = / > Grade 2, requiring surgical correction in absence of SUI and with urodynamically demonstrated OSI. Ability to give informed consent and willingness to participate are required
Exclusion criteria
Contraindication to surgery in general such as being medically unfit for surgery, the presence of pelvic infection, malignancy, fistula, congenital or neurogenic bladder disorder, and inability to give informed consent.