Extrait

Background and study aims Stress incontinence is the involuntary leakage of urine during physical activity, effort, exercise, or simply coughing or laughing. The aim of the study is to compare the current surgical treatment with a newer type of surgery. The current standard surgical treatment, Standard Mid-urethral Slings (SMUS), involves insertion of a special sling (mesh/ tape) underneath the urethra (bladder outlet) to provide support and help to prevent urinary leakage. The standard procedures have good success rates (85%) and high patient satisfaction rates. They require the patient to have a general anaesthetic. The newer procedure (SIMS: Single Incision Mini-Slings) has more recently been developed. This is a mini-version of the standard procedure and uses the same type of tape material. However, it requires a single cut in the vagina and is less invasive, and hence can be performed under local anaesthetic with less discomfort. It has been shown to have earlier recovery and earlier return to work and normal activities. Who can participate? Women who are scheduled for having surgery to treat stress urinary incontinence (SUI) can participate in this study. The potential participants are only approached to participate in the study if/when they have made their informed decision, according to the local standard clinical practice, to undergo SMUS procedure, Potential participants will be advised to refer to the trial patient information leaflets and discuss with their surgeons. What does the study involve? Women are randomly allocated to one of the two surgery types provided that their surgeon agrees that either type of surgery is suitable and after following the local standard clinical care procedures. All women are asked to complete assessment questionnaires at certain time points - before surgery and again at 4 weeks,3 months and annual for 3 years after surgery. Women also complete a 14-day diary immediately after their operation What are the possible risks of participating? There are no benefits associated with participating. Obviously there are risks associated with any surgical procedure but we do not think that there are disadvantages or additional risks to participants by participating in the study. Whichever group women are allocated to, their operation will be performed by a competent and trained surgeon. There are risks associated with all procedures and anaesthetics which will be explained to women, as per standard clinical care, prior to surgery. Steps are always taken to ensure that these risks are minimised. Where is the study run from? Aberdeen Royal Infirmary and 22 other NHS hospitals (UK) When is the study starting and how long is it expected to run for? December 2013 to February 2020 Who is funding the study? National Institute for Health Research (UK) Who is the main contact? Centre for Healthcare Randomised Trials [email protected]

Critère d'inclusion

• Adult women with stress urinary incontinence

Liens

• isrctn
• ictrp