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MiniMo-trial.


- candidate number14176
- NTR NumberNTR3783
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-jan-2013
- Secondary IDsNL28973.018.09 MEC Academisch Medisch Centrum (Amsterdam)
- Public TitleMiniMo-trial.
- Scientific TitleA prospective multi-national randomized comparison of the effectiveness and safety of MiniArc® and Monarc®.
- ACRONYMMiniMo.
- hypothesisIf MiniArc® would prove to be equally efficient as a Monarc® transobturator subfascial hammock and it would also be less morbid (including post-operative pain), the MiniArc could be the most cost-effective strategy to deal with SUI that is available at the moment.
- Healt Condition(s) or Problem(s) studiedStress urinary incontinence, Mid urethral sling, Post-operative pain, Cost-effectiveness , Monarc, MiniArc
- Inclusion criteriaFemale symptomatic stress urinary incontinence resulting from urethral hypermobility and/or ISD (intrinsic sphincter deficiency).
- Exclusion criteria1. Subjects who have stage 2 or more genital prolaps, according to the ICS-classification;
2. Subjects who undergo surgery for recurrence of stress incontinence;
3. Subjects who undergo concomitant surgical procedures;
4. Subjects who are pregnant or want to become pregnant;
5. Subjects are not capable of giving informed consent.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 6-jan-2010
- planned closingdate1-apr-2015
- Target number of participants192
- InterventionsSurgical correction of symptomatic stress-incontinence with single-incision sling (MiniArc) or trans-obturator sling (Monarc).
- Primary outcome1. Efficacy as surgical correction of stress urinary incontinence;
2. Post-operative pain.
- Secondary outcome1. Complications;
2. Morbidity and post-operative recovery;
3. The need for repeated stress-incontinence surgery or specialized physiotherapy;
4. Pelvic floor function;
5. Cost-effectiveness from a societal perspective.
- TimepointsBefore operation, 4 weeks and 12/18/24/36 months after operation, patients are asked to fill in a validated questionnaire concerning pelvic floor problems and general functioning. Also they have to complete a diary during the first 4 weeks after operation, concerning pain, use of analgetics and activities of daily life. 6 Months after operation an interview by telephone will take place to complete a short questionnaire. Physical examination including a cough stress test will take place before operation, 4 weeks and 12/18/24/36 months after operation.
- Trial web sitehttp://www.studies-obsgyn.nl/home/page.asp?page_id=859
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMD. René P. Schellart
- CONTACT for SCIENTIFIC QUERIESMD, PhD Jan-Paul W.R. Roovers
- Sponsor/Initiator Academic Medical Center (AMC, Amsterdam)
- Funding
(Source(s) of Monetary or Material Support)
American Medical Systems, Inc.
- PublicationsN/A
- Brief summaryBackground of the study:
Stress urinary incontinence (SUI) is a worldwide common problem, especially suffering women. In the past many operative techniques are developed to treat stress urinary incontinence. One of the most successful techniques is the TVT-procedure (tension free vaginal tape). Since its introduction, more than 1,000,000 procedures with TVT have been performed worldwide. A recent Cochrane review concluded that the cure rates after TVT placement were similar to those after open abdominal retropubic suspension with a low complication rate. Initially suburethral tapes followed a retropubic route during insertion. Later, the trans-obturator route was developed. One of the most used transobturator slings is the Monarc. It has been shown that the trans-obturator route is associated with a lower risk on post-operative bladder retention and overactive bladder symptoms. Furthermore, the trans-obturator route is safer as, during this procedure, it is almost impossible to perforate the bladder. However, trans-obturator slings also carry some risk on morbidity of which muscle pain (due to perforation of the obturator muscles) and bleeding (due to perforation of the obturator vessels) are the most important. With the intention to reduce the invasiveness of the retropubic and trans-obturator approach, the MiniArc was developed.

Objective of the study:
To randomly compare MiniArc and Monarc for: ƒ{ efficacy as surgical correction of stress-incontinence ƒ{ post-operative pain ƒ{ complications ƒ{ morbidity and post-operative recovery ƒ{ the need for repeated stress-incontinence surgery or specialized physiotherapy ƒ{ pelvic floor function ƒ{ cost-effectiveness from a societal perspective

Study design:
Prospective multi-national randomised controlled trial (the Netherlands, Belgium, France).

Study population:
Patients who are planned to undergo surgical correction of symptomatic stress-incontinence.

Intervention:
Surgical correction of symptomatic stress-incontinence with mini-sling (MiniArc) or trans-obturator sling (Monarc).

Primary study parameters/outcome of the study:
1. Efficacy as surgical correction of stress urinary incontinence;
2. Post-operative pain.

Secundary study parameters/outcome of the study:
1. Complications;
2. Morbidity and post-operative recovery;
3. The need for repeated stress-incontinence surgery or specialized physiotherapy;
4. Pelvic floor function;
5. Cost-effectiveness from a societal perspective.
- Main changes (audit trail)
- RECORD6-jan-2013 - 20-jan-2013


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