|- candidate number||8534|
|- NTR Number||NTR2558|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||6-okt-2010|
|- Secondary IDs||10-195 METC UMCU|
|- Public Title||A trial comparing two different tapes used for surgical treatment of stress urinary incontinence.|
|- Scientific Title||A randomised controlled trial comparing the TVT-O® with the Ajust® as primary surgical treatment of female stress urinary incontinence.|
|- hypothesis||Reducing postoperative pain with a mini-sling.|
|- Healt Condition(s) or Problem(s) studied||Stress urinary incontinence, Mid urethral sling, TVT-O, Ajust|
|- Inclusion criteria||1. Predominant stress incontinence;|
2. Stress incontinence is confirmed;
3. Completed conservative therapy;
4. Sandvic index >3;
5. Good knowledge of dutch language.
|- Exclusion criteria||1. Postvoid residual volume > 100cc;|
2. History of anti-incontinence surgery;
3. Prolapse POPQ st 2 or >;
4. Desire for future pregnancy / childbirth;
5. Co-morbidity (ASA 3 or 4);
6. History of recurrent cystitis;
7. Psychiatric illness;
8. Poor cognitive function;
9. Chronic or current neurologic illness.
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2010|
|- planned closingdate||1-sep-2012|
|- Target number of participants||145|
|- Interventions||Mid uerthral sling placement ( TVT-O or ajust).|
|- Primary outcome||The primary endpoint of the study is the immediate and postoperative pain (up to 6 weeks) after an Ajust® or TVT-O® procedure.|
|- Secondary outcome||Objective cure of the SUI at 6 and 12 months follow up:|
1. Subjective cure and improvement of the SUI at 6 and 12 months follow up;
2. Complications after the procedures;
3. De novo obstructive or irritative bladder symptoms;
4. Time to return to normal daily activities/work.
|- Timepoints||Inclusion 12-18 months.|
|- Trial web site||www.studies-obsgyn.nl/toast|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| K.J. Schweitzer|
|- CONTACT for SCIENTIFIC QUERIES|| K.J. Schweitzer|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU)|
(Source(s) of Monetary or Material Support)
|- Brief summary||Rationale: |
For the surgical treatment of women with urinary stress incontinence the so-called synthetic midurethral sling has become the Gold-standard. There are two separate ways to place the sling. The first technique is the retropubic approach, the Tension-free Vaginal Tape (TVT®). This technique carries the risk of bladder perforation during surgery. The second approach, the transobturator route (TVT-O®), has an almost zero risk of bladder perforation but is associated with more groin pain as compared to the retropubic TVT®. The groin pain is most likely due to perforation of the external obturator and adductor muscles of the upper leg. The new transobturator device Ajust® does not penetrate these muscles and is therefore in theory less painful as compared to the TVT-O®, with the benefit of reducing the risk of bladder perforation as compared to the retropubic TVT®.
Primary Objective: To compare the immediate and postoperative pain (up to 6 weeks) between the Ajust® and TVT-O® procedures.
1. Objective cure of the SUI at 6 and 12 months follow up;
2. Subjective cure and improvement of the SUI at 6 and 12 months follow up;
3. Complications during and after the procedures;
4. De novo obstructive or irritative bladder symptoms;
5. Time to return to normal daily activities/work.
Randomised controlled trial.
Woman between 35 - 80 years of age with urinary stress incontinence.
The TVT-O® device will be compared to the Ajust® device.
Main study parameters/endpoints:
The difference between the Ajust® and TVT-O® procedure in immediate and postoperative pain (up to 6 weeks), complications, obstructive or irritative bladder symptoms, objective and subjective cure, and resuming daily activities.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The burden related to the study is minimal. It mainly consists of the use questionnaires at regular intervals and weekly telephone interviews (up to 6 weeks) of approximately 5-10 minutes. Except for the one year follow-up all other visits are part of the regular care. No additional risks, other than those that are known to be related to any stress incontinence surgery, are expected to be related to the new Ajust® device. The Ajust® device is officially registered in Europe and clinical available.
|- Main changes (audit trail)|
|- RECORD||6-okt-2010 - 24-okt-2010|