Objective: Primary Objective: to compare the immediate and postoperative pain (up to 6 weeks) between the Ajust® and TVT-O® proceduresSecondary Objective(s): 1. Objective cure of the SUI at 6 and 12 months follow up2. Subjective cure and improvement…
ID
Source
Brief title
Condition
- Genitourinary tract disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The difference between the Ajust® and TVT-O® procedure in immediate and
postoperative pain (up to 6 weeks)
Secondary outcome
The difference between the procedures in immediate and postoperative pain (up
to 6 weeks), complications, obstructive or irritative bladder symptoms,
objective and subjective cure, and resuming daily activities.
Background summary
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 Ajust device will be placed in the same
direction as the TVT-O in order to minimize the risk of bladder perforation.
Different from the TVT-O is that the needle only pass the obturator foramen. A
polypropylene anchor provides fixation. One of the benefits will be that the
needle won't penetrate the muscles and is therefore in theory less painful as
compared to the TVT-O®.
Study objective
Objective: Primary Objective: to compare the immediate and postoperative pain
(up to 6 weeks) between the Ajust® and TVT-O® procedures
Secondary Objective(s):
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
Study design
Randomised controlled trial
Intervention
The TVT-O® device will be compared to the Ajust® device
Study burden and risks
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
Heidelberglaan 100
3584 CX Utrecht
NL
Heidelberglaan 100
3584 CX Utrecht
NL
Listed location countries
Age
Inclusion criteria
1. Predominant stress urinary incontinence
2. The stress urinary incontinence is confirmed during physical examination, stress test or urodynamic assessment.
3. They have completed conservative treatment for their stress urinary incontinence, pelvic floor muscle training program
Exclusion criteria
1. A post voiding bladder volume of more than 100 ml.
2. History of anti-incontinence surgery
3. Genital prolapse Stage 2 or more according to the POP-Q classification
4. Patients desire for future pregnancy and childbirth
5. Co-morbidity
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL32171.041.10 |