No registrations found.
ID
Source
Brief title
Health condition
1. Genital prolapse;
2. stress urinary incontinence.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Absence of urinary (stress) incontinence and subsequent treatment for urinary (stress) incontinence.
Secondary outcome
1. Anatomical results and repeated treatment for pelvic organ prolapse;
2. Disease specific and general quality of life;
3. Morbidity and quality adjusted life-years;
4. General satisfaction;
5. Costs.
Background summary
Pelvic organ prolapse and stress urinary incontinence co-exist in about 40% of the women with genital prolapse. Because the TVT has been proven to be as successful as the Burch colposuspension in the treatment of stress incontinence, combining vaginal prolapse repair with a mid urethral sling procedure in these women has become an attractive treatment option. Concomitant surgery showed to be an effective treatment for stress urinary incontinence in observational studies. However, literature about possible adverse effects such as obstructive voiding symptoms and detrusor overactivity is not consistent. Besides, concomitant surgery will result in over treatment as the correction of a cystocele showed a 5-year success rate of 37% in the relief of stress incontinence. Thus, concomitant surgery will probably result in less postoperative complaints of stress incontinence but may lead to adverse effects and over treatment. The objective of the CUPIDO-1-trial is to determine whether vaginal prolapse repair is equally effective as concomitant vaginal surgery in women with genital prolapse and symptoms of stress urinary incontinence.
Study objective
Compared to vaginal prolapse repair, concomitant vaginal surgery in women with genital prolapse and predominant stress urinary incontinence decreases the risk of postoperative urinary incontinence without increasing other lower urinary tract symptoms.
Study design
6 weeks, 6 months, 12 months.
Intervention
Only vaginal prolapse repair or vaginal prolapse repair combined with mid urethral sling procedure.
Martini Hospital
PO Box 30.033
Marinus Ploeg van der
Groningen 9700 RM
The Netherlands
+31 (0)50-5247700
ploegjm@mzh.nl
Martini Hospital
PO Box 30.033
Marinus Ploeg van der
Groningen 9700 RM
The Netherlands
+31 (0)50-5247700
ploegjm@mzh.nl
Inclusion criteria
Women undergoing vaginal prolapse surgery for stage 2 or more genital prolapse with predominant stress urinary incontinence.
Exclusion criteria
1. Age < 19 year;
2. Mentally disabled or in any other way unable to give informed consent;
3. Pregnancy or the intention to become pregnant in the future;
4. < 12 months post partum (delivery or other termination after 20 weeks);
5. Prior surgery for urinary incontinence;
6. Recent pelvic surgery such as prolapse surgery and hysterectomy (< 6 months);
7. History of bladder or urethral surgery or known lower urinary tract anomaly (ie. diverticulum);
8. Systemic disease known to affect bladder function (ie. Parkinson's disease, MS, spina bifida);
9. Planned or current cancer chemotherapy or radiotherapy;
10. Participation in another treatment intervention trial that might influence trial results;
11. Sign of chronic retention defined as > 300 mL. retention after normal voiding. 12. isolated posterior compartment prolapse.
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 |
|---|---|
| NTR-new | NL1154 |
| NTR-old | NTR1197 |
| Other | AMC Amsterdam, The Netherlands : MEC 05/286 # 07.17.1758 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |