stress urinary incontinence unintended urine loss.
Conditions
Interventions
Surgical correction of symptomatic stress-incontinence with mini-sling
(MiniArc) or trans-obturator sling (Monarc) .
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Female symptomatic stress urinary incontinence resulting from urethral hypermobility and/or ISD (intrinsic sphincter deficiency).
Exclusion criteria
Exclusion criteria: 1. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. efficacy as surgical correction of stress urinary incontinence. 2. post-operative pain. | — |
Secondary
| Measure | Time frame |
|---|---|
| 3. complications. 4. morbidity and post-operative recovery. 5. the need for repeated stress-incontinence surgery or specialized physiotherapy. 6. pelvic floor function. 7. cost-effectiveness from a societal perspective. | — |
Countries
Netherlands
Outcome results
None listed