Surgical Treatment of Urge Incontinence
Conditions
Keywords
urge urinary incontinence, cesa, vasa, TOT, solifenacin
Brief summary
Urge urinary incontinence can be a disorder caused by destroyed pelvic structures. We repaired the uteri-sacral ligaments (USL) by cesa or vasa. The study evaluates if solifenacin can lead to continence after surgery or if also the pubo-urethral ligaments (PUL) need to be repaired.
Detailed description
It was hypothesized that urge urinary incontinence in women is based on the destruction of the uteri-sacral ligaments (USL)and the pubourethral ligaments (PUL). In a preliminary study (URGE I) we repaired the USL by cesa or vasa. Those patients who are still incontinent after cesa and vasa get the repair of the PUL by means of trans-obturator tapes (TOT). That treatment is compared to conservative medical treatment. Cross over after completion of three months is possible if no continence is achieved.
Interventions
PROCEDURETOT
DRUGsolifenacin
Sponsors
Klinikum der Universität Köln
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* prior vasa or cesa operation as part of the URGE I study * stress urinary incontinence * mixed urinary incontinence
Exclusion criteria
* previous urogynecological surgery * avulsion of cesa or vasa tape * pregnancy * neurologic/psychological reasons for incontinence * body weight \>100kg * syndrome of dry overactive bladder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| cure of incontinence | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| improvement of urge symptoms | 3 months |
Countries
Germany
Contacts
Primary ContactWolfram H Jager, PhD
Backup ContactPeter Mallmann, PhD
Outcome results
None listed