Trial document
This study has been imported from ClinicalTrials.gov without additional data checks.
DRKS00006365
Trial Description
Title
Phase 1/2 Study of the Effect of TOT or Solifenacin After Cesa or Vasa on Urge Urinary Incontinence
Trial Acronym
URGE-II
URL of the Trial
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Brief Summary in Lay Language
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.
Brief Summary in Scientific Language
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.
Do you plan to share individual participant data with other researchers?
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Description IPD sharing plan:
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Organizational Data
- DRKS00006365
- 2014/10/01
- 2012/11/28
- yes
- [---]*
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Secondary IDs
- NCT01737918 (ClinicalTrials.gov)
- URGE-II (Klinikum der Universität Köln)
Health Condition or Problem studied
- Surgical Treatment of Urge Incontinence
Interventions/Observational Groups
- Procedure: TOT
- Drug: solifenacin
Characteristics
- Interventional
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- Randomized controlled trial
- Open (masking not used)
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- Active control (effective treament of control group)
- Treatment
- Crossover
- I-II
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Primary Outcome
- cure of incontinence; time frame: 3 months
Secondary Outcome
- improvement of urge symptoms; time frame: 3 months
Countries of Recruitment
- Germany
Locations of Recruitment
Recruitment
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- 2013/01/31
- 120
- Multicenter trial
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Inclusion Criteria
- Female
- 40 Years
- 85 Years
Additional 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
Addresses
-
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- Klinikum der Universität Köln
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- Study Supervisor
- Wolfram H Jager, PhD
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- Wolfram H Jager, PhD
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- wolfram.jaeger at uk-koeln.de
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Sources of Monetary or Material Support
-
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- Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status
- Recruiting ongoing
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Trial Publications, Results and other Documents
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- 4
- 2016/01/14
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