Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006365

Trial Description

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Title

Phase 1/2 Study of the Effect of TOT or Solifenacin After Cesa or Vasa on Urge Urinary Incontinence

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Trial Acronym

URGE-II

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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.

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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.

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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)
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Health Condition or Problem studied

  •   Surgical Treatment of Urge Incontinence
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Interventions/Observational Groups

  •   Procedure: TOT
  •   Drug: solifenacin
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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

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Secondary Outcome

- improvement of urge symptoms; time frame: 3 months

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
  •  
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Recruitment

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  •   2013/01/31
  •   120
  •   Multicenter trial
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Inclusion Criteria

  •   Female
  •   40   Years
  •   85   Years
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Additional Inclusion Criteria

- prior vasa or cesa operation as part of the URGE I study

- stress urinary incontinence

- mixed urinary incontinence

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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

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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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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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    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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Additional Trial Attributes

  • Urological disease 
  • If other, please specify 
  • Study recommendations 
  • If other, please specify 
  • German director of clinical investigation 
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    • [---]*
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    •   [---]*
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  • Further contact 
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    • [---]*
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  • Function of contact 
  • Non-interventional study 
  • Stage 
  • If other, please specify 
  • Onset of therapy 
  • If other, please specify 
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   4
  •   2016/01/14
* This entry means the parameter is not applicable or has not been set.