Trial document




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

  DRKS00006365

Trial Description

start of 1:1-Block title

Title

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

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

URGE-II

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

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.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

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.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00006365
  •   2014/10/01
  •   2012/11/28
  •   yes
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   NCT01737918  (ClinicalTrials.gov)
  •   URGE-II  (Klinikum der Universität Köln)
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Surgical Treatment of Urge Incontinence
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Procedure: TOT
  •   Drug: solifenacin
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Crossover
  •   I-II
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

- cure of incontinence; time frame: 3 months

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- improvement of urge symptoms; time frame: 3 months

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  •  
  •  
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   [---]*
  •   2013/01/31
  •   120
  •   Multicenter trial
  •   [---]*
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Female
  •   40   Years
  •   85   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

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

- stress urinary incontinence

- mixed urinary incontinence

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

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

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinikum der Universität Köln
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Study Supervisor
    • Wolfram H Jager, PhD 
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Wolfram H Jager, PhD 
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
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.