Trial document





This trial has been registered retrospectively.
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  DRKS00004218

Trial Description

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Title

Randomised controlled trial comparing biofeedback training and specific bladder neck effective pelvic floor rehabilitation in stress urinary incontinent women

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Trial Acronym

PREVENT

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The aim of the study is to assess the incontinence mechanism in stress urinary incontinent women and to compare two different pelvic floor rehabilitation programs. Ultrasound, electromyography (muscle activity measurement) and urethral pressure measurements will be performed to evaluate the individual incontinence mechanism.
Patients will be randomly assigned to biofeedback therapy or a pelvic floor rehabilitation programme using ultrasound. There will be 3 treatment sessions, lasting between 30-60 min. Follow up will be performed at 6 weeks, 6 and 12 months using questionnaires and part of the measurements will be repeated.
Our hypothesis is, that both therapies are equivalent.

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Brief Summary in Scientific Language

The aim of this study is to assess which known continence mechanisms (maximum urethral closure pressure=UCP, bladder neck support=BNsupp, pelvic floor pre-contraction=PFpreC) fail during provoked urinary leakage. With the subjects standing, all measurements are taken at rest, during coughing, nose blowing and isometric resistance lifting. Thereafter women will be randomly assigned to vaginal EMG-biofeedback (Periform probe) or specific bladder neck effective pelvic floor rehabilitation using perineal ultrasound.

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Organizational Data

  •   DRKS00004218
  •   2013/08/14
  •   [---]*
  •   yes
  •   Approved
  •   EA1/297/10, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  •   U1111-1145-0841 
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Health Condition or Problem studied

  •   N39.3 -  Stress incontinence
  •   N39.42 -  [generalization N39.4: Other specified urinary incontinence]
  •   N81.1 -  Cystocele
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Interventions/Observational Groups

  •   Vaginal EMG-Biofeedback: 3 months of pelvic floor training 2-3 times per day for 10 min with Periform probe
  •   Specific bladder neck effective pelvic floor rehabilitation applying perineal ultrasound; three appointments, 30-60 min. Pelvic floor contractions will be practiced followed by integration into daily life.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   investigator/therapist
  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Improvement of pelvic floor symptoms /quality of life employing validated pelvic floor questionnaire at all clinical posttherapeutic visits (after 6 weeks, after 6 months, after 1 year)

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Secondary Outcome

Evaluation of pelvic floor pre-contraction, bladder neck elevation, pelvic floor muscle configuration, length of pelvic floor contraction applying perineal ultrasound at all scheduled follow up appointments (after 6 weeks, after 6 months, after 1 year)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/06/10
  •   108
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Motivation to undergo conservative treatment

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Exclusion Criteria

neurological diseases, inability to understand German

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Addresses

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    • Charité Universitätsmedizin
    • Ms.  PD Dr.  Kaven  Baessler 
    • Hindenburgdamm 30
    • 12203  Berlin
    • Germany
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    • Charité Universitätsmedizin
    • Ms.  PD Dr. med.  Kaven  Baessler 
    • Hindenburgdamm 30
    • 12203  Berlin
    • Germany
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    • Charité Universitätsmedizin
    • Ms.  PD Dr. med.  Kaven  Baessler 
    • Hindenburgdamm 30
    • 12203  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.