Trial document




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  DRKS00007897

Trial Description

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Title

Pessary insertion directly post partum: does it reduce pelvic organ prolapse symptoms one year postpartum compared with standard care? A randomised controlled trial

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Trial Acronym

PP-Pess

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URL of the Trial

[---]*

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Brief Summary in Lay Language

We would like to assess whether an early pessary therapy of pelvic organ prolapse directly after vaginal birth will help to reduce pelvic floor problems. Pessaries are commonly used to conservatively treat symptoms of prolapse but their early use after birth has not been examined and it is unclear whether a complete remission can be obtained.

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Brief Summary in Scientific Language

The aim of this randomised controlled trial is to assess whether an early pessary therapy after vaginal birth will reduce pelvic floor disorders at six weeks and one year postpartum in comparison to standard care (no intervention in the first six weeks postpartum). Pessaries are a commonly used conservative treatment option for stress urinary incontinence and pelvic organ prolapse.
We want to allow a patient-preference-group who will receive vaginal electrical stimulation if they decline Standard (no intervention).
The nullhypothesis ist, that there is no difference in postpartum incidences of prolapse symptoms (patient-centered outcome) and objective pelvic organ prolapse (POPQ) one year post partum in women with (study group) and without pessary (control group) insertion.

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Organizational Data

  •   DRKS00007897
  •   2016/12/02
  •   [---]*
  •   yes
  •   Approved
  •   EA2-050-16, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   N81.1 -  Cystocele
  •   N39.3 -  Stress incontinence
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Interventions/Observational Groups

  •   Pessary insertion day 1-3 postpartum (modifiable Hodge or ring pessary), for 4-6 weeks
  •   Standard care (no Intervention)
  •   Patient-preference groups: pessary or standard care
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   investigator/therapist, caregiver, assessor, data analyst
  •   Control group receives no treatment
  •   Treatment
  •   Factorial
  •   N/A
  •   N/A
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Primary Outcome

Pelvic floor function (Prolapse symptoms) 12 months postpartum (assessment with validated Pelvic Floor Questionnaire)

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Secondary Outcome

Prolapse (POPQ) and pelvic floor symptoms 6 weeks and one year postpartum (German version of Australian Pelvic Floor Questionnaire)
Interim analysis scheduled at 6 weeks to assess
pelvic floor function

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/12/15
  •   302
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   45   Years
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Additional Inclusion Criteria

Primipara, vaginal birth, physical and mental health, able to attend follow up examination

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Exclusion Criteria

Death of Fetus, severe birth trauma, postpartum hysterectomy, severe pain, unable to attend follow up, neurological diseases, previous pelvic floor operation

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Addresses

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    • Charité Campus Benjamin Franklin
    • 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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    • Charité Universitätsmedizin
    • Ms.  PD Dr. med.  Kaven  Baessler 
    • Hindenburgdamm 30
    • 12203  Berlin
    • Germany
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    • Bundesministerium für Wirtschaft und Energie
    • Scharnhorststr. 34-37
    • 10115  Berlin
    • 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.