RCT About Two Different Regimens of Clean Intermittent Catheterization in Women With Overt Postpartum Urinary Retention
NCT ID: NCT05188963
Last Updated: 2023-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
96 participants
INTERVENTIONAL
2021-06-29
2025-06-28
Brief Summary
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Participants will be randomized to one of two groups with different cut-offs for accepted postvoid residual urine (150 ml vs 250 ml).
Primary endpoint is be the time to regain normal bladder function in each group. Secondary endpoints are 1) presence/absence of bacteriuria or urinary tract infections, 2) the duration of hospital stay, 3) scores on the adapted version of the German pelvic floor questionnaire section about bladder function and postpartum symptoms.
The calculated sample size is 96 (48 in each group).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Women with postvoid residual volume cut-off at 150 ml
Intermittent catheterization
Intermittent catheterization is performed as treatment for urinary retention. Treatment is stopped when postvoid urinary retention volume is below the threshold of each group.
Women with postvoid residual volume cut-off at 250 ml
Intermittent catheterization
Intermittent catheterization is performed as treatment for urinary retention. Treatment is stopped when postvoid urinary retention volume is below the threshold of each group.
Interventions
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Intermittent catheterization
Intermittent catheterization is performed as treatment for urinary retention. Treatment is stopped when postvoid urinary retention volume is below the threshold of each group.
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years at delivery date.
* Delivery at study site.
* signed informed consent.
Exclusion Criteria
* Language barrier.
18 Years
65 Years
FEMALE
No
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Soren Lange
Fellow, Principal Investigator, M.D.
Locations
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Medical University of Vienna/Allgemeines Krankenhaus Wien
Vienna, , Austria
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1093/2021
Identifier Type: -
Identifier Source: org_study_id
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