RCT About Two Different Regimens of Clean Intermittent Catheterization in Women With Overt Postpartum Urinary Retention
- Conditions
- Postpartum PeriodUrinary Retention
- Interventions
- Procedure: Intermittent catheterization
- Registration Number
- NCT05188963
- Lead Sponsor
- Medical University of Vienna
- Brief Summary
A randomized controlled trial of two different regimens of intermittent catheterization in women with overt postpartum urinary retention.
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 96
- Diagnosed overt postpartum urinary retention.
- Age ≥ 18 years at delivery date.
- Delivery at study site.
- signed informed consent.
- Refusal to participate.
- Language barrier.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Women with postvoid residual volume cut-off at 150 ml Intermittent catheterization - Women with postvoid residual volume cut-off at 250 ml Intermittent catheterization -
- Primary Outcome Measures
Name Time Method Time to regain normal bladder function 3 months The time until bladder function returned to normal.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Medical University of Vienna/Allgemeines Krankenhaus Wien
🇦🇹Vienna, Austria