A Randomized Control Trial About Two Different Regimens of Clean Intermittent Catheterization in Women With Overt PUR: the DICOPUR Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Urinary Retention
- Sponsor
- Medical University of Vienna
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- Time to regain normal bladder function
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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).
Investigators
Soren Lange
Fellow, Principal Investigator, M.D.
Medical University of Vienna
Eligibility Criteria
Inclusion Criteria
- •Diagnosed overt postpartum urinary retention.
- •Age ≥ 18 years at delivery date.
- •Delivery at study site.
- •signed informed consent.
Exclusion Criteria
- •Refusal to participate.
- •Language barrier.
Outcomes
Primary Outcomes
Time to regain normal bladder function
Time Frame: 3 months
The time until bladder function returned to normal.