RCT About Two Different Regimens of Clean Intermittent Catheterization in Women With Overt Postpartum Urinary Retention

Not Applicable

Recruiting

• Conditions: Postpartum Period; Urinary Retention

• 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

Study Timeline

• Study Start: 2021-06-29
• Study First Submitted: 2021-12-27
• Study First Submitted QC: 2022-01-11
• Study First Posted: 2022-01-12
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-14
• Last Update Posted: 2023-03-15
• Primary Completion: 2025-06-28
• Study Completion: 2025-06-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 96

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to regain normal bladder function	3 months	The time until bladder function returned to normal.

Trial Locations

Locations (1)

Medical University of Vienna/Allgemeines Krankenhaus Wien; 🇦🇹 Vienna, Austria