NCT05188963

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

A Randomized Control Trial About Two Different Regimens of Clean Intermittent Catheterization in Women With Overt PUR: the DICOPUR Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Urinary Retention
• Postpartum Period

Interventions

Type	Name	Description
PROCEDURE	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.

Timeline

• Start date: 2021-06-29
• Primary completion: 2025-06-28
• Completion: 2025-06-28
• First posted: 2022-01-12
• Last updated: 2023-03-15

Locations

1 site across 1 country: Austria