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

• Sponsor: Medical University of Vienna (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05188963
• Collaborator: (none)
• Enrollment: 96
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 4

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Urinary Retention; Postpartum Period	Procedure: Intermittent catheterization	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 96 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Control Trial About Two Different Regimens of Clean Intermittent Catheterization in Women With Overt PUR: the DICOPUR Trial
• Actual Study Start Date: Jun 29, 2021
• Anticipated Primary Completion Date: Jun 28, 2023
• Anticipated Study Completion Date: Jun 28, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Women with postvoid residual volume cut-off at 150 ml	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.
Experimental: Women with postvoid residual volume cut-off at 250 ml	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.

Outcome Measures

Primary Outcome Measures

1. Time to regain normal bladder function [3 months]

   The time until bladder function returned to normal.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Vienna/Allgemeines Krankenhaus Wien	Vienna		Austria	1090

Sponsors and Collaborators

• Medical University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Soren Lange, Fellow, Principal Investigator, M.D., Medical University of Vienna
• ClinicalTrials.gov Identifier: NCT05188963
• Other Study ID Numbers: 1093/2021
• First Posted: Jan 12, 2022
• Last Update Posted: Jan 31, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Soren Lange, Fellow, Principal Investigator, M.D., Medical University of Vienna: postpartum urinary retention; intermittent catheterization; postvoid residual volume; postpartum
• Additional relevant MeSH terms: Urinary Retention

Study Results

No Results Posted as of Jan 31, 2022