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NCT05188963 Clinical Trial

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

Urinary Retention Clinical Trial

— DICOPUR  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05188963
Other study ID # 1093/2021
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 29, 2021
Est. completion date June 28, 2025

Study information
Verified date March 2023
Source Medical University of Vienna
Contact Sören Lange, Dr.med.
Phone +43 (0)1-40400-29150
Email soeren.lange@meduniwien.ac.at
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Recruiting
Enrollment 96
Est. completion date June 28, 2025
Est. primary completion date June 28, 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Austria Medical University of Vienna/Allgemeines Krankenhaus Wien Vienna

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time to regain normal bladder function The time until bladder function returned to normal. 3 months
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