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

NCT05188963 | Unknown

• 1 other identifier: 1093/2021
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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).

Conditions

Urinary Retention; Postpartum Period

Keywords

postpartum urinary retention; intermittent catheterization; postvoid residual volume; postpartum

Outcome Measures

Primary Outcomes (1)

• Time to regain normal bladder function

  The time until bladder function returned to normal.

  3 months

Study Arms (2)

Women with postvoid residual volume cut-off at 150 ml

ACTIVE COMPARATOR

Procedure: Intermittent catheterization

Women with postvoid residual volume cut-off at 250 ml

EXPERIMENTAL

Procedure: Intermittent catheterization

Interventions

Intermittent catheterization PROCEDURE

Intermittent catheterization is performed as treatment for urinary retention. Treatment is stopped when postvoid urinary retention volume is below the threshold of each group.

Women with postvoid residual volume cut-off at 150 ml; Women with postvoid residual volume cut-off at 250 ml

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed overt postpartum urinary retention.
• Age ≥ 18 years at delivery date.
• Delivery at study site.
• signed informed consent.

You may not qualify if:

• Refusal to participate.
• Language barrier.

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna/Allgemeines Krankenhaus Wien

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Urinary Retention

Interventions

Intermittent Urethral Catheterization

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Urinary Catheterization; Catheterization; Therapeutics; Investigative Techniques

Central Study Contacts

Sören Lange, Dr.med.

CONTACT

+43 (0)1-40400-29150; soeren.lange@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow, Principal Investigator, M.D.

Study Record Dates

• First Submitted: December 27, 2021
• First Posted: January 12, 2022
• Study Start: June 29, 2021
• Primary Completion: June 28, 2025
• Study Completion: June 28, 2025
• Last Updated: March 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)