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

NCT05188963 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2023-03-15

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-29
Primary Completion
2025-06-28
Completion
2025-06-28

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05188963 on ClinicalTrials.gov