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

Primary Purpose

Urinary Retention, Postpartum Period

Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Intermittent catheterization
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Retention focused on measuring postpartum urinary retention, intermittent catheterization, postvoid residual volume, postpartum

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Medical University of Vienna/Allgemeines Krankenhaus WienRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Women with postvoid residual volume cut-off at 150 ml

Women with postvoid residual volume cut-off at 250 ml

Arm Description

Outcomes

Primary Outcome Measures

Time to regain normal bladder function
The time until bladder function returned to normal.

Secondary Outcome Measures

Full Information

First Posted
December 27, 2021
Last Updated
March 14, 2023
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT05188963
Brief Title
RCT About Two Different Regimens of Clean Intermittent Catheterization in Women With Overt Postpartum Urinary Retention
Acronym
DICOPUR
Official Title
A Randomized Control Trial About Two Different Regimens of Clean Intermittent Catheterization in Women With Overt PUR: the DICOPUR Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 29, 2021 (Actual)
Primary Completion Date
June 28, 2025 (Anticipated)
Study Completion Date
June 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Retention, Postpartum Period
Keywords
postpartum urinary retention, intermittent catheterization, postvoid residual volume, postpartum

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Women with postvoid residual volume cut-off at 150 ml
Arm Type
Active Comparator
Arm Title
Women with postvoid residual volume cut-off at 250 ml
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Intermittent catheterization
Intervention Description
Intermittent catheterization is performed as treatment for urinary retention. Treatment is stopped when postvoid urinary retention volume is below the threshold of each group.
Primary Outcome Measure Information:
Title
Time to regain normal bladder function
Description
The time until bladder function returned to normal.
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sören Lange, Dr.med.
Phone
+43 (0)1-40400-29150
Email
soeren.lange@meduniwien.ac.at
Facility Information:
Facility Name
Medical University of Vienna/Allgemeines Krankenhaus Wien
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sören Lange, Dr. med.
Phone
+43 (0)1-40400-29150
Email
soeren.lange@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Barbara Bodner-Adler, Univ.-Prof., Dr. med.
First Name & Middle Initial & Last Name & Degree
Wolfgang Umek, Univ.-Prof., Dr. med.
First Name & Middle Initial & Last Name & Degree
Pateisky Petra, Dr.med.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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