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

NCT ID: NCT05188963

Last Updated: 2023-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-29

Study Completion Date

2025-06-28

Brief Summary

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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).

Detailed Description

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Conditions

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Urinary Retention Postpartum Period

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Women with postvoid residual volume cut-off at 150 ml

Group Type ACTIVE_COMPARATOR

Intermittent catheterization

Intervention Type 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 250 ml

Group Type EXPERIMENTAL

Intermittent catheterization

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Soren Lange

Fellow, Principal Investigator, M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Medical University of Vienna/Allgemeines Krankenhaus Wien

Vienna, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Sören Lange, Dr.med.

Role: CONTACT

+43 (0)1-40400-29150

Facility Contacts

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Sören Lange, Dr. med.

Role: primary

+43 (0)1-40400-29150

Other Identifiers

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1093/2021

Identifier Type: -

Identifier Source: org_study_id

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