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

Medical University of Vienna

Status: Enrolling

Conditions: Urinary Retention; Postpartum Period

Treatments: Procedure: Intermittent catheterization

Study type: Interventional

Funder types: Other

Identifiers

NCT05188963

1093/2021

Details and patient eligibility

About

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).

Enrollment: 96 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

Women with postvoid residual volume cut-off at 150 ml

Active Comparator group

Treatment:

Procedure: Intermittent catheterization

Women with postvoid residual volume cut-off at 250 ml

Experimental group

Treatment:

Procedure: Intermittent catheterization