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

A Randomized Control Trial About Two Different Regimens of Clean Intermittent Catheterization in Women With Overt PUR: the DICOPUR Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05188963
Acronym
DICOPUR
Enrollment
96
Registered
2022-01-12
Start date
2021-06-29
Completion date
2025-06-28
Last updated
2023-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum Period, Urinary Retention

Keywords

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

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).

Interventions

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

Medical University of Vienna
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Time to regain normal bladder function3 monthsThe time until bladder function returned to normal.

Countries

Austria

Contacts

Primary ContactSören Lange, Dr.med.
soeren.lange@meduniwien.ac.at+43 (0)1-40400-29150

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026