Urinary RetentionDICOPURNCT05188963
RCT About Two Different Regimens of Clean Intermittent Catheterization in Women With Overt Postpartum Urinary Retention
A study testing Intermittent catheterization in people with Urinary Retention and Postpartum Period, run by Medical University of Vienna at 1 site in Austria.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Urinary Retention, Postpartum Period
- What is being tested?
- Intermittent catheterization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteAustria
- Study dates
- 29 Jun 2021to 28 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed overt postpartum urinary retention.
- Age ≥ 18 years at delivery date.
- Delivery at study site.
- signed informed consent.
Who cannot join
- Refusal to participate.
- Language barrier.
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna/Allgemeines Krankenhaus Wien
Vienna, 1090
Sören Lange, Dr. med., +43 (0)1-40400-29150, soeren.lange@meduniwien.ac.at
Barbara Bodner-Adler, Univ.-Prof., Dr. med.
About this study
Official title: A Randomized Control Trial About Two Different Regimens of Clean Intermittent Catheterization in Women With Overt PUR: the DICOPUR Trial
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
- Being tested
- Intermittent catheterization
- Keywords
- postpartum urinary retention, intermittent catheterization, postvoid residual volume, postpartum
- Medical subject headings
- Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent catheterizationProcedure or surgery
Intermittent catheterization is performed as treatment for urinary retention. Treatment is stopped when postvoid urinary retention volume is below the threshold of each group.
| Study group | Role | What they receive |
|---|---|---|
| Women with postvoid residual volume cut-off at 150 ml | Active comparator | Not described Receives: Procedure: Intermittent catheterization |
| Women with postvoid residual volume cut-off at 250 ml | Experimental | Not described Receives: Procedure: Intermittent catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to regain normal bladder function
The time until bladder function returned to normal.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start29 Jun 2021
- Primary completion28 Jun 2025 (estimated)
- Study completion28 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary RetentionStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soren Lange, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05188963
- Sponsor's protocol ID
- 1093/2021
- Acronym
- DICOPUR
- Status last verified
- Mar 2023
- First submitted
- 27 Dec 2021
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial About Two Different Regimens of Clean Intermittent Catheterization in Women With Overt PUR: the DICOPUR Trial
- ClinicalTrials.gov ID
- NCT05188963
- Acronym / sponsor ID
- DICOPUR / 1093/2021
- Conditions
- Urinary Retention, Postpartum Period
- Keywords
- postpartum urinary retention, intermittent catheterization, postvoid residual volume, postpartum
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 29 Jun 2021 (actual)
- Primary completion
- 28 Jun 2025 (estimated)
- Study completion
- 28 Jun 2025 (estimated)
- First posted
- 12 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with postvoid residual volume cut-off at 150 ml | Active comparator | Procedure: Intermittent catheterization |
| Women with postvoid residual volume cut-off at 250 ml | Experimental | Procedure: Intermittent catheterization |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed overt postpartum urinary retention.
- Age ≥ 18 years at delivery date.
- Delivery at study site.
- signed informed consent.
Key exclusion criteria (2 listed)
- Refusal to participate.
- Language barrier.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent catheterizationIntermittent catheterization is performed as treatment for urinary retention. Treatment is stopped when postvoid urinary retention volume is below the threshold of each group. | Procedure or surgery | Women with postvoid residual volume cut-off at 150 ml, Women with postvoid residual volume cut-off at 250 ml |
Primary outcome
Time to regain normal bladder function
Time frame: 3 months
The time until bladder function returned to normal.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent catheterization in people with Urinary Retention and Postpartum Period, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sören Lange, Dr.med. (+43 (0)1-40400-29150, soeren.lange@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to regain normal bladder function (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.