Retention, UrinaryNCT04104165
Treatment of Postpartum Urinary Retention
A study testing Foley Catheter in people with Retention, Urinary, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
The aim of the study is to evaluate what is the most effective catheterization duration to resolve covert and overt postpartum urinary retention following vaginal delivery and caesarean delivery, with the highest patients' satisfaction. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Retention, Urinary
- What is being tested?
- Foley Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2020to 31 May 2022
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women who deliver at one of the centers included in the study
- Overt postpartum urinary retention which refers to the absence of spontaneous micturition within six to eight hours of vaginal delivery; or within six to eight hours following removal of an indwelling catheter after cesarean delivery
- Covert postpartum urinary retention diagnosed by ultrasound or catheterization of more than 150cc
Who cannot join
- Spontaneous micturition 6-8 hours following vaginal or cesarean delivery
- postpartum urinary retention less than 150cc on ultrasound
- Known urinary tract infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intermittent Versus Continous Catheterization for Treatment of Postpartum Urinary Retention.
The aim of the study is to evaluate what is the most effective catheterization duration to resolve covert and overt postpartum urinary retention following vaginal delivery and caesarean delivery, with the highest patients' satisfaction.
Read the detailed description
- Women who are unable to micturate for more than 6-8 hours following vaginal delivery or within six to eight hours following removal of an indwelling catheter after cesarean delivery (overt postpartum urinary retention), or women with postvoid residual bladder volume of at least 150 mL (covert postpartum urinary retention) will be randomized into 2 groups: one group will include women who are catheterized intermittently every 6-8 hours up to a total time of 48 hours. If at any time, post voiding residual volume is less than 150cc (assessed by ultrasound or by catheterization), no additional catheterization is needed. The second group will include women which will have an indwelling catheter inserted for 24 hours. The catheter will be removed 24 hours following its insertion and post voiding residual volume will be assessed 6 hours following the catheter removal (by ultrasound or by catheterization). In cases of post voiding residual volume more than 150 cc or women are unable to micturate spontaneously, an indwelling catheter will be inserted for additional 24 hours.
- After 48 hours from postpartum urinary retention diagnosis, an indwelling catheter will be inserted for additional time that will be set at every center by its common protocol.
- Conditions
- Retention, Urinary
- Being tested
- Foley Catheter
- Medical subject headings
- Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foley CatheterDevice
Foley catheter used for treatment of urinary retention
| Study group | Role | What they receive |
|---|---|---|
| Intermittent catheterization | Active comparator | women who are catheterized intermittently every 6-8 hours up to a total time of 48 hours Receives: Device: Foley Catheter |
| Continous catheterization | Active comparator | women which will have an indwelling catheter inserted for 24 hours Receives: Device: Foley Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean time for urinary retention resolution.
Mean time for urinary retention resolution following the intervention.
Measured: Up to 10 days from diagnosis
Secondary outcomes (2)
Urinary tract infection rate
Incidence of Urinary tract infections
Measured: Up to 96 hours from diagnosis
Length of hospital stay
Length of hospital stay
Measured: Up to 96 hours from diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start1 Jan 2020
- Primary completion30 Apr 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Retention, UrinaryStudies of the same condition, open and under way.
- 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
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ROY LAUTERBACH MD, Rambam Health Care Campus
- Investigators
- Roy Lauterbach, MD, Principal investigator, Rambam Healthcare Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04104165
- Sponsor's protocol ID
- 0515-19-RMB
- Status last verified
- Aug 2022
- First submitted
- 24 Sep 2019
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bachar G, Siegler Y, Kabakov E, Lauterbach R, Justman N, Ben-Ezry E, Weiner E, Ganor-Paz Y, Yefet E, Khamaisi T, Nachum Z, Massalha M, Shamali K, Khatib N, Zipori Y, Weiner Z, Vitner D. Intermittent vs continuous catheterization for postpartum urinary retention: A multicenter randomized controlled trial. Am J Obstet Gynecol MFM. 2023 Oct;5(10):101084. doi: 10.1016/j.ajogmf.2023.101084. Epub 2023 Jul 8.
PubMed 37423430
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Versus Continous Catheterization for Treatment of Postpartum Urinary Retention.
- ClinicalTrials.gov ID
- NCT04104165
- Acronym / sponsor ID
- 0515-19-RMB
- Conditions
- Retention, Urinary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 26 Sep 2019 (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.
The aim of the study is to evaluate what is the most effective catheterization duration to resolve covert and overt postpartum urinary retention following vaginal delivery and caesarean delivery, with the highest patients' satisfaction.
Detailed description
- Women who are unable to micturate for more than 6-8 hours following vaginal delivery or within six to eight hours following removal of an indwelling catheter after cesarean delivery (overt postpartum urinary retention), or women with postvoid residual bladder volume of at least 150 mL (covert postpartum urinary retention) will be randomized into 2 groups: one group will include women who are catheterized intermittently every 6-8 hours up to a total time of 48 hours. If at any time, post voiding residual volume is less than 150cc (assessed by ultrasound or by catheterization), no additional catheterization is needed. The second group will include women which will have an indwelling catheter inserted for 24 hours. The catheter will be removed 24 hours following its insertion and post voiding residual volume will be assessed 6 hours following the catheter removal (by ultrasound or by catheterization). In cases of post voiding residual volume more than 150 cc or women are unable to micturate spontaneously, an indwelling catheter will be inserted for additional 24 hours.
- After 48 hours from postpartum urinary retention diagnosis, an indwelling catheter will be inserted for additional time that will be set at every center by its common protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent catheterization | Active comparator | Device: Foley Catheterwomen who are catheterized intermittently every 6-8 hours up to a total time of 48 hours |
| Continous catheterization | Active comparator | Device: Foley Catheterwomen which will have an indwelling catheter inserted for 24 hours |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women who deliver at one of the centers included in the study
- Overt postpartum urinary retention which refers to the absence of spontaneous micturition within six to eight hours of vaginal delivery; or within six to eight hours following removal of an indwelling catheter after cesarean delivery
- Covert postpartum urinary retention diagnosed by ultrasound or catheterization of more than 150cc
Key exclusion criteria (3 listed)
- Spontaneous micturition 6-8 hours following vaginal or cesarean delivery
- postpartum urinary retention less than 150cc on ultrasound
- Known urinary tract infection
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 |
|---|---|---|
| Foley CatheterFoley catheter used for treatment of urinary retention | Device | Continous catheterization, Intermittent catheterization |
Primary outcome
Mean time for urinary retention resolution.
Time frame: Up to 10 days from diagnosis
Mean time for urinary retention resolution following the intervention.
2 secondary outcomes
Urinary tract infection rate
Time frame: Up to 96 hours from diagnosis
Length of hospital stay
Time frame: Up to 96 hours from diagnosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- Derived from this study: PubMed 37423430Bachar G, Siegler Y, Kabakov E, Lauterbach R, Justman N, Ben-Ezry E, Weiner E, Ganor-Paz Y, Yefet E, Khamaisi T, Nachum Z, Massalha M, Shamali K, Khatib N, Zipori Y, Weiner Z, Vitner D. Intermittent vs continuous catheterization for postpartum urinary retention: A multicenter randomized controlled trial. Am J Obstet Gynecol MFM. 2023 Oct;5(10):101084. doi: 10.1016/j.ajogmf.2023.101084. Epub 2023 Jul 8.
- 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.
Roy Lauterbach, MD principal investigator
Rambam Healthcare Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foley Catheter in people with Retention, Urinary, run by Rambam Health Care Campus at 1 site in Israel.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 16 Aug 2022. 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 Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean time for urinary retention resolution. (time frame: Up to 10 days from diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04104165, which also lists 1 linked publication.
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 16 Aug 2022.