Urinary RetentionNCT02865551
Urinary Retention After Vaginal Delivery With Epidural Anesthesia.
A study testing Foley catheter, Short term catheter and Epidural anesthesia in people with Urinary Retention, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
The investigators intend to compare the rate of urinary retention among female patients after vaginal delivery under epidural anesthesia, depending on bladder catheterization type, either by a foley catheter inserted adjacent to epidural anesthesia or intermittent catheterization applied every 4 hours during labor. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Urinary Retention
- What is being tested?
- Foley catheter, Short term catheter and Epidural anesthesia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jul 2019to 31 Dec 2023
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients in labor designated for vaginal delivery with epidural anesthesia.
Who cannot join
- Patients with neurological problems including gestational diabetes.
- Patients either designated for elective cesarean delivery or emergent cesarean delivery.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rambam health care campus
Haifa
Roy Lauterbach, MD, 0529432416, r_lauterbach@rambam.health.gov.il
Roy Lauterbach, MD
About this study
Official title: The Rate of Urinary Retention in Women After Vaginal Delivery With Epidural Anesthesia Who Underwent Prolonged Catheterization Compared With Intermittent Catheterization During Labor.
The investigators intend to compare the rate of urinary retention among female patients after vaginal delivery under epidural anesthesia, depending on bladder catheterization type, either by a foley catheter inserted adjacent to epidural anesthesia or intermittent catheterization applied every 4 hours during labor.
Read the detailed description
An explanation about the study will be delivered to each participant and each participant will sign a confirmed consent. Patients will be randomized between 2 groups of treatment: 1. intermittent catheterization applied every 4 hours during labor. 2. foley catheter inserted adjacent to epidural anesthesia.
In patients with a foley catheter, the catheter will be removed soon after delivery. Participants will be followed by a clinician post labor. An abdominal US will be performed either 4 hours after delivery or after the participant urinates to check the bladder volume.
Patient information including demographic information, information regarding the patient's pregnancy and delivery will be collected from the patient's electronic record.
- Conditions
- Urinary Retention
- Being tested
- Foley catheter, Short term catheter, Epidural anesthesia
- 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
Extended bladder catheterization after epidural anesthesia.
Short term catheterDevice
Intermittent catheterization every 4 hours after epidural anesthesia.
Epidural anesthesiaDrug
Performance of epidural anesthesia by a certified anesthesiologist.
| Study group | Role | What they receive |
|---|---|---|
| Extended catheterization | Experimental | Participants in which a foley catheter will be inserted adjacent to epidural anesthesia during labor. Receives: Device: Foley catheter; Drug: Epidural anesthesia |
| Intermittent catheterization | Experimental | Participants in which a short term catheter will be inserted every 4 hours during labor after epidural anesthesia until delivery. Receives: Device: Short term catheter; Drug: Epidural anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of urinary retention after vaginal delivery with epidural anesthesia
Measured: Up to 3 days
Secondary outcomes (1)
Rate of urinary tract infections
Measured: Up to 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study start1 Jul 2019
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Dec 2023 (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.
- 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
- 160 participants (estimated)
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
- Lior Lowenstein, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02865551
- Sponsor's protocol ID
- 0141-15-RMB
- Status last verified
- Jan 2023
- First submitted
- 9 Aug 2016
- Last updated
- 25 Jan 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 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Rate of Urinary Retention in Women After Vaginal Delivery With Epidural Anesthesia Who Underwent Prolonged Catheterization Compared With Intermittent Catheterization During Labor.
- ClinicalTrials.gov ID
- NCT02865551
- Acronym / sponsor ID
- 0141-15-RMB
- Conditions
- Urinary Retention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 12 Aug 2016 (estimated)
- 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 investigators intend to compare the rate of urinary retention among female patients after vaginal delivery under epidural anesthesia, depending on bladder catheterization type, either by a foley catheter inserted adjacent to epidural anesthesia or intermittent catheterization applied every 4 hours during labor.
Detailed description
An explanation about the study will be delivered to each participant and each participant will sign a confirmed consent. Patients will be randomized between 2 groups of treatment: 1. intermittent catheterization applied every 4 hours during labor. 2. foley catheter inserted adjacent to epidural anesthesia.
In patients with a foley catheter, the catheter will be removed soon after delivery. Participants will be followed by a clinician post labor. An abdominal US will be performed either 4 hours after delivery or after the participant urinates to check the bladder volume.
Patient information including demographic information, information regarding the patient's pregnancy and delivery will be collected from the patient's electronic record.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extended catheterization | Experimental | Device: Foley catheter, Drug: Epidural anesthesiaParticipants in which a foley catheter will be inserted adjacent to epidural anesthesia during labor. |
| Intermittent catheterization | Experimental | Device: Short term catheter, Drug: Epidural anesthesiaParticipants in which a short term catheter will be inserted every 4 hours during labor after epidural anesthesia until delivery. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Female patients in labor designated for vaginal delivery with epidural anesthesia.
Key exclusion criteria (2 listed)
- Patients with neurological problems including gestational diabetes.
- Patients either designated for elective cesarean delivery or emergent cesarean delivery.
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 catheterExtended bladder catheterization after epidural anesthesia. | Device | Extended catheterization |
| Short term catheterIntermittent catheterization every 4 hours after epidural anesthesia. | Device | Intermittent catheterization |
| Epidural anesthesiaPerformance of epidural anesthesia by a certified anesthesiologist. | Drug | Extended catheterization, Intermittent catheterization |
Primary outcome
Rate of urinary retention after vaginal delivery with epidural anesthesia
Time frame: Up to 3 days
1 secondary outcome
Rate of urinary tract infections
Time frame: Up to 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 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.
Lior Lowenstein, MD principal investigator
Rambam Health Care 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, Short term catheter and Epidural anesthesia in people with Urinary Retention, 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 1 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 25 Jan 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roy Lauterbach, MD (972529432416, r_lauterbach@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of urinary retention after vaginal delivery with epidural anesthesia (time frame: Up to 3 days). 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 25 Jan 2023.