Urinary RetentionNCT07125326
How the Method of Bladder Emptying After Epidural Placement in Labor Affects Postpartum Voiding
A study testing Intermittent catheterization and Continuous catheterization in people with Urinary Retention and Urinary Tract Infection (Diagnosis), run by University of Pittsburgh at 1 site in United States.
Trial summary
At least ten percent of patients have postpartum urinary retention or difficulty urinating after birth, which can cause incontinence and other urinary problems long-term. After getting an epidural placed, patients should be numb in their pelvic region. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Retention, Urinary Tract Infection (Diagnosis), Postpartum Acute Urinary Retention
- What is being tested?
- Intermittent catheterization and Continuous catheterization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2025to 21 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant patients planning vaginal delivery presenting in labor or for induction of labor
- Age 18 years and older
- Live fetus
- Receive epidural anesthesia
Who cannot join
- those under 18 years old
- those with stillbirth
- those with baseline overactive bladder symptoms, neurogenic bladder diagnoses, or otherwise using bladder catheterization during pregnancy
- Patients will be excluded from UTI analyses if:
- they received antibiotics intrapartum
- had bacteriuria diagnosed by a clean catch specimen showing >100,000 CFU/mL of a single bacterial species, regardless of symptoms
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15217
About this study
Official title: Intermittent Versus Continuous Bladder Catheterization in Epiduralized Laboring Patients: a Non-blinded Randomized Controlled Trial
At least ten percent of patients have postpartum urinary retention or difficulty urinating after birth, which can cause incontinence and other urinary problems long-term. After getting an epidural placed, patients should be numb in their pelvic region. This numbness makes it difficult to feel the need to urinate, so patients need a urinary catheter placed to empty the bladder. Some patients have one catheter placed throughout their labor and others have a catheter placed to empty the bladder then removed every few hours. The investigators are studying whether placing a catheter once or catheterizing multiple times affects the rate of postpartum urinary problems and infection.
Read the detailed description
This is a randomized controlled trial to assess the effect of bladder catheterization method during labor with epidural anesthesia on the rate of postpartum urinary retention.
- Conditions
- Urinary Retention, Urinary Tract Infection (Diagnosis), Postpartum Acute Urinary Retention, Postpartum Care, Voiding Dysfunction
- Being tested
- Intermittent catheterization, Continuous catheterization
- Keywords
- catheterization, foley, catheter, urinary retention, voiding dysfunction, epidural, labor, bladder catheterization
- Medical subject headings
- Urinary Retention, Urinary Tract Infections, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent catheterizationProcedure or surgery
intermittent bladder catheterization every four hours, or shorter intervals if volume exceeds 500mL per expert recommendation
Continuous catheterizationProcedure or surgery
One catheter is placed in the bladder until pushing
| Study group | Role | What they receive |
|---|---|---|
| Intermittent catheterization | Active comparator | Not described Receives: Procedure: Intermittent catheterization |
| Continuous catheterization | Active comparator | Not described Receives: Procedure: Continuous catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum urinary retention
Urinary retention defined as overt inability to void at six hours after last bladder emptying postpartum or symptomatic incomplete emptying, or covert retention of >150cc urine in the bladder after voiding Collecting number of participants who experience this
Measured: Three days postpartum
Secondary outcomes (7)
Postpartum urinary tract infection
Culture-proven urinary tract infection without pre-existing infection documented on admission for delivery Collecting number of participants who experience this
Measured: One week postpartum
Patient satisfaction
Title: Patient satisfaction Minimum rating 1, maximum 5, with 5 corresponding to better outcome Each question will be interpreted alone rather than aggregated
Measured: Immediately postpartum
Nurse satisfaction
Title: Nurse satisfaction Minimum rating 1, maximum 5, with 5 corresponding to better outcome Each question will be interpreted alone rather than aggregated
Measured: Immediately postpartum
Voiding function at 2 weeks
Urinary Distress Inventory-6 questionnaire answers, to be analyzed individually (0-4) and also summed, with higher total score indicating worse function from 0 to 24
Measured: 2 weeks postpartum
Voiding function at 6 weeks
Urinary Distress Inventory-6 questionnaire answers, to be analyzed individually (0-4) and also summed, with higher total score indicating worse function from 0 to 24
Measured: 6 weeks postpartum
Voiding function at 6 months
Urinary Distress Inventory-6 questionnaire answers, to be analyzed individually (0-4) and also summed, with higher total score indicating worse function from 0 to 24
Measured: 6 months postpartum
Voiding function at one year
Urinary Distress Inventory-6 questionnaire answers, to be analyzed individually (0-4) and also summed, with higher total score indicating worse function from 0 to 24
Measured: one year postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start9 Dec 2025
- Primary completion21 May 2026
- Study completion21 May 2027 (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 University of PittsburghThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Allocation will be determined based on a previously generated randomization scheme created by the NCI Clinical Trials Randomization Tool.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Lands, University of Pittsburgh
- Investigators
- Anna Binstock, MD, Study chair, UPMC Magee-Womens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07125326
- Sponsor's protocol ID
- STUDY24030142
- Status last verified
- Jun 2026
- First submitted
- 4 Aug 2025
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Versus Continuous Bladder Catheterization in Epiduralized Laboring Patients: a Non-blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07125326
- Acronym / sponsor ID
- STUDY24030142
- Conditions
- Urinary Retention, Urinary Tract Infection (Diagnosis), Postpartum Acute Urinary Retention, Postpartum Care, Voiding Dysfunction
- Keywords
- catheterization, foley, catheter, urinary retention, voiding dysfunction, epidural, labor, bladder catheterization
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 9 Dec 2025 (actual)
- Primary completion
- 21 May 2026 (actual)
- Study completion
- 21 May 2027 (estimated)
- First posted
- 15 Aug 2025 (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.
At least ten percent of patients have postpartum urinary retention or difficulty urinating after birth, which can cause incontinence and other urinary problems long-term. After getting an epidural placed, patients should be numb in their pelvic region. This numbness makes it difficult to feel the need to urinate, so patients need a urinary catheter placed to empty the bladder. Some patients have one catheter placed throughout their labor and others have a catheter placed to empty the bladder then removed every few hours. The investigators are studying whether placing a catheter once or catheterizing multiple times affects the rate of postpartum urinary problems and infection.
Detailed description
This is a randomized controlled trial to assess the effect of bladder catheterization method during labor with epidural anesthesia on the rate of postpartum urinary retention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Allocation will be determined based on a previously generated randomization scheme created by the NCI Clinical Trials Randomization Tool.
| Arm | Type | Receives |
|---|---|---|
| Intermittent catheterization | Active comparator | Procedure: Intermittent catheterization |
| Continuous catheterization | Active comparator | Procedure: Continuous catheterization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pregnant patients planning vaginal delivery presenting in labor or for induction of labor
- Age 18 years and older
- Live fetus
- Receive epidural anesthesia
Key exclusion criteria (6 listed)
- those under 18 years old
- those with stillbirth
- those with baseline overactive bladder symptoms, neurogenic bladder diagnoses, or otherwise using bladder catheterization during pregnancy
- they received antibiotics intrapartum
- had bacteriuria diagnosed by a clean catch specimen showing >100,000 CFU/mL of a single bacterial species, regardless of symptoms
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 bladder catheterization every four hours, or shorter intervals if volume exceeds 500mL per expert recommendation | Procedure or surgery | Intermittent catheterization |
| Continuous catheterizationOne catheter is placed in the bladder until pushing | Procedure or surgery | Continuous catheterization |
Primary outcome
Postpartum urinary retention
Time frame: Three days postpartum
Urinary retention defined as overt inability to void at six hours after last bladder emptying postpartum or symptomatic incomplete emptying, or covert retention of >150cc urine in the bladder after voiding Collecting number of participants who experience this
7 secondary outcomes
Postpartum urinary tract infection
Time frame: One week postpartum
Patient satisfaction
Time frame: Immediately postpartum
Nurse satisfaction
Time frame: Immediately postpartum
Voiding function at 2 weeks
Time frame: 2 weeks postpartum
Voiding function at 6 weeks
Time frame: 6 weeks postpartum
Voiding function at 6 months
Time frame: 6 months postpartum
Voiding function at one year
Time frame: one year postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Urinary Retention
Not yet recruiting
Effect of Voiding Position (Standing in the Shower vs. Sitting) on Post- Void Residual Urine Volume (PVR) After Removal of Urinary Catheter in Women Following Vaginal Delivery With Epidural Analgesia: A Double- Blind Randomized Controlled Trial
Postpartum Urinary Retention
Recruiting
Pelvic Health Electrically Evoked Recording (PEER) 2 Study
Overactive Bladder, Fecal Incontinence
Not yet recruitingObservational study
Long-Term Effectiveness and Safety of Sacral Neuromodulation With InterStim for Lower Urinary Tract Dysfunction
Overactive Bladder (OAB), Urgency Urinary Incontinence
Active, not recruiting
Preoperative Pelvic Floor Physical Therapy to Minimize Stress Urinary Incontinence After Holmium Laser Enucleation of the Prostate
Benign Prostatic Hyperplasia With Outflow Obstruction, Urinary Retention
Recruiting
Evaluating the Clinical Efficacy of Thulio vs. Holmium Laser Enucleation of the Prostate
BPH With Symptomatic Lower Urinary Tract Symptoms, BPH With Urinary Obstruction
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.
Anna Binstock, MD study chair
UPMC Magee-Womens Hospital
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 and Continuous catheterization in people with Urinary Retention and Urinary Tract Infection (Diagnosis), run by University of Pittsburgh at 1 site in United States.
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 6 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: under way, not looking for participants, as of the sponsor's last update on 12 Jun 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Postpartum urinary retention (time frame: Three days postpartum). 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 12 Jun 2026.