Catheterization Methods for Postpartum Urinary Problems

Overseen By Elena Lands, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Must not be taking: Antibiotics

Disqualifiers: Under 18, Stillbirth, Overactive bladder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: During labor

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different catheter methods during childbirth affect urinary problems afterward. Some women receive a catheter once for the entire labor (continuous catheterization), while others have it placed and removed several times (intermittent catheterization). Researchers aim to determine if one method results in fewer urinary issues or infections. This trial is suitable for pregnant women planning a vaginal delivery and receiving an epidural. As an unphased trial, participants can contribute to important research that may enhance childbirth experiences for future mothers.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these catheterization methods are safe for postpartum urinary problems?

A previous study found that using an intermittent catheter helped women recover from urinary retention after childbirth more quickly, with 96% to 100% of patients improving within 2 to 5 days. This method also resulted in higher patient satisfaction compared to continuous catheter use.

Research suggests that continuous catheterization might lead to more natural births. However, it does not clearly outperform intermittent catheterization in other areas. Both methods are generally well-tolerated, and the choice between them often depends on individual needs and doctor recommendations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores two different catheterization methods—continuous and intermittent—to address postpartum urinary problems. While both methods are already used in medical settings, this trial aims to find out which one is more effective and comfortable for new mothers. By comparing these approaches, the study could potentially improve postpartum care by tailoring treatments to better meet individual needs, leading to faster recovery and increased comfort for patients.

What evidence suggests that this trial's catheterization methods could be effective for postpartum urinary problems?

This trial will compare intermittent catheterization with continuous catheterization for managing postpartum urinary problems. Studies have shown that intermittent catheter use resolves urinary retention after childbirth faster than continuous catheter use. Specifically, the average time for improvement was shorter with intermittent catheters. Research also indicates that women using intermittent catheters report higher satisfaction. Additionally, intermittent catheters reduced urination problems and lowered the risk of urinary tract infections (UTIs). Overall, intermittent catheterization appears more effective in managing urinary issues after childbirth. ^{1 3 6 7 8}

Who Is on the Research Team?

Anna Binstock, MD

Principal Investigator

UPMC Magee-Womens Hospital

Are You a Good Fit for This Trial?

This trial is for postpartum individuals who have had an epidural during labor. It's focused on those at risk of urinary retention or difficulty urinating after birth. Participants should not currently have liver disease, urinary tract infection, or other conditions that could interfere with the study.

Inclusion Criteria

I am 18 years old or older.

Pregnant patients planning vaginal delivery presenting in labor or for induction of labor

Live fetus

Exclusion Criteria

Patients with stillbirth

I am under 18 years old.

I have overactive bladder symptoms or use a catheter.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either intermittent or continuous bladder catheterization during labor with epidural anesthesia

During labor

Immediate Postpartum

Assessment of postpartum urinary retention and patient/nurse satisfaction

Immediately postpartum

Follow-up

Participants are monitored for urinary function and potential urinary tract infections

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Continuous catheterization
• Intermittent catheterization

Trial Overview The study investigates how bladder emptying methods affect postpartum voiding issues. Two approaches are tested: continuous catheterization (one catheter throughout labor) versus intermittent catheterization (catheter placed and removed every few hours).

How Is the Trial Designed?

Group I: Intermittent catheterization Active Control 1 Intervention

Group II: Continuous catheterization Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2589933323002264

Intermittent vs continuous catheterization for postpartum ... The mean time to postpartum urinary retention resolution was significantly shorter in the intermittent catheterization group than in the continuous ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9206615/

Postpartum urinary retention: what are the sequelae? A ... Our findings show that 8.2%, 6.7%, and 4.9% of the women have long-term voiding difficulties after 1, 2, and 3 years respectively, requiring ...

3. ajog.org ajog.org/article/S0002-9378(22)00977-2/fulltext

Management of postpartum urinary retention: a multi-center ... Mean time to PUR resolution was significantly shorter in the intermittent catheterization group (10.211.8 vs. 26.59.0 hours, p< 0.001), with 75% and 93% ...

4. nature.com nature.com/articles/s41598-017-18065-8

Impact of systematic urinary catheterization protocol in ... Systematic intermittent catheterization 2 hours post-delivery was effective at decreasing cPUR by 47% in women undergoing instrumental ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37423430/

Intermittent vs continuous catheterization for postpartum ... The mean time to postpartum urinary retention resolution was significantly shorter in the intermittent catheterization group than in the continuous ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10183908/

Intermittent versus Continuous Catheterization and ... Primary outcomes: 2nd stage of labor length; anesthetic dose. Secondary outcomes: postpartum urinary retention; postpartum urinary infection ...

7. scielo.br scielo.br/j/rbgo/a/L8Tj5m7PWtxrDj9ZqyCVYzs/

Systematic Review and Meta-analysis Intermittent versus ... We concluded that there is no clear advantage to either method, although continuous catheterization was associated with a greater occurrence of eutocic births.

8. tau.amegroups.org tau.amegroups.org/article/view/114176/html

Effects of clean intermittent catheterization and transurethral ... The clean intermittent catheterization technique has been confirmed to be safe and effective in patients suffering from neurogenic lower urinary ...