Optimizing the Management of Postpartum Urinary Retention

Not Applicable

Terminated

• Conditions: Urinary Retention
• Interventions: Other: Duration of Indwelling Catheter

• Registration Number: NCT04187365
• Lead Sponsor: Northwestern University

Brief Summary

A study aimed at characterizing the comparing duration of catheterization for treatment of postpartum urinary retention (PUR) and characterizing short and long-term pelvic floor symptoms in women who have PUR.

Detailed Description

The purpose of the study is to compare clinical outcomes of women with bladder distension injuries due to postpartum urinary retention (PUR) who have varying duration of catheterization for initial treatment of postpartum urinary retention.

Hypotheses

1. Longer duration of therapeutic catheterization will be associated with resolution of postpartum voiding dysfunction in women who sustain severe bladder distension injuries due to postpartum urinary retention.

Definition of resolution of postpartum voiding dysfunction:

A. A post void residual volume of less than half of initial instilled volume on the first retrograde voiding trial, AND B. No need for re-treatment for urinary retention within 1 week

2. The incidence of postpartum urinary retention (PUR) will vary by route of delivery, with operative vaginal delivery having the highest incidence.

3. Risk factors for PUR will be related to intrapartum and delivery conditions

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2019-11-22
• Study First Submitted: 2019-12-03
• Study First Submitted QC: 2019-12-03
• Study First Posted: 2019-12-05
• Primary Completion: 2022-02-27
• Study Completion: 2022-02-27
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-12
• Last Update Posted: 2022-04-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

1. Age greater than or equal to 18.
2. Vaginal or cesarean delivery at term (37 weeks gestational age or later) of live-born infants.
3. English or Spanish speaking and reading.

Read More

Exclusion Criteria

1. Adults unable to consent.
2. Women under the age of 18.
3. Women who are currently pregnant (All women in the study will have already delivered).
4. Prisoners or detained individuals.
5. Women who chronically use a urinary catheter for another medical condition.
6. Women with a neurological disease with bladder manifestations (examples: Cerebrovascular accidents, Multiple sclerosis, Parkinson disease, cerebral palsy).
7. Women with preeclampsia requiring magnesium treatment for seizure prevention.
8. Women with prior PUR
9. Women on anticholinergic medications.
10. Women who are actively being treated for a UTI.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GROUP 2 (Severe PUR)	Duration of Indwelling Catheter	Women in GROUP 2 will be a randomized to either 3 or 7 days of indwelling catheterization.

Primary Outcome Measures

Name	Time	Method
To evaluate whether 3 days of indwelling catheterization is inferior to 7 days in resolving postpartum urinary retention.	1 year

Trial Locations

Locations (1)

Northwestern Medicine; 🇺🇸 Chicago, Illinois, United States