Optimizing the Management of Postpartum Urinary Retention (PUR)

Optimizing the Management of Postpartum Urinary Retention: Postpartum Urinary Retention (PUR) Study

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.

Study Overview

• Status: Terminated
• Conditions: Urinary Retention
• Intervention / Treatment: Other: Duration of Indwelling Catheter

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

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: GROUP 1 (NonSevere PUR and women without PUR); Women in GROUP 1 will be prospectively observed to characterize their clinical outcomes.
Experimental: GROUP 2 (Severe PUR); Women in GROUP 2 will be a randomized to either 3 or 7 days of indwelling catheterization.	Other: Duration of Indwelling Catheter; Foley catheter

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Sarah Collins, MD, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2019
• Primary Completion (Actual): February 27, 2022
• Study Completion (Actual): February 27, 2022

Study Registration Dates

• First Submitted: December 3, 2019
• First Submitted That Met QC Criteria: December 3, 2019
• First Posted (Actual): December 5, 2019

Study Record Updates

• Last Update Posted (Actual): April 20, 2022
• Last Update Submitted That Met QC Criteria: April 12, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urination Disorders; Urinary Retention
• Other Study ID Numbers: STU00210382

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No