PUR: Optimizing the Management of Postpartum Urinary Retention

• Sponsor: Northwestern University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT04187365
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Actual Duration (Months): 27.2
• Patients Per Site Per Month: 2.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Retention	Other: Duration of Indwelling Catheter	N/A

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:

1. 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

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

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Intervention Model Description: In Arm 2, women with severe postpartum urinary retention will be randomized to 3 or 7 days of foley catheter.In Arm 2, women with severe postpartum urinary retention will be randomized to 3 or 7 days of foley catheter.
• Masking: None (Open Label)
• Masking Description: No masking.
• Primary Purpose: Treatment
• Official Title: Optimizing the Management of Postpartum Urinary Retention: Postpartum Urinary Retention (PUR) Study
• Actual Study Start Date: Nov 22, 2019
• Actual Primary Completion Date: Feb 27, 2022
• Actual Study Completion Date: Feb 27, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern Medicine	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University

Investigators

• Principal Investigator: Sarah Collins, MD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sarah Collins, Assistant Professor, Department of Obstetrics & Gynecology, Northwestern University
• ClinicalTrials.gov Identifier: NCT04187365
• Other Study ID Numbers: STU00210382
• First Posted: Dec 5, 2019
• Last Update Posted: Apr 20, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Urinary Retention

Study Results

No Results Posted as of Apr 20, 2022