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Optimizing the Management of Postpartum Urinary Retention (PUR)

Primary Purpose

Urinary Retention

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Duration of Indwelling Catheter
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Retention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Northwestern Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

GROUP 1 (NonSevere PUR and women without PUR)

GROUP 2 (Severe PUR)

Arm Description

Women in GROUP 1 will be prospectively observed to characterize their clinical outcomes.

Women in GROUP 2 will be a randomized to either 3 or 7 days of indwelling catheterization.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 3, 2019
Last Updated
April 12, 2022
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT04187365
Brief Title
Optimizing the Management of Postpartum Urinary Retention
Acronym
PUR
Official Title
Optimizing the Management of Postpartum Urinary Retention: Postpartum Urinary Retention (PUR) Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Terminated
Why Stopped
Study was terminated prematurely due to challenges with recruitment and feasibility of continuing the study
Study Start Date
November 22, 2019 (Actual)
Primary Completion Date
February 27, 2022 (Actual)
Study Completion Date
February 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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 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 The incidence of postpartum urinary retention (PUR) will vary by route of delivery, with operative vaginal delivery having the highest incidence. Risk factors for PUR will be related to intrapartum and delivery conditions

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Retention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GROUP 1 (NonSevere PUR and women without PUR)
Arm Type
No Intervention
Arm Description
Women in GROUP 1 will be prospectively observed to characterize their clinical outcomes.
Arm Title
GROUP 2 (Severe PUR)
Arm Type
Experimental
Arm Description
Women in GROUP 2 will be a randomized to either 3 or 7 days of indwelling catheterization.
Intervention Type
Other
Intervention Name(s)
Duration of Indwelling Catheter
Intervention Description
Foley catheter
Primary Outcome Measure Information:
Title
To evaluate whether 3 days of indwelling catheterization is inferior to 7 days in resolving postpartum urinary retention.
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age greater than or equal to 18. Vaginal or cesarean delivery at term (37 weeks gestational age or later) of live-born infants. English or Spanish speaking and reading. Exclusion Criteria: Adults unable to consent. Women under the age of 18. Women who are currently pregnant (All women in the study will have already delivered). Prisoners or detained individuals. Women who chronically use a urinary catheter for another medical condition. Women with a neurological disease with bladder manifestations (examples: Cerebrovascular accidents, Multiple sclerosis, Parkinson disease, cerebral palsy). Women with preeclampsia requiring magnesium treatment for seizure prevention. Women with prior PUR Women on anticholinergic medications. Women who are actively being treated for a UTI.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Collins, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Optimizing the Management of Postpartum Urinary Retention

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