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
About this trial
This is an interventional treatment trial for Urinary Retention
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.
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
NCT ID
NCT04187365
First Posted
December 3, 2019
Last Updated
April 12, 2022
Sponsor
Northwestern University
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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