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Clinical Trials/NCT04187365
NCT04187365
Terminated
Not Applicable

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

Northwestern University1 site in 1 country70 target enrollmentNovember 22, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Urinary Retention
Sponsor
Northwestern University
Enrollment
70
Locations
1
Primary Endpoint
To evaluate whether 3 days of indwelling catheterization is inferior to 7 days in resolving postpartum urinary retention.
Status
Terminated
Last Updated
4 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
November 22, 2019
End Date
February 27, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sarah Collins

Assistant Professor, Department of Obstetrics & Gynecology

Northwestern University

Eligibility Criteria

Inclusion Criteria

  • Age greater than or equal to
  • 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
  • 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.

Outcomes

Primary Outcomes

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

Time Frame: 1 year

Study Sites (1)

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