Optimizing the Management of Postpartum Urinary Retention

NCT04187365 | Terminated

• 1 other identifier: STU00210382
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Retention

Outcome Measures

Primary Outcomes (1)

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

  1 year

Study Arms (2)

GROUP 1 (NonSevere PUR and women without PUR)

NO INTERVENTION

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

GROUP 2 (Severe PUR)

EXPERIMENTAL

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

Other: Duration of Indwelling Catheter

Interventions

Duration of Indwelling Catheter OTHER

Foley catheter

GROUP 2 (Severe PUR)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Medicine

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Urinary Retention

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Sarah Collins, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Obstetrics & Gynecology

Model Details: In Arm 2, women with severe postpartum urinary retention will be randomized to 3 or 7 days of foley catheter.

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 5, 2019
• Study Start: November 22, 2019
• Primary Completion: February 27, 2022
• Study Completion: February 27, 2022
• Last Updated: April 20, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)