Optimizing the Management of Postpartum Urinary Retention | NCT04187365

Studies
Optimizing the Management of Postpartum Urinary Retention

NCT04187365

Sponsor

Northwestern University

Status

Terminated

Last Update Posted

Apr 20, 2022Actual

Enrollment

70Actual

Phase

Not Applicable

Conditions

Urinary Retention

Interventions

Duration of Indwelling Catheter

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study was terminated prematurely due to challenges with recruitment and feasibility of continuing the study

Expanded Access Info

Start Date

Nov 22, 2019Actual

Primary Completion Date

Feb 27, 2022Actual

Completion Date

Feb 27, 2022Actual

First Submitted Date

Dec 3, 2019

First Submission Date that Met QC Criteria

Dec 3, 2019

First Posted Date

Dec 5, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 12, 2022

Last Update Posted Date

Apr 20, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sarah Collins, Assistant Professor, Department of Obstetrics & Gynecology, Northwestern UniversityPrincipal Investigator

Lead Sponsor

Northwestern UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Duration of Indwelling Catheter	Other	Foley catheter	GROUP 2 (Severe PUR)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate whether 3 days of indwelling catheterization is inferior to 7 days in resolving postpartum urinary retention.		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sarah Collins, MD	Northwestern University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Northwestern Medicine		Chicago	Illinois	60611	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016055	Urinary Retention

Ancestor Terms

ID	Term
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided