Postop Catheterization for Urinary Retention | NCT04030377

Studies
Postop Catheterization for Urinary Retention

NCT04030377

Sponsor

Endeavor Health

Status

Terminated

Last Update Posted

Jul 24, 2019Actual

Enrollment

47Actual

Phase

Not provided

Conditions

Urinary Retention

Interventions

Not provided

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

Jul 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Insufficient enrollment, question addressed by other researchers

Expanded Access Info

Start Date

Apr 2010Actual

Primary Completion Date

Dec 2014Actual

Completion Date

Feb 20, 2015Actual

First Submitted Date

Jul 19, 2019

First Submission Date that Met QC Criteria

Jul 22, 2019

First Posted Date

Jul 24, 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

Jul 22, 2019

Last Update Posted Date

Jul 24, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

This study investigates patient's preference and satisfaction with choice of catheterization after surgical urogynecological procedures.

Detailed Description

Preoperatively, the enrolled patient receives information about risks and benefits of three ways of bladder catheterization as means of management of postoperative urinary retention. Based on this information, the patient chooses her preferred way of postoperative catheterization in case she experiences acute urinary retention after surgery. After the surgery, those patients requiring catheterization postoperatively evaluate their experience in a postoperative questionnaire.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

47Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient satisfaction with choice of catheterization method	Assessed through post-operative questionnaire completion	2 weeks after index procedure

Secondary Outcomes

Measure	Description	Time Frame
Assessment of complication rates	Comparison of complication rates between intermittent vs. indwelling catheterization: data derived from review of participant medical record	2 weeks after index procedure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All female patients who undergo urogynecological surgery procedures at NorthShore University HealthSystem and consent to participate

Exclusion Criteria:

Patients who cannot read, comprehend, and write in English

Accepts Healthy Volunteers

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

Adult women presenting to the urogynecology offices at NorthShore University HealthSystem with a urogynecologic diagnosis desiring surgical management.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sylvia M Botros, MD	Endeavor Health	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NorthShore University HealthSystem		Skokie	Illinois	60076	United States

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