NCT04030377

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2015

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 24, 2019

Completed
Last Updated

July 24, 2019

Status Verified

July 1, 2019

Enrollment Period

4.7 years

First QC Date

July 19, 2019

Last Update Submit

July 22, 2019

Conditions

Urinary Retention

Outcome Measures

Primary Outcomes (1)

  • Patient satisfaction with choice of catheterization method

    Assessed through post-operative questionnaire completion

    2 weeks after index procedure

Secondary Outcomes (1)

  • Assessment of complication rates

    2 weeks after index procedure

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Patients who cannot read, comprehend, and write in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NorthShore University HealthSystem

Skokie, Illinois, 60076, United States

Location

MeSH Terms

Conditions

Urinary Retention

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Sylvia M Botros, MD

    Endeavor Health

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2019

First Posted

July 24, 2019

Study Start

April 1, 2010

Primary Completion

December 1, 2014

Study Completion

February 20, 2015

Last Updated

July 24, 2019

Record last verified: 2019-07

Locations

US(1)