- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04030377
Postop Catheterization for Urinary Retention
July 22, 2019 updated by: NorthShore University HealthSystem
Treatment of Postoperative Urinary Retention - WHAT DO WOMEN WANT?
This study investigates patient's preference and satisfaction with choice of catheterization after surgical urogynecological procedures.
Study Overview
Status
Terminated
Conditions
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.
Study Type
Observational
Enrollment (Actual)
47
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
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Skokie, Illinois, United States, 60076
- NorthShore University Healthsystem
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Adult women presenting to the urogynecology offices at NorthShore University HealthSystem with a urogynecologic diagnosis desiring surgical management.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient satisfaction with choice of catheterization method
Time Frame: 2 weeks after index procedure
|
Assessed through post-operative questionnaire completion
|
2 weeks after index procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of complication rates
Time Frame: 2 weeks after index procedure
|
Comparison of complication rates between intermittent vs. indwelling catheterization: data derived from review of participant medical record
|
2 weeks after index procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Sylvia M Botros, MD, NorthShore University Healthsystem
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2010
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
February 20, 2015
Study Registration Dates
First Submitted
July 19, 2019
First Submitted That Met QC Criteria
July 22, 2019
First Posted (Actual)
July 24, 2019
Study Record Updates
Last Update Posted (Actual)
July 24, 2019
Last Update Submitted That Met QC Criteria
July 22, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EH11-096
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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