Voiding Disorders Clinical Trial
Official title:
Home vs. Office Foley Catheter Removal in Women With Voiding Difficulty Following Pelvic Reconstructive Surgery: A Randomized Controlled Trial
Verified date | August 2022 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the patient satisfaction with voiding assessment remotely after removal of Foley catheter at home by the patient or her caregiver compared to removal at the office by a healthcare provider in patients who have been diagnosed to have voiding difficulty after pelvic reconstructive surgery.
Status | Completed |
Enrollment | 78 |
Est. completion date | August 19, 2021 |
Est. primary completion date | August 19, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: - Women with post-operative voiding difficulty requiring catheterization after pelvic reconstructive surgery or surgery for urinary incontinency. Exclusion Criteria: - A Pelvic Reconstructive Surgery/Urogynecology fellow or attending physician may deem patients ineligible based on patients post-operative voiding trial. |
Country | Name | City | State |
---|---|---|---|
United States | Yale University | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient Satisfaction | At the routine 2-4 week post-operative visit, patients will be given an internally developed 5 item visual analogue scale regarding their experience with the Foley-catheter removal. The item used as the primary outcome measure will ask "How satisfied were you with the overall removal process of the Foley catheter?"
Lower scores indicate less satisfaction, higher scores higher satisfaction. |
Up to 4 weeks | |
Secondary | Removal Method Negative Emotions | At the routine 2-4 week post-operative visit, patients will be given an internally developed 5 item visual analogue scale regarding their experience with the Foley-catheter removal. This item used asks "Did you experience any negative emotions during the removal process (e.g. fear, anxiety ect.)?"
Lower scores indicate greater negative emotions, higher scores indicate fewer negative emotions. |
Up to 4 weeks | |
Secondary | Removal Method Recommendation | At the routine 2-4 week post-operative visit, patients will be given an internally developed 5 item visual analogue scale regarding their experience with the Foley-catheter removal. This item used asks "How likely would you be to recommend your method of Foley catheter removal to a friend/family member, if they were in the same situation?"
Lower scores indicate less likely to recommend, higher scores indicate more likely to recommend. |
Up to 4 weeks | |
Secondary | Removal Method Convenience | At the routine 2-4 week post-operative visit, patients will be given an internally developed 5 item visual analogue scale regarding their experience with the Foley-catheter removal. This item used asks "How convenient was the process of Foley catheter removal (e.g. time, ease ect.)?"
Lower scores indicate less convenient, higher scores indicate more convenient. |
Up to 4 weeks | |
Secondary | Removal Method Preference | At the routine 2-4 week post-operative visit, patients will be given an internally developed 5 item visual analogue scale regarding their experience with the Foley-catheter removal. This item used asks "Where would you prefer your Foley catheter removed?"
Lower scores indicate preference for office removal, higher scores indicate preference for home removal. |
Up to 4 weeks |
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