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The purpose of this study is to compare UTI rates and patient satisfaction associated with indwelling Foley catheter verses a valved catheter in patients who are being discharged home with a catheter after urogynecologic procedures via a Randomized Clinical Trial.
The purpose of this study is to compare UTI rates and patient satisfaction associated with indwelling Foley catheter verses a valved catheter in patients who are being discharged home with a catheter after urogynecologic procedures via a Randomized Clinical Trial. Total number of participants will be 100. Inclusion criteria is all patients undergoing pelvic reconstructive surgery/anti-incontinence procedures who are planned to be discharged home with a catheter. Exclusion criteria is intra-operative bladder injury during index surgery; intra-operative complication requiring continuous bladder drainage; and/or dementia/altered cognitive function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indwelling Foley Catheter | Other | These patients will have a traditional foley catheter with attached drainage bag (Indwelling Foley Catheter). |
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| Self-Contained Valved Catheter | Other | These patients will have a BARD Flip Flo Catheter Valve attached to the original foley catheter (Self-Contained Valved Catheter). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Foley Catheter vs Self-Contained Valved Catheter | Device | This study aims to compare UTI rates and patient satisfaction between an indwelling Foley catheter group (established SOC); and a relatively (FDA-approved) new valved addition to the Foley catheter which requires no drainage bag. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of urinary tract infections | Number of urine cultures positive for infection (taken at voiding trial visit and post-operative visit). | Up to 4 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction | Foley satisfaction questionnaire will be collected at post-operative voiding trial office visit. | Up to 5 days after surgery |
| Number of days until spontaneous void/Number of calls for device-related issues |
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Inclusion Criteria:
All patients undergoing pelvic reconstructive surgery/anti-incontinence procedures who are planned to be discharged home with a catheter.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charbel G Salamon, MD, MS | Atlantic Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlantic Urogynecology Associates | Morristown | New Jersey | 07960 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34184246 | Derived | Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4. |
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| ID | Term |
|---|---|
| D055499 | Catheter-Related Infections |
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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This study aim is to compare UTI rates and patient satisfaction associated with indwelling Foley catheter vs a valved catheter in patients who are being discharged home with a catheter after urogynecologic proecures via a Randomized Clinical Trial.
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|
Number of days until spontaneous void and number of call for device-related issues.
| Up to 4 weeks after surgery |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |