Urethral Catheter Removal After Urologic Procedure Clinical Trial
Official title:
Trial of Void With Saline Bladder Instillation, a Randomized Controlled Trial
| NCT number | NCT03609476 |
| Other study ID # | AMC4851 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | May 24, 2017 |
| Est. completion date | May 19, 2020 |
| Verified date | July 2020 |
| Source | Albany Medical College |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study is being done to see if there is a difference between the traditional method of removing a urethral catheter after surgery and waiting for the patient to urinate on their own to the saline instillation method which places either room temperature or warmed saline into the patient's bladder through the catheter before removing the catheter.
| Status | Completed |
| Enrollment | 108 |
| Est. completion date | May 19, 2020 |
| Est. primary completion date | May 19, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patients undergoing trial of void after placement of indwelling urethral catheter after urologic procedure Exclusion Criteria: - Patient incontinent at baseline. - Patient has chronic indwelling urinary catheter or uses clean intermittent catheterization at home. - Patient has documented neurogenic bladder. - No trained person to administer the instillation or perform consent. - Patient refusal to participate. - Patient unable to give informed consent. - Patient is a prisoner. - Patient is pregnant. - Patient unable to participate in notifying nursing of voids. - Nursing is unable to measure post void residual with bladder scan machine secondary to body habitus or other anatomical abnormality. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Albany Medical College | Albany | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Ronald Kaufman, MD |
United States,
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* Note: There are 19 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time from catheter removal to determination of passing void trial | The time from when the urinary catheter is removed to a successful voiding trial defined as Void of at least 100ml AND Post Void residual (PVR) <150 or <2/3 of the voided volume | 6 hours | |
| Secondary | Catheter free rate | Subject questioned at 30 day follow up if required to have a catheter placed after leaving the hospital | 30 days | |
| Secondary | Urinary tract infection free rate | Determined at 30 day phone call to patient | 30 days | |
| Secondary | Post void residual (PVR) | Successful PVR is <150ml or <2/3 of the voided volume | Within 30 days |