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This study will be a double-blind, randomized control trial, with one additional unblinded arm. This study has been designed to identify a means of improving quality of life for patients requiring in-office cystoscopy. Percutaneous tibial nerve stimulation (PTNS) has been shown to improve quality of life and symptom control in multiple urological conditions based on shared neuroanatomical structures between the genitourinary system and the tibial nerve The goal of this project is to demonstrate the efficacy and safety of PTNS in minimizing patient discomfort during cystoscopy to develop a larger randomized control trial in the near future.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Cystoscopy | Active Comparator | Patients will undergo a standard of care cystoscopy |
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| PTNS and Cystoscopy | Experimental | Patients will undergo PTNS while undergoing cystoscopy |
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| Sham PTN and Cystoscopy | Sham Comparator | Patients will undergo a sham PTNS procedure while undergoing cystoscopy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous Tibial Nerve Stimulation (PTNS) | Procedure | PTNS is neuromodulation that uses electricity to stimulate the nervous system, specifically the posterior tibial nerve, and is minimally invasive. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Discomfort | To assess the ability of percutaneous tibial nerve stimulation to improve patient discomfort during routine office-based cystoscopy based on a 10-point visual analogue scale (VAS) by comparing median and interquartile ranges between groups. A score of 0 will indicate no pain whereas a score of 10 indicates the worst pain imaginable. | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of PTNS: adverse events | To determine the safety of PTNS for use in the setting of routine office-based cystoscopy based on rate of adverse events as defined by the Clavien-Dindo classification system | One year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Holzbeierlein, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Health System | Kansas City | Kansas | 66160 | United States |
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This study will be a double-blind, randomized control trial, with one additional unblinded arm. The two blinded arms will be PTNS and sham PTNS, with the additional unblinded arm being standard of care
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| Sham Percutaneous Tibial Nerve Stimulation (PTNS) | Procedure | Patients will be connected to the PTNS device but the device will remain off for the entirety of the procedure |
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| Standard Cystoscopy | Procedure | Patient will undergo standard cystoscopy |
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