Utilization of PTNS During Office-Based Cystoscopy

Study Overview
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Brief Summary
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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.

Official Title
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Utilization of Percutaneous Tibial Nerve Stimulation During Office-Based Cystoscopy: A Pilot Study

Conditions
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Cystoscopy

Intervention / Treatment
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* Procedure: Percutaneous Tibial Nerve Stimulation (PTNS)
* Procedure: Sham Percutaneous Tibial Nerve Stimulation (PTNS)
* Procedure: Standard Cystoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 18 years of age or older Patients undergoing routine office-based cystoscopy by a urology provider Exclusion Criteria: Patients for whom ancillary procedures are performed during cystoscopy, including ureteral stent removal, bladder stone removal, biopsy, or fulguration Patients undergoing cystoscopy due to concern for urologic injury Patients undergoing cystoscopy due to concern for prosthetic abnormality, including erosion or malposition Patients who perform clean intermittent catheterization Patients with pre-existing neurological pathology, including but not limited to multiple sclerosis, spinal cord injury, Parkinson's disease, or peripheral neuropathy of any etiology Patients having undergone prior non-endoscopic prostatectomy (radical prostatectomy, simple prostatectomy) Patients with a history of interstitial cystitis/chronic pelvic pain Patients who have taken an analgesic (excluding 81mg aspirin) in the past 12 hours Patients with a history of urethral stricture disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Cystoscopy<br>Patients will undergo a standard of care cystoscopy | Procedure: Standard Cystoscopy<br>* Patient will undergo standard cystoscopy<br>|
| Experimental: PTNS and Cystoscopy<br>Patients will undergo PTNS while undergoing cystoscopy | Procedure: Percutaneous Tibial Nerve Stimulation (PTNS)<br>* PTNS is neuromodulation that uses electricity to stimulate the nervous system, specifically the posterior tibial nerve, and is minimally invasive.<br>Procedure: Standard Cystoscopy<br>* Patient will undergo standard cystoscopy<br>|
| Sham Comparator: Sham PTN and Cystoscopy<br>Patients will undergo a sham PTNS procedure while undergoing cystoscopy | Procedure: Sham Percutaneous Tibial Nerve Stimulation (PTNS)<br>* Patients will be connected to the PTNS device but the device will remain off for the entirety of the procedure<br>Procedure: Standard Cystoscopy<br>* Patient will undergo standard cystoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cystoscopy, Urology