Utilization of PTNS During Office-Based Cystoscopy

University of Kansas Medical Center45 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Cystoscopy

Interventions

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.

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

Standard CystoscopyPROCEDURE

Patient will undergo standard cystoscopy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Kansas Health System

Kansas City, Kansas, United States

Outcomes

Primary Outcomes

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.

Time frame: One year

Secondary Outcomes

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

Time frame: One year

Data from ClinicalTrials.gov

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