Utilization of PTNS During Office-Based Cystoscopy

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

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 Overview

• Status: Completed
• Conditions: Cystoscopy
• Intervention / Treatment: Procedure: Standard Cystoscopy; Procedure: Percutaneous Tibial Nerve Stimulation (PTNS); Procedure: Sham Percutaneous Tibial Nerve Stimulation (PTNS)

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Investigators: Principal Investigator: Jeffrey Holzbeierlein, MD, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2020
• Primary Completion (Actual): September 18, 2020
• Study Completion (Actual): April 26, 2021

Study Registration Dates

• First Submitted: June 17, 2020
• First Submitted That Met QC Criteria: June 18, 2020
• First Posted (Actual): June 19, 2020

Study Record Updates

• Last Update Posted (Actual): October 16, 2024
• Last Update Submitted That Met QC Criteria: October 11, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Cystoscopy; Urology
• Other Study ID Numbers: 145954

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No