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Utilization of PTNS During Office-Based Cystoscopy

NCT04440579 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2024-10-16

No results posted yet for this study

Summary

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.

Conditions

  • Cystoscopy

Interventions

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.

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

PROCEDURE

Standard Cystoscopy

Patient will undergo standard cystoscopy

Sponsors & Collaborators

  • University of Kansas Medical Center

    lead OTHER

Principal Investigators

  • Jeffrey Holzbeierlein, MD · University of Kansas Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-07
Primary Completion
2020-09-18
Completion
2021-04-26

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04440579 on ClinicalTrials.gov