Utilization of PTNS During Office-Based Cystoscopy

NCT04440579 | Completed

• 1 other identifier: 145954
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cystoscopy; Urology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety of PTNS: adverse events

  One year

Study Arms (3)

Standard Cystoscopy

ACTIVE COMPARATOR

Patients will undergo a standard of care cystoscopy

Procedure: Standard Cystoscopy

PTNS and Cystoscopy

EXPERIMENTAL

Patients will undergo PTNS while undergoing cystoscopy

Procedure: Percutaneous Tibial Nerve Stimulation (PTNS); Procedure: Standard Cystoscopy

Sham PTN and Cystoscopy

SHAM COMPARATOR

Patients will undergo a sham PTNS procedure while undergoing cystoscopy

Procedure: Sham Percutaneous Tibial Nerve Stimulation (PTNS); Procedure: Standard 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.

PTNS and Cystoscopy

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

Sham PTN and Cystoscopy

Standard Cystoscopy PROCEDURE

Patient will undergo standard cystoscopy

PTNS and Cystoscopy; Sham PTN and Cystoscopy; Standard Cystoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years of age or older
• Patients undergoing routine office-based cystoscopy by a urology provider

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Health System

Kansas City, Kansas, 66160, United States

Location

Study Officials

• Jeffrey Holzbeierlein, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: June 19, 2020
• Study Start: August 7, 2020
• Primary Completion: September 18, 2020
• Study Completion: April 26, 2021
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)