Utilization of PTNS During Office-Based Cystoscopy

Not Applicable

Completed

• Conditions: Cystoscopy
• Interventions: Procedure: Standard Cystoscopy; Procedure: Sham Percutaneous Tibial Nerve Stimulation (PTNS); Procedure: Percutaneous Tibial Nerve Stimulation (PTNS)

• Registration Number: NCT04440579
• Lead Sponsor: University of Kansas Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-17
• Study First Submitted QC: 2020-06-18
• Study First Posted: 2020-06-19
• Study Start: 2020-08-07
• Primary Completion: 2020-09-18
• Study Completion: 2021-04-26
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Cystoscopy	Standard Cystoscopy	Patients will undergo a standard of care cystoscopy
Sham PTN and Cystoscopy	Sham Percutaneous Tibial Nerve Stimulation (PTNS)	Patients will undergo a sham PTNS procedure while undergoing cystoscopy
PTNS and Cystoscopy	Standard Cystoscopy	Patients will undergo PTNS while undergoing cystoscopy
PTNS and Cystoscopy	Percutaneous Tibial Nerve Stimulation (PTNS)	Patients will undergo PTNS while undergoing cystoscopy
Sham PTN and Cystoscopy	Standard Cystoscopy	Patients will undergo a sham PTNS procedure while undergoing cystoscopy

Primary Outcome Measures

Name	Time	Method
Patient Discomfort	One year	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.

Secondary Outcome Measures

Name	Time	Method
Safety of PTNS: adverse events	One year	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

Trial Locations

Locations (1)

University of Kansas Health System; 🇺🇸 Kansas City, Kansas, United States