Utilization of PTNS During Office-Based Cystoscopy

Cystoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04440579
• Other study ID #: 145954
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2020
• Est. completion date: December 2021

Study information

• Verified date: June 2020
• Source: University of Kansas Medical Center
• Contact: Katherine Glavin
• Phone: 913-588-8721
• Email: kglavin[@]kumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: December 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystoscopy

Intervention

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 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
• Standard Cystoscopy
Patient will undergo standard cystoscopy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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