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OpenTrials
Completed

NCT Number: NCT04440579

Utilization of PTNS During Office-Based Cystoscopy

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.

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Key information

Conditions

Cystoscopy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Health System

Kansas City, Kansas, 66160, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Standard Cystoscopy

Procedure

Patient will undergo standard cystoscopy

Primary outcomes

  1. Patient Discomfort

    Time frame: 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 outcomes

  1. Safety of PTNS: adverse events

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jun 19, 2020
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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