Utilization of Percutaneous Tibial Nerve Stimulation During Office-Based Cystoscopy: A Pilot Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Cystoscopy
- Sponsor
- University of Kansas Medical Center
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Patient Discomfort
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Jeffrey Holzbeierlein
Principal Investigator
University of Kansas Medical Center
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
- Safety of PTNS: adverse events(One year)