Utilization of Percutaneous Tibial Nerve Stimulation During Office-Based Cystoscopy: A Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Patient Discomfort
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Masking Description
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
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Standard Cystoscopy
Patients will undergo a standard of care cystoscopy
Intervention: Standard Cystoscopy (Procedure)
PTNS and Cystoscopy
Patients will undergo PTNS while undergoing cystoscopy
Intervention: Percutaneous Tibial Nerve Stimulation (PTNS) (Procedure)
PTNS and Cystoscopy
Patients will undergo PTNS while undergoing cystoscopy
Intervention: Standard Cystoscopy (Procedure)
Sham PTN and Cystoscopy
Patients will undergo a sham PTNS procedure while undergoing cystoscopy
Intervention: Sham Percutaneous Tibial Nerve Stimulation (PTNS) (Procedure)
Sham PTN and Cystoscopy
Patients will undergo a sham PTNS procedure while undergoing cystoscopy
Intervention: Standard Cystoscopy (Procedure)
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)
Investigators
Jeffrey Holzbeierlein
Principal Investigator
University of Kansas Medical Center