Cystoscopy
Conditions
Keywords
Cystoscopy, Urology
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.
Interventions
PTNS is neuromodulation that uses electricity to stimulate the nervous system, specifically the posterior tibial nerve, and is minimally invasive.
PROCEDURESham 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
PROCEDUREStandard Cystoscopy
Patient will undergo standard cystoscopy
Sponsors
University of Kansas Medical Center
Study design
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
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed