Utilization of PTNS During Office-Based Cystoscopy
Completed · Not applicable · Has a placebo group
Conditions studied: Cystoscopy
In brief
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.
Key facts
- Study ID
- NCT04440579
- Run by
- University of Kansas Medical Center
- People needed
- 45
- Starts
- 2020-08-07
- Expected to finish
- 2021-04-26
- Last updated by the study team
- 2024-10-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients 18 years of age or older
- Patients undergoing routine office-based cystoscopy by a urology provider
You may not qualify if…
- 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
Where it is running
- University of Kansas Health System — Kansas City, Kansas, United States
Full record on ClinicalTrials.gov
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