Utilization of PTNS During Office-Based Cystoscopy

University of Kansas

Status: Completed

Conditions: Cystoscopy

Treatments: Procedure: Standard Cystoscopy; Procedure: Sham Percutaneous Tibial Nerve Stimulation (PTNS); Procedure: Percutaneous Tibial Nerve Stimulation (PTNS)

Study type: Interventional

Funder types: Other

Identifiers

NCT04440579

145954

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

Standard Cystoscopy

Active Comparator group

Description:

Patients will undergo a standard of care cystoscopy

Treatment:

Procedure: Standard Cystoscopy

PTNS and Cystoscopy

Experimental group

Description:

Patients will undergo PTNS while undergoing cystoscopy

Treatment:

Procedure: Percutaneous Tibial Nerve Stimulation (PTNS)

Procedure: Standard Cystoscopy

Sham PTN and Cystoscopy

Sham Comparator group

Description:

Patients will undergo a sham PTNS procedure while undergoing cystoscopy

Treatment:

Procedure: Sham Percutaneous Tibial Nerve Stimulation (PTNS)

Procedure: Standard Cystoscopy