Utilization of PTNS During Office-Based Cystoscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-07

Study Completion Date

2021-04-26

Brief Summary

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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.

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Detailed Description

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Conditions

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Cystoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

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

Study Groups

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Standard Cystoscopy

Patients will undergo a standard of care cystoscopy

Group Type ACTIVE_COMPARATOR

Standard Cystoscopy

Intervention Type PROCEDURE

Patient will undergo standard cystoscopy

PTNS and Cystoscopy

Patients will undergo PTNS while undergoing cystoscopy

Group Type EXPERIMENTAL

Percutaneous Tibial Nerve Stimulation (PTNS)

Intervention Type PROCEDURE

PTNS is neuromodulation that uses electricity to stimulate the nervous system, specifically the posterior tibial nerve, and is minimally invasive.

Standard Cystoscopy

Intervention Type PROCEDURE

Patient will undergo standard cystoscopy

Sham PTN and Cystoscopy

Patients will undergo a sham PTNS procedure while undergoing cystoscopy

Group Type SHAM_COMPARATOR

Sham Percutaneous Tibial Nerve Stimulation (PTNS)

Intervention Type PROCEDURE

Patients will be connected to the PTNS device but the device will remain off for the entirety of the procedure

Standard Cystoscopy

Intervention Type PROCEDURE

Patient will undergo standard cystoscopy

Interventions

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Percutaneous Tibial Nerve Stimulation (PTNS)

PTNS is neuromodulation that uses electricity to stimulate the nervous system, specifically the posterior tibial nerve, and is minimally invasive.

Intervention Type PROCEDURE

Sham 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

Intervention Type PROCEDURE

Standard Cystoscopy

Patient will undergo standard cystoscopy

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No