TENS Used for Pain Management During Office Cystoscopy Botox Injections

NCT04448171 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-08-20

Study results available
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Summary

The purpose of this study is to determine how Transcutaneous Electric Nerve Stimulation (TENS) units affects pain management during office cystoscopic Botox injections and patient satisfaction with the procedure .

Conditions

Interventions

DEVICE

Active TENS

Standard TENS unit with four pads affixed to the lower back area, will be used in this arm. The TENS device will be set to an active setting.

DEVICE

Sham TENS

Standard TENS unit with four pads affixed to the lower back area, will be used in this arm. The TENS device will be set to an inactive setting.

Sponsors & Collaborators

Principal Investigators

  • John A Occhino, MD, MS · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-28
Primary Completion
2023-10-31
Completion
2023-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04448171 on ClinicalTrials.gov