TENS Used for Pain Management During Office Cystoscopy Botox Injections

NCT04448171 | Terminated Results FDA Device

• 1 other identifier: 20-003510
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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

Overactive Bladder

Keywords

Overactive Bladder; Botox injection - bladder; TENS

Outcome Measures

Primary Outcomes (1)

• Change in Participant Reported Pain Score From Baseline to Intra-Procedure

  Using the participant-reported numerical pain scale, the change in participant reported pain was measured. This change was measured between two time points, baseline and intra-procedure. The participant-reported pain scale ranges from 0 (no pain) to 10 (worst pain) with higher scores indicating worse pain. When analyzing the data, the scale was multiplied by a factor of 10 to get a 100-point scale. Final results are reported using the 100-point scale ranging from 0 (no pain) to 100 (worst pain) with higher scores indicating worse pain.

  Baseline; intra-procedure

Secondary Outcomes (1)

• Change in Participant Satisfaction From Post Procedure to 10 Minutes Following Completion of Cystoscopy

  Postprocedure, 10 minutes following completion of cystoscopy

Study Arms (2)

Activated TENS Unit with standard pain control measures

ACTIVE COMPARATOR

Activated TENS Unit with standard pain control measures during Office Based Cystoscopic Intra-detrusor Onabotulinumtoxin A Injection

Device: Active TENS

Sham TENS Unit with standard pain control measures

PLACEBO COMPARATOR

Sham TENS Unit with standard pain control measures during Office Based Cystoscopic Intra-detrusor Onabotulinumtoxin A Injection

Device: Sham TENS

Interventions

Active TENS DEVICE

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.

Activated TENS Unit with standard pain control measures

Sham TENS DEVICE

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.

Sham TENS Unit with standard pain control measures

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females age 18 years or older
• Scheduled to receive intra-detrusor Onabotulinumtoxin-A injection for Overactive Bladder in the outpatient clinic
• Reads, speaks, and understands the English language
• Able to understand the requirements of the study, including randomization
• Willing and able to provide written informed consent

You may not qualify if:

• Previous use of TENS therapy within one year prior to study enrollment
• Allergy to adhesives
• Currently has an implanted pacemaker or automatic cardiac defibrillator
• History of epilepsy
• Currently pregnant or within 12 weeks postpartum
• Unwilling to be randomized

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The study was terminated early due to low enrollment.

Results Point of Contact

• Title: John Occhino, M.D., M.S.
• Organization: Mayo Clinic

Occhino.John@mayo.edu

507-538-5883

Study Officials

• John A Occhino, MD, MS

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participant, the physician administering the Botox, and the study coordinator (outcomes assessor) assigned to the study will be blinded to the randomization. Both groups of participants will receive the TENS unit electrode placement by the assigned clinical nurse who is not blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: June 25, 2020
• Study Start: October 28, 2020
• Primary Completion: October 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 20, 2025
• Results First Posted: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)