Recruiting

TENS Analgesia

Sponsor:

University of Rochester

Code:

NCT06369922

Conditions

Stress Incontinence Female

Urinary Incontinence

Urinary Incontinence,Stress

Pain

Pain Acute

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TENS

Control TENS

Study Details

Brief summary:

This will be a double-blind randomized control trial in women with stress urinary incontinence who are undergoing an outpatient transurethral bulking procedure for stress urinary incontinence. Subjects will be identified by the University of Rochester urologists and urogynecologists participating in the study who currently oversee stress incontinence care. Subjects will be randomized into two groups. One group will be undergoing the cystoscopy with transcutaneous electrical nerve stimulation (TENS) for analgesia, and the second group will have the cystoscopy with placebo TENS.

Conditions

Stress Incontinence Female

Urinary Incontinence

Urinary Incontinence,Stress

Pain

Pain Acute

Study ID

NCT06369922

Start date

Jul 1, 2024

Status verified date

May, 2026

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • • Women, Age ≥18 years

  • Diagnosis of SUI
  • Scheduled to undergo transurethral bulking in the office
  • Able to read/write English

Exclusion Criteria:

  • • Cutaneous damage such as ulcers or broken skin on target treatment area

  • Currently implanted cardiac pacemaker or defibrillator
  • Pre-procedural use of opioids for pain management, less than 8 hours from last dose
  • Participants with altered sensation below the umbilicus

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active TENS

In the active treatment group, the TENS unit will remain on up to 30 minutes (10 minutes pre-procedure, during the procedure and during the questionnaires).

sham comparator: Control TENS

The sham stimulation group will undergo the same procedure; however, the TENS stimulation current will be reduced to a minimal detectable level and turned off after 20 seconds.

Interventions

TENS

This device will then be used for deep transcutaneous nerve stimulation at the T10-L1 and S2-S4 levels. The device will be placed and activated 5 minutes before the procedure. and the device will remain active during the procedure and will be turned off as soon as the procedure is complete (the procedure typically takes 5-15 minutes). The TENS units have pre-program settings, improving convenience, reproducibility, and reliability. Study staff will be instructed to perform TENS using an "Acupuncture" mode on the provided TENS units. The amplitude will be adjusted to a comfortable sensation that does not cause pain using adhesive electrodes. One TENS unit is able to support 4 TENS electrodes. The TENS electrodes (8 cm x 5 cm) will be placed on bilateral paraspinal muscles. The intensity of the stimulation (Hz) will be adjusted to the subjective comfort of the subject.

Control TENS

This device will then be used for deep transcutaneous nerve stimulation at the T10-L1 and S2-S4 levels. The device will be placed and activated 5 minutes before the procedure. and the device will remain active during the procedure and will be turned off as soon as the procedure is complete (the procedure typically takes 5-15 minutes). The TENS units have pre-program settings, improving convenience, reproducibility, and reliability. Study staff will be instructed to perform TENS using an "Acupuncture" mode on the provided TENS units. The amplitude will be adjusted to a comfortable sensation that does not cause pain using adhesive electrodes. One TENS unit is able to support 4 TENS electrodes. The TENS electrodes (8 cm x 5 cm) will be placed on bilateral paraspinal muscles. The intensity of the stimulation (Hz) will be adjusted to the subjective comfort of the subject.

Primary outcome measure

  • Mean pain measured by Visual Analog Scale (VAS) [ Time Frame: Before procedure ]
  • Mean pain measured by Visual Analog Scale (VAS) [ Time Frame: Approximately 2-5 minutes into the procedure ]
  • Mean pain measured by Visual Analog Scale (VAS) [ Time Frame: within 10 minutes after procedure ]

Central Contacts and Locations

Central contacts

Jared M Floch, DO, MS

585-895-9301jared_floch@urmc.rochester.edu

Diego Hernandez-Aranda, MD

585-487-3400diego_hernandezaranda@urmc.rochester.edu

Locations

Pelvic Health and Continence Specialties

Recruiting

Rochester, New York, United States, 14623

Contacts

Jared M Floch, DO, MS

585-895-9301jared_floch@urmc.rochester.edu

Diego Hernandez-Aranda, MD

(585) 487-3400diego_hernandezaranda@urmc.rochester.edu

Principal Investigator:

Jared M Floch, DO, MS

More Information

Sponsor

University of Rochester

Last update posted

May 13, 2026

Last verified

May, 2026

Keywords

  • TENS
  • pain
  • Transcutaneous Electrical Nerve Stimulation Analgesia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Rochester on 2026-05-13.