TENS Analgesia During Outpatient Urethral Bulking for Stress Urinary Incontinence.

Part of paid clinical trials in Rochester, New York.

Sponsor
University of Rochester
Study ID
NCT06369922
Status
Recruiting
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Conditions

  • Pain
  • Pain Acute
  • Stress Incontinence Female
  • Urinary Incontinence
  • Urinary Incontinence,Stress

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TENS — PROCEDURE
    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 — PROCEDURE
    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.

Study Details

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.

Key Dates

Start date
Jul 1, 2024
Status verified
May 2026
Primary completion
Jan 31, 2027
Completion
Jun 1, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Mean pain measured by Visual Analog Scale (VAS) [ Time Frame: Before procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Pelvic Health and Continence SpecialtiesRochesterNew York14623
Jared M Floch, DO, MS
[email protected]
585-895-9301
Diego Hernandez-Aranda, MD
[email protected]
(585) 487-3400
Jared M Floch, DO, MS (PRINCIPAL_INVESTIGATOR)

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