TENS Analgesia During Outpatient Urethral Bulking for Stress Urinary Incontinence.

NARecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

July 1, 2024

Primary Completion Date

March 31, 2026

Study Completion Date

June 1, 2026

Conditions
Stress Incontinence FemaleUrinary IncontinenceUrinary Incontinence,StressPainPain Acute
Interventions
PROCEDURE

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."

PROCEDURE

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."

Trial Locations (1)

14623

RECRUITING

Pelvic Health and Continence Specialties, Rochester

All Listed Sponsors
lead

University of Rochester

OTHER