Nerve Stimulation Using a TENS to Provide Pain Relief During Surgery for Overactive Bladder

NACompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

December 14, 2020

Primary Completion Date

March 3, 2022

Study Completion Date

March 3, 2022

Conditions
Urinary IncontinenceOveractive BladderPain, 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 (procedure typically will take from 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 (procedure typically will take from 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)

14642

University of Rochester Medical Center, Rochester

All Listed Sponsors
lead

University of Rochester

OTHER

NCT05330117 - Nerve Stimulation Using a TENS to Provide Pain Relief During Surgery for Overactive Bladder | Biotech Hunter | Biotech Hunter