The Effects of TTNS, TTNS Combined With PHUS, and Conventional Therapy With PHUS in the Treatment of PFC.

NARecruitingINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

February 21, 2024

Primary Completion Date

February 25, 2026

Study Completion Date

February 25, 2026

Conditions
ConstipationConstipation - Functional
Interventions
DEVICE

The transcutaneous posterior tibial nerve stimulation device

In addition to their conventional treatment, subjects in both TTNS groups will complete eight weeks of home TTNS treatment (3 sessions per week), and each session will last for 20 minutes. Stimulation will be provided by a portable device (Chattanooga®, ContinuumTM, Hixson, TN, USA). The device will be pre-programmed to apply a bi-phasic squared wave with a pulse width of 200μsec, and a pulse frequency of 20 Hz. These are default settings for TTNS that have been used in previous studies for urinary and fecal incontinence59,62,67. Two self-adhesive electrodes (5 x 5 cm) will be placed over the ankle area, one approximately 3 to 4 cm above the medial tibial malleolus and a second electrode just below the medial malleolus of the same leg.

OTHER

PSUS

Handheld US

Trial Locations (1)

91120

RECRUITING

Hadassah Hebrew University Hospital, Jerusalem

All Listed Sponsors
lead

Hadassah Medical Organization

OTHER