Clinical Research Directory

Inclusion Criteria: * Signed informed consent * Age ≥18 years * Diagnosis of fecal incontinence (urge, passive, or mixed type) with at least 1 episode of involuntary stool leakage requiring hygiene intervention or underwear change per month for ≥3 months * Vaizey (St. Mark's) Incontinence Score ≥8 * Ability to understand study procedures and comply with the 12-week home intervention * Willingness to attend all study visits and assessments * Stable medical management for fecal incontinence for at least 4 weeks prior to enrollment Exclusion Criteria: * Complete spinal cord injury above the conus medullaris * Active inflammatory bowel disease flare requiring systemic therapy or not in clinical remission * Rectal prolapse requiring surgical intervention * Severe symptomatic hemorrhoids interfering with anorectal assessments or device use * Active anal fissure or perianal fistula * Active colorectal cancer or history of colorectal cancer within 5 years * Colorectal surgery within the previous 6 months * Pregnancy or planned pregnancy during study participation * Implanted cardiac pacemaker or defibrillator * Other implanted electrical devices contraindicating electrical stimulation * Previous specialized pelvic floor physiotherapy, biofeedback therapy, EMG-guided rehabilitation, or anal electrical stimulation within 3 months prior to randomization * Cognitive impairment preventing understanding of study procedures or informed consent * Uncontrolled severe diarrhea (\>5 liquid stools/day) * Anal stenosis preventing probe insertion * Severe anal sphincter defect (\>120° on ultrasound) requiring surgical repair * Isolated severe rectal sensory dysfunction without significant sphincter dysfunction * Previous pelvic radiotherapy * Concurrent participation in another interventional clinical trial