Tokyo, Feb. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060541) titled 'Study on the effects of transanal ultrasound therapy for fecal and urinary leakage' on Jan. 31.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Suzuki Proctology-Moriguchi Internal Medicine Clinic

Condition: Condition - Fecal and urinary incontinence Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To retrospectively evaluate the effects of transanal ultrasound therapy on symptoms of fecal and urinary incontinence. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Transanal high-intensity focused ultrasound (HIFU) therapy

Eligibility: Age-lower limit - 36 years-old = Gender - Male Key inclusion criteria - Evaluation of fecal incontinence using the Wexner score (Cleveland Clinic Florida Fecal Incontinence Score: CCFIS) performed before treatment and within 3 months after treatment.

Evaluation of urinary incontinence using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) performed before treatment and within 3 months after treatment.

Written informed consent for participation in the clinical study obtained after treatment. Key exclusion criteria - Concomitant use of other treatments for incontinence.

Missing evaluation scores (Wexner score or ICIQ-SF).

Loss to follow up after treatment.

Cases in which patients consented to the procedure but did not provide written informed consent for participation in the clinical study. Target Size - 50

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2025 Year 09 Month 16 Day Date of IRB - 2025 Year 10 Month 01 Day Anticipated trial start date - 2025 Year 10 Month 16 Day Last follow-up date - 2025 Year 12 Month 16 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069252

Disclaimer: Curated by HT Syndication.