Tokyo, Feb. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060538) titled 'A study investigating the effects of ultrasound treatment on urinary leakage, fecal 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 - Urinary incontinence Fecal incontinence Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the effectiveness of transvaginal and transanal high-intensity focused ultrasound (HIFU) in improving symptoms of urinary incontinence, fecal incontinence in female patients. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Transvaginal and/or transanal high-intensity focused ultrasound (HIFU) therapy performed as a single-session treatment.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Female Key inclusion criteria - - Patients with urinary incontinence, fecal incontinence. - Patients who underwent transvaginal or transanal high-intensity focused ultrasound (HIFU) treatment. - Patients with available clinical evaluations before and after treatment. - Patients for whom comprehensive consent, including opt-out consent, was obtained. Key exclusion criteria - - Patients with symptoms attributable to causes other than urinary incontinence, fecal incontinence. - Patients with insufficient clinical data for evaluation. - Patients without available clinical assessments before and after treatment. - Patients with severe comorbidities or general conditions that made evaluation difficult. - Patients for whom comprehensive consent, including opt-out consent, was not obtained. Target Size - 50

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2024 Year 09 Month 10 Day Date of IRB - 2024 Year 11 Month 27 Day Anticipated trial start date - 2025 Year 02 Month 08 Day Last follow-up date - 2025 Year 03 Month 04 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069206

Disclaimer: Curated by HT Syndication.