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A study investigating the effects of ultrasound treatment on urinary leakage, fecal leakage

Clinical evaluation of transvaginal and transanal high-intensity focused ultrasound treatment for urinary and fecal incontinence - HIFU-TA Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000060538
Enrollment
50
Registered
2026-01-31
Start date
2025-02-08
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary incontinence Fecal incontinence

Interventions

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

Sponsors

Suzuki Proctology-Moriguchi Internal Medicine Clinic
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Change in the severity of urinary and fecal incontinence symptoms assessed by the ICIQ-SF score and Wexner score before treatment and within 3 months after treatment.

Secondary

MeasureTime frame
- Time to symptom improvement based on patient-reported outcomes. - Comparison of treatment effects according to incontinence subtype (stress, urge, and mixed). - Changes in anorectal manometric parameters, including maximum resting pressure and maximum squeeze pressure, before treatment and approximately 2 months after treatment. - Re-treatment rate and recurrence during the follow-up period.

Countries

Japan

Contacts

Public ContactShunsuke Suzuki

Suzuki Proctology-Moriguchi Internal Medicine Clinic Suzuki Proctology-Moriguchi Internal Medicine Clinic

suzukikoumon47@outlook.jp0196240405

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026