UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060538 |
|---|---|
| Receipt number | R000069206 |
| Scientific Title | Clinical evaluation of transvaginal and transanal high-intensity focused ultrasound treatment for urinary and fecal incontinence |
| Date of disclosure of the study information | 2026/01/31 |
| Last modified on | 2026/01/31 18:31:46 |
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Basic information
Public title
A study investigating the effects of ultrasound treatment on urinary leakage, fecal leakage
Acronym
HIFU-ConCotinence Trial
Scientific Title
Clinical evaluation of transvaginal and transanal high-intensity focused ultrasound treatment for urinary and fecal incontinence
Scientific Title:Acronym
HIFU-TA Study
Region
| Japan |
Condition
Condition
Urinary incontinence
Fecal incontinence
Classification by specialty
| Gastroenterology | Gastrointestinal surgery | Obstetrics and Gynecology |
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
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.
Key secondary outcomes
- 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.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Transvaginal and/or transanal high-intensity focused ultrasound (HIFU) therapy performed as a single-session treatment.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shunsuke |
| Middle name | |
| Last name | Suzuki |
Organization
Suzuki Proctology-Moriguchi Internal Medicine Clinic
Division name
Suzuki Proctology-Moriguchi Internal Medicine Clinic
Zip code
0200016
Address
16-14 Nasukawa-cho, Morioka, Iwate, Japan
TEL
0196240405
suzukikoumon47@outlook.jp
Public contact
Name of contact person
| 1st name | Shunsuke |
| Middle name | |
| Last name | Suzuki |
Organization
Suzuki Proctology-Moriguchi Internal Medicine Clinic
Division name
Suzuki Proctology-Moriguchi Internal Medicine Clinic
Zip code
0200016
Address
16-14 Nasukawa-cho, Morioka, Iwate, Japan
TEL
0196240405
Homepage URL
suzukikoumon47@outlook.jp
Sponsor or person
Institute
Suzuki Proctology-Moriguchi Internal Medicine Clinic
Institute
Department
Personal name
Shunsuke Suzuki
Funding Source
Organization
Suzuki Proctology-Moriguchi Internal Medicine Clinic
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Japanese Organization for Safety Assessment of Clinical Research
Address
13-16 Sanjo Minami-machi, Ashiya-shi, Hyogo 659-0086, Japan
Tel
0797-22-5511
info.rinrishinsa@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
鈴木肛門外科・守口内科 (岩手県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
24
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 31 | Day |
Last modified on
| 2026 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069206
