UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060541 |
|---|---|
| Receipt number | R000069252 |
| Scientific Title | Clinical evaluation of transanal ultrasound therapy for fecal and urinary incontinence |
| Date of disclosure of the study information | 2026/01/31 |
| Last modified on | 2026/01/31 22:09:13 |
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Basic information
Public title
Study on the effects of transanal ultrasound therapy for fecal and urinary leakage
Acronym
TA-US Study
Scientific Title
Clinical evaluation of transanal ultrasound therapy for fecal and urinary incontinence
Scientific Title:Acronym
TA-US Clinical Study
Region
| Japan |
Condition
Condition
Fecal and urinary incontinence
Classification by specialty
| Gastroenterology | Gastrointestinal surgery | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To retrospectively evaluate the effects of transanal ultrasound therapy on symptoms of fecal and urinary incontinence.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate changes in the severity of fecal and urinary incontinence before and after treatment using the Wexner score and the ICIQ-SF score (within 3 months after treatment).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Transanal high-intensity focused ultrasound (HIFU) therapy
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
| 36 | years-old | <= |
Age-upper limit
| 88 | 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 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
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
47
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
| 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 |
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/icdr_e/ctr_view.cgi?recptno=R000069252
