UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043999 |
|---|---|
| Receipt number | R000050248 |
| Scientific Title | The efficiency of biofeedback therapy for fecal incontinence, prospective multicenter clinical study |
| Date of disclosure of the study information | 2021/04/26 |
| Last modified on | 2023/05/29 18:34:34 |
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Basic information
Public title
Prospective multicenter clinical study of biofeedback therapy for fecal incontinence
Acronym
Clinical study of biofeedback therapy for fecal incontinence
Scientific Title
The efficiency of biofeedback therapy for fecal incontinence, prospective multicenter clinical study
Scientific Title:Acronym
Clinical study of biofeedback therapy for fecal incontinence
Region
| Japan |
Condition
Condition
fecal incontinence
Classification by specialty
| Gastroenterology | Gastrointestinal surgery | Rehabilitation medicine |
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarify of efficacy for biofeedback therapy for fecal incontinence that does not improve with conventional therapy
.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ordinal scale (evaluate post-intervention fecal incontinence symptoms: worse, same, improved, cured)
Key secondary outcomes
VAS (Visual Analogue Scale)
FISI (Fecal Incontinence Severity Index)
SF36 (MOS short form 36 health survey)
FIQLS (Fecal Incontinence Quality of Life Scale)
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
| Maneuver |
Interventions/Control_1
Biofeedback therapy for anal contraction
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Fecal incontinence patients who did not get sufficient symptom improvement even after 3 months or more of conservative therapy such as medication, diet therapy, suppository, enema, etc.
The patients who have never received biofeedback therapy.
Patients are willing and able to comply with this study procedures
Key exclusion criteria
Anal or rectal stenosis
Rectal cancer
Rectal prolapse
Active inflammatory bowel disease
Within 3 months from anorectal surgery
Pregnant or planning to become pregnant
Currently using Trans Anal Irrigation therapy
Fecal Incontinence due to Functional diarrhea
Neurogenic defecation disorders
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | tomoko |
| Middle name | |
| Last name | takahashi |
Organization
Kameda Medical Center
Division name
Gastroenterological surgery
Zip code
2968602
Address
929 Higashi-cho, Kamogawa City Chiba
TEL
04-7092-2211
takahashi.tomoko@kameda.jp
Public contact
Name of contact person
| 1st name | tomoko |
| Middle name | |
| Last name | takahashi |
Organization
Kameda Medical Center
Division name
Gastroenterological surgery
Zip code
2968602
Address
929 Higashi-cho, Kamogawa City Chiba
TEL
04-7092-2211
Homepage URL
takahashi.tomoko@kameda.jp
Sponsor or person
Institute
Kameda Medical Center
Department of Gastroenterological surgery
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Coloproctology Center Takano Hospital, Shota Takano
jichi Medical University, Gastroenterological, General and Transplant Surgery, Toshiki Mimura
JCHO Yokkaichi Hazu Medical Center, Satoru Umegae
Tsujinaka Hospital Kashiwanoha, Yukihiro Hamahata
Niigata Rinko Hospital, Takashi Kobayashi
Miyazaki Sorano Clinic, Junichi Oga
Kagawa Prefectural Shirotori Hospital, Toshiki Yamakawa
Ohama Dai-ichi Hospital, Koutarou Shigaki
Sameshima Hospital, Takashi Sameshima
Matsushima Hospital, joji Kuromizu
Kawasaki gastroenterology proctology department hospital, Shunichi Kawasaki
Kure Medical Association Hospital, Hideto Fujimori
JCHO Tokyo Yamate Medical Center, Mihoko Seki
Sapporo Medical University, Department of surgery, Surgical Oncology and Science, Emi Akizuki
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kameda Medical Center
Address
929 Higashi-cho, Kamogawa City Chiba
Tel
04-7092-2211
clinical_research@kameda.jp
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
| 2021 | Year | 04 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
23
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
| 2019 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 04 | Month | 21 | Day |
Last modified on
| 2023 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050248
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/11/12 | 亀田BFBforFI倫理審査承認書３.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
