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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043999
Receipt No. 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 2021/04/21

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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
Email 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
Email takahashi.tomoko@kameda.jp

Sponsor
Institute Kameda Medical Center
Department of Gastroenterological surgery
Institute
Department

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
Email 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
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 Enrolling by invitation
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 01 Month 31 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
2021 Year 04 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050248

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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