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Prospective multicenter clinical study of biofeedback therapy for fecal incontinence

The efficiency of biofeedback therapy for fecal incontinence, prospective multicenter clinical study - Clinical study of biofeedback therapy for fecal incontinence

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000043999
Enrollment
40
Registered
2021-04-26
Start date
2019-08-01
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

fecal incontinence

Interventions

Biofeedback therapy for anal contraction

Sponsors

Kameda Medical Center Department of Gastroenterological surgery
Lead 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 Kurom
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Ordinal scale (evaluate post-intervention fecal incontinence symptoms: worse, same, improved, cured)

Secondary

MeasureTime frame
VAS (Visual Analogue Scale) FISI (Fecal Incontinence Severity Index) SF36 (MOS short form 36 health survey) FIQLS (Fecal Incontinence Quality of Life Scale)

Countries

Japan

Contacts

Public Contacttomoko takahashi

Kameda Medical Center Gastroenterological surgery

takahashi.tomoko@kameda.jp04-7092-2211

Outcome results

None listed

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