Status:
COMPLETED
Assessment of Anatomic, Physiologic and Biomechanical Characteristics of the Anal Canal and Pelvic Floor. An Observational Pilot Study
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
Nano-Tera.ch, Lausanne
Spitäler Schaffhausen
Conditions:
Fecal Incontinence
Eligibility:
All Genders
60+ years
Brief Summary
With the project Smart Muscle for Incontinence Treatment (SMIT) a multidisciplinary consortium consisting of representatives ranging from clinical medicine via microelectronics towards biomaterial sci...
Detailed Description
Background Fecal incontinence (FI) is affecting self-confidence and can lead to social isolation and even loss of employment Often conservative treatment as the first option is ineffective and surgic...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Informed Consent as documented by signature
- Absence of ano-rectal or pelvic floor symptoms (patient history, Wexner score and Longo's obstructed defecation syndrome (ODS) score =0. Appendix Constipation and Faecal Incontinence Score form)
- MRI safety (no metallic implants. Appendix MRI safety form)
- Normal weighted (20\<BMI\<30)
- Age ≥ 60 years
- Exclusion Criteria
- Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
- Known or suspected non-compliance, drug or alcohol abuse
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- age (\<18 years old)
- history of complicated child delivery
- previous anorectal surgery
Exclusion
Key Trial Info
Start Date :
March 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02263170
Start Date
March 1 2015
End Date
November 1 2015
Last Update
November 24 2015
Active Locations (1)
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1
Universitätsklinik für Viszerale Chirurgie und Medizin Bauchzentrum Bern (Inselspital Bern)
Bern, Switzerland, 3010