Assessment of Anatomic, Physiologic and Biomechanical Characteristics of the Anal Canal and Pelvic Floor. An Observational Pilot Study

NCT02263170 | Completed DMC

• 1 other identifier: KEK-BE: 048/2014
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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 science aims to develop a novel implant to treat faecal incontinence. The aim of this campaign includes development of implantable prototype devices acting as artificial continence muscles using low-voltage electrically activated polymers (EAPs) controlled by implemented pressure sensors and the patient. Subsequently, the knowledge of the anatomical and biomechanical properties of the anal sphincter complex are of cardinal importance. Most of the existing data on anatomy and physiology results is based on old studies and almost no data on biomechanical properties are available. However, new technologies or even merging data from different examination methods might provide new information in this field.

Conditions

Fecal Incontinence

Outcome Measures

Primary Outcomes (1)

• Sphincter morphology

  Functional sphincter variables are: anal canal length, resting, squeeze, and relaxation pressures, squeeze time, anal pressure in response to coughing, RAIR (percentage of anal relaxation), rectal volume filling to first sensation, urge and maximal tolerable volume, and distension of the anal canal in response to different filling volumes. Anatomical parameters are: distinction between internal and external sphincter (yes/no), sphincter lengths, sphincter thickness, and sphincter volumes.

  At baseline

Secondary Outcomes (2)

• Test feasibility of FLIP in measuring the biomechanical properties of the anal canal

  At baseline

• Test feasibility of merging 3D US data and MR images

  At baseline

Study Arms (1)

All study participants

Healthy (m/f), normal weighted

Other: MRI (magnetic resonance imaging); Other: US (ultra sound); Other: FLIP (functional luminal imaging probe); Other: HRAM (high resolution anal manometry)

Interventions

MRI (magnetic resonance imaging) OTHER

Assessment of the sphincter morphology

All study participants

US (ultra sound) OTHER

Assessment of the sphincter morphology

All study participants

FLIP (functional luminal imaging probe) OTHER

Assessment of the biomechanical properties of the sphincter region

All study participants

HRAM (high resolution anal manometry) OTHER

Assessment of the biomechanical properties of the sphincter region

All study participants

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited by flyers and advertisement in internet.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Nano-Tera.ch, Lausanne: collaborator
• Spitäler Schaffhausen: collaborator
• University of Bern: collaborator
• University of Basel: collaborator

Study Sites (1)

Universitätsklinik für Viszerale Chirurgie und Medizin Bauchzentrum Bern (Inselspital Bern)

Bern, 3010, Switzerland

Location

Related Links

• Related Info

MeSH Terms

Conditions

Fecal Incontinence

Interventions

Magnetic Resonance Spectroscopy; CASP8 and FADD-Like Apoptosis Regulating Protein

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Death Domain Receptor Signaling Adaptor Proteins; Adaptor Proteins, Signal Transducing; Intracellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Tumor Necrosis Factor Receptor-Associated Peptides and Proteins; Apoptosis Regulatory Proteins; Carrier Proteins; Proteins

Study Officials

• Bert Müller, Prof. Dr.

  Biomaterials Science Center (BMC) University of Basel c/o University Hospital Basel 4031 Basel

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2014
• First Posted: October 13, 2014
• Study Start: March 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: November 24, 2015

Record last verified: 2015-11

Locations

CH (1)