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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02263170
Recruitment Status : Completed
First Posted : October 13, 2014
Last Update Posted : November 24, 2015
Sponsor:
Collaborators:
Nano-Tera.ch, Lausanne
Spitäler Schaffhausen
University of Bern
University of Basel
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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.


Condition or disease Intervention/treatment
Fecal Incontinence Other: MRI (magnetic resonance imaging) Other: US (ultra sound) Other: FLIP (functional luminal imaging probe) Other: HRAM (high resolution anal manometry)

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Assessment of Anatomic, Physiologic and Biomechanical Characteristics of the Anal Canal and Pelvic Floor. An Observational Pilot Study
Study Start Date : March 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Group/Cohort Intervention/treatment
All study participants
Healthy (m/f), normal weighted
Other: MRI (magnetic resonance imaging)
Assessment of the sphincter morphology

Other: US (ultra sound)
Assessment of the sphincter morphology

Other: FLIP (functional luminal imaging probe)
Assessment of the biomechanical properties of the sphincter region

Other: HRAM (high resolution anal manometry)
Assessment of the biomechanical properties of the sphincter region




Primary Outcome Measures :
  1. Sphincter morphology [ Time Frame: At baseline ]
    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.


Secondary Outcome Measures :
  1. Test feasibility of FLIP in measuring the biomechanical properties of the anal canal [ Time Frame: At baseline ]
    Test the ability of FLIP in order to assess the biomechanical properties of the human anal sphincter complex in sufficient quality

  2. Test feasibility of merging 3D US data and MR images [ Time Frame: At baseline ]
    Test feasibility of merging 3D US data and 3D MR images (full body MR and endoanal coil MR) in order to get a more precise anatomical image at once



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants will be recruited by flyers and advertisement in internet.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02263170


Locations
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Switzerland
Universitätsklinik für Viszerale Chirurgie und Medizin Bauchzentrum Bern (Inselspital Bern)
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Nano-Tera.ch, Lausanne
Spitäler Schaffhausen
University of Bern
University of Basel
Investigators
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Study Director: Bert Müller, Prof. Dr. Biomaterials Science Center (BMC) University of Basel c/o University Hospital Basel 4031 Basel

Additional Information:
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT02263170    
Other Study ID Numbers: KEK-BE: 048/2014
First Posted: October 13, 2014    Key Record Dates
Last Update Posted: November 24, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Phenobarbital
Anticonvulsants
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
GABA Agents
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers