Anal Health in Rectal Microbicide Studies

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Anal Health in Rectal Microbicide Studies

• Ross D. Cranston MD FRCP
• Assistant Professor
• University of Pittsburgh

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Plan

• Anatomy and physiology
• Adverse events in microbicide studies
• Anal diagnoses
• RAI and the anal canal
• Anal care for populations who have RAI

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The Anorectum

• Ryan 2000, Shattock 2003

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Anal Sphincter

• Resting 70 mmHg
• (ref. vagina 0 mmHg)
• Squeeze 180 mmHg

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Perception (Anus vs. Rectum)
Anus Rectum
Sensation Hot Cold Wet Dry Light touch Pin prick Distension Pleasure Pain Distension Pleasure Pain
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Rectal Microbicide AE Reporting

• AE severity will be graded per the Division of
  AIDS Table for Grading Adult and Pediatric
  Adverse Events, Version 1.0, December 2004
  (Clarification dated August 2009) and the Rectal
  Grading Table for Use in Microbicide Studies,
  Addendum 3 in the Division of AIDS Table for
  Grading Severity of Adult and Pediatric Adverse
  Events, Version 1.0, December 2004 (Clarification
  dated August 2009)

Adverse Events Adverse Events
Anal Rectal
Symptoms and signs 11 13
MTN 007 protocol
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Anal Diagnoses
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RAI and the Anal Canal

• Increase in anal
• Fissure
• Fistula
• Abscess
• Ulceration
• Herpes simplex
• Human papillomavirus/dysplasia/cancer

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Anal Care in Populations who have RAI

• Increasing anal awareness
• What can go wrong?
• It is NOT always a hemorrhoid
• When to seek help?

Pitt 2007
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Feminine Hygiene Aisle
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Fantasy Shopping Aisle
Anal Health
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Summary

• The anal canal is distinct from the rectum with a
  unique set of diagnoses
• Anal sensation informs the perception of rectal
  products including candidate rectal microbicides
• Study clinicians must be aware of anal conditions
  and examine ppts appropriately
• There is a need to increase anal awareness in
  populations who have RAI

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AIDShilfe
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Thank You