Methods: A prospective trial investigated safety and tolerability of circumferential anal RFA using BarrxTM 60 RFA focal catheters (Medtronic, Sunnyvale CA) in subjects with ≥1 anal SCJ HSIL. The entire SCJ was ablated to treat baseline and occult HSIL(s). Subject symptoms and quality of life were assessed with non-validated surveys prior to ablation, for 28 days post-ablation, and at 3, 6, 9, and 12 months post-ablation. Subjects reported their experiences on a visual scale ranging from 0 to 10 (0 no experience, 10 greatest severity).
Results: Ten males (9 HIV+) enrolled. Median post-ablation anal pain was 5 (range 2-9) but resolved to a minimal level (0 or 1) within a median of 20 (0-29) days. During the first week after RFA, seven subjects experienced mild or moderate anal bleeding, not requiring any intervention. Median days to bleeding resolution was 1 (range 0-4) days. Seven subjects experienced mild or moderate incontinence (mucous or stool discharge) following treatment. One subject developed thin stool and straining to pass bowel movements at 3 months after significant diarrhea several weeks before. He had a soft, circumferential, mid canal scar that was easily dilated. All symptoms resolved. Narcotics usage for pain relief was minimal (N= 3 subjects) and median days of pain reliever usage was 13 (3-22) for non-narcotics and 8 (4-14) for narcotics. All subjects who tried receptive anal sex post-RFA succeeded, including the subject with the dilated stricture. Median subject score for worry about anal canal condition was 4.5 (range 0-8) falling to 0.5 (range 0-5) 9 to 12 months post-RFA.
Conclusion: Circumferential RFA of anal canal HSIL in HIV+ subjects was well-tolerated with easily controlled pain, minimal bleeding and minimal adverse events.
Medtronic: Investigator , Research support
S. Hasan, Medtronic: Employee , Salary
Medtronic: Shareholder , Stock options