Characterization of the histological response to the Butterfly Prostatic Retraction Device in patients with benign prostatic hyperplasia.

PURPOSE: The Butterfly Prostatic Retraction Device ("Butterfly") is a permanent nitinol implant for benign prostatic hyperplasia. This study examines the chronic response of prostate tissue to the Butterfly in histological specimens from patients in the Butterfly pilot clinical study. METHODS: Retrospective qualitative and semi-quantitative review of histological specimens of seven (7) patients who participated in the Butterfly pilot clinical study. Patients had at least 1-month implantation with the Butterfly prior to implant removal and TURP. Tissue samples were graded by two pathologists. RESULTS: Four out of six patients had IPSS decreased from baseline. All seven patients' samples had signs of chronic inflammation; one demonstrated acute inflammation and one demonstrated fibrosis. In three cases, intraglandular calcification was identified. There was no ischemic necrosis induced by the implant, and no encrustation, urethral edema, or cellular atypia was noted. CONCLUSION: The Butterfly demonstrated an overall favorable safety profile in terms of tissue response. This study demonstrates that there is no significant tissue reaction in the prostatic urethra due to presence of Butterfly device.

The Butterfly: A Novel Minimally Invasive Transurethral Retraction Device for Benign Hypertrophy of the Prostate.

INTRODUCTION: The Butterfly Prostatic Retraction device is a novel transurethral implant designed to dilate the prostatic urethra and treat lower urinary tract symptoms. We assessed its safety, efficacy and impact on urinary flow, ejaculation, and quality of life. MATERIALS AND METHODS: We included 64 men, treated for benign prostate hyperplasia for at least 1 year. All patients had Qmax≤ 13 mL/s and IPSS >12. Insertion of the device was performed via cystoscopy. Follow-up visits were performed at 2 weeks, 1, 3, 6, and 12 months and included uroflowmetry, IPSS, QoL, and sexual function questionnaires. Cystoscopy was performed on 3 and 12 months. RESULTS: Patients age was 50-83 years. 28 patients completed a 1-year follow-up with an intact device. Mean Qmax improved by 2 mL/s (25%), IPSS median drop was 10 points (40%), and QoL score was 1.5 points (38%). Sexually active patients reported antegrade ejaculation. On cystoscopy, gradual coverage of the devices with urethral mucosa was observed. In 1 patient, the device was repositioned. In 19 patients, the device was removed. 12 patients returned to alpha-blocker therapy and 7 patients underwent TURP. One patient developed a bulbar urethral stricture. CONCLUSIONS: We demonstrated feasibility and good tolerability of the Butterfly device.

Anorectal application of 5% lidocaine cream reduces pain prior to periprostatic nerve block during transrectal ultrasound guided prostate biopsy: Randomized, prospective controlled study.

OBJECTIVES: Trans rectal ultrasound guided prostate biopsy with periprostatic nerve block (PPNB) is performed following probe insertion and manipulation leaving these initial maneuvers uncovered in terms of pain control. We evaluated whether topical analgesia reduces pain during early stages of the procedure. PATIENTS AND METHODS: Seven group prospective, randomized controlled study: groups 1-3: nerve block with 5 ml 1% lidocaine bilaterally plus perianal topical application of 10 ml 5% lidocaine cream. Groups 4-6 as in 1-3 plus digital application of 10 ml 5% lidocaine cream internally on rectal walls. For each approach exposure times were 5 (groups 1 and 4), 10 (groups 2 and 5) and 20 (groups 3 and 6) min, respectively. The control group (7) received PPNB only. Patients filled a 0-10 visual analogue scale (VAS) at five points: after probe insertion, during probe manipulation, following PPNB, after prostate biopsies and a global pain estimation. RESULTS: Two hundred and fifty-two patients were enrolled. Significant differences in VAS between all study groups and controls were observed at the pre-biopsy stages of the procedure. In multivariate analysis adjusted for prostate specific antigen, diabetes mellitus status, spinal disease, abnormal digital rectal examination and non- benign prostate hyperplasia histology, significance remained for probe insertion and intra-rectal manipulation. For each exposure time no significant differences were observed between topical application and topical + intra-rectal application. After PPNB, differences between study and control groups disappeared. CONCLUSION: Topical anesthesia significantly reduces pain during early stages of prostate biopsy. Perianal application sufficed whereas intra-rectal application of local anesthetics does not add to pain control. Perianal application for 10 min seems to be optimal.