An implantable ligation device that achieves male sterilization without cutting the vas deferens.

OBJECTIVES: To determine whether the Vasclip implant procedure would (a) be equivalent to vasectomy in producing azoospermia, (b) produce greater patient satisfaction postoperatively, and (c) result in lower complication rates, postoperative pain, hematoma formation, spermatic granuloma, and surgical site infection when compared with historical controls. METHODS: Sterilization and complications were studied in 124 consecutive patients. RESULTS: Successful sterilization, defined by azoospermia at 10 to 14 months, was observed in 116 of 119 subjects. The effectiveness seemed to be equivalent to that of vasectomy. The incidence of postoperative pain and hematoma formation was similar to that with standard methods. The Vasclip procedure had similar infection rates and seemed to have lower rates of sperm granuloma when compared with vasectomy. In 3 subjects with persistent presence of sperm, histologic examination after traditional vasectomy indicated that misalignment of the device led to partial vas incision with recanalization. Patient acceptability was high: of the clinical study patients, 99% of survey respondents would recommend that other men considering a vasectomy have the Vasclip procedure. CONCLUSIONS: The Vasclip implant procedure represents a new, effective, office-based alternative to vasectomy. Physicians' benefits can include reduced procedural time and reduction of postprocedural complications. Potential patients' benefits include reduced risk of postoperative infection and sperm granuloma formation.

Long-term pooled analysis of multicenter studies of cooled thermotherapy for benign prostatic hyperplasia results at three months through four years.

OBJECTIVES: To determine the long-term efficacy of cooled thermotherapy in the treatment of lower urinary tract symptoms of clinical benign prostatic hyperplasia. METHODS: A total of 541 men underwent cooled thermotherapy treatment in six multicenter studies in the United States, England, and Canada. Both fixed and random effects models were used to pool the data across the six studies. The treatment response was measured as the difference between the urinary tract symptoms at baseline versus those at 3, 12, 24, 36, and 48 months after therapy. The treatment response included changes in the American Urological Association Symptom Score (AUA symptom score), peak urinary flow rate in milliliters per second (Qmax), and quality of life (QOL). RESULTS: The baseline measures were comparable across the studies. At 3 months, the AUA symptom score had improved by a mean of 11.6 (55%), Qmax by a mean of 4.0 (51%), and QOL by a mean of 2.3 (53%). These changes persisted with only slight attenuation through 48 months (corresponding mean changes of 43%, 35%, and 50%). These changes were highly statistically significant (P <0.0001 to 0.01). An improvement of at least 25% was achieved for the AUA symptom score and QOL by more than 85% of men and by more than 65% of men for Qmax. CONCLUSIONS: This pooled analysis of six multicenter studies of cooled thermotherapy, involving 541 men, found highly significant improvements in AUA symptom score, Qmax, and QOL. The results were highly consistent across the studies. The improvements reflected changes from baseline values of 45% to 50% for AUA symptom score and QOL and 35% to 40% for Qmax at a follow-up duration up to 48 months after therapy. The level of improvement for all three measures remained high at 48 months, indicating that the response is durable.