How I Do It: Temporarily Implanted Nitinol Device (iTind).

Benign prostatic hyperplasia is a common and progressive disease affecting aging men which has a significant impact on quality of life. The second-generation Temporarily Implanted Nitinol Device (iTind) is an FDA approved temporary prostatic urethral device which can be deployed using standard flexible cystoscopy without sedation or general anesthesia. The device is left in-situ for 5 to 7 days and is then entirely removed in the office, using an open-ended silicone catheter. Prospective, randomized data indicate that iTind has favorable functional and sexual patient outcomes. Readers will familiarize themselves with iTind, significant historical studies and the technique for deploying iTind using a flexible cystoscope in the office setting.

Challenging the Myth: Transvaginal Mesh is Not Associated with Carcinogenesis.

PURPOSE: We sought to determine if there was a potential link between synthetic polypropylene mesh implantation for transvaginal pelvic organ prolapse and stress urinary incontinence, and carcinogenesis using statewide administrative data. MATERIALS AND METHODS: Women who underwent transvaginal surgery for pelvic organ prolapse or stress urinary incontinence with mesh between January 2008 and December 2009 in New York State were identified using ICD-9-CM procedure codes and CPT-4 codes. Patients in the mesh cohort were individually matched to 2 control cohorts based on comorbidities and procedure date. Carcinogenesis was determined before and after matching at 1, 2 and 3 years, and during the entire followup time. RESULTS: A total of 2,229 patients who underwent mesh based pelvic organ prolapse surgery and 10,401 who underwent sling surgery for stress urinary incontinence between January 2008 and December 2009 were included in the study. Mean followup was 6 years (range 5 to 7). Exact matching between the mesh and control cohorts resulted in 1,870 pairs for pelvic organ prolapse mesh and cholecystectomy (1:2), 1,278 pairs for pelvic organ prolapse mesh and hysterectomy (1:1), 7,986 pairs for sling and cholecystectomy (1:1) and 3,810 pairs for sling and hysterectomy (1:1). Transvaginal mesh implantation was not associated with an increased risk of a cancer diagnosis (pelvic/local cancers or any cancer) at 1 year and during the entire followup of up to 7 years. CONCLUSIONS: Transvaginal surgery with implantation of mesh was not associated with the development of malignancy at a mean followup of 6 years.

Is vaginal mesh a stimulus of autoimmune disease?

BACKGROUND: Polypropylene mesh has been used as a means of reinforcing weak tissues in women with pelvic organ prolapse and stress urinary incontinence. OBJECTIVE: We sought to investigate a potential link between the development of systemic/autoimmune disorders and synthetic polypropylene mesh repairs. STUDY DESIGN: New York State Department of Health Statewide Planning and Research Cooperative System data were utilized to conduct this retrospective cohort study. Adult women undergoing surgery for pelvic organ prolapse with vaginally implanted mesh from January 2008 through December 2009 in inpatient and ambulatory surgery settings in New York State were identified. Two separate control cohorts were created to compare outcomes, including a screening colonoscopy cohort and a vaginal hysterectomy cohort for benign gynecologic conditions (without pelvic organ prolapse repair or sling). Patients in the mesh cohort were individually matched to the control cohorts based on demographics, comorbidities, and procedure date. The development of systemic/autoimmune disease was determined before and after matching for 1-year, 2-year, 3-year, and entire follow-up (up to 6 years until December 2014) and differences between groups were evaluated. RESULTS: A total of 2102 patients underwent mesh-based pelvic organ prolapse surgery from January 2008 through December 2009. In the control cohorts, 37,298 patients underwent colonoscopy and 7338 underwent vaginal hysterectomy. When patients were matched based on demographics, comorbidities, and procedure time, mesh-based surgery was not associated with an increased risk of developing autoimmune disease at any of the evaluated time periods. CONCLUSION: Mesh-based vaginal surgery was not associated with the development of systemic/autoimmune diseases. These data refute claims against mesh as a cause of systemic disease.

New Technologies for Treatment of Benign Prostatic Hyperplasia.

BPH is a common disease in aging men which impacts quality of life. With advancing age expectation coupled with the rising demand for BPH therapy, new technologies have been developed that target rapid recovery and symptom relief, low complication rates, and the ability to perform the procedure in an outpatient setting with local anesthesia. MIST technologies have fostered BPH medical care with ejaculation preservation. Techniques and outcomes for BPH technologies including Aquablation, Rezum, UroLift, iTind, Optilume BPH, XFLO, Zenflow, and Butterfly are reviewed and evaluated. Given the novelty of these technologies, long-term data are required to assess safety and efficacy.

The Mechanism of Action of cTIND for Minimally Invasive Ischemic Incision of the Prostate: In Vivo Study.

OBJECTIVES: To understand the histologic changes of prostate tissue induced by temporary implantable nitinol device (cTIND) in a canine model. METHODS: The cTIND is a small, symmetric device comprised of nitinol wire loops welded together on an axis, which exert radial force on the tissue to induce a targeted ischemic effect. The cTIND was implanted in three live canine models, which were monitored for 14 days post-index procedure. Device placement was monitored via serial fluoroscopy and biologic effects of cTIND were studied via histopathology. RESULTS: The cTIND was successfully placed in the canine models and remained securely in position until the animal was sacrificed on postoperative day 14. The cTIND treated tissue demonstrated an abrupt transition from normal, viable prostatic glandular tissue to an area of shrunken necrosis and fibrosis between the two. CONCLUSION: In the canine models, the cTIND created focal areas of ischemic necrosis resulting in incisions in the peri-urethral prostate with minimal inflammation.

The iTind Temporarily Implanted Nitinol Device for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A Multicenter, Randomized, Controlled Trial.

OBJECTIVE: To report the results of a multicenter, randomized, controlled trial with a temporarily implanted nitinol device (iTind; Medi-Tate Ltd, Hadera, Israel) compared to sham for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. MATERIALS AND METHODS: Men 50 years or older were randomized 2:1 between iTind and sham procedure arms. A self-expanding, temporary nitinol device was placed for 5-7 days and an 18F Foley catheter was inserted and removed for the iTind and sham group, respectively. Patients were assessed at baseline, 1.5, 3, and 12 months postoperatively using the IPSS, peak urinary flow rate, residual urine, quality of life, and the International Index of Erectile Function. Unblinding occurred at 3 months. RESULTS: A total of 175 men (mean age 61.1 ± 6.5) participated (118 iTind vs 57 sham). A total of 78.6% of patients in the iTind arm showed a reduction of ≥3 points in IPSS, vs 60% of patients in the control arm at 3 months. At 12 months, the iTind group reported a 9.25 decrease in IPSS (P< .0001), a 3.52ml/s increase in peak urinary flow rate (P < .0001) and a 1.9-point reduction in quality of life (P < .0001). Adverse events were typically mild and transient, most Clavien-Dindo grade I or II, in 38.1% of patients in the iTind arm and 17.5% in the control arm. No de novo ejaculatory or erectile dysfunction occurred. CONCLUSION: Treatment with the second-generation iTind provided rapid and sustained improvement in lower urinary tract symptoms for the study period while preserving sexual function.

Safety of Tamsulosin: A Systematic Review of Randomized Trials with a Focus on Women and Children.

INTRODUCTION: Although tamsulosin is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH), it has also been assessed in clinical studies for other conditions/symptoms and in other populations such as women and children. In this systematic review of randomized studies, the overall safety of tamsulosin was assessed, focusing on these understudied populations. METHODS: Literature searches were conducted using Embase, Medline, and PubMed (inception-December 2015). A study was included if patients were randomized to receive treatment with any dose of tamsulosin capsules, tablets, or an oral controlled absorption system and numerical safety results were reported. RESULTS: Overall, 160 articles involving 46,072 participants met the inclusion criteria. Of these, four studies included women only and three included children. The mean [standard deviation (SD)] age ranged from 7.3 (4.2) to 76.8 (7.1) years. The studies (n; %) evaluated healthy subjects (18; 11%) or patients with lower urinary tract symptoms/BPH (90; 56%), ureteral stones/renal colic (42; 26%), prostatitis (4; 3%), or other conditions (6; 4%). Patients discontinued tamsulosin primarily because of adverse events (AEs) or insufficient response. AEs in women and children were abdominal pain, asthenia, constipation, dizziness, dry mouth, drowsiness, dyspepsia, headache, incontinence, nasal congestion, nausea, orthostatic hypotension, and somnolence. Due to heterogeneity across studies, statistical analysis could not be conducted. DISCUSSION: No unexpected AEs were observed in an all-comers population treated with tamsulosin for various conditions/symptoms. The overall safety profile in women and children seemed to be generally consistent with the profile in men, the indicated population.

Histologic Inflammatory Response to Transvaginal Polypropylene Mesh: A Systematic Review.

To evaluate the inflammatory response following transvaginal implantation of polypropylene (PP) mesh. A comprehensive literature search was performed in the following databases from inception in April 2017: Ovid MEDLINE, Ovid EMBASE, and The Cochrane Library (Wiley). The studies retrieved were screened for eligibility against predefined inclusion and exclusion criteria. Twenty-three articles were included in this review. Following the implantation of PP mesh, there are immediate and local inflammatory responses. PP mesh elicits an inflammatory response that decreases over time; however, no studies documented a complete resolution. Further studies are needed to determine if there is a complete resolution of inflammation or if it persists.

No increased risk of carcinogenesis with mesh-based hernia repairs.

BACKGROUND: The use of synthetic mesh has been placed under considerable scrutiny. We sought to evaluate whether there is a link between placement of synthetic polypropylene mesh for hernia repair and a subsequent cancer diagnosis. METHODS: Adult men undergoing mesh-based hernia repair from January 2008-December 2009 in New York State were identified and followed through December 2014. Control cohorts of men undergoing cholecystectomy and total knee replacement were control cohorts. RESULTS: 1894 patients undergoing hernia repair, 912 patients in the cholecystectomy control cohort, and 1099 in the TKA control cohort with a cancer diagnosis. In the matched analyses of mesh-based hernia repair and cholecystectomy patients 6.5% vs. 7.1% developed cancer. In the matched analysis of hernia patients and TKA patients, 9.3% vs. 9.1% developed cancer. No association between mesh-based hernia surgery and increased risk of cancer was found. CONCLUSIONS: Mesh-based hernia repair was not associated with an increased risk of subsequent development of cancer in men.

Extraperitoneal laparoscopic prostatectomy (adenomectomy) for obstructing benign prostatic hyperplasia: transvesical and transcapsular (Millin) techniques.

PURPOSE: We describe extraperitoneal laparoscopic resection of large prostatic adenomas (<100 g) as an alternative to open simple prostatectomy by both the transcapsular or Millin and the transvesical approaches. PATIENTS AND METHODS: We have performed more than 20 laparoscopic prostatectomies (adenomectomies) for benign prostatic hyperplasia (BPH) for glands >100 g. The initial two cases, with follow-up longer than 1 year, are included in this report. Using an extraperitoneal approach, enucleation of the obstructing prostatic lobes was performed with the aid of a Harmonic Scalpel and laparoscopic claw forceps. Hemostatic sutures were placed at 5 and 7 o'clock. The urethrovesical junction (transvesical) or capsulotomy (Millin) were closed in an interrupted fashion using intracorporeal sutures. RESULTS: Both procedures were successful. The total operative time was 180 minutes for first the case and 120 minutes for the second. The adenoma removed was approximately 138 g in the first case and 102 g in the second case. The estimated blood loss was <50 mL and <200 mL, respectively. The postoperative courses were unremarkable. Analgesic requirements were minimal, and the patient was discharged on postoperative day 2 and 3, respectively. A follow-up examination at 1, 3, 6, and 12 months showed that the flow rate is >20 mL and the postvoiding residual volume 0, with normal continence and sexual potency in both men. CONCLUSIONS: Extraperitoneal laparoscopic simple prostatectomy is a simple straightforward technique. Minimal bleeding, a reduced transfusion rate, shorter hospitalization, and faster recovery are additional advantages. This minimally invasive technique is a reasonable alternative to open simple prostatectomy for large glands with reduced morbidity.

Use of herbal supplements for overactive bladder.

Anticholinergics, specifically antimuscarinic agents, are the most common medications prescribed for overactive bladder (OAB). The most common side effects of these agents are dry mouth and constipation, although other more concerning effects include changes in blood pressure, pulse rate, or heart rhythm when treatment is initiated. Herbal treatments are an increasingly popular alternative for treating OAB. A 2002 survey of US adults aged ≥ 18 years conducted by the Centers for Disease Control and Prevention indicated that 74.6% of those with OAB had used some form of complementary and alternative medicine. The World Health Organization estimates that 80% of the world's population presently uses herbal medicine for some aspect of primary health care. Women were more likely than men to use complementary and alternative medicine. The authors review the most commonly used herbal medications for OAB.