Magnetic resonance imaging-guided transurethral ultrasound ablation for benign prostatic hyperplasia: 12-month clinical outcomes of a phase I study.

OBJECTIVES: To investigate the safety and feasibility of magnetic resonance imaging (MRI)-guided transurethral ultrasound ablation (TULSA) for the treatment of benign prostatic obstruction (BPO). PATIENTS AND METHODS: An investigator-initiated, prospective, registered (NCT03350529), phase I study enrolled men with lower urinary tract symptoms due to benign prostatic hyperplasia in need of surgical intervention. Patients were followed for 12 months after TULSA. Uroflowmetry, prostate-specific antigen (PSA) level, and a comprehensive set of functional questionnaires including the Expanded Prostate cancer Index Composite-26, International Prostate Symptom Score (IPSS) and five-item version of the International Index of Erectile Function were obtained at baseline and every 3 months afterwards. MRI was obtained at baseline, and at 3 and 12 months after TULSA. Medication use before and after TULSA were recorded. Adverse events (AEs) were reported using the Clavien-Dindo classification. RESULTS: A total of 10 men underwent TULSA with no severe AEs encountered. The baseline median (interquartile range [IQR]) age and prostate volume were 68 (63-72) years and 53 (45-66) mL, respectively. At baseline, six patients were moderately symptomatic and four patients severely symptomatic. Nine patients at baseline were on BPO medication. The median (IQR) improvement in the IPSS was 82%, from 17.5 (15.3-23.0) at baseline to 4.0 (2.3-6.3) at 12 months. Similarly, the median maximum urinary flow rate improved by 101%, from a median (IQR) of 12.4 (8.8-17.6) mL/s at baseline to 21.8 (17.6-26.5) mL/s at 12 months. Improvements were already seen at 3 months. The median prostate volume and PSA reduction at 12 months were 33% and 48%, respectively. There were no changes in continence, sexual, erectile or bowel functions. At 12 months, five out of six men with normal ejaculatory function before TULSA reported normal antegrade ejaculations. All patients taking BPO medication before TULSA discontinued medication after TULSA. CONCLUSION: TULSA appears to be a safe and effective treatment for BPO, with promising 12-month follow-up outcomes. Further studies with larger cohorts are needed to confirm the observed results.

Hyperbaric oxygen therapy in the prevention and management of tracheal and oesophageal anastomotic complications.

OBJECTIVES: Failure of anastomotic healing is a morbid complication after airway or oesophageal surgery. Hyperbaric oxygen therapy (HBOT) has been used extensively in the management of complex wound-healing problems. We demonstrate the use of HBOT to rescue at-risk anastomoses or manage anastomotic failures in thoracic surgery. METHODS: Retrospective review of 25 patients who received HBOT as part of the management of tracheal or oesophageal anastomotic problems during 2007-2018. HBOT was delivered at 2 atm with 100% oxygen in 90-min sessions. RESULTS: Twenty-three patients underwent airway resection and reconstruction while 2 patients underwent oesophagectomy. There were 16 (70%) laryngotracheal and 7 (30%) tracheal resections. Necrosis at the airway anastomosis was found in 13 (57%) patients, partial dehiscence in 2 (9%) patients and both in 6 (26%) patients. HBOT was prophylactic in 2 (9%) patients. Patients received a median of 9.5 HBOT sessions (interquartile range 5-19 sessions) over a median course of 8 days. The airway anastomosis healed in 20 of 23 (87%) patients. Overall, a satisfactory long-term airway outcome was achieved in 19 (83%) patients; 4 patients failed and required reoperation (2 tracheostomies and 1 T-tube). HBOT was used in 2 patients after oesophagectomy to manage focal necrosis or ischaemia at the anastomosis, with success in 1 patient. Complications from HBOT were infrequent and mild (e.g. ear discomfort). CONCLUSIONS: HBOT should be considered as an adjunct in the management of anastomotic problems after airway surgery. It may also play a role after oesophagectomy. Possible mechanisms of action are rapid granulation, early re-epithelialization and angiogenesis.

Effect of a Fucoidan Extract on Insulin Resistance and Cardiometabolic Markers in Obese, Nondiabetic Subjects: A Randomized, Controlled Trial.

OBJECTIVES: To determine whether a fucoidan extract reduced insulin resistance and/or altered other cardiometabolic markers in an obese, nondiabetic population. DESIGN: Single-site, double-blinded, placebo-controlled, randomized controlled trial. SETTING/LOCATION: Hobart, Tasmania, Australia. SUBJECTS: Eligible subjects were obese, with no history of diabetes, and ages between 18 and 65 years. INTERVENTIONS: Subjects were randomly assigned, in even blocks of 10, to either active fucoidan 500 mg or placebo capsules twice daily for 90 days, with identical measurements performed at baseline and follow-up. OUTCOME MEASURES: The primary outcome was insulin resistance, defined by the homeostasis model of assessment (HOMA) values. Secondary outcomes were lipid profile, glycosylated hemoglobin, urea electrolytes and creatinine, liver function tests, full/complete blood count, fasting insulin, fasting glucose, quantitative insulin sensitivity check index, glucose area under the curve, weight, body mass index, waist circumference, and systolic and diastolic blood pressure. The trial was registered with the Australian New Zealand Clinical Trial Registry (ACTRN12614000495628) and the Therapeutic Goods Administration (2014/0348), and was funded by Marinova Pty. Ltd. RESULTS: There were no differences in the 90-day outcome measures between placebo and active treatment in the intention-to-treat-analysis (n = 35 for active, n = 37 for placebo). The mean change in HOMA scores was 0 for the placebo and -0.1 for the active groups (p = 0.73). Self-reported adherence was high, consistent with capsule counting at the conclusion of the trial. CONCLUSIONS: Fucoidan taken twice daily for a period of 90 days did not markedly affect insulin resistance or other measured parameters of cardiometabolic health in an obese, nondiabetic cohort. This could be due to an intrinsic lack of efficacy, lower than measured adherence, or because longer therapy and/or higher baseline insulin resistance are required to exert a significant effect.

Exploring the costs and effectiveness of the Drug and Alcohol Withdrawal Network: a home-based alcohol and other drug withdrawal service.

The Drug and Alcohol Withdrawal Network (DAWN) is a home-based withdrawal service based in Perth, Western Australia. Literature on outcomes, costs and client attitudes towards this type of home-based detoxification in Australia is sparse. Therefore, this study assessed these factors for clients enrolled over a 5-year period (July 2011-June 2016). Client experience was explored through semi-structured interviews with 10 clients. Over the study period, 1800 clients (54% male, mean age 38 years) were assessed, and there were 2045 episodes of care. Although most first-episode clients (52%) listed alcohol as the primary drug of concern, the proportion listing methamphetamine increased from 4% in 2011-12 to 23% in 2015-16. In 94% (n=639) of withdrawal detoxification episodes with completed surveys, clients used their 'drug of primary concern' most days or more often at baseline; this had reduced to 23% (n=149) at the conclusion of detoxification. Five-year direct costs were A$4.8million. Clients valued the person-centred holistic approach to care, including linking with other health providers. Barriers included low awareness of the program and difficulties finding an appropriate support person. Further exploration of cost-effectiveness would substantiate the apparently lower per client cost, assuming medical suitability for both programs, for home-based relative to inpatient withdrawal.

Hyperbaric oxygen therapy for the treatment of anastomotic complications after tracheal resection and reconstruction.

OBJECTIVE: Failure of anastomotic healing is a rare but serious complication of laryngotracheal resection. Treatment options include reoperation, tracheostomy, or T-tube placement. Hyperbaric oxygen therapy (HBOT) is the delivery of 100% O2 at pressures greater than 1 atm, and has been shown to enhance wound healing after tracheal resection in animal models. To date, there have been no reports describing its usefulness in humans after tracheal resection. METHODS: Five consecutive patients with varying degrees of failed anastomotic healing, from necrotic cartilage to partial separation identified by bronchoscopy were treated with HBOT. HBOT was administered for 90 minutes via a hyperbaric chamber pressurized to 2 atm with 100% oxygen. Patients were treated with daily or twice daily HBOT. Four of 5 patients had buttressing of the anastomosis by strap muscle at the initial surgery. RESULTS: All patients had evidence of anastomotic healing on bronchoscopy. None of the patients in this series required tracheostomy, T-tube, or reoperation after initiation of HBOT. On average it took 9.6 days for healing to occur (5-14 days). The size of the anastomotic defect ranged between 3 and 13 mm. One patient required bilateral tympanostomy tubes for inner ear discomfort and experienced blurry vision as complications of HBOT. One patient developed tracheal stenosis from granulation tissue that required bronchoscopic debridement. CONCLUSIONS: In select patients with anastomotic complications after tracheal resection, HBOT may aid in healing and avoid tracheostomy. Future investigations are necessary to further define the benefits of HBOT in the management of airway anastomotic complications.