Phase 3 clinical trials of gefapixant, a P2X3 receptor antagonist, have completed enrollment with refractory chronic cough (RCC) or unexplained chronic cough (UCC) patients; preliminary baseline characteristics are presented here.METHODS: COUGH-2 (NCT03449147) is a Phase 3, randomized, placebo-controlled, double-blind, parallel-group trial to evaluate subjects $ 18 years of age, diagnosed with RCC or UCC ($1 year), and with $40 mm on the Cough Severity Visual Analog Scale (VAS). The primary efficacy study period is 24 weeks with a 28-week extension period. Interventions include placebo, gefapixant 15 mg, or gefapixant 45 mg (1:1:1 ratio). Objective and subjective measures will be assessed; the primary endpoint is 24-hour cough frequency (average frequency over 24 hours at Week 24). The primary hypothesis is that at least 1 gefapixant dose level is superior to placebo in reducing 24-hour cough frequency by Week 24. RESULTS:In COUGH-2, 1314 patients were randomized and treated. Baseline demographics are in the Table . Regional distribution is Europe (56%), N. America (22%), Asia Pacific (6.2%), and Other (17%). The demographics were balanced among regions except for longer duration of cough among N. American patients (mean 14 years) vs. other regions (mean 6 to 12 years).CONCLUSIONS: Preliminary baseline characteristics of patients randomized in COUGH-2 are consistent with the demographics observed in other clinical studies of RCC/UCC.CLINICAL IMPLICATIONS: This global study will inform the efficacy and safety profile of gefapixant in the treatment of patients with RCC and UCC.

Transurethral resection of the prostate (TURP) continues to be an effective intervention for certain indications; and this procedure is still one of the most commonly performed in urology. The use of a 3-way catheter with continuous bladder irrigation (CBI) post-TURP is widely practiced in a bid to prevent clot retention. We report our unique experience with the use of 2-way urethral catheters post-TURP surgery.   Methodology Data was prospectively collected for 143 consecutive patients who underwent a bipolar TURP between July 2015 and October 2017. The following outcomes where measured and compared against the literature: resection time, resected weight, haemoglobin level, hospital stay, catheterization days, transfusion rate and complications. Results Two-way 18-French catheters were used in 132/143 (91.7%) patients. The remaining 11/143 (8.3%) patients had a 3-way 22-French catheter and CBI immediately post-TURP. There were no incidences of clot retention requiring a return to theatre. There were 2/132 (1.5%) patients requiring transfusion who received 2-way catheterization. The average resection time was 44.8 (10-100) minutes, with a mean resected weight of 22.8 (2.0-70.0) grams. Post-operatively, we found minimal drop in haemoglobin levels, with a fall of 0.7 g/dL on average, with a range of 0.1-3.4 g/dL. Mean length of stay following TURP was 1.45 days (1-18), and 101/132 (76.5%) of patients had a successful trial without catheter on the first post-operative day. Conclusion Our outcomes compare favorably with the published data. This study suggests it may be possible to reduce the cost and resources associated with the use of 3-way catheters and CBI post-TURP surgery by using a 2-way catheter instead. Despite this, appropriate patient selection for this novel technique needs to be adopted. Our results would suggest that patients with smaller prostates or limited resections might be suitable for a 2-way urethral catheter post-TURP.

No abstract

No abstract

No abstract