Long-Term Outcomes in KEYNOTE-052: Phase II Study Investigating First-Line Pembrolizumab in Cisplatin-Ineligible Patients With Locally Advanced or Metastatic Urothelial Cancer.

Purpose: The phase II single-arm KEYNOTE-052 study evaluated the efficacy and safety of first-line pembrolizumab for patients with locally advanced or metastatic cisplatin-ineligible urothelial carcinoma (UC).

Patients And Methods: Three hundred seventy patients received pembrolizumab 200 mg intravenously every 3 weeks for up to 24 months. Positive tumor programmed death ligand 1 (PD-L1) expression was defined as combined positive score (CPS) ≥ 10.

Pembrolizumab as First-line Therapy in Cisplatin-ineligible Advanced Urothelial Cancer (KEYNOTE-052): Outcomes in Older Patients by Age and Performance Status.

Background: Patients with treatment-naive advanced urothelial cancer (UC) ineligible for cisplatin-based chemotherapy are typically older and have comorbidities, representing a difficult-to-treat population.

Objective: To evaluate the safety and antitumor activity of first-line pembrolizumab in subgroups of cisplatin-ineligible older patients (aged ≥65 and ≥75 yr) with advanced UC in KEYNOTE-052 (NCT02335424), including those with poor performance status (Eastern Cooperative Oncology Group performance status score 2 [ECOG PS2]).

Design, Setting, And Participants: Patients were cisplatin ineligible, had treatment-naive, histologically/cytologically confirmed, locally advanced/metastatic UC with measurable disease (Response Evaluation Criteria in Solid Tumors version 1.

Vibegron (RVT-901/MK-4618/KRP-114V) Administered Once Daily as Monotherapy or Concomitantly with Tolterodine in Patients with an Overactive Bladder: A Multicenter, Phase IIb, Randomized, Double-blind, Controlled Trial.

Background: Antimuscarinics have shown modest efficacy with unwanted side effects in patients with overactive bladder (OAB). Efficacy of vibegron, a new β3-adrenergic receptor agonist, for OAB is unknown.

Objective: To evaluate the efficacy of once-daily oral vibegron in OAB patients (primary), and its safety, tolerability, and efficacy when administered alone or concomitantly with tolterodine (secondary).

A phase 2b multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of vaginal rings containing nomegestrol acetate or etonogestrel and 17β-estradiol in the treatment of women with primary dysmenorrhea.

Objective: To evaluate the effect of investigational vaginal rings containing nomegestrol acetate (NOMAC) plus 17β-estradiol (E2) or etonogestrel (ENG) plus E2 in women with moderate to severe primary dysmenorrhea.

Study Design: This was a Phase 2b randomized, placebo-controlled, multicenter, double-blind study. We randomized participants to one of five treatment groups: four hormonal rings and one placebo ring.

Phase II dose-finding study on ovulation inhibition and cycle control associated with the use of contraceptive vaginal rings containing 17β-estradiol and the progestagens etonogestrel or nomegestrol acetate compared to NuvaRing.

Purpose: To identify at least one contraceptive vaginal ring that effectively inhibits ovulation and demonstrates cycle control that is non-inferior to NuvaRing (Merck Sharp & Dohme B.V., The Netherlands) in terms of an unscheduled bleeding incidence, with a non-inferiority margin of 10%.

Safety and efficacy of the NuvaRing® Applicator in healthy females: a multicenter, open-label, randomized, 2-period crossover study.

Introduction: We assessed performance and safety of the NuvaRing® Applicator.

Methods: We randomized women (18-45 years) to insert a placebo ring using the applicator or fingers-only and then vice versa. We assessed outcomes post-insertion and then 24-72 h later.

Perioperative use of etoricoxib reduces pain and opioid side-effects after total abdominal hysterectomy: a double-blind, randomized, placebo-controlled phase III study.

Objective: To evaluate the effects of two different doses of etoricoxib delivered perioperatively compared with placebo and standard pain management on pain at rest, pain with mobilization, and use of additional morphine/opioids postoperatively.

Research Design And Methods: In this double-blind, placebo-controlled, randomized clinical trial, we evaluated postoperative pain following total abdominal hysterectomy over 5 days in patients receiving placebo or etoricoxib administered 90 min prior to surgery and continuing postoperatively. Patients were randomly assigned to receive either placebo (n = 144), etoricoxib 90 mg/day (n = 142), or etoricoxib 120 mg/day (n = 144).

Variability of urodynamic parameters in patients with overactive bladder.

Aims: To report interpatient, intrapatient, and study site variability of urodynamic study (UDS) parameters in patients with overactive bladder (OAB).

Methods: Fifty-eight patients with OAB participated in a randomized, double-blind, placebo-controlled, urodynamic trial of an experimental OAB drug. Patients underwent 3 serial cystometries (CMGs) at three times: screening, pre-dose, and 4-hr postdose.

A multicenter, double-blind, randomized, placebo controlled trial of a neurokinin-1 receptor antagonist for overactive bladder.

Purpose: Neurokinin-1 receptor dependent mechanisms may regulate urinary frequency and urgency. We conducted this study to assess the efficacy and tolerability of the neurokinin-1 receptor antagonist serlopitant vs placebo or tolterodine in patients with overactive bladder.

Materials And Methods: This randomized, double-blind, 69-center trial enrolled adults with overactive bladder (8 or more average daily micturitions and 1 or more daily urge incontinence episodes).

Bladder dysfunction in mice with experimental autoimmune encephalomyelitis.

The vast majority of patients with multiple sclerosis (MS) develop bladder control problems including urgency to urinate, urinary incontinence, frequency of urination, and retention of urine. Over 60% of MS patients show detrusor-sphincter dyssynergia, an abnormality characterized by obstruction of urinary outflow as a result of discoordinated contraction of the urethral sphincter muscle and the bladder detrusor muscle. In the current study we examined bladder function in female SWXJ mice with different defined levels of neurological impairment following induction of experimental autoimmune encephalomyelitis (EAE), an animal model of central nervous system inflammation widely used in MS research.

Management of iatrogenic foreign bodies of the bladder and urethra following pelvic floor surgery.

Objective: Literature regarding the management of iatrogenic foreign body in the bladder and urethra following female pelvic reconstructive surgery, especially mesh erosion, are sparse. We present our recent experience with the removal of iatrogenic foreign bodies from the bladder and urethra and propose a treatment algorithm.

Methods: A retrospective review yielded 22 patients with iatrogenic foreign body in the bladder or urethra between 1/1998 and 12/2005.

Sexually transmitted infections.

This article addresses the importance of screening for sexually transmitted diseases as a form of secondary prevention. The differential diagnoses of genital ulcers or inflammatory disorders of the genitourinary tract, with a higher index of suspicion for sexually transmitted disease, are discussed, as well as currently recommended treatment options for the same.

Office based transurethral needle ablation of the prostate with analgesia and local anesthesia.

Purpose: We evaluated the efficacy and feasibility of performing office based transurethral needle ablation of the prostate with analgesia and local anesthesia.

Materials And Methods: A total of 56 consecutive patients underwent transurethral needle ablation of the prostate for symptomatic benign prostatic hyperplasia. Oral rofecoxib (50 mg) and ciprofloxacin (250 mg) were administered before the procedure with 25 mg hydroxyzine and 50 to 100 mg meperidine intramuscularly.

Results of cystocele repair: a comparison of traditional anterior colporrhaphy, polypropylene mesh and porcine dermis.

Purpose: Because traditional anterior colporrhaphy can have a high recurrence rate, we assessed the recurrence rate of 3 methods of cystocele repair, including 1) traditional anterior colporrhaphy, 2) repair using porcine dermis interposition graft and 3) repair using polypropylene mesh. Additionally, we compared the rate of erosion of porcine dermal graft with that of polypropylene mesh.

Materials And Methods: The records of patients who underwent cystocele repair by the same urologist using porcine dermal graft, polypropylene mesh or traditional repair from January 1999 to August 2005 were reviewed.

Injectable neuromodulatory agents: botulinum toxin therapy.

Botulinum toxin therapy is a diverse treatment option for various dysfunctions of the lower urinary tract. The limited but growing clinical experience reveals that temporary chemodenervation with reduction or loss of neuronal activity at the target organ may be achieved with minimal risk. This highly favorable risk-benefit ratio in urology is derived from the clinical ability to treat an end-organ condition effectively with controllable site-specific delivery (eg, subcutaneous, intramuscular, or instillation) combined with high affinity for toxin uptake by the peripheral cholinergic nerves.

Results of a simplified technique for buried penis repair.

Purpose: The buried penis can cause secondary phimosis, recurrent balanitis and social embarrassment. We report our results using a simplified technique for repair.

Materials And Methods: A retrospective chart review of 83 consecutive patients undergoing buried penis repair between March 1995 and March 2001 was performed.