BPH - Benign Prostatic Enlargement

Sumitomo Pharma Announces FDA Acceptance of Supplemental New Drug Application for Vibegron in Men with Overactive Bladder Symptoms Receiving Pharmacological Therapy for Benign Prostatic Hyperplasia

  • Supplemental New Drug Application (sNDA) submission based on Phase 3 study of vibegron 75mg (GEMTESA) demonstrating statistically significant reductions in daily micturition and urgency episodes
  • If approved, vibegron will be the first and only beta-3 agonist for the treatment of men with OAB symptoms receiving pharmacological therapy for BPH

Reno, Nevada (UroToday.com) -- Sumitomo Pharma America, Inc. (SMPA), announced the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for vibegron (GEMTESA®), a beta-3 adrenergic receptor (β3) agonist, dosed once-daily (75 mg), for the treatment of men with overactive bladder (OAB) symptoms receiving pharmacological therapy for benign prostatic hyperplasia (BPH). If approved, vibegron will be the first and only beta-3 agonist for the treatment of men with OAB symptoms receiving pharmacological therapy for BPH. The FDA has set a target action date in Q3 of FY2024, under the Prescription Drug User Fee Act (PDUFA).

Transurethral Resection of the Prostate in Younger Men: Effectiveness and Long-term Outcomes.

This study aims to investigate the efficacy and outcomes of transurethral resection of the prostate (TURP) in the context of younger male patients.

Males aged ≤55 who underwent TURP at Rambam Health Care Campus from January 2011 to August 2023 were retrospectively reviewed.

Is there a best timing for benign prostatic hyperplasia surgery?

Treatment of lower urinary tract symptoms (LUTS) related to benign prostatic hyperplasia (BPH) has shifted over the last decades, with medical therapy becoming the primary treatment modality while surgery is being reserved mostly to patients who are not responding to medical treatment or presenting with complications from BPH.

Aquablation versus HoLEP in patients with benign prostatic hyperplasia: a comparative prospective non-randomized study.

The question of best surgical treatment for lower urinary tract symptoms (LUTS) due to benign prostate hyperplasia (BPH) remains controversial. We compared the outcomes of aquablation and holmium laser enucleation of the prostate ("HoLEP") in a prospective cohort.

Modified holmium laser enucleation for benign prostatic obstruction to preserve sexual and ejaculatory function.

To report ejaculatory and urinary results in patients who underwent holmium laser enucleation of the prostate (HoLEP) with selective laser enucleation of the median lobe (MLHoLEP).

Patients with lower urinary tract symptoms (LUTS)/benign prostatic obstruction (BPO) who underwent MLHoLEP to preserve ejaculatory function in a single center were retrospectively identified.

Transperineal Laser Ablation of the Prostate for Symptomatic Benign Prostatic Hyperplasia: Long-Term Follow-Up in 40 Patients.

To evaluate the long-term efficacy and safety of proprietary transperineal laser ablation (TPLA) of the prostate.

Patients with symptomatic benign prostatic hyperplasia underwent TPLA with a 1064-nm continuous-wave diode laser.

Evaluation of learning curves for contact laser vaporization of the prostate using the 980 nm diode laser for benign prostatic hyperplasia.

We investigated the background of patients who underwent contact laser vaporization of the prostate (CVP) surgery and the learning curve of the operators.

A total of 207 patients who underwent CVP surgery for benign prostatic hyperplasia between August 2018 and March 2023 were included in this study.

Efficacy and Safety of Vibegron for Persistent Symptoms of Overactive Bladder in Men Being Pharmacologically Treated for Benign Prostatic Hyperplasia: Results From the Phase 3 Randomized Controlled COURAGE Trial.

Efficacy and safety of vibegron, a β3-adrenergic receptor agonist, was assessed among men with symptoms of overactive bladder (OAB) receiving pharmacologic treatment for benign prostatic hyperplasia (BPH) in a phase 3 randomized controlled trial.

The effect of pelvic floor muscle training in men with benign prostatic hyperplasia and overactive bladder.

Men with overactive bladder (OAB) and benign prostatic hyperplasia (BPH), will have deterioration in the quality of life.

The aim of this study was to evaluate the effect of combining pelvic floor muscle training with the urgency suppression technique (PFMT-st) and silodosin in comparison with silodosin in men with benign prostatic hyperplasia (BPH) and overactive bladder (OAB) after 12 weeks of treatment.

Minimally invasive interventions for lower urinary tract symptoms: What sits between medical therapy and transurethral resection of the prostate.

There are a variety of medical and surgical treatment options available today for the management of lower urinary tract symptoms (LUTS) secondary to bladder outlet obstruction due to benign prostatic hyperplasia (BPH).

Two-year long-term follow-up of treatment with the Optilume BPH catheter system in a randomized controlled trial for benign prostatic hyperplasia (The PINNACLE Study).

Patient outcomes were assessed 2 years after treatment with the Optilume BPH Catheter System, a minimally invasive surgical therapy for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).

Urethral-sparing laparoscopic simple prostatectomy for the treatment of benign prostatic hyperplasia with asymptomatic urethral stricture after urethral stricture surgery.

To evaluate the efficacy of urethral-sparing laparoscopic simple prostatectomy (US-LSP) for the treatment of large-volume (>80 ml) benign prostatic hyperplasia (BPH) with asymptomatic urethral stricture (urethral lumen > 16 Fr) after urethral stricture surgery.

The oxytocin antagonist cligosiban reduces human prostate contractility: Implications for the treatment of benign prostatic hyperplasia.

With increasing life expectancy, benign prostatic hyperplasia (BPH) consequently affects more ageing men, illustrating the urgent need for advancements in BPH therapy. One emerging possibility may be the use of oxytocin antagonists to relax smooth muscle cells in the prostate, similar to the currently used (although often associated with side effects) α1-adrenoceptor blockers.

Benign Prostatic Hyperplasia Surgery: A Snapshot of Trends, Costs, and Surgical Retreatment Rates in the USA.

An increasing number of novel surgical treatments (NSTs) for benign prostatic hyperplasia (BPH) have been proposed over time to achieve similar functional outcomes, but better perioperative and sexual outcomes than traditional procedures.

The role of remote diagnostics to better assess uroflow variability: insights from combining at home uroflows and frequency volume charts from 19,868 voids using a novel, hand held, cellular embedded device.

To examine how representative 24-hour data collection is of the overall patient experience utilizing a home uroflow device in men with benign prostatic hyperplasia.

Home uroflow data was collected with the iO Urology CarePath device from men at a single urology clinic and retrospectively analyzed.

A prospective analysis of thulium laser enucleation in benign prostatic hyperplasia comparing low- and high-power approaches for prostates exceeding 80 g.

To compare the perioperative and functional outcomes of low-power and high-power thulium:YAG VapoEnucleation (ThuVEP) of the prostate for the treatment of large-volume benign prostatic hyperplasia (BPH) (> 80 ml).

Efficacy and safety of photoselective vaporization of the prostate using the Greenlight XPS 180W laser and simple prostatectomy for high-volume prostate hypertrophy: a comparative analysis.

This study aimed to compare the safety and efficacy of treatment using simple prostatectomy (SP) and using photoselective vaporization of the prostate (PVP) with a 180W GreenLight XPS laser in patients with high-volume prostate hypertrophy.

Real-world experience of water vapour therapy (Rezum) in patients with benign prostatic enlargement: a retrospective single-center study.

Water vapor thermal therapy (Rezum) is a minimally invasive treatment for benign prostatic enlargement (BPE). Studies reporting urodynamic results regarding the procedure are rare. Our study aimed to assess the effectiveness of Rezum on urinary outcome parameters in a consecutive series of patients and compare urodynamic data before and after treatment.

How I Do It: Teaching holmium laser enucleation of the prostate (HoLEP).

Holmium laser enucleation of the prostate (HoLEP) is considered a size-independent technique to treat benign prostatic hyperplasia. This safe and effective procedure is increasingly being adopted in urology training programs worldwide, yet limited teaching strategies have been described.

Surgical Advances in Treating Benign Prostatic Hyperplasia in Africa: What About the Endoscopic Approach?

To assess the practices, trends, and challenges associated with the use of endoscopic techniques in Africa related to the surgical treatment of benign prostatic hyperplasia METHODS: The questionnaire, which was based on Google Forms, assessed several points related to the surgical management of benign prostatic hyperplasia.