Kristie L. Kahl

The Mini-patch, an on-demand transcutaneous perineal electrical stimulator, significantly increased intravaginal ejaculatory latency time (IELT) in men experiencing premature ejaculation (PE), according to study results presented at the 2022 American Urological Association (AUA) Annual Meeting.

Geometric mean IELT at baseline was 67 seconds, which significantly increased to 123 seconds (

 < .0001) in the active device group, compared with 63 seconds at baseline, which increased to just 81 seconds (

The IELT significantly increased by 3.22-fold in the Mini-patch device group, compared with the sham group (

Moreover, overall geometric mean time fold increases of IELT in the active device group compared with the sham group were 1.7 (95% CI, 1.5-2.1), compared with 1.2 (95% CI, 1.0-1.6).

No serious adverse events (AEs) were reported.

Because available treatments for PE can have limited efficacy and low adherence, the investigators aimed to evaluate the feasibility, safety, and efficacy of the Mini-patch.

In the bi-center, international, prospective, randomized, double-blind, 2-arm, sham- controlled, clinical study, patients were randomized 2:1 to receive the active (n = 34) or sham (n = 17) device.

Eligibility criteria included IELT values and medical/sexual history.

Safety was evaluated by the incidence of treatment-emergent AEs, and efficacy was evaluated through Clinical Global Impression of Change (CGIC) scores, Premature Ejaculation Profile (PEP) questionnaire outcomes, and the Mini-patch safety profile.

Device efficacy by mean fold change in geometric mean IELT served as the study’s primary end point.

“Mini-patch has the potential to become a leading on-demand, noninvasive, and drug-free treatments for PE,” the investigators concluded.

1. Shechter A, Mondaini N, Serefoglu EC, et al. Novel on-demand treatment for lifelong premature ejaculation using transcutaneous perineal mini-patch stimulator. 

. 207(55);5S:e1045. doi:JU.0000000000002670.11.

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The IELT significantly increased by 3.22-fold in the Mini-patch device group, compared with the sham group (P = .0047).

Transcutaneous perineal electrical stimulator improves intravaginal ejaculatory latency time

Uro-oncologic surgery using the da Vinci Single-Port (SP) robotic system, compared with the Multi-Port (MP) system, improved patient-reported cosmetic and pain outcomes, according to results presented at the 2022 American Urological Association (AUA) Annual Meeting.

Luca Morgantini, MD, University of Illinois Chicago, and colleagues aimed to determine patient-reported advantages of cosmetic and psychometric surgical outcomes from the da Vinci SP robotic system—which utilizes a single 25-mm incision—for urological procedures, compared with the MP system, the previous model that utilizes multiple 5- to 22-mm incisions.

In the prospective study, patients who underwent uro-oncologic surgery by 3 urologists at the University of Illinois at Chicago from April 2021 to November 2021 were evaluated. Twenty (n = 77) and 90 days (n = 37) after surgery, patients completed a Patient Scar Assessment Questionnaire (PSAQ), which includes 5 subscales: appearance, symptoms, consciousness, satisfaction with appearance, and satisfaction with symptoms.

At 20 days, 24 patients who underwent surgery with the MP system and 53 who underwent the SP system answered the questionnaire, and 13 and 24, respectively, completed it at 90 days.

Twenty days after surgery with the SP and MP systems, there was a significant difference in the percentage of those taking pain medication (50% vs 21%, respectively; 

Ninety days after surgery with the SP and MP systems, there was a significant difference in appearance between the 2 groups (14 vs 12; 

“This study demonstrates the superiority of the SP in patient-reported cosmetic and pain outcomes on short- and long-term follow-up after uro-oncological surgical procedures,” the study authors concluded in their abstract. “Symptomatic and cosmetic advantages are present at the 20-day follow up, with better scar appearance being significant also 90 days after surgery.”

1. Morgantini L, Del Pino M, Bharadwaj A, et al. A Prospective Study of Single-Port Versus Multi-Port Patient Reported Surgical Outcomes. 

. 207(55);5S:e1036. doi:JU.0000000000002669.03.

“This study demonstrates the superiority of the SP in patient-reported cosmetic and pain outcomes on short- and long-term follow-up after uro-oncological surgical procedures,” the study authors concluded.

Single-port uro-oncologic surgery improves patient-reported outcomes

Surgery using Holmium laser enucleation of the prostate (HoLEP) to treat lower urinary tract symptoms (LUTS) as a result of benign prostatic enlargement (BPE) improved uroflowmetry, as well as lower mean hospital stays and postoperative catheterizations, as compared with adenomectomy and transurethral resection of the prostate (TURP), according to results presented at the 2022 AUA Annual Meeting.

According to the abstract, current literature suggests that HoLEP could replace other techniques as a size-independent surgical treatment for BPE. “Holmium laser enucleation of the prostate is a novel technique for the treatment of lower urinary tract symptoms resulting from benign prostatic enlargement,” the authors explained in the abstract.

Therefore, the investigators aimed to prospectively analyze the improvement in uroflowmetry (Qmax), hospitalization days, postoperative catheterization, urinary incontinence, and erectile dysfunction (ED) in 180 patients treated with TURP and HoLEP for prostates < 90 cc (n = 38 and 51, respectively) and in those treated with open adenomectomy and HoLEP for prostates > 90 cc (n = 51 and 40), from January 2020 to October 2021.

Among those with prostate volumes > 90 cc, HoLEP, compared with adenomectomy, demonstrated a mean improvement in Qmax at 6 to 12 months of 27.4 mL/s vs 20.9 mL/s, respectively (

 = .03), a mean hospital stay of 2.4 days vs 4.6 days (

 < .001), and a mean postoperative catheterization of 4.1 days vs 10 days (

 < .001). Four patients had ED during follow-up after HoLEP, compared with 9 patients treated with adenomectomy.

Among those with prostate volumes < 90cc, HoLEP compared with TURP, demonstrated a mean improvement in Qmax at 6 to 12 months of 23.2 mL/s vs 14.35 mL/s (

 = .001), a mean hospital stay of 1.71 days vs 2 days (

 = .072), and a mean postoperative catheterization of 3.9 days vs 3.97 days (

 = .83). Eight patients had ED during follow-up after HoLEP, compared with 3 patients tested with TURP.

“HoLEP had a greater uroflowmetry improvement compared to open adenomectomy and TURP,” the investigators concluded. “The mean hospital stay and postoperative catheterization days were reduced compared to open adenomectomy, but there were no differences in this aspect with TURP.”

1. Beltran M, Pallas Y, Povo I, et al. Surgical Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Enlargement by Holmium Laser Enucleation of the Prostate Versus Transurethral Resection of the Prostate and Open Adenomectomy. 

. 207(55);5S:e1037. doi:JU.0000000000002669.05

HoLEP improves outcomes in patients with LUTS related to benign prostatic enlargement

A single dose, at either 24 mg or 48 mg, of URO-902 was safe and well tolerated, while also demonstrating clinically relevant efficacy and improved quality of life in women with overactive bladder (OAB) and urge urinary incontinence (UUI), according to interim results from a phase 2a trial (NCT04211831) presented at the 2022 American Urological Association (AUA) Annual Meeting.

At the AUA Annual Meeting, Kenneth M. Peters, MD, professor and chair of urology at Oakland University William Beaumont School of Medicine in Rochester, Michigan, presented on data from the prespecified, 12-week interim analysis of the 48-week trial.

At week 12 of the trial, both 24- and 48-mg doses of URO-902, compared with placebo, demonstrated clinically relevant improvements in the following areas:

mean daily micturitions (LS mean change from baseline [CFB], ‒2.5 [95% CI, ‒3.5 to ‒1.4; 

 = .0297] and ‒3.0 [95% CI, ‒4.0 to ‒1.9; 

 = .0044] vs ‒1.0 [95% CI, ‒2.0 to 0.1], respectively),

urgency episodes (LS mean CFB, ‒2.4 [95% CI, ‒3.9 to ‒0.8; 

 = .2060] and ‒3.4 [95% CI, ‒4.9 to ‒1.9; 

UUI episodes (LS mean CFB, ‒2.4 [95% CI, ‒3.4 to ‒1.4; 

 = .8564] and ‒2.6 [95% CI, ‒3.6 to ‒1.6; 

OAB questionnaire symptom bother score (LS mean CFB, ‒24.1 [95% CI, ‒34.5 to 13.7; 

 = .0431] and ‒25.3 [95% CI, ‒35.3 to ‒15.2; 

proportion of patient global impression of change responders (LS mean CFB, 40.9% [95% CI, ‒15.4% to 37.9%; 

 = .4093] and 57.7% [95% CI, 3.4%-52.8%; 

Among patients who received URO-902 at the 24- and 48-mg doses, 45.5% (n = 10) and 46.2% (n = 12), respectively, experienced treatment-emergent adverse events (TEAEs), compared with 50.0% (n = 13) receiving placebo. Among all 3 cohorts, the most common AE was urinary tract infection, occurring in 0%, 15.4%, and 3.8% of patients, respectively. One patient on the 48-mg dose arm experienced asymptomatic elevated postvoid residual (PVR) urine volume at week 2, which resolved spontaneously and did not require catheterization.

No TEAEs led to treatment discontinuation, and there were no severe AEs that were related to the agent.

Long-term follow-up of the study is ongoing.

“In this pre-specified 12-week analysis of a phase 2a trial of women with OAB and UUI, a single dose of URO-902 24 mg or 48 mg was associated with clinically relevant improvement in efficacy and quality of life and was safe and well tolerated,” Peters concluded.

According to Urovant Sciences, URO-902, an investigational, novel, locally injected gene therapy product (plasmid human cDNA encoding maxi-K channel), has the potential to be the first gene therapy for patients with OAB, and, If approved, could address an unmet need for patients who have failed oral pharmacologic therapies.

The multicenter, randomized, double-blind, placebo-controlled, dose-escalation phase 2a study included women aged 40 to 79 years with OAB and UUI who were not adequately managed with oral OAB medications. Investigators randomized 80 patients to receive either single-dose URO-902 24 mg (n = 22), URO-902 48 mg (n = 26), or placebo (n = 26) administered by intradetrusor injection via cystoscopy under local anesthesia.

Safety served as the primary end point and was assessed by AEs and PVR urine. Exploratory end points included change from baseline to week 12 in mean daily micturitions, urgency episodes, UUI episodes, and quality of life measures.

Of the 80 patients randomized, 68 completed week 12, and 74 were included in the intent-to-treat population.

Mean age was 64.7 years (SD, 7.1) and 13.5% had prior treatment with onabotulinumtoxinA.

“We are encouraged by these positive results and pending the completion of the study in fall 2022 and we look forward to discussing next steps for the URO-902 clinical development plan,” Sef Kurstjens, MD, PhD, Executive Vice President and Chief Medical Officer of Urovant Sciences, said in a press release.

1. Peters K, Enemchukwu E, Kalota S, Greene H. Efficacy and safety of a novel gene therapy (URO-902; pVAX/hSlo) in female patients with overactive bladder and urge urinary incontinence: results from a phase 2a trial. 

. 2022;207(5S):e1048. doi:10.1097/JU.0000000000002671.03.

2. Urovant Sciences to present interim data from phase 2a study of potential novel gene therapy, URO-902, and new analyses of data from phase 3 EMPOWUR extension trial of GEMTESA (vibegron) 75 mg at 2022 American Urological Association Annual Meeting. News release. Urovant Sciences April 13, 2022. Accessed May 13, 2022. https://ir.urovant.com/news-releases/news-release-details/urovant-sciences-present-interim-data-phase-2a-study-potential

3. Urovant Sciences announces positive topline results of Phase 2a trial of its potential novel gene therapy, URO-902. News release. Urovant Sciences. March 7, 2022. Accessed May 13, 2022

"A single dose of URO-902 24 mg or 48 mg was associated with clinically relevant improvement in efficacy and quality of life and was safe and well tolerated," says Kenneth M. Peters, MD.

Kristie L. Kahl

Articles

Transcutaneous perineal electrical stimulator improves intravaginal ejaculatory latency time

Single-port uro-oncologic surgery improves patient-reported outcomes

HoLEP improves outcomes in patients with LUTS related to benign prostatic enlargement

URO-902 appears safe, efficacious in treating OAB, UUI in female patients