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Tadalafil relieves lower urinary tract symptoms secondary to benign prostatic hyperplasia

McVary, Kevin T; Roehrborn, Claus G; Kaminetsky, Jed C; Auerbach, Stephen M; Wachs, Barton; Young, Jay M; Esler, Anne; Sides, Gregory D; Denes, Bela S
PURPOSE: We assessed the efficacy and safety of tadalafil dosed once daily for lower urinary tract symptoms secondary to benign prostatic hyperplasia. MATERIALS AND METHODS: Following a 4-week, single-blind, placebo run-in 281 men were randomly assigned (1:1) to 5 mg tadalafil for 6 weeks, followed by dose escalation to 20 mg for 6 weeks or 12 weeks of placebo. RESULTS: Tadalafil significantly improved the mean change from baseline in International Prostate Symptom Score at 6 weeks (5 mg tadalafil -2.8 vs placebo -1.2) and at 12 weeks (5/20 mg tadalafil -3.8 vs placebo -1.7). Larger changes were observed with inclusion of the placebo run-in at 12 weeks (5/20 mg tadalafil -7.1 vs placebo -4.5). Significant improvements were also seen in the International Prostate Symptom Score irritative and obstructive domains, the International Prostate Symptom Score quality of life index, a question about urinary symptom improvement and the Benign Prostatic Hyperplasia Impact Index (significant at 12 weeks) vs placebo. International Prostate Symptom Score and International Index of Erectile Function erectile function domain scores significantly improved in the 56% of men with lower urinary tract symptoms/benign prostatic hyperplasia who were sexually active and had erectile dysfunction. Changes in uroflowmetry parameters were similar in the placebo and tadalafil groups. Commonly reported (2% or greater) treatment emergent adverse events were "erection increased," dyspepsia, back pain, headache, nasopharyngitis and upper respiratory tract infection (each 5.1% or less). No change in post-void residual volume was seen with tadalafil treatment. CONCLUSIONS: Tadalafil once daily was well tolerated and demonstrated clinically meaningful and statistically significant symptomatic improvement for lower urinary tract symptoms/benign prostatic hyperplasia. Tadalafil also improved erectile function in men with lower urinary tract symptoms and erectile dysfunction.
PMID: 17382741
ISSN: 0022-5347
CID: 72799

Early sildenafil dose optimization and personalized instruction improves the frequency, flexibility, and success of sexual intercourse in men with erectile dysfunction

Steidle, C P; McCullough, A R; Kaminetsky, J C; Crowley, A R; Siegel, R L; Deriesthal, H; Tseng, L-J
We investigated the effect of early sildenafil dose optimization and personalized instructions on sexual intercourse success in 1109 men beginning sildenafil therapy for erectile dysfunction. In phase 1 (4 weeks), patients followed the instructions contained in the sildenafil (50 mg) sample pack and had 1.4 sexual intercourse attempts per week with 82% success. Patients (17%) had a second intercourse attempt (80% successful): 58% occurred within 4 h, 20% within 5-8 h, and 22% within 9-24 h of the first attempt. In phase 2 (4 weeks), sildenafil was adjusted as needed (53% to 100 mg, and 2% to 25 mg), and investigators provided personalized instructions to facilitate patient success. Sexual intercourse attempts increased to 1.7 per week, with 91% success, and 18% were followed by a second attempt, of which 91% were successful. Most patients requested the 100-mg dose, which helped improve sexual intercourse frequency, flexibility and success
PMID: 16858367
ISSN: 0955-9930
CID: 125908

Comorbid LUTS and erectile dysfunction: optimizing their management

Kaminetsky, Jed C
BACKGROUND AND SCOPE: Lower urinary tract symptoms (LUTS) related to benign prostatic hyperplasia (BPH), and sexual dysfunction such as erectile dysfunction (ED), are highly prevalent in men over the age of 50. LUTS and ED have a negative impact on sexual function and when comorbid, result in reduced quality of life. The goal of this article is to discuss the relationship between ED and LUTS, describe the diagnostic workup of these disorders, explore the current treatment options, and examine how treatments may affect this population. Medline (1980-2006), Cochrane reviews, and the American Urological Association 2006 General Meeting abstracts were searched for relevant clinical trials and reviews with the terms: benign prostatic hyperplasia, lower urinary tract symptoms, erectile dysfunction, sexual dysfunction, alpha-adrenergic receptor antagonists, alpha-blockers, 5alpha-reductase inhibitors, phosphodiesterase type-5 inhibitors, transurethral resection of the prostate, transurethral microwave thermotherapy, transurethral needle ablation, adverse events, alfuzosin, doxazosin, tamsulosin, terazosin, dutasteride, finasteride, sildenafil, tadalafil, vardenafil. However, because of the volume of literature, this article is not a systematic review. FINDINGS: Although age is an independent risk factor for both LUTS and ED, studies report that LUTS is also an independent risk factor for ED. Treatments for LUTS include pharmacologic, minimally invasive, and surgical therapies. Among pharmacologic options, alpha1-adrenergic receptor (alpha1-AR) antagonists provide effective treatment with a low risk of sexual side-effects; some of these drugs have been reported to improve sexual function. The treatment of LUTS may improve ED. Phosphodiesterase type 5 inhibitors (PDE-5s) are considered first-line therapy for ED. Comorbid LUTS and ED are treated with an alpha1-AR antagonist and a PDE-5; however, this combination must be used with caution because of vasodilatory adverse events associated with both classes of drugs. CONCLUSIONS: Optimal management includes screening to identify patients with comorbid LUTS and ED, and the use of treatments that minimize both vasodilatory and sexual side-effects
ORIGINAL:0007412
ISSN: 1473-4877
CID: 69458

Benefits of a new testosterone gel formulation for hypogonadal men

Kaminetsky, Jed C
Hypogonadism is a common problem in men. It affects 2% to 30% of men aged 40 to 59 years, 20% to 45% aged 60 to 69 years, 34% to 70% aged 70 to 79 years, and most men aged >80 years. Hypogonadism is also highly prevalent in men with chronic illnesses, such as HIV infection. The low testosterone (T) levels associated with hypogonadism impair sexual function and many other aspects of health and well-being. In aging men and in those who are chronically ill, impaired gonadal function is characterized by subtle changes at many stages of T regulation. T therapy reverses the effects of hypogonadism, improving sexual function, body composition, mood, and well-being. Although many forms of T therapy are available, some therapies have limitations that render them ineffective or inconvenient. A new type of T gel has improved pharmacokinetic and clinical profiles compared with other forms of T therapy. This T gel has been shown to be effective in older men and in men with HIV infection, despite unsatisfactory response to earlier T-gel therapy
PMID: 16651207
ISSN: 1098-3597
CID: 69459

Testosterone therapy in hypogonadal men. Introduction

Kaminetsky, Jed C
PMID: 16651206
ISSN: 1098-3597
CID: 69460

Medications with the potential to enhance sexual responsivity in women

Bartlik, Barbara; Kaplan, Peter; Kaminetsky, Jed; Roentsch, George; Goldberg, James
Outlines several medications that have proven effective for male erectile disorders, that may prove to be effective in treating sexual disorders (arousal and orgasm difficulties) of women. They include sildenafil; alprostadil; a topical preparation of aminophylline, isosorbide dinitrate, and co-dergocrine mesylate; the psychostimulants methylphenidate and dextroamphetamine; ephedrine; bupropion and other antidepressants and anxiolytics; apomorphine; oxytocin; testosterone and other hormones; and alternative medicines such as ginkgo biloba, ginseng, and ma huang. Brief case illustrations are included. None of these medications have been systematically studied in female clinical populations. It is suggested that due to resistance to and funding difficulties in conducting research on women's sexuality, there have not been gains (comparable to those for men) in development of pharmacological treatments for female sexual disorders.
PSYCH:1999-00368-004
ISSN: 0048-5713
CID: 69463

Endoscopic treatment of vesicoureteral reflux in children with neurogenic bladders

Kaminetsky JC; Hanna MK
Endoscopic subureteral injection of Teflon was performed in 12 children (20 ureters) with neurogenic bladders and vesicoureteral reflux (grades III-IV). Follow-up evaluation by ultrasonography and voiding cystourethrogram at three-month intervals up to two years revealed successful correction of the reflux in 70 percent of the ureters
PMID: 2000682
ISSN: 0090-4295
CID: 14112