Biomedical subjects

Sidney Glina

Publications and source records attributed to Sidney Glina.

14 recordsLinked to original sources

PubMed2006

Self-esteem, confidence, and relationships in men treated with sildenafil citrate for erectile dysfunction: results of two double-blind, placebo-controlled trials.

BACKGROUND: Men with erectile dysfunction (ED) often have low self-esteem, confidence, and sexual relationship satisfaction. OBJECTIVE: We evaluated the impact of sildenafil citrate and its generalizability across cultures on self-esteem, confidence, and sexual relationship satisfaction in men with ED using the Self-Esteem And Relationship (SEAR) questionnaire. DESIGN: Pooled analysis of 2 double-blind, placebo-controlled, flexible-dose trials of sildenafil with identical protocols: 1 was conducted in the United States and the other in Mexico, Brazil, Australia, and Japan. PATIENTS: Men > or = 18 years old with ED. MEASUREMENTS: The impact of treatment on psychosocial factors associated with ED was determined by patient responses to the SEAR questionnaire. Erectile function was determined using the International Index of Erectile Function (IIEF) and a global efficacy question. Successful sexual intercourse attempts were derived from event logs of sexual activity. Treatment effect sizes were calculated for all study outcomes. RESULTS: Compared with patients who received placebo (n = 274), patients who received sildenafil (n = 279) reported significantly greater improvements (P < .0001) in self-esteem, confidence, sexual relationship satisfaction, and in all sexual function domains of the IIEF. Treatment effect sizes were large (range, 0.7 to 1.2) for all SEAR components, and improvement in psychosocial measures showed moderate to high correlations (range, 0.50 to 0.83, P < .0001) with improvement in erectile function, percentage of successful intercourse attempts, and global efficacy. CONCLUSIONS: In men with ED from 5 different nations, sildenafil produced substantial improvements in self-esteem, confidence, and sexual relationship satisfaction. Improvements in these psychosocial factors were observed crossculturally and correlated significantly and tangibly with improvements in erectile function.

Adult↗

PubMed2006

Evaluation of the efficacy and safety of once-a-day dosing of tadalafil 5mg and 10mg in the treatment of erectile dysfunction: results of a multicenter, randomized, double-blind, placebo-controlled trial.

BACKGROUND: Erectile dysfunction (ED) is a chronic disease; however, therapy is currently administered as needed with oral phosphodiesterase 5 (PDE5) inhibitors like tadalafil. Because the 17.5-h half-life of tadalafil enables therapeutic plasma levels to be sustained with daily administration, tadalafil is a good candidate for once daily dosing therapy. METHODS: This multicenter, randomized, double-blind, placebo-controlled, parallel-group, 12-week study enrolled 268 men 1:2:2 to placebo, tadalafil 5mg, and tadalafil 10mg taken once daily. Primary efficacy measures included changes in the International Index of Erectile Function Erectile Function domain (IIEF EF), Sexual Encounter Profile diary Questions 2 (SEP2: successful penetration), and 3 (SEP3: successful completion of intercourse), and tolerability. Secondary measures included percentage of patients at endpoint who reported improved erectile function (EF), and percentage who reported "no ED" (IIEF EF score 26-30). RESULTS: For patients who took placebo, tadalafil 5mg, and tadalafil 10mg, changes from baseline to endpoint were, respectively, 0.9, 9.7, and 9.4 for IIEF EF; 11.2, 36.5, and 39.4 for SEP2; and 13.2, 45.5, and 50.1 for SEP3. At endpoint, 28.3%, 84.5%, and 84.6% reported improved erections, and 8.3%, 51.5%, and 50.5% reported "no ED," respectively. All comparisons between tadalafil and placebo were significant (p<0.001). Adverse events that occurred in at least 5% of patients were dyspepsia, headache, back pain, upper abdominal pain, and myalgia; nine patients (3.4%) discontinued because of adverse events. CONCLUSIONS: Once-a-day tadalafil 5mg or 10mg was well tolerated and significantly improved EF in men with ED.

Adult↗

PubMed2006

Erectile function and assessments of erection hardness correlate positively with measures of emotional well-being, sexual satisfaction, and treatment satisfaction in men with erectile dysfunction treated with sildenafil citrate (Viagra).

We aimed to determine whether erectile function (EF) and assessments of erection hardness correlate positively with measures of psychosocial outcomes (ie, emotional well-being, sexual satisfaction, and satisfaction with erectile dysfunction [ED] treatment) in men treated with sildenafil citrate (Viagra; Pfizer Inc, New York, NY). Data were collected from 33 worldwide phase 2, 3, and 4 sildenafil clinical trials, which included almost 10,000 men with ED. Most of these trials were randomized, double-blind, and placebo-controlled (n = 27) and were undertaken to assess doses of 50 mg adjustable to 25 mg or 100 mg, depending on efficacy and tolerability (n = 32). Doses were taken approximately 1 hour before anticipated sexual activity but not more often than once daily. EF was assessed with use of the EF domain of the International Index of Erectile Function (IIEF) and with assessments of erection hardness (Erection Hardness Grading Scale [EHGS] and IIEF Q2 [the frequency of erections hard enough for penetration]). Change (baseline to end point) in emotional well-being in men treated for ED was assessed with the Self-Esteem and Relationship (SEAR) questionnaire, which consisted of the Confidence domain (ie, the Self-Esteem subscale and Overall Relationship subscale) and the Sexual Relationship domain. End point treatment satisfaction (overall, speed of onset, and duration of action) was assessed with the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS). The IIEF was used to assess change and end point sexual satisfaction by means of the Intercourse Satisfaction domain, Q7 (frequency of satisfactory sexual intercourse), and the Overall Satisfaction domain (ie, Q13, satisfaction with sex life, and Q14, satisfaction with sexual relationship). In men treated with sildenafil for ED, scores for measures of EF (IIEF EF domain, IIEF Q2) and the percentage of erections graded completely hard and fully rigid (EHGS grade 4) correlated positively with scores for measures of psychosocial outcomes (SEAR emotional well-being, IIEF sexual satisfaction, and EDITS ED treatment satisfaction), indicating that when EF improved and erection hardness increased, these measures of psychosocial function also improved.

Clinical Trials as Topic↗

PubMed2006

Lower urinary tract symptoms and erectile dysfunction are highly prevalent in ageing men.

OBJECTIVE: To evaluate a possible correlation between the International Prostate Symptom Score (IPSS) and the Sexual Health Inventory for Men (SHIM) in an unselected population of men presenting to a clinic, as lower urinary tract symptoms (LUTS) and erectile dysfunction (ED) are highly prevalent in ageing men, and recent largely community-based epidemiological studies reported a close association between ED and LUTS. PATIENTS AND METHODS: This was a cross-sectional study in an unselected consecutive sample of 118 men aged >40 years attending a urology clinic; the reason for consulting was not ascertained. While in the waiting room the men were asked to participate in the study and on agreement were given the IPSS and the SHIM to complete. RESULTS: The mean (range) age of the participants was 61.7 (45-82) years. Overall, 19 (16%) and 47 (40%) of the men reported having moderate or severe LUTS, respectively. Erectile problems were also common, the prevalence of moderate ED was 11% and complete ED 29%. The Pearson correlation coefficient between the IPSS and the SHIM was - 0.32 (P < 0.001). CONCLUSION: There was a close correlation between the IPSS and SHIM in this unselected population of men, adding evidence favouring a close association between LUTS and ED.

Age Factors↗

PubMed2006

Timing of dose relative to sexual intercourse attempt in previous sildenafil citrate users treated with tadalafil.

OBJECTIVES: Tadalafil, a phosphodiesterase type 5 inhibitor, has an extended period of effectiveness, up to 36 hours, for the treatment of erectile dysfunction (ED). Changes in behavior of long-term sildenafil users were evaluated by assessing time of dose relative to sexual intercourse attempts during treatment with sildenafil and tadalafil. MATERIALS AND METHODS: This open-label study was conducted in men with ED and a history of >or=6-week prior sildenafil use in Australia, New Zealand, Asia, Central and Eastern Europe, the Middle East, and Latin America. Patients continued sildenafil treatment for 4 weeks, then switched to tadalafil for 8 weeks. Timing of sexual intercourse attempt relative to dose was assessed through patient diaries for the final 4 weeks of each treatment period. Patients continued their treatment of choice in an extension period. RESULTS: A total of 2,760 men (mean age 54.4 years) with a median duration of prior sildenafil use of 474 days were enrolled. Significant increases in median time from dose to intercourse attempt were observed when changing treatment from sildenafil citrate (1.21 hours) to tadalafil (3.25 hours; P < 0.001). Fifty-nine percent of intercourse attempts were within 4 hours of dosing when patients were treated with tadalafil (88% with sildenafil). The proportion of intercourse attempts per patient made >4 hours after dose was considerably higher during the tadalafil than during the sildenafil assessment period. Similar daily cycles of frequency of dosing and intercourse attempts were observed in all study periods and were characterized by a small peak in the morning and a large peak in the evening. When changing treatment to tadalafil, patients administered the drug earlier in the day and over a broader period of time. CONCLUSION: Following the dosing instructions reflecting tadalafil's extended period of effectiveness, men with a history of established sildenafil use changed their dose-attempt behavior when treated with tadalafil.

Adult↗

PubMed2006

Sildenafil citrate improves self-esteem, confidence, and relationships in men with erectile dysfunction: Results from an international, multi-center, double-blind, placebo-controlled trial.

INTRODUCTION: Erectile dysfunction (ED) can significantly impact a man's relationships and well-being. AIM: We assessed changes in self-esteem, confidence, sexual relationship satisfaction, and overall relationship satisfaction in men with ED using the validated Self-Esteem And Relationship questionnaire (SEAR). METHODS: This was a 12-week, double-blind, placebo-controlled, flexible-dose (25, 50, 100 mg, as needed) international study of sildenafil in men > or =18 years of age in Mexico, Brazil, Australia, and Japan. MAIN OUTCOME MEASURES: The primary study outcome was change in self-esteem from baseline to the end of treatment. Secondary study measures were changes in other SEAR components, International Index of Erectile Function (IIEF) domains, percentage of intercourse attempts that were successful, and the response to a global efficacy question at the end of treatment. RESULTS: Patients were well balanced for age and duration of ED (placebo = 149 and sildenafil = 151). Compared with placebo, sildenafil significantly improved self-esteem, confidence, sexual relationship satisfaction, and overall relationship satisfaction (P < 0.0001). The psychosocial measures of well-being assessed with the SEAR were positively correlated (range 0.60-0.86, P < 0.0001) with erectile function, the frequency of achieving erections that allowed satisfactory sexual intercourse, the percentage of successful sexual intercourse attempts, and global treatment efficacy. CONCLUSIONS: Significant improvements in self-esteem, confidence, sexual relationship satisfaction, and overall relationship satisfaction after treatment of ED with sildenafil were consistent among countries. These data suggest a substantial cross-cultural improvement in well-being after successful treatment of ED with sildenafil.

Adult↗

PubMed2004

Finasteride-associated male infertility.

Finasteride is a potent and specific inhibitor of the 5alpha-reductase enzyme in men. Clinical studies have shown that finasteride 1mg/day is effective for promoting hair growth in men with male pattern hair loss. However, there is a concern about the use of finasteride, especially in young fertile patients, because of its action on testosterone metabolism. This paper describes 3 cases of young patients who had very poor seminal quality during finasteride treatment (1 mg/day), and their seminal quality greatly improved after cessation of finasteride treatment. Two of them presented with a left varicocele and the other was obese. We hypothesize that finasteride may not dramatically change the spermatogenesis process in healthy men, but in patients with conditions related to infertility, an amplification of the negative influence of finasteride could occur. Future studies should be done to clarify the extent of the effect of finasteride in patients fertility problems.

Adult↗

PubMed2004

Standards for clinical trials in male sexual dysfunction: erectile dysfunction and rapid ejaculation.

INTRODUCTION: The introduction of safe and effective therapies for sexual dysfunctions depend upon appropriate clinical protocol design, study procedures, data collection and analysis. AIM: To provide recommendations/guidelines concerning state-of-the-art knowledge for standards for clinical trials in sexual dysfunction in men, particularly in the areas of erectile dysfunction and rapid ejaculation. METHODS: An International Consultation in collaboration with the major urology and sexual medicine associations assembled over 200 multidisciplinary experts from 60 countries into 17 committees. Committee members established specific objectives and scopes for various male and female sexual medicine topics. The recommendations concerning state-of-the-art knowledge in the respective sexual medicine topic represent the opinion of experts from five continents developed in a process over a 2-year period. Concerning the Standards for Clinical Trials in Male Sexual Dysfunction Committee, there were six experts from four countries. MAIN OUTCOME MEASURE: Expert opinion was based on grading of evidence-based medical literature, widespread internal committee discussion, public presentation and debate. RESULTS: Drug development requires a multiphased approach. Phase 1 studies investigate multiple-dose safety, tolerability and pharmacokinetic issues. Phase 2 programs explore dose ranging (lowest effective, maximally tolerated and toxic doses). Phase 3 trials provide the substantial evidence including drug-drug interaction data and studies in special populations. Clinical studies require validated outcome assessment instruments conducted in defined but representative patient populations. Daily diaries or per-event questionnaires are patient-reported outcomes that assist in retrospective questionnaire interpretation. A qualified biostatistician should calculate the sample power for the trial, type of statistical model and design employed, use of covariate or subgroup analyses, and calculation of effect sizes. CONCLUSIONS: More research is needed in developing standards for use in the development of clinical trials and outcomes assessment researching either erectile dysfunction or rapid ejaculation.

Consensus↗

PubMed2003

Sperm tail flexibility test: a simple test for selecting viable spermatozoa for intracytoplasmic sperm injection from semen samples without motile spermatozoa.

PURPOSE: The objective was to describe the results of the injection of immotile spermatozoa with flexible tails when only immotile spermatozoa are present in the semen sample. METHODS: A retrospective study was conducted to analyze the procedure results for 10 couples who participated in our intracytoplasmic sperm injection program. The sperm tail was considered flexible when it moved up and down independently of the head movement, and it was considered inflexible when the movement occurred together (tail plus head). The fertilization and pregnancy rate were analyzed. RESULTS: The normal fertilization rate (presence of 2 pronuclei) was 30.3% (40/132), and the abnormal fertilization rate (presence of less than or more than 2 pronuclei) was 6.81% (9/132). A total of 52 embryos were obtained with 9 transfer procedures performed (pregnancy rate: 11.12%). CONCLUSIONS: The sperm tail flexibility test (STFT) is an easy and cost-effective way for selecting viable immotile spermatozoa and can be used as an alternative method for determining the viability of spermatozoa. This test seems to be a simple and risk-free method when compared to the swelling test.

Adult↗

PubMed2002

A cost-effective screening test for detecting AZF microdeletions on the human Y chromosome.

PCR-based screening of microdeletions in the azoospermic factor (AZF) on the Yq chromosome is an accepted means of identifying a common genetic cause of male infertility, responsible for 5-15% of cases associated with a low sperm count (</=5 x 10(6) sptz/ml). Based on an extensive analysis of the literature, we have established a cost-effective preliminary PCR-based diagnostic screening test, with a set of six pairs of primers ("set-of-6") that have the capability of detecting up to 95% of the Y microdeletion cases already published. These primers are: sY84 in AZFa, sY114, sY129, sY143 in AZFb, and sY149, sY254 in AZFc. Initially, the set-of-6 was tested with 13 other pairs of primers covering the three AZF subregions. A sample of 114 infertile men was tested and 10 (8.8%) microdeletions were found, 3 of which were among the 26 (11.5%) idiopathic azoospermic men. These results showed that all detected microdeletions would be identified using the set-of-6 only. Another sample of 34 patients was subsequently tested using the set-of-6 and 3 (8.8%) microdeletions were found in this group. A comparison of our results with those reported in the literature showed similar microdeletion detection frequencies, demonstrating that the set-of-6 primers provides a reliable, simple and cost-effective way of detecting AZF deletions.

Base Sequence↗

PubMedDate not supplied

Percutaneous epididymal sperm aspiration (PESA) in men with obstructive azoospermia.

OBJECTIVES: Assessing the efficiency of repeated percutaneous epididymal sperm aspiration (PESA) in men with obstructive azoospermia, and also the possibility of cryopreservation of remaining material for future use in intracytoplasmic sperm injection (ICSI). METHOD: Retrospective study, in which 79 procedures of PESA were assessed in 58 patients (mean age = 45 years), whose partners had mean age of 34 years. Vasectomy was the most frequent cause of obstructive azoospermia (n = 46). RESULTS: Motile spermatozoa were obtained in 65 procedures (82%). PESA was twice repeated for 15 patients, 3 times for 5 patients, and 4 times for 1 patient. Spermatozoa were found in 13 (87%) patients in the second attempt, in 4 (80%) patients in the third attempt, and in the only patient that had accomplished 4 procedures. In 30 procedures (37%), we have obtained enough material for cryopreservation. In 12 among the 13 samples thawed (n = 13 patients), motile spermatozoa were found, and ICSI was accomplished. Four patients that did not use their samples requested the elimination of the material. Total rate of pregnancy per transference was 21/55 (38%). In 14 PESA procedures, it was not possible to find spermatozoa; in these cases, the patients opted for accomplishing the procedure of testicular sperm aspiration (TESA). CONCLUSION: PESA is an efficient and simple method of retrieving spermatozoa, allowing repeated procedures. Additionally, spermatozoa collected through PESA can be cryopreserved.

Journal Article↗

PubMedDate not supplied

Renal cell carcinoma in childhood.

The renal cell carcinoma (RCC) rarely occurs in childhood. We report here 3 cases of RCC in children. Two girls and 1 boy aged 14, 8 and 13 years old, respectively, presented with gross hematuria as their main complaint. They underwent ultrasonography and computerized tomography, which revealed unilateral renal tumor with lymph nodal involvement in all 3 cases. They were treated with radical nephrectomy associated with regional lymphadenectomy, with histopathology of RCC. Incomplete adjuvant radiotherapy was performed in 2 cases and no complementary treatment in the other one. All are disease-free in a period ranging from 9 to 77 months after diagnosis. Radical nephrectomy associated with regional lymphadenectomy is the best treatment for RCC in childhood. The disease appears to have a less aggressive behavior in children.

Adolescent↗

PubMedDate not supplied

Testicular histopathological diagnosis as a predictive factor for retrieving spermatozoa for ICSI in non-obstructive azoospermic patients.

OBJECTIVE: Histological testicular pattern has a predictive role in the possibility of finding spermatozoa for ICSI in cases of non-obstructive azoospermia because some individuals could show residual spermatogenic sites in the testis. The aim of this study was to evaluate the sperm retrieval rate in each of the histopathological groups (hypospermatogenesis--Hypo, spermatogenic maturation arrest--MA, Sertoli cell only--SCO and testicular hyalinization) in patients assisted in our clinic. MATERIALS AND METHODS: Retrospective study from March 1997 to October 2002. We analyzed 14 patients with mean age of 34.3 +/- 0.7, with non-obstructive azoospermia. All patients were submitted to previous diagnostic biopsy (Bx) elsewhere and came to our institution for treatment. After an average of 12 months (8-20), they were submitted to a new Bx procedure to retrieve sperm. RESULTS: Previous diagnostic Bx showed the following histopathological results: 5 patients with MA, 4 with Hypo and 5 SCO. In the following Bx (for sperm retrieval) spermatozoa was found in 33% of the procedures in patients with MA, 50% in patients with Hypo and 40% of the procedures in patients with SCO. CONCLUSION: Previous diagnostic Bx can help in patient counseling concerning the result of sperm retrieval.

Adult↗

PubMedDate not supplied

Recovery of spermatogenesis after microsurgical subinguinal varicocele repair in azoospermic men based on testicular histology.

OBJECTIVE: Analyze whether testicular histologic patterns from a group of azoospermic men with varicocele is predictive of treatment outcome after subinguinal microsurgical varicocele repair. MATERIALS AND METHODS: Seventeen azoospermic men underwent bilateral open single testis biopsy and microsurgical subinguinal repair of clinical varicoceles. RESULTS: Histopathology of testicular biopsies revealed hypospermatogenesis (HYPO) in 6 men, maturation arrest (MA) in 5, and Sertoli cell-only (SCO) in 6. Overall, presence of spermatozoa in the ejaculates was achieved in 47% (8/17) of men after varicocele repair, but only 35% (6/17) of them had motile sperm in their ejaculates. Only men with testicular histology revealing HYPO (5/6) or maturation arrest (3/5) had improvement after surgery. Median (25%-75% percentile) postoperative motile sperm count for both groups were 0.9 x 10(6)/mL (0.1-1.8 x 10(6)/mL) and 0.7 x 10(6)/mL (0.1-1.1), respectively (p = 0.87). The mean time for appearance of spermatozoa in the ejaculates was 5 months (3 to 9 months). One (HYPO) of 8 (12.5%) men who improved after surgery contributed to an unassisted pregnancy. Postoperative testicular biopsies obtained from patients who had no improvement after surgery revealed that testicular histology diagnosis remained unchanged. Successful testicular sperm retrieval for intracytoplasmic sperm injection (ICSI) was achieved in 4 of 9 (44.4%) individuals who did not improve after surgery, including 1 man with testicular histology exhibiting SCO. CONCLUSIONS: Microsurgical varicocele repair in nonobstructive azoospermic men with clinical varicoceles can result in sperm appearance in the ejaculate when hypospermatogenesis or maturation arrest is found on testicular histology diagnosis.

Adult↗