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Fertility restoration using autologous testicular tissue transplantation is relevant for infertile men surviving from childhood cancer and, possibly, in men with absent or incomplete spermatogenesis resulting in the lack of spermatozoa in the ejaculate (non-obstructive azoospermia, NOA). Currently, testicular tissue from pre-pubertal boys extracted before treatment with gonadotoxic cancer therapy can be cryopreserved with good survival of spermatogonial stem cells. However, strategies for fertility restoration, after successful cancer treatment, are still experimental and no clinical methods have yet been developed. Similarly, no clinically available treatments can help men with NOA to become biological fathers after failed attempts of testicular surgical sperm retrieval. We present a case of a 31-year-old man with NOA who had three pieces of testis tissue (each â¼2 × 4 × 2 mm3) extracted and cryopreserved in relation to performing microdissection testicular sperm extraction (mTESE). Approximately 2 years after mTESE, the thawed tissue pieces were engrafted in surgically created pockets bilaterally under the scrotal skin. Follow-up was performed after 2, 4, and 6 months with assessment of reproductive hormones and ultrasound of the scrotum. After 6 months, all engrafted tissue was extracted and microscopically analyzed for the presence of spermatozoa. Furthermore, parts of the extracted tissue were analyzed histologically and by immunohistochemical analysis. Active blood flow in the engrafted tissue was demonstrated by doppler ultrasound after 6 months. No spermatozoa were found in the extracted tissue. Histological and immunohistochemical analysis demonstrated graft survival with intact clear tubules and normal cell organization. Sertoli cells and spermatocytes with normal morphology were located near the basement membrane. MAGE-A and VASA positive spermatogonia/spermatocytes were detected together with SOX9 positive Sertoli cells. Spermatocytes and/or Sertoli cells positive for γH2AX was also detected. In summary, following autologous grafting of frozen-thawed testis tissue under the scrotal skin in a man with NOA, we demonstrated graft survival after 6 months. No mature spermatozoa were detected; however, this is likely due to the pre-existing spermatogenic failure.
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Azoospermia , Testículo , Adulto , Humanos , Masculino , Criança , Testículo/patologia , Sêmen , Espermatozoides/patologia , Espermatogônias , Células de Sertoli , Azoospermia/cirurgia , Azoospermia/patologia , Recuperação EspermáticaRESUMO
STUDY DESIGN: Cohort study OBJECTIVES: The purpose of this study was to evaluate the performance of a re-engineered device (Ferticare 2.0), which is replacing the previous standard (Ferticare 1.0) for penile vibratory stimulation in men with spinal cord injury. Most men with spinal cord injury are anejaculatory, requiring medical assistance to obtain their semen. Penile vibratory stimulation is generally recognized as the standard of care for semen retrieval in these anejaculatory men. SETTING: Major Research University in Miami, Florida, USA. METHODS: The Ferticare 2.0 device was applied to 15 men with spinal cord injury in a three-step protocol simulating normal use. Step 1: one device (2.5 mm amplitude, 100 Hz) was applied to the glans penis for 2 min. Step 2: If no ejaculation occurred, the amplitude was increased to 4.0 mm (100 Hz) and the device similarly applied. Step 3: If no ejaculation occurred, two devices, each 2.5 mm and 100 Hz were applied to the dorsum and frenulum of the glans penis. Participants at risk for autonomic dysreflexia were pretreated with sublingual nifedipine (20 mg), 15 min prior to stimulation. Blood pressure and other symptoms of autonomic dysreflexia were monitored. Participants answered a questionnaire about their experience with the device. RESULTS: Thirteen of 15 participants ejaculated with the device. No adverse events occurred. All participants commented they would recommend the device to other men with spinal cord injury. CONCLUSIONS: A re-engineered device, the Ferticare 2.0, is safe and effective for inducing ejaculation in men with spinal cord injury.
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Disreflexia Autonômica , Traumatismos da Medula Espinal , Ejaculação , Humanos , Masculino , Pênis , Traumatismos da Medula Espinal/complicações , Traumatismos da Medula Espinal/terapia , VibraçãoRESUMO
The aim of this study was to evaluate patient-reported outcomes of Collagenase Clostridium Histolyticum (CCHi) for Peyronie's Disease. Patients treated with 2-4 cycles of CCHi between 01/2016 and 08/2018 were asked to fill out the "bother domain" of the Peyronie's Disease Questionnaire (PDQ) at scheduled appointments for injections. CCHi cycles involved two injections (0.58 mg) separated by 48-72 hr. During the study, 34 patients were treated, seven patients were excluded due to incomplete baseline values. Mean (standard deviation) PDQ bother domain baseline score was 11.1 (2.6). ANOVA demonstrated statistically significant effects of injections (p < .001) with a decrease in PDQ bother domain scores 6 weeks after the 1st cycle (9.9 [3.3], p = .013), 6 weeks after the 2nd cycle (8.2 [4.0], p = .009) and 6 weeks after the 3rd cycle (6.5 [3.6], p < .001). After 2-4 cycles of CCHi treatment, patients reported changes in penile curvature as "Worse" (0), "No Change" (2), "Little decrease" (10), Decrease (10) and "Significant decrease" (4). After completion of CCHi treatment, 82% of patients still reported that vaginal intercourse was difficult or impossible. Patients with Peyronie's Disease undergoing CCHi treatment reported statistically significant decreases in PDQ bother domain scores. However, most patients still report difficulty with intercourse after treatment.
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Colagenase Microbiana , Induração Peniana , Humanos , Injeções Intralesionais , Masculino , Marketing , Medidas de Resultados Relatados pelo Paciente , Induração Peniana/tratamento farmacológico , Pênis , Estudos Prospectivos , Resultado do TratamentoRESUMO
BACKGROUND: The standard therapy for women with unexplained infertility is gonadotropin or clomiphene citrate. Ovarian stimulation with letrozole has been proposed to reduce multiple gestations while maintaining live birth rates. METHODS: We enrolled couples with unexplained infertility in a multicenter, randomized trial. Ovulatory women 18 to 40 years of age with at least one patent fallopian tube were randomly assigned to ovarian stimulation (up to four cycles) with gonadotropin (301 women), clomiphene (300), or letrozole (299). The primary outcome was the rate of multiple gestations among women with clinical pregnancies. RESULTS: After treatment with gonadotropin, clomiphene, or letrozole, clinical pregnancies occurred in 35.5%, 28.3%, and 22.4% of cycles, and live birth in 32.2%, 23.3%, and 18.7%, respectively; pregnancy rates with letrozole were significantly lower than the rates with standard therapy (gonadotropin or clomiphene) (P=0.003) or gonadotropin alone (P<0.001) but not with clomiphene alone (P=0.10). Among ongoing pregnancies with fetal heart activity, the multiple gestation rate with letrozole (9 of 67 pregnancies, 13%) did not differ significantly from the rate with gonadotropin or clomiphene (42 of 192, 22%; P=0.15) or clomiphene alone (8 of 85, 9%; P=0.44) but was lower than the rate with gonadotropin alone (34 of 107, 32%; P=0.006). All multiple gestations in the clomiphene and letrozole groups were twins, whereas gonadotropin treatment resulted in 24 twin and 10 triplet gestations. There were no significant differences among groups in the frequencies of congenital anomalies or major fetal and neonatal complications. CONCLUSIONS: In women with unexplained infertility, ovarian stimulation with letrozole resulted in a significantly lower frequency of multiple gestation but also a lower frequency of live birth, as compared with gonadotropin but not as compared with clomiphene. (Funded by the National Institutes of Health and others; ClinicalTrials.gov number, NCT01044862.).
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Clomifeno/uso terapêutico , Fármacos para a Fertilidade Feminina/uso terapêutico , Gonadotropinas/uso terapêutico , Infertilidade Feminina/tratamento farmacológico , Nitrilas/uso terapêutico , Indução da Ovulação/métodos , Gravidez Múltipla/estatística & dados numéricos , Triazóis/uso terapêutico , Adolescente , Adulto , Feminino , Humanos , Letrozol , Nascido Vivo/epidemiologia , Gravidez , Taxa de Gravidez , Adulto JovemRESUMO
PURPOSE OF REVIEW: Men with spinal cord injury (SCI) commonly suffer from erectile dysfunction and ejaculatory dysfunction. The literature regarding the causes and treatment of these two important problems was reviewed. RECENT FINDINGS: Many of the erectile dysfunction treatments applied to able bodied individuals are also useful in the SCI population, although there are differences in the goals and results of treatment. Ejaculatory dysfunction can be treated with either penile vibratory stimulation or electroejaculation with high success rates. Pregnancies are possible, but poor quality sperm quality in male SCI patients leads to pregnancy rates lower than is observed in the able-bodied population. Although effective treatments are available for erectile and ejaculatory dysfunction in men with SCIs, many challenges remain in optimizing the treatment of these individuals.
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Disfunção Erétil/terapia , Infertilidade Masculina/terapia , Traumatismos da Medula Espinal/complicações , Disfunção Erétil/etiologia , Humanos , Infertilidade Masculina/etiologia , MasculinoRESUMO
BACKGROUND: Clomiphene is the current first-line infertility treatment in women with the polycystic ovary syndrome, but aromatase inhibitors, including letrozole, might result in better pregnancy outcomes. METHODS: In this double-blind, multicenter trial, we randomly assigned 750 women, in a 1:1 ratio, to receive letrozole or clomiphene for up to five treatment cycles, with visits to determine ovulation and pregnancy, followed by tracking of pregnancies. The polycystic ovary syndrome was defined according to modified Rotterdam criteria (anovulation with either hyperandrogenism or polycystic ovaries). Participants were 18 to 40 years of age, had at least one patent fallopian tube and a normal uterine cavity, and had a male partner with a sperm concentration of at least 14 million per milliliter; the women and their partners agreed to have regular intercourse with the intent of conception during the study. The primary outcome was live birth during the treatment period. RESULTS: Women who received letrozole had more cumulative live births than those who received clomiphene (103 of 374 [27.5%] vs. 72 of 376 [19.1%], P=0.007; rate ratio for live birth, 1.44; 95% confidence interval, 1.10 to 1.87) without significant differences in overall congenital anomalies, though there were four major congenital anomalies in the letrozole group versus one in the clomiphene group (P=0.65). The cumulative ovulation rate was higher with letrozole than with clomiphene (834 of 1352 treatment cycles [61.7%] vs. 688 of 1425 treatment cycles [48.3%], P<0.001). There were no significant between-group differences in pregnancy loss (49 of 154 pregnancies in the letrozole group [31.8%] and 30 of 103 pregnancies in the clomiphene group [29.1%]) or twin pregnancy (3.4% and 7.4%, respectively). Clomiphene was associated with a higher incidence of hot flushes, and letrozole was associated with higher incidences of fatigue and dizziness. Rates of other adverse events were similar in the two treatment groups. CONCLUSIONS: As compared with clomiphene, letrozole was associated with higher live-birth and ovulation rates among infertile women with the polycystic ovary syndrome. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and others; ClinicalTrials.gov number, NCT00719186.).
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Clomifeno/uso terapêutico , Fármacos para a Fertilidade Feminina/uso terapêutico , Infertilidade Feminina/tratamento farmacológico , Nitrilas/uso terapêutico , Síndrome do Ovário Policístico/complicações , Triazóis/uso terapêutico , Adulto , Clomifeno/efeitos adversos , Clomifeno/farmacologia , Método Duplo-Cego , Feminino , Fármacos para a Fertilidade Feminina/efeitos adversos , Fármacos para a Fertilidade Feminina/farmacologia , Humanos , Infertilidade Feminina/etiologia , Estimativa de Kaplan-Meier , Letrozol , Nascido Vivo , Fase Luteal , Masculino , Nitrilas/efeitos adversos , Nitrilas/farmacologia , Ovulação/efeitos dos fármacos , Gravidez , Qualidade de Vida , Triazóis/efeitos adversos , Triazóis/farmacologiaRESUMO
PURPOSE OF REVIEW: For many diseases that place a large burden on our health care system, men often have worse health outcomes than women. As the largest single provider of health care to men in the USA, the Veterans Health Administration (VA) has the potential to serve as leader in the delivery of improved men's health care to address these disparities. RECENT FINDINGS: The VA system has made recent strides in improving benefits for aspects of men's health that are traditionally poorly covered, such as treatment for male factor infertility. Despite this, review of Quality Enhancement Research Initiatives (QUERIs) within the VA system reveals few efforts to integrate disparate areas of care into a holistic men's health program. Policies to unify currently disparate aspects of men's health care will ensure that the VA remains a progressive model for other health care systems in the USA.
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Prestação Integrada de Cuidados de Saúde/normas , Serviços de Saúde/normas , Saúde do Homem/normas , Melhoria de Qualidade , United States Department of Veterans Affairs/normas , Saúde dos Veteranos/normas , Prestação Integrada de Cuidados de Saúde/economia , Serviços de Saúde/economia , Saúde Holística/economia , Saúde Holística/normas , Humanos , Masculino , Saúde do Homem/economia , Melhoria de Qualidade/economia , Estados Unidos , United States Department of Veterans Affairs/economia , Saúde dos Veteranos/economiaRESUMO
INTRODUCTION: Sildenafil has been evaluated in >16 000 men with erectile dysfunction (ED) in double-blind, placebo-controlled trials. AIM: To assess efficacy and safety of sildenafil in ED by ethnicity (white, black Asian) and age (≤45, 46-60, ≥61 years). METHODS: Data were pooled from 38 double-blind, placebo-controlled, flexible-dose trials. Most had starting sildenafil doses of 50 mg once daily, ~1 hour before sexual activity, with adjustment to 100 or 25 mg as needed. MAIN OUTCOME MEASURES: Change from baseline in International Index of Erectile Function erectile function (IIEF-EF) domain score assessed with analysis of covariance and a Global Assessment Question (GAQ; "Did the treatment improve your erections?") at endpoint assessed with logistic regression analysis. RESULTS: 4120 and 3714 men received sildenafil and placebo, respectively (2740 and 2671 White; 407 and 385 Black; 973 and 658 Asian). For sildenafil vs. placebo groups, overall treatment differences for IIEF-EF domain and GAQ were significant for each ethnic and age group (P<.0001); significant treatment-by-ethnicity and treatment-by-age interactions were also observed for change in IIEF-EF domain scores (P<.05), with differences significantly greater for White vs. Black (P<.0001), White vs. Asian (P=.0163), and Asian vs. Black (P=.0036) men. A significant treatment-by-ethnicity interaction was observed for GAQ (P=.0004). The OR comparison for GAQ was significantly greater (P=.0001) with sildenafil vs. placebo in White (OR=11.2) or Asian (OR=12.4) men vs. Black men (OR=5.1). Adverse-event rates were generally similar, with some age variations. CONCLUSIONS: Sildenafil is effective and well-tolerated regardless of ethnicity or age; however, treatment effects can vary.
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Disfunção Erétil/tratamento farmacológico , Citrato de Sildenafila/uso terapêutico , Agentes Urológicos/uso terapêutico , Adulto , Negro ou Afro-Americano , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Asiático , Esquema de Medicação , Disfunção Erétil/etnologia , Humanos , Masculino , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento , População BrancaRESUMO
OBJECTIVE: To examine the effect of penile vibratory stimulation (PVS) in the preservation and restoration of erectile function and urinary continence in conjunction with nerve-sparing radical prostatectomy (RP). PATIENTS AND METHODS: The present study was conducted between July 2010 and March 2013 as a randomized prospective trial at two university hospitals. Eligible participants were continent men with an International Index of Erectile Function-5 (IIEF-5) score of at least 18, scheduled to undergo nerve-sparing RP. Patients were randomized to a PVS group or a control group. Patients in the PVS group were instructed in using a PVS device (FERTI CARE(®) vibrator). Stimulation was performed at the frenulum once daily by the patients in their own homes for at least 1 week before surgery. After catheter removal, daily PVS was re-initiated for a period of 6 weeks. Participants were evaluated at 3, 6 and 12 months after surgery with the IIEF-5 questionnaire and questions regarding urinary bother. Patients using up to one pad daily for security reasons only were considered continent. The study was registered at http://clinicaltrials.gov/ (NCT01067261). RESULTS: Data from 68 patients were available for analyses (30 patients randomized to PVS and 38 patients randomized to the control group). The IIEF-5 score was highest in the PVS group at all time points after surgery with a median score of 18 vs 7.5 in the control group at 12 months (P = 0.09), but the difference only reached borderline significance. At 12 months, 16/30 (53%) patients in the PVS group had reached an IIEF-5 score of at least 18, while this was the case for 12/38 (32%) patients in the control group (P = 0.07). There were no significant differences in the proportions of continent patients between groups at 3, 6 or 12 months. At 12 months 90% of the PVS patients were continent, while 94.7% of the control patients were continent (P = 0.46). CONCLUSION: The present study did not document a significant effect of PVS. However, the method proved to be acceptable for most patients and there was a trend towards better erectile function with PVS. More studies are needed to explore this possible effect further.
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Disfunção Erétil/prevenção & controle , Incontinência Urinária/prevenção & controle , Idoso , Disfunção Erétil/etiologia , Humanos , Masculino , Pessoa de Meia-Idade , Prostatectomia/efeitos adversos , Prostatectomia/métodos , Recuperação de Função Fisiológica , Resultado do Tratamento , Incontinência Urinária/etiologiaRESUMO
IMPORTANCE: Advances in the treatment of childhood cancer have significantly improved survival rates, with more than 80% of survivors reaching adulthood. However, gonadotoxic cancer treatments endanger future fertility, and prepubertal males have no option to preserve fertility by sperm cryopreservation. In addition, boys with cryptorchidism are at risk of compromised fertility in adulthood. OBJECTIVE: To investigate current evidence for male fertility restoration strategies, explore barriers to clinical implementation, and outline potential steps to overcome these barriers, a scoping review was conducted. This knowledge synthesis is particularly relevant for prepubertal male cancer survivors and boys with cryptorchidism. EVIDENCE REVIEW: The review was conducted after the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews criteria and previously published guidelines and examined studies using human testis tissue of prepubertal boys or healthy male adults. A literature search in PubMed was conducted, and 72 relevant studies were identified, including in vivo and in vitro approaches. FINDINGS: In vivo strategies, such as testis tissue engraftment and spermatogonial stem cell transplantation, hold promise for promoting cell survival and differentiation. Yet, complete spermatogenesis has not been achieved. In vitro approaches focus on the generation of male germ cells from direct germ cell maturation in various culture systems, alongside human induced pluripotent stem cells and embryonic stem cells. These approaches mark significant advancements in understanding and promoting spermatogenesis, but achieving fully functional spermatozoa in vitro remains a challenge. Barriers to clinical implementation include the risk of reintroducing malignant cells and introduction of epigenetic changes. CONCLUSION: Male fertility restoration is an area in rapid development. On the basis of the reviewed studies, the most promising and advanced strategy for restoring male fertility using cryopreserved testis tissue is direct testis tissue transplantation. RELEVANCE: This review identifies persistent barriers to the clinical implementation of male fertility restoration. However, direct transplantation of frozen-thawed testis tissue remains a promising strategy that is on the verge of clinical application.
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INTRODUCTION: On June 24, 2022, the US Supreme Court issued its decision on Dobbs v Jackson Women's Health Organization (Dobbs). This decision had major implications on female reproductive choices, but also had potential implications on their male counterparts. We sought to determine the association of Dobbs with the number and characteristics of men seeking vasectomy. METHODS: A retrospective review was performed to determine the number of vasectomy consults and procedures completed at a single Michigan health system in the 6 months following Dobbs (June 24, 2022-December 24, 2022) vs the same 6-month time frame between 2019 and 2021. Another retrospective review was conducted in the 3 months following Dobbs (June 24, 2022-September 24, 2022) vs the same days in 2021 to determine the number of vasectomy consults completed and to evaluate for differences in the characteristics of these men. RESULTS: In the 6 months after Dobbs, there was a 150% and 160% increase in vasectomy consults and procedures completed, respectively, compared to a similar time frame in 2019 to 2021. In the 3 months after Dobbs, there was a 225% increase in new vasectomy consults compared to a similar time frame in 2021. There were no differences in the age, race, religion, median household income, or insurance type of men seeking vasectomy consult pre- vs post-Dobbs. Partnerless men (odds ratio 3.66) and those without children (odds ratio 2.85) were more likely than married men and those with 3 or more children, respectively, to seek vasectomy consult post-Dobbs. CONCLUSIONS: Dobbs was associated with a marked increase in vasectomy consultations and procedures at our institution in the state of Michigan. Future studies are needed to determine the long-term implications of Dobbs on vasectomy practices and determine if vasectomy practices differ by states and their respective abortion laws.
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Vasectomia , Gravidez , Criança , Humanos , Feminino , Masculino , Instalações de Saúde , Renda , Encaminhamento e Consulta , Saúde da MulherAssuntos
Fertilização in vitro , Inseminação , Contagem de Células , Feminino , Humanos , Gravidez , EspermatozoidesRESUMO
The pathophysiology of erectile dysfunction after radical prostatectomy (RP) is believed to include neuropraxia, which leads to temporarily reduced oxygenation and subsequent structural changes in penile tissue. This results in veno-occlusive dysfunction, therefore, penile rehabilitation programmes focus on tissue oxygenation. Animal studies support the use of phosphodiesterase type 5 inhibitors (PDE5Is) after cavernous nerve damage but results from human studies are contradictory. The largest study to date found no long-term effect of either daily or on-demand PDE5I administration after RP compared with placebo. The effects of prostaglandin and vacuum erection devices are questionable and high-quality studies are lacking. Better documentation for current penile rehabilitation and/or better rehabilitation protocols are needed. One must be careful not to repeat the statement that penile rehabilitation improves erectile function after RP so many times that it becomes a truth even without the proper scientific backing.
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Disfunção Erétil/etiologia , Disfunção Erétil/reabilitação , Ereção Peniana , Prostatectomia/efeitos adversos , Prostatectomia/reabilitação , Alprostadil/administração & dosagem , Animais , Ensaios Clínicos como Assunto , Disfunção Erétil/fisiopatologia , Humanos , Masculino , Inibidores da Fosfodiesterase 5/uso terapêutico , Processos Psicoterapêuticos , VácuoRESUMO
The removal of non-pathogenic foreskin from the penis of healthy neonates and infants for non-religious reasons is routinely practiced in many parts of the world. High level data from well-designed randomized controlled trials of circumcision in neonates and infants does not guide clinical practice. Reliable counts of immediate and short term circumcision complications are difficult to estimate. Emerging evidence suggests routine neonatal circumcision could lead to long term psychological, physical, and sexual complications in some men. The stigma associated with discussing circumcision complications creates a prevalence paradox where the presence of significant circumcision complications is higher than reported. Prior to the Internet, there were very few forums for men from diverse communities, who were troubled about their circumcision status, to discuss and compare stories. To investigate the long term consequences of circumcision, we reviewed 135 posts from 109 individual users participating in a circumcision grief subsection of Reddit, an internet discussion board. We identified three major categories of complications: physical such as pain during erections and lost sensitivity, psychological such as anxiety and violation of autonomy, and sexual such as feeling that the sexual experience was negatively altered or being unable to complete a sexual experience. We also identified a "discovery process" where some men described coming into awareness of their circumcision status. These findings suggest that neonatal circumcision can have significant adverse consequences for adult men. The removal of normal foreskin tissue should be limited to adult men who choose the procedure for cosmetic reasons or when medically indicated.
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Circuncisão Masculina , Pênis , Masculino , Adulto , Recém-Nascido , Humanos , Autorrelato , Pênis/cirurgia , Circuncisão Masculina/efeitos adversos , Circuncisão Masculina/métodos , Comportamento Sexual , Prepúcio do Pênis/cirurgiaRESUMO
INTRODUCTION: A single-armed, prospective, multicenter international study evaluated the redesigned Coloplast Titan One Touch Release (OTR) pump inflatable penile prosthesis. The OTR pump has a unique release valve that permits deflation of the implant with one squeeze of opposing touch pads. AIMS: To assess the impact of a new penile prosthesis design, the Titan OTR, on patient ease of operation. Furthermore, to assess patient satisfaction, surgeon acceptance, and the ease with which patients were trained in device operation in the clinic setting. METHODS: A total of 113 eligible patients from eight centers were recruited from men presenting with erectile dysfunction without prior prosthetic implantation. The subjects had a mean age of 61 years, and had a number of comorbidities, including diabetes (31.9%), hypertension (34.5%), and Peyronie's disease (23.9%). All underwent implantation of the study device. MAIN OUTCOME MEASURES: Questionnaires were used to capture patient satisfaction as well as physician feedback on ease of implantation and patient education. A paired analysis was completed for patient satisfaction at 6 (N = 96) and 12 (N = 90) months. RESULTS: Overall satisfaction with the device was 90.6% and 90.0% at 6 and 12 months, respectively. The primary end point, ease of deflation, was seen in 70.8% and 73.3% at these two time points, with the 12-month value statistically better than historical controls. Physicians overwhelmingly reported straightforward/simple intraoperative product preparation (97.3%) and equivalent or easier training compared with their previous pump of choice (96.4%). Adverse events for all subjects (N = 113) included removal of the device in four cases (3.5%) for infection and one case for chronic pain (0.8%). CONCLUSIONS: The Titan OTR represents an advance in penile prosthetic technology that is well accepted by patients and physicians. The study design allowed for realistic evaluation of the new technology aimed at enhancing clinical outcomes.
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Atitude do Pessoal de Saúde , Satisfação do Paciente , Prótese de Pênis , Competência Clínica , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Desenho de PróteseRESUMO
Background: Infertile men with non-obstructive azoospermia (NOA) have impaired spermatogenesis. Dilated and un-dilated atrophic seminiferous tubules are often present in the testes of these patients, with the highest likelihood of active spermatogenesis in the dilated tubules. Little is known about the un-dilated tubules, which in NOA patients constitute the majority. To advance therapeutic strategies for men with NOA who fail surgical sperm retrieval we aimed to characterize the spermatogonial stem cell microenvironment in atrophic un-dilated tubules. Methods: Testis biopsies approximately 3x3x3 mm3 were obtained from un-dilated areas from 34 patients. They were classified as hypospermatogenesis (HS) (n=5), maturation arrest (MA) (n=14), and Sertoli cell only (SCO) (n= 15). Testis samples from five fertile men were included as controls. Biopsies were used for histological analysis, RT-PCR analysis and immunofluorescence of germ and Sertoli cell markers. Results: Anti-Müllerian hormone mRNA and protein expression was increased in un-dilated tubules in all three NOA subtypes, compared to the control, showing an immature state of Sertoli cells (p<0.05). The GDNF mRNA expression was significantly increased in MA (P=0.0003). The BMP4 mRNA expression showed a significant increase in HS, MA, and SCO (P=0.02, P=0.0005, P=0.02, respectively). The thickness of the tubule wall was increased 2.2-fold in the SCO-NOA compared to the control (p<0.05). In germ cells, we found the DEAD-box helicase 4 (DDX4) and melanoma-associated antigen A4 (MAGE-A4) mRNA and protein expression reduced in NOA (MAGE-A: 46% decrease in HS, 53% decrease in MA, absent in SCO). In HS-NOA, the number of androgen receptor positive Sertoli cells was reduced 30% with a similar pattern in mRNA expression. The γH2AX expression was increased in SCO as compared to HS and MA. However, none of these differences reached statistical significance probably due to low number of samples. Conclusions: Sertoli cells were shown to be immature in un-dilated tubules of three NOA subtypes. The increased DNA damage in Sertoli cells and thicker tubule wall in SCO suggested a different mechanism for the absence of spermatogenesis from SCO to HS and MA. These results expand insight into the differences in un-dilated tubules from the different types of NOA patients.
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Azoospermia , Oligospermia , Azoospermia/genética , Azoospermia/patologia , Azoospermia/terapia , Humanos , Masculino , Oligospermia/genética , Oligospermia/metabolismo , RNA Mensageiro/metabolismo , Túbulos Seminíferos/metabolismo , Túbulos Seminíferos/patologia , Espermatogônias/metabolismoRESUMO
BACKGROUND: Surgical extraction of testicular spermatozoa is needed in men with nonobstructive azoospermia (NOA) who wish to become biological fathers. Based on available uncontrolled studies with unspecific patient selection, microdissection testicular sperm extraction (mTESE), having a sperm retrieval rate (SRR) of 50%, is considered the most efficient sperm retrieval procedure. However, no randomized clinical trials for comparison of different sperm retrieval procedures exist. Testicular sperm aspiration (TESA) is simple and commonly used, and we hypothesized that this technique using multiple needle passes would give similar SRRs to mTESE. OBJECTIVE: To compare mTESE and multiple needle-pass TESA in men with NOA. DESIGN, SETTING, AND PARTICIPANTS: A randomized clinical trial was performed between June 2017 and April 2021, with inclusion of 100 men with NOA from four centers in Denmark and Sweden. All participants received treatment at the same institution. INTERVENTION: Participants were randomized to mTESE (n = 49) or multiple needle-pass TESA (n = 51). Patients with failed multiple needle-pass TESA proceeded directly to salvage mTESE. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome was SRR. Secondary outcomes included complications and changes in reproductive hormones after surgery. RESULTS AND LIMITATIONS: Spermatozoa were retrieved in 21/49 (43%) men after mTESE and in 11/51 (22%) men after multiple needle-pass TESA (rate difference -0.21; 95% confidence interval -0.39 to -0.03; p = 0.02). The combined SRR for multiple needle-pass TESA + salvage mTESE was 15/51 (29%). No complications occurred after multiple needle-pass TESA only, while 5/89 (6%) men having mTESE experienced a complication requiring surgical intervention. Overall, no statistically significant differences in reproductive hormones were observed between groups after 6 mo. Limitations include the low number of patients in secondary outcome data. CONCLUSIONS: In direct comparison, SRR was higher in mTESE than in multiple needle-pass TESA. PATIENT SUMMARY: Men with azoospermia need surgical extraction of spermatozoa to become biological fathers. In this randomized trial, we compared two surgeries (microdissection testicular sperm extraction [mTESE] and testicular sperm aspiration [TESA]) and found that mTESE gives a higher sperm retrieval rate than multiple needle-pass TESA.
Assuntos
Azoospermia , Recuperação Espermática , Azoospermia/complicações , Azoospermia/cirurgia , Feminino , Hormônios , Humanos , Masculino , Microdissecção/métodos , Estudos Retrospectivos , Sêmen , Espermatozoides , Testículo/cirurgiaRESUMO
INTRODUCTION: Within a study evaluating the redesigned AMS 700MS inflatable penile prosthesis (IPP) (American Medical Systems, Minnetonka, MN, USA), one site used new length measurement technique (NLMT), a more aggressive dilation and measurement of the corpora cavernosa on a stretched penis, to address penile shortening. AIM: To compare cylinder size and patient satisfaction, between a NLMT and traditional sizing for IPP implantation. METHODS: Fourteen men received IPPs using NLMT, and 55 with traditional sizing. Nationwide sales data from 2005 to 2008 for AMS 700 IPPs was obtained from AMS for comparison; additional surveys captured patient satisfaction. MAIN OUTCOME MEASURE: Demographic data, cylinder sizes, and patient satisfaction were compared between the NLMT and standard techniques. RESULTS: The Fisher's exact test (P<0.001) showed a significant difference between the cylinder sizes with NLMT as compared with standard techniques. Of the 14 NLMT patients, 71.4% (10) received cylinders>21 cm long and 28.6% (4) received cylinders<21 cm long, as compared with 12.7% (7) and 87.3% (48), respectively, for patients implanted by traditional techniques. There were ethnic differences between the samples: 42.9% (6) NLMT patients were of African-American descent, as compared with 10.9% (6) in the standard technique group. However, longer cylinders were utilized more often, with 83.3% (5) of African-Americans treated using the NLMT; as compared with 33.3% (2) of the standard technique group. Nationwide data reveal 12.3% of patients routinely receive 21 cm cylinders. At 6 months postimplantation, patient satisfaction with NLMT was no different than standard techniques. There were no distal erosions, complications, infections, or pain concerns reported through 24 months among the NLMT patients. CONCLUSIONS: The NLMT resulted in a larger number of subjects implanted with larger cylinders. Satisfaction with performance and complication rates for NLMT patients was comparable to those implanted using standard techniques.
Assuntos
Satisfação do Paciente , Implante Peniano/métodos , Fatores Etários , Disfunção Erétil/cirurgia , Humanos , Masculino , Pessoa de Meia-Idade , Implante Peniano/instrumentação , Prótese de PênisRESUMO
Intracytoplasmic sperm injection (ICSI) has allowed reproduction options through assisted reproductive technologies (ARTs) for men with no spermatozoa within the ejaculate (azoospermia). In men with non-obstructive azoospermia (NOA), the options for spermatozoa retrieval are testicular sperm extraction (TESE), testicular sperm aspiration (TESA), or micro-surgical sperm extraction (microTESE). At the initial time of spermatozoa removal from the testis, spermatozoa are immobile. Independent of the means of spermatozoa retrieval, the subsequent steps of removing spermatozoa from seminiferous tubules, determining spermatozoa viability, identifying enough spermatozoa for oocyte injections, and isolating viable spermatozoa for injection are currently performed manually by laboratory microscopic dissection and collection. These laboratory techniques are highly labor-intensive, with yield unknown, have an unpredictable efficiency and/or success rate, and are subject to inter-laboratory personnel and intra-laboratory variability. Here, we consider the potential utility, benefits, and shortcomings of developing technologies such as motility induction/stimulants, microfluidics, dielectrophoresis, and cell sorting as andrological laboratory add-ons to reduce the technical burdens and variabilities in viable spermatozoa isolation from testicular samples in men with NOA.