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Biomedical subjects

Mark A Barone

Publications and source records attributed to Mark A Barone.

11 recordsLinked to original sources

Frequency and patterns of early recanalization after vasectomy.

BACKGROUND: Our understanding of early post-vasectomy recanalization is limited to histopathological studies. The objective of this study was to estimate the frequency and to describe semen analysis patterns of early recanalization after vasectomy. METHODS: Charts displaying serial post-vasectomy semen analyses were created using the semen analysis results from 826 and 389 men participating in a randomized trial of fascial interposition (FI) and an observational study of cautery, respectively. In the FI trial, participants were randomly allocated to vas occlusion by ligation and excision with or without FI. In the cautery study, sites used their usual cautery occlusion technique, two with and two without FI. Presumed early recanalization was based on the assessment of individual semen analysis charts by three independent reviewers. Discrepancies were resolved by consensus. RESULTS: Presumed early recanalization was characterized by a very low sperm concentration within two weeks after vasectomy followed by return to large numbers of sperm over the next few weeks. The overall proportion of men with presumed early recanalization was 13% (95% CI 12%-15%). The risk was highest with ligation and excision without FI (25%) and lowest for thermal cautery with FI (0%). The highest proportion of presumed early recanalization was observed among men classified as vasectomy failures. CONCLUSION: Early recanalization, occurring within the first weeks after vasectomy, is more common than generally recognized. Its frequency depends on the occlusion technique performed.

Follow-Up Studies↗

Vasectomy in the United States, 2002.

PURPOSE: We estimated the number of vasectomies performed in the United States in 2002 and gathered information on the vasectomy procedures and protocols used. It follows similar studies done in 1991 and 1995. MATERIALS AND METHODS: A retrospective mail survey with telephone followup was performed in 2,300 urologists, family physicians and general surgeons randomly sampled from the American Medical Association Physician Masterfile. RESULTS: The response rate was 73.8%. An estimated 526,501 vasectomies were performed in 2002 for a rate of 10.2/1,000 men 25 to 49 years old. Overall 37.8% of physicians reported currently using no scalpel vasectomy and almost half of the vasectomies performed in 2002 were no scalpel vasectomies. Methods of vas occlusion varied in and among specialties with a combination of ligation and cautery being most common (41.0% of cases). Of the physicians 45.6% reported routinely performing fascial interposition, 94.4% reported removing a vas segment, 23.3% reported routinely folding back 1 or 2 ends of the vas and 7.5% reported using open-ended vasectomy. Followup protocols varied widely. Of respondents 53.5% reported charging $401 to $600 for vasectomy in 2002. CONCLUSIONS: Although the estimated number of vasectomies performed in the United States during 2002 represents an increase from 1991 and 1995, incidence rates remained unchanged at approximately 10/1,000 men 25 to 49 years old. The percent of vasectomies performed using no scalpel vasectomy as well as the number of physicians who reported that they use no scalpel vasectomy increased substantially since 1995. Wide variation in surgical techniques and followup protocols were found.

Adult↗

A comparison of vas occlusion techniques: cautery more effective than ligation and excision with fascial interposition.

BACKGROUND: Vasectomy techniques have been the subject of relatively few rigorous studies. The objective of this analysis was to compare the effectiveness of two techniques for vas occlusion: intraluminal cautery versus ligation and excision with fascial interposition. More specifically, we aimed to compare early failure rates, sperm concentrations, and time to success between the two techniques. METHODS: We compared semen analysis data from men following vasectomy using two occlusion techniques. Data on intraluminal cautery came from a prospective observational study conducted at four sites. Data on ligation and excision with fascial interposition came from a multicenter randomized controlled trial that evaluated the efficacy of ligation and excision with versus without fascial interposition. The surgical techniques used in the fascial interposition study were standardized. The surgeons in the cautery study used their customary techniques, which varied among sites in terms of type of cautery, use of fascial interposition, excision of a short segment of the vas, and use of an open-ended technique. Men in both studies had semen analyses two weeks after vasectomy and then approximately every four weeks. The two outcome measures for the analyses presented here are (a) time to success, defined as severe oligozoospermia, or <100,000 sperm/mL in two consecutive semen analyses; and (b) early vasectomy failure, defined as >10 million sperm/mL at week 12 or later. RESULTS: Vasectomy with cautery was associated with a significantly more rapid progression to severe oligozoospermia and with significantly fewer early failures (1% versus 5%). CONCLUSION: The use of cautery improves vasectomy outcomes. Limitations of this comparison include (a) the variety of surgical techniques in the cautery study and differences in methods of fascial interposition between the two studies, (b) the uncertain correlation between sperm concentrations after vasectomy and the risk of pregnancy, and (c) the use of historical controls and different study sites.

Cautery↗

Effectiveness of vasectomy using cautery.

BACKGROUND: Little evidence supports the use of any one vas occlusion method. Data from a number of studies now suggest that there are differences in effectiveness among different occlusion methods. The main objectives of this study were to estimate the effectiveness of vasectomy by cautery and to describe the trends in sperm counts after cautery vasectomy. Other objectives were to estimate time and number of ejaculations to success and to determine the predictive value of success at 12 weeks for final status at 24 weeks. METHODS: A prospective, non-comparative observational study was conducted between November 2001 and June 2002 at 4 centers in Brazil, Canada, the UK, and the US. Four hundred men who chose vasectomy were enrolled and followed for 6 months. Sites used their usual cautery vasectomy technique. Earlier and more frequent than normal semen analyses (2, 5, 8, 12, 16, 20, and 24 weeks after vasectomy) were performed. Planned outcomes included effectiveness (early failure based on semen analysis), trends in sperm counts, time and number of ejaculations to success, predictive value of success at 12 weeks for the outcome at 24 weeks, and safety evaluation. RESULTS: A total of 364 (91%) participants completed follow-up. The overall failure rate based on semen analysis was 0.8% (95% confidence interval 0.2, 2.3). By 12 weeks 96.4% of participants showed azoospermia or severe oligozoospermia (< 100,000 sperm/mL). The predictive value of a single severely oligozoospermia sample at 12 weeks for vasectomy success at the end of the study was 99.7%. One serious unrelated adverse event and no pregnancies were reported. CONCLUSION: Cautery is a very effective method for occluding the vas. Failure based on semen analysis is rare. In settings where semen analysis is not practical, using 12 weeks as a guideline for when men can rely on their vasectomy should lessen the risk of failure compared to using a guideline of 20 ejaculations after vasectomy.

Adult↗

Vasectomy surgical techniques: a systematic review.

BACKGROUND: A wide variety of surgical techniques are used to perform vasectomy. The purpose of this systematic review was to assess if any surgical techniques to isolate or occlude the vas are associated with better outcomes in terms of occlusive and contraceptive effectiveness, and complications. METHODS: We searched MEDLINE (1966-June 2003), EMBASE (1980-June 2003), reference lists of retrieved articles, urology textbooks, and our own files looking for studies comparing two or more vasectomy surgical techniques and reporting on effectiveness and complications. From 2,058 titles or abstracts, two independent reviewers identified 224 as potentially relevant. Full reports of 219 articles were retrieved and final selection was made by the same two independent reviewers using the same criteria as for the initial selection. Discrepancies were resolved by involving a third reviewer. Data were extracted and methodological quality of selected studies was assessed by two independent reviewers. Studies were divided in broad categories (isolation, occlusion, and combined isolation and occlusion techniques) and sub-categories of specific surgical techniques performed. Qualitative analyses and syntheses were done. RESULTS: Of 31 comparative studies (37 articles), only four were randomized clinical trials, most studies were observational and retrospective. Overall methodological quality was low. From nine studies on vas isolation, there is good evidence that the no-scalpel vasectomy approach decreases the risk of surgical complications, namely hematoma/bleeding and infection, compared with incisional techniques. Five comparative studies including one high quality randomized clinical trial provided good evidence that fascial interposition (FI) increases the occlusive effectiveness of ligation and excision. Results of 11 comparative studies suggest that FI with cautery of the vas lumen provides the highest level of occlusive effectiveness, even when leaving the testicular end open. Otherwise, firm evidence to support any occlusion technique in terms of increased effectiveness or decreased risk of complications is lacking. CONCLUSIONS: Current evidence supports no-scalpel vasectomy as the safest surgical approach to isolate the vas when performing vasectomy. Adding FI increases effectiveness beyond ligation and excision alone. Occlusive effectiveness appears to be further improved by combining FI with cautery. Methodologically sound prospective controlled studies should be conducted to evaluate specific occlusion techniques further.

Humans↗

Vasectomy by ligation and excision, with or without fascial interposition: a randomized controlled trial [ISRCTN77781689].

BACKGROUND: Randomized controlled trials comparing different vasectomy occlusion techniques are lacking. Thus, this multicenter randomized trial was conducted to compare the probability of the success of ligation and excision vasectomy with, versus without, fascial interposition (i.e. placing a layer of the vas sheath between two cut ends of the vas). METHODS: The trial was conducted between December 1999 and June 2002 with a single planned interim analysis. Men requesting vasectomies at eight outpatient clinics in seven countries in North America, Latin America, and Asia were included in the study. The men were randomized to receive vasectomy with versus without fascial interposition. All surgeons performed the vasectomies using the no-scalpel approach to the vas. Participants had a semen analysis two weeks after vasectomy and then every four weeks up to 34 weeks. The primary outcome measure was time to azoospermia. Additional outcome measures were time to severe oligozoospermia (<100 000 sperm/mL) and vasectomy failure based on semen analyses. RESULTS: We halted recruitment after the planned interim analysis, when 841 men had been enrolled. Fascial interposition decreased time to azoospermia (hazard ratio [HR], 1.35; P < 0.0001) and time to severe oligozoospermia (HR, 1.32; P < 0.0001) and reduced failures based on semen analysis by about half, from 12.7% (95% confidence interval [CI], 9.7 to 16.3) to 5.9% (95% CI, 3.8 to 8.6) (P < 0.0001). Older men benefited less from fascial interposition than younger men in terms of the speed of achieving azoospermia. However, the number of vasectomy failures was reduced to a similar degree in all age groups. Slightly more adverse events occurred in the fascial interposition group, but the difference was not significant. These failure rates may appear high to practitioners in countries such as the USA, but they are similar to results from other careful studies of ligation and excision techniques. CONCLUSION: Fascial interposition significantly improves vasectomy success when ligation and excision is the method of vas occlusion. A limitation of this study is that the correlation between postvasectomy sperm concentrations and risk of pregnancy is not well quantified.

Adult↗

Intravaginal practices, HIV and other sexually transmitted diseases among South African women.

BACKGROUND AND OBJECTIVES: Intravaginal practices, including wiping, douching, or inserting substances into the vagina, have been hypothesized to increase women's risk of HIV infection. However, data on the prevalence of these practices, and associations with HIV and other sexually transmitted diseases (STD), are limited. STUDY DESIGN: We interviewed 2,897 women participating in a gynecologic screening study in Cape Town, South Africa, about their intravaginal practices. After clinical examination, cervical and blood samples were collected and tested for HIV and other STD [corrected]. RESULTS: Of the 831 (29%) women reporting some type of intravaginal practice, 48% reported using only water and cloth to clean inside the vagina, whereas 17% reported using antiseptics or detergents. Most women (53%) reported practices as part of regular hygiene. Intravaginal practices were strongly associated with behavioral risk factors, and recent multiple sexual partners [corrected]. Intravaginal practices were associated with prevalent HIV infection (adjusted odds ratio, 1.74; 95% confidence interval, 1.37-2.20), but were not associated with other STDs. CONCLUSION: Prospective studies that include detailed measurements of correlated sexual risk behaviors are required to discern whether this association is causal in nature; if so, these behaviors could represent an important area for future HIV prevention interventions.

Adult↗

A prospective study of time and number of ejaculations to azoospermia after vasectomy by ligation and excision.

PURPOSE: We obtained detailed information on the time and number of ejaculations to azoospermia after vasectomy by ligation and excision. MATERIALS AND METHODS: Men seeking vasectomy at 3 public clinics in Mexico City were invited to participate in this prospective noncomparative study. Vasectomy was performed using the no-scalpel technique. The vas was occluded using 2 silk sutures and the segment of vas between the ligatures was excised. Men were followed biweekly up to 24 weeks after vasectomy or until azoospermia was confirmed. Semen was examined at each visit for sperm concentration and motility. The main outcome measure was azoospermia in uncentrifuged semen samples. RESULTS: The life table rate for time to azoospermia was 81.5/100 men (95% CI 76.2 to 86.9) by the end of the study. Cumulative Kaplan-Meier event probability attained a maximum of 79.5/100 men (95% CI 73.7 to 85.2) at 70 ejaculations. Only 60/100 and 27.9/100 men were azoospermic by 12 weeks and 20 ejaculations, respectively. These end points are the commonly recommended waiting periods when semen analysis is unavailable. Of the 217 men 36 (16.6%) did not achieve azoospermia by 24 weeks, of whom 25 (11.5% of all participants) were considered to have vasectomy failure. CONCLUSIONS: Our results suggest that it is not possible to develop guidelines for clearance based only on the time or number of ejaculations when ligation and excision are performed. In addition, of the methods for vas occlusion during vasectomy ligation and excision may not provide the best success rates.

Adult↗

Characteristics of men receiving vasectomies in the United States, 1998-1999.

CONTEXT: Even though vasectomy is a popular method of contraception in the United States, there is limited information on the characteristics of men choosing vasectomy and why they decide to undergo the procedure. METHODS: A nationwide, practice-based survey of 719 men receiving vasectomies was conducted between July 1998 and June 1999. RESULTS: Low-income, minority and less educated men were underrepresented among vasectomy recipients. The majority of men were married or cohabiting (91%), non-Hispanic and white (87%), and educated beyond high school (81%). Only 7% of men had annual household incomes of less than $25,000, and fewer than 1% paid for the procedure using public funding; 81% of respondents paid through private insurance or a health maintenance organization. Half of men reported choosing vasectomy over a reversible method because it is the most secure means of preventing pregnancy, and 62% chose vasectomy over tubal ligation because the procedure is simpler and safer. Doctors and nurses were the most important sources of information about vasectomy (cited by 31% of respondents), followed by wives or partners (25%) and friends (23%). CONCLUSIONS: Despite the diversity of the U.S. population, vasectomy recipients are a homogeneous group. By identifying users of vasectomy and underserved groups, our findings should assist service providers and program managers in planning strategies to reduce the large difference in levels of vasectomy use among men of different races, ethnicities and income groups.

Adult↗