Keywords
Male Sterilization, Surgical Procedure, Vasectomy, Family Planning Services, Developing Countries, Practice Guideline, Quality of Health Care, Guideline Adherence
This article is included in the International Conference on Family Planning gateway.
Male Sterilization, Surgical Procedure, Vasectomy, Family Planning Services, Developing Countries, Practice Guideline, Quality of Health Care, Guideline Adherence
Vasectomy is generally regarded as a simple, safe, very effective, and highly cost-effective contraceptive method. In the early 2000s, randomized trials1,2, comparative studies3–5, systematic reviews6,7 and expert consultations8 showed that specific surgical techniques are associated with better safety and effectiveness of the procedure. More recently published North American and European practice guidelines on vasectomy based their recommendations on these findings9–12.
Although the uptake of vasectomy is low in most low-resource countries, some have active vasectomy programs13. The objectives of this study were to determine 1) what vasectomy surgical techniques are recommended in evidence-based practice guidelines to reduce surgical complications (bleeding and infections) and to maximize occlusion and contraceptive effectiveness, and 2) if these techniques are integrated in the vasectomy norms and standards, and current practice of targeted low-resource countries.
The recommended techniques of the two surgical steps of the vasectomy procedure (isolation/exposition and occlusion of the vas deferens) were extracted by the author from the following vasectomy practice guidelines: the European Association of Urology (2012)9, American Urological Association (2012, 2015)10, the Faculty of Sexual & Reproductive Healthcare (FSRH) of United Kingdom (2104)11, and the Canadian Urological Association (2016)12. The level of evidence, strength of recommendation and the most relevant underlying evidence from systematic reviews supporting the recommendations was also extracted.
A convenience sample of eight low-resource countries from Africa, Asia and America known by the author to provide vasectomy services on different scales was selected. India, Nepal, Mexico, and Colombia (through Profamilia, a non-profit non-governmental organisation) have large and structured vasectomy programs with thousands of men vasectomized each year while private or governmental smaller scale initiatives exist in Kenya, Rwanda, Honduras and Haiti.
For each country, the most recent document describing vasectomy techniques that should be used (national standards/norms) and/or that are performed was first identified through personal contact with individuals from or acquainted with vasectomy in selected countries. In addition, in order to validate the currency of documents retrieved, a Google search was performed twice, in spring 2018 and April 2019, using the name of the country, “vasectomy” or “male sterilization”, and key words from the title of documents already identified. No date limits were imposed. The retrieved Google search pages were scanned until no more related documents were found. PubMed or Google Scholar search was not performed because, as expected, none of the relevant documents initially retrieved was published as peer-reviewed article.
The surgical techniques recommended and/or commonly performed to isolate/expose (classic technique with a scalpel, NSV) and to occlude the vas (simple LE, LE+FI, cautery) in the selected countries were extracted from the retrieved documents. Additional information on the surgical techniques commonly performed as obtained by personal contact with key informants was also reported. Guideline recommendations were compared to and contextualized with vasectomy techniques performed in the selected countries.
Excerpts of recommendations from the four practice guidelines are presented in Table 1. Although the assessment of the evidence and the strength of the recommendations vary across the four guidelines, they all agree that a minimally invasive (MIV) technique including the no-scalpel technique (known as the no-scalpel vasectomy (NSV)) should be perform to isolate and expose the vas deferens. The criteria of a MIV technique are: 1) a skin opening of ≤10 mm, 2) minimal dissection of the vas and perivasal tissues, and 3) no use of skin sutures10. Among the MIV techniques, NSV is the most studied. Two systematic reviews concluded that NSV - based on high-quality evidence - is significantly associated with a lower risk of surgical complications, namely bleeding and/or hematomas6,7.
Guideline | Excerpts of recommendations | LE | SR |
---|---|---|---|
Vas isolation | |||
EAU9 | The no-scalpel vasectomy technique of isolation of the vas deferens is associated with fewer early complications, such as infections, haematomas, and less postoperative pain. | - | - |
AUA10 | Isolation of the vas should be performed using a minimally-invasive vasectomy (MIV) technique such as the no-scalpel vasectomy (NSV) technique or other MIV technique. | B* | S* |
FSRH11 | A minimally invasive approach should be used to expose and isolate the vas deferens during vasectomy, as this approach results in fewer early complications in comparison to other methods. | A† | R† |
CUA12 | NSV is associated with a significantly lower risk of postoperative complications (hematoma, pain, infection) than conventional vasectomy. | A-B‡ | R‡ |
Vas occlusion | |||
EAU9 | Early recanalisation can be decreased by cautery (with either thermal or electrocautery devices) of the vas deferens and by fascial interposition. | 1a§ | A§ |
AUA10 | The ends of the vas should be occluded by one of three divisional methods: Mucosal cautery (MC) with fascial interposition (FI) and without ligatures or clips applied on the vas; MC without FI and without ligatures or clips applied on the vas; Open ended vasectomy leaving the testicular end of the vas unoccluded, using MC on the abdominal end and FI; or by the non-divisional method of extended electrocautery. | C* | R* |
FSRH11 | Cauterisation followed by division of the vas deferens, with or without excision, is associated with the lowest likelihood of early recanalisation (failure) when compared to other occlusion techniques. Division of the vas on its own is not an acceptable technique because of the associated failure rate. It should be accompanied by diathermy or ligation and fascial interposition. | A† | R† |
CUA12 | Fascial interposition during vasectomy is associated with a significantly higher rate of azoospermia at three months than no interposition. Cautery of the vas is associated with a lower risk of failure (defined as >100 000/ml sperm in the ejaculate) than fascial interposition. | B‡ | R‡ |
*AUA nomenclature: Grade A - high quality evidence: well-conducted randomized clinical trials (RCTs); exceptionally strong observational studies; Grade B - moderate quality evidence: RCTs with some weaknesses; generally strong observational studies; Grade C - low quality evidence: observational studies that provide conflicting information or design problems (such as very small sample size); Standards are directive statements that an action should (benefits outweigh risks/burdens) or should not (risks/burdens outweigh benefits) be undertaken based on Grade A or Grade B evidence. Recommendations are directive statements that an action should (benefits outweigh risks/burdens) or should not (risks/burdens outweigh benefits) be undertaken based on Grade C evidence.
†FSRH nomenclature: Grade A - Evidence based on randomised controlled trials; no strength of recommendations specified.
‡CUA nomenclature: Grade A - Based on clinical studies of good quality and consistency with at least one randomized trial; Grade B - Based on well-designed studies (prospective, cohort), but without good randomized clinical trials; Grade C - Based on poorer quality studies (retrospective, case series, expert opinion).
§EAU nomenclature: Grade 1a - Evidence obtained from meta-analysis of randomised trials; Recommendation A - Based on clinical studies of good quality and consistency addressing the specific recommendations and including at least one randomised trial.
EAU, European Association of Urology; AUA, American Urological Association; FSRH, Faculty of Sexual & Reproductive Healthcare; CUA, Canadian Urological Association: LE, Level of evidence; SR, Strength of recommendation.
The guidelines also all agree that cautery of the mucosa of the vas lumen, preferably combined with interposing the fascia between the divided ends of the vas (fascial interposition (FI)), should be used to occlude the vas. Moderate-quality evidence from cohort studies showed that the “classical” ligation and excision (LE) technique consisting in putting two ligatures on the vas deferens and excising a small (1 cm) vas segment in between is associated with a high risk of occlusion failure based on post-vasectomy semen analysis, from 8 to 13%2,3,14–16, and contraceptive failure, from 4% after 3 years to 9% after 10 years17–19. Although a high-quality randomized trial2 demonstrated that LE combined with FI on the testicular end can reduce the risk of failure by 50%, occlusion failure rate remained high at 5.9% (95% confidence interval 3.8% to 8.6%). Moderate quality evidence based on comparative cohort studies showed that combining cautery of the mucosa of the vas with either electro- or thermal-cautery, preferably combined with FI, is associated with the lowest risk of occlusion failure (<1%)10,11.
National standards and practices in targeted low-resource countries are described in Table 2 All countries selected have national standards/norms20–27; editions range from 2009 to 2018 (Table 2).
The NSV is the preferred recommended technique to expose the vas in all eight countries. Only three countries, Kenya20, India22, and Haiti27, mention that the “classic” technique, requiring a larger opening of the scrotal skin with a scalpel, is still acceptable.
Countries with large vasectomy programs are in italics.
Country | Vas isolation | Vas occlusion | |||
---|---|---|---|---|---|
Classic | NSV | LE | LE+FI | Cautery | |
Kenya 200920 | S | S | S | P* | |
Rwanda 201521 | S | S | S | ||
India 201322 | S | S | S | S | |
Nepal 201023 | S | S | S | ||
Mexico 200924 | S | S | |||
Honduras 201025 | S | S | |||
Colombia 201826 | S | S | S | ||
Haiti 200927 | S | S | P* |
The most commonly vas occlusion technique recommended in the national standards is the LE combined with FI. Documents from India22 and Nepal23 mention that simple LE is also acceptable, Kenya only name LE20, and Haiti do not mention any occlusion technique27. The use of cautery is limited to four countries: Kenya, Rwanda, Haiti, and Colombia. Haiti and Kenya benefit from the support of No-Scalpel Vasectomy International (NSVI), a non-governmental organisation promoting and providing free NSV services in low-resource countries. In these two countries most vasectomies are done through NSVI. Thermal cautery, using a low-cost portable thermal cautery unit, combined with FI28 is the vas occlusion technique recommended by NSVI (personal communication with Dr. Doug Stein, President of NSVI). In Rwanda, mucosal cautery of the vas combined with FI28 has been successfully introduced in 201029 and is now recommended to be used for occluding the vas21. Profamilia in Colombia has recently introduced thermal cautery combined with FI28 as one of their recommended techniques, in addition to LE+FI26. They aim to train all urologists from their family planning clinic network over year 2019 (personal communication with Dr. Diana Torres, chief urologist at Profamilia). Colombia is then the only one of the four large vasectomy programs to recommend using cautery (Table 2).
Creating and sustaining successful vasectomy programs in low-resource countries is challenging. Demand for vasectomy, access to services, and enabling environment must all be mutually reinforced13. Skillful vasectomy providers performing best practice surgical techniques is an essential component contributing to the success of vasectomy programs in countries where acceptance of vasectomy is low, follow-up of patients for complications is difficult, and access to post-vasectomy semen analysis to confirm success (or failure) of the procedure is not available.
On one hand, as recommended in the evidence-based vasectomy guidelines, NSV is uniformly adopted in the selected low-resource countries for isolating the vas deferens, minimizing the risk of bleeding and infection. On the other hand, cautery, which is recommended for occluding the vas in the guidelines, is seldom encountered in the targeted countries. In these countries, the most common standard for occluding the vas is LE+FI.
Although no vasectomy occlusion technique has been shown to be superior in term of contraceptive effectiveness in comparative trials9, research evidence support the adoption of cautery over LE+FI for occluding the vas in low-resource settings4,5,30. Occlusion failure risks of 2.1%31 2.5%32, 2.6%33, 5.9%2 and 7.6%34 have been reported for the LE+FI technique; these are much higher than the higher acceptable risk of occlusion failure of vasectomy, which is 1%10. In addition, even if FI is recommended to be combined with LE to decrease failure rate, it may not be commonly performed. In 2004, it was estimated that more than 95%, 97%, and 99% of vasectomies were done with simple LE without FI in India, Nepal, and Bangladesh despite country standards35. If no FI is added to LE, the occlusive failure risk is even higher and contraceptive failure may parallel occlusion failure. In a cohort of 1263 men from rural Nepal who had a vasectomy mostly performed by simple LE, 2.3% still had 500,000 sperm/ml or more in their semen 1 to 3 years after the procedure and the pregnancy rate reported was 4.2% after 3 years17. Finally, modelling the cost per couple-years of protection of LE, LE+FI, cautery, and cautery + FI in India, Kenya, and Mexico showed that cautery-based techniques are the most cost-effective methods36.
This study has two main limitations. First, the sample of this convenience sample of eight countries is small. They were purposely chosen however to illustrate the situation in large and small vasectomy programs located on three continents. Second, some of the documents reviewed may be outdated. It is very only recently that Profamilia in Colombia updated their standards to include cautery combined with FI as the preferred occlusion technique of the vas26. To the author’s knowledge, Haiti, Nepal, and Mexico are currently updating their male sterilization norms and standards. A future assessment of the norms and standards of the targeted countries and other low-resource countries with active vasectomy program may yield different results.
In conclusion, in low-resource countries NSV is largely adopted for vas isolation in accordance with evidence-based guidelines but recommended techniques for vas occlusion are not. Providing the most effective vasectomy surgical techniques increase users’ confidence and satisfaction regarding male sterilization13 and may lead to higher acceptability and increase uptake.
All data underlying the results are available as part of the article and no additional source data are required.
This study was funded by the Bill & Melinda Gates Foundation [OPP1181398] and The Michel-Labrecque Fund for Male Reproductive Health from the Laval University Fondation.
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Is the work clearly and accurately presented and does it cite the current literature?
Partly
Is the study design appropriate and is the work technically sound?
Yes
Are sufficient details of methods and analysis provided to allow replication by others?
Yes
If applicable, is the statistical analysis and its interpretation appropriate?
Yes
Are all the source data underlying the results available to ensure full reproducibility?
Partly
Are the conclusions drawn adequately supported by the results?
Partly
References
1. Seamans Y, Harner-Jay CM: Modelling cost-effectiveness of different vasectomy methods in India, Kenya, and Mexico.Cost Eff Resour Alloc. 2007; 5: 8 PubMed Abstract | Publisher Full TextCompeting Interests: No competing interests were disclosed.
Reviewer Expertise: Board Certified by American Board of Urology/American Urologic Association
Is the work clearly and accurately presented and does it cite the current literature?
Yes
Is the study design appropriate and is the work technically sound?
Yes
Are sufficient details of methods and analysis provided to allow replication by others?
Yes
If applicable, is the statistical analysis and its interpretation appropriate?
Not applicable
Are all the source data underlying the results available to ensure full reproducibility?
Yes
Are the conclusions drawn adequately supported by the results?
Yes
Competing Interests: No competing interests were disclosed.
Reviewer Expertise: I am a Professor of Urology and Reproductive Medicine in Research at Weill Cornell Medicine of Cornell University, I am an expert in no-scalpel vasectomy. Working with Dr. Marc Goldstein at Cornell, I played a key role in bringing the no-scalpel vasectomy to North America. I authored/co-authored a number of articles, videos and instructive surgical manuals on the no-scalpel vasectomy.
Is the work clearly and accurately presented and does it cite the current literature?
Yes
Is the study design appropriate and is the work technically sound?
Yes
Are sufficient details of methods and analysis provided to allow replication by others?
Yes
If applicable, is the statistical analysis and its interpretation appropriate?
Not applicable
Are all the source data underlying the results available to ensure full reproducibility?
Yes
Are the conclusions drawn adequately supported by the results?
Yes
Competing Interests: I worked with Michel Labrecque on several studies about 10 to 15 years ago and we became and remain friends. A more recent connection is being co-authors on a letter to the editor in 2015. I do not believe that this affects my ability to objectively review this article.
Reviewer Expertise: Before retiring from FHI 360, I spent approximately 10 years working on clinical studies of vasectomy techniques, and authored / co-authored a number of papers on this subject.
Alongside their report, reviewers assign a status to the article:
Invited Reviewers | |||
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