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Poor Compliance With Postvasectomy Semen Testing: Analysis of Factors and Barriers
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POOR COMPLIANCE WITH POST-VASECTOMY SEMEN TESTING: ANALYSIS OF FACTORS AND BARRIERS Aaron Bradshaw , Eric Ballon-Landa , Richmond Owusu , Tung-Chin Hsieh PII: DOI: Reference:
S0090-4295(19)31026-X https://doi.org/10.1016/j.urology.2019.10.026 URL 21866
To appear in:
Urology
Received date: Revised date: Accepted date:
2 September 2019 3 October 2019 15 October 2019
Please cite this article as: Aaron Bradshaw , Eric Ballon-Landa , Richmond Owusu , Tung-Chin Hsieh , POOR COMPLIANCE WITH POST-VASECTOMY SEMEN TESTING: ANALYSIS OF FACTORS AND BARRIERS, Urology (2019), doi: https://doi.org/10.1016/j.urology.2019.10.026
This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2019 Published by Elsevier Inc.
POOR COMPLIANCE WITH POST-VASECTOMY SEMEN TESTING: ANALYSIS OF FACTORS AND BARRIERS
Aaron Bradshaw, Eric Ballon-Landa, Richmond Owusu, Tung-Chin Hsieh UC San Diego Health and VA San Diego Health Systems
*Correspondence Eric Ballon-Landa, M.D., M.P.H. Department of Urology UC San Diego Health 200 W. Arbor Drive #8897 San Diego, CA 92103-8897 Telephone: (619) 543-2009 Fax: (619) 543-6573 Mail: [email protected]
Key Words: Vasectomy, Semen Analysis, Patient Non-Compliance Abstract Word Count: 247 Manuscript Word Count: 2081
The authors have no financial acknowledgements or affiliations to disclose in relation to this manuscript.
ABSTRACT OBJECTIVES: To ensure procedure success, American Urological Association Guidelines recommend post-vasectomy semen analysis; however, current literature suggests poor compliance. We sought to measure post-vasectomy semen analysis compliance and assess barriers to completion.
METHODS: A retrospective review was performed of vasectomies at San Diego Veterans Administration Hospital and UC San Diego Health between 2006 and 2018. Patients received pre-procedural counseling regarding semen analysis necessity. Post-procedural management included follow-up visit within 2-4 weeks and semen analysis after 15-20 ejaculations. Demographics and periprocedural variables were collected. Telephone interviews assessed patient reported reasons for noncompliance. Multivariable analysis was performed for factors associated with semen analysis.
RESULTS: 503 men, mean age 38.8 years, underwent vasectomy at San Diego Veterans Administration Hospital (n=331) and UC San Diego (n=172). Overall, 80% completed clinical follow-up (n=401) and 53% completed semen analysis (n=268). The cohorts exhibited significantly different rates of semen analysis completion (46% vs 67%, p<0.001) and clinical follow-up (64% vs 85%, p=0.038). No difference was observed in age, fatherhood or marital
status. On multivariable analysis, fatherhood was the only factor associated with noncompliance of semen analysis (OR 0.52, 95% CI 0.33 – 0.83). Among men interviewed, the primary barriers to semen analysis completion were distance (38%), time constraints (34%), and forgetfulness (23%). 92% reported increased likelihood of completion with home-based semen testing.
CONCLUSIONS: Patients demonstrated poor post-vasectomy semen analysis compliance despite preprocedural counseling. Given that distance and time constraints limited compliance, incorporating home-based semen testing may improve the quality of care for men undergoing vasectomy.
Word count = 247
LEGEND: Standard abbreviation key: PVSA=Post-vasectomy semen analysis AUA=American Urological Association UCSD=University of California, San Diego Health SDVA=San Diego Veterans Administration Hospital FDA=Food and Drug Administration
INTRODUCTION: As one of few contraception options available exclusively for men, vasectomy is an option for permanent sterilization. Vasectomy is the most common non-diagnostic urologic surgery performed in the United States and is the primary form of contraception in up to 11% of married couples.1 Approximately 1% of American men age 25 to 49 years old undergo the operation yearly.2 A recent retrospective study estimated that between 514,000 and 588,000 American men underwent vasectomy yearly between 2007 and 2015.3 Vasectomy does not produce sterility in the immediate post-operative period, and may take weeks to months to do so.4 Clinical follow up with post-vasectomy semen analysis (PVSA) to ensure success is essential. Current American Urological Association (AUA) guidelines recommend a first PVSA at 8 to 16 weeks as decided by the surgeon, with repeat PVSA performed every four to six weeks until successful occlusion is established.1 Use of additional contraceptive methods is recommended until PVSA is completed and vasectomy success is confirmed. The published rates of compliance with PVSA vary widely. However, several larger studies show that approximately two-thirds of men return to perform PVSA (between 50% and 65%).1,5-7 Despite overall relatively poor compliance, formal studies which address barriers to post-vasectomy follow-up are scarce. Variations in sample patient populations, clinical practice setting and intensity of patient counseling regarding the necessity of follow-up may influence patient adherence. The Veterans Administration Health System provides care for a steadily growing number of Americans, up from 5 million in 2007 to 6 million in 2016.8 This system
represents the primary health system for many men of reproductive age, yet to our knowledge, no studies evaluating post-vasectomy follow-up have been performed in this population. Comparison of follow-up between a sample veteran population and community-based care may provide an opportunity for novel insight into follow-up barriers. The specific aims of this project are as follows: to assess the compliance rate for PVSA across different patient populations; to assess differences in follow-up patterns between veteran and non-veteran men; to determine barriers of post-vasectomy assessment; and to develop strategies to address patient barriers to follow-up.
MATERIAL AND METHODS: A retrospective chart review of University of California, San Diego Health (UCSD) and San Diego Veterans Administration Hospital (SDVA) patients undergoing vasectomy in the years 2006-2018 was performed. Demographics and periprocedural variables were collected. No exclusion criteria were implemented. Prior to vasectomy, patients received counseling regarding the need for confirmatory PVSA, which was repeated at the time of the procedure as well as at the post-operative visit both verbally and in printed handouts. Standard postprocedural management included follow-up visit within 2-4 weeks and PVSA after 15-20 ejaculations. PVSA was ordered as a walk-in order at the time of follow-up clinic visit. A semistructured telephone survey was performed of patients who did not complete PVSA to qualitatively analyze barriers to follow-up. The primary outcome was completion of postvasectomy semen analysis. Secondary outcomes included post-vasectomy clinic visit and patient reported barriers to follow-up.
Patient demographic and procedural data of the entire cohort was reported using mean or median, and standard deviation or interquartile range for continuous variables and frequency/proportions for categorical variables. A telephone survey was performed of SDVA and UCSD patients who failed to complete PVSA using a standard script. Patients were asked to rank primary and secondary factors contributing to lack of follow-up from the following list: time constraints related to sample delivery, distance to delivery site, and forgetfulness. Patients were then allowed to identify any additional barriers they considered to be a factor for noncompliance. Additionally, using a simple yes or no metric, we assessed the likelihood to followup if a semen test was available to be performed at home. Patient demographics, outcomes, and telephone survey results were analyzed using Chisquare and two-tailed T-tests as indicated. The PVSA-completing cohort and non-PVSAcompleting cohort were compared for demographics, pre-procedural and procedural variables as well as post-procedural outcomes. Main outcomes were compared between SDVA and UCSD cohorts. Telephone survey data recording barriers to follow-up was pooled across all responding patients. Cox regression multivariable analysis was performed for primary outcome. Analysis was performed using both Microsoft Excel and SPSS Statistics software programs. Calculations were made using a statistical significance level of p=0.05. All study procedures were reviewed and approved by our institutional review board.
RESULTS: 503 men, mean age 38.8 years, underwent vasectomy at SDVA (n=331) and UCSD (n=172) during the study period. (Table 1) From the entire cohort, 53% (268) completed PVSA
and 80% (401) completed a standard follow-up visit in clinic. No differences were observed between men completing PVSA and those who did not complete PVSA for mean age, marital status, fatherhood, or genital exam (unremarkable exam vs. difficult vas palpation vs. other abnormality). There were no differences noted in pre-operative platelet count or prescription of blood thinners between those completing PVSA and those who did not; however, differences were noted in these two groups with respect to ethnicity and body mass index (BMI). Men who completed PVSA had a lower mean BMI (29.4 vs. 30.6, p=0.015) and were more likely to be White or Other ethnicity (White: 65.7% vs. 61.3%; Other: 14.9% vs. 9.8%; overall p=0.006). Men completing PVSA were more likely to undergo an office-based procedure (87% vs. 80%, p=0.047) performed by an attending as the primary surgeon (43% vs 28%, p=0.001). (Table 1) No differences were observed in surgical techniques including number of incisions, ligation method, performance of electrocautery, and interposition. Following vasectomy, there was no difference in median time to follow-up visit, although men completing PVSA were more likely to attend a follow-up visit (85.8% vs. 72.8%, p<0.001). There were no noted differences in complication rates, types of complications, or pathologic findings. When comparing post-procedural outcomes between the SDVA and UCSD cohorts, significant differences were noted in both completion of post-operative follow-up visit and PVSA. (Table 2) UCSD patients had higher rates of post-operative follow-up (84.9% vs. 63.6%, p=0.038) and PVSA completion (66.9% vs. 46.2%, p<0.001). Similarly, UCSD patients were more likely to have an office-based procedure (95.9% vs. 77.6%, p<0.001) completed by an attending physician (93.6% vs. 6.0%, p<0.001). However, no difference was noted in the median time to follow-up or time to PVSA completion between these two groups.
In a multivariable analysis of factors affecting completion of PVSA, fatherhood was independently associated with decreased rate of PVSA completion (OR 0.531, p=0.007). (Table 3) BMI, ethnicity, age, marital status, and completion of post-operative follow-up visit were not associated with PVSA completion. 73 patients who failed to complete PVSA were interviewed via telephone; the survey response of rate was 31% (73/235). Of this group, 25 cited distance, 28 cited time constraints, and 17 cited forgetfulness as primary barrier to PVSA completion. 5 cited distance, 7 cited time constraints, and 9 forgetfulness as secondary barriers. Various other personal reasons were cited as responsible for lack of PVSA completion, including relocation to other cities and completion at an outside facility. No patients independently mentioned cost of PVSA testing as a significant consideration. 67 patients (91.7%) reported that they would be more likely to complete PVSA if it was possible to perform testing at home.
COMMENT: Similar to previous studies reporting PVSA compliance rate, our analysis revealed consistently low PVSA completion across different patient populations.5-7,9 Notably, SDVA patients did have significantly lower PVSA completion rates when compared to UCSD patients, as well as a lower rate of post-vasectomy follow-up. Possible factors underpinning the 20% difference in follow-up rates between SDVA and UCSD were not captured by statistical analysis as our sample size was limited. Counseling was performed in a similar manner in both sites and was repeated both verbally and in writing during multiple clinical encounters by physician and nursing staff. The difference may reflect socioeconomic or health literacy differences between
the two groups. Although more procedures at SDVA were performed in the operating room by trainees, patient counseling was the same at both sites and these peri-procedural factors likely have a limited effect on follow-up. Nevertheless, these particular differences may serve to limit the generalizability of the SDVA findings to a community-based population, and further analysis is warranted to explore how this gap may be narrowed. One clinical factor that differed between patients completing PVSA and those who did not, was the higher rate of post-operative follow-up visit (85.8% vs. 72.8%) in those who completed PVSA. Given that the SDVA cohort had lower rates of both follow-up visit and PVSA completion, it is possible that failure to attend a post-operative visit may be partially responsible for lower PVSA compliance in this patient population. No studies correlating postoperative follow-up with PVSA completion currently exist. Per AUA guidelines, men should wait 8-16 weeks until PVSA completion, potentially long after their recovery and post-operative visits have been completed.1 As increasing time passes following vasectomy, the likelihood of completing semen analysis dwindles. While not independently associated with PVSA completion on multivariable analysis, increased emphasis on post-operative patient tracking may still improve PVSA compliance. Clinicians looking to monitor PVSA completion rate may therefore implement tracking systems or automated reminders for patients calibrated around median post-operative follow-up (74 days SDVA, 86 days UCSD) to improve follow-up visit rate. Other social and logistical factors likely affect PVSA completion yet remain incompletely identified and may be more difficult for the clinician to address. Our study is unique in its attempt to assess these barriers to PVSA completion. Smucker et al performed a retrospective survey of 124 men who underwent vasectomy to better understand barriers to PVSA.10 The
authors found that greater than 50% of men agreed that the process of semen collection and delivery was inconvenient and embarrassing; however, they did not assess primary factors involved in noncompliance and found no difference in responses when stratified by PVSA completion status. Our analysis of men who did not submit PVSA found that time constraints and distance to delivery site were the primary barriers to PVSA compliance; however, fatherhood was the only factor negatively associated with compliance on multivariable analysis. Previous fatherhood likely is associated with reduced patient concern over a repeat pregnancy vs. those patients who have never before fathered children. Given that our analysis upheld previously established low rates of PVSA completion and identified barriers to completion, actions to specifically address these barriers could significantly improve the delivery of quality care. Our study findings are subject to a few limitations. First, the retrospective nature of data collection leads to the possibility of recall bias in the patient survey. Second, the nature of the telephone survey may have led to incomplete identification of all possible barriers to follow-up. Our low survey response rate also may have skewed the results, although this is in line with a modern population; perhaps additional interventions could have been undertaken to maximize our response rate.11 Although no men independently identified cost as a barrier to PVSA completion, the estimated self-pay out-of-pocket expense associated with completing PVSA is 227 dollars at UCSD (institutional financial data); this may serve as a significant barrier, particularly for uninsured individuals. However, the survey results generated an understanding of several domains in which to guide future inquiry regarding optimal follow-up practices.
The barriers to PVSA completion of distance and time can potentially be addressed with simple interventions. AUA guidelines recommend that patients submitting a semen sample from home ensure that it is examined within 2 hours of ejaculation.1 Increasing the availability of additional sample drop-off locations could decrease both travel time and distance, but would require increased facility and labor costs. Alternatively, improved availability of home-based semen testing not requiring sample delivery to drop-off locations would negate the geographical, logistical, and social concerns that limit some men from participating in test completion. Most men interviewed in our study reported that they would be more likely to have completed PVSA at home. In the last decade, meaningful strides have been taken in home-based fertility testing. The SpermCheck vasectomy test is FDA approved and currently available, with a single test being 96% specific for diagnosing sperm counts greater than 250,000 sperm/mL, and a sensitivity of 93%.12 According to published meta-analyses, azoospermia is achieved in a median of greater than 80% of patients after 3 months and 20 ejaculations, although 1.4% of patients do continue to have persistent nonmotile sperm following vasectomy. 13 While consecutive negative tests with the SpermCheck vasectomy test would indeed confer a high negative predictive value for sperm counts >250,000, this test does not screen for motility of the sperm present, and the cut off remains significantly higher than the standard 100,000 nonmotile sperm/mL used to declare sterility.1 Other studies intended for home semen analysis have been developed with the intention of determining overall viability of sperm for conception instead of absence of sperm for contraception. While there is potential for improved tests to be useful in the future, presently no home-based tests for post-vasectomy semen analysis are in
widespread use within the United States. A limiting factor for these commercially available tests includes cost; as these are more widely disseminated, the cost should decrease, while insurance approval would decrease the cost-sharing on the part of the individual as well.
CONCLUSIONS: Consistent with previously established analysis, we found that despite pre-procedural counseling both veteran and non-veteran patients had poor PVSA compliance. Given that distance and time constraints were identified as key barriers to compliance, addressing these factors has the potential to positively affect compliance rates. Future incorporation of homebased semen testing, increased locations for sample delivery, or post-vasectomy patient notifications scheduled around median times to PVSA completion may improve the quality of post-vasectomy care.
Word count = 2254
REFERENCES: 1. Sharlip ID, Belker AM, and Honig S et al. Vasectomy: AUA guideline. J Urol 2012; 188(6 Suppl): 2482-91. 2. Barone MA, Hutchinson PL, and Johnson CH et al. Vasectomy in the United States, 2002. J Urol 2006; 176(1):232–6 3. Ostrowski KA, Holt SK, and Haynes B et al. Evaluation of vasectomy trends in the USA. Urology. 2018; 118:76-79. 4. Cortes M, Flick A, and Barone MA et al. Results of a pilot study of the time to azoospermia after vasectomy in Mexico City. Contraception. 1997; 56(4): 215-22. 5. Belker AM, Sexter MS, and Sweitzer SJ et al. The high rate of noncompliance for postvasectomy semen examination: medical and legal considerations. J Urol. 1990; 144(2 Pt 1): 284-6. 6. Chawla A, Bowles B, and Zini A. Vasectomy follow-up: clinical significance of rare nonmotile sperm in postoperative semen analysis. Urology. 2004; 64(6): 1212-5. 7. Maatman TJ, Aldrin L, and Carothers GG. Patient noncompliance after vasectomy. Fertil Steril. 1997; 68(3):552-5. 8. VA Utilization Profile: FY 2016. National Center for Veterans Analysis and Statistics. United States Department of Veterans Affairs. Released November 2017. 9. Duplisea J and Whelan T. Compliance with semen analysis. J Urol. 2013; 189(6):2248-2251. 10. Smucker DR, Mayhew HE, and Nordlund DJ et al. Postvasectomy semen analysis: why patients don’t follow-up. J Am Board Fam Pract. 1991; 4:5-9. 11. Weston D, Parsons V, Ntani G, et al. Mixed Contact Methods to Improve Response to a Postal Questionnaire. Occup Med (Lond) 2017; 67:305-7. 12. Klotz KL, Coppola MA, and Labrecque M et al. Clinical and Consumer Trial Performance of a Sensitive Immunodiagnostic Home Test That Qualitatively Detects Low Concentrations of Sperm Following Vasectomy. J Urol 2008; 180: 2569. 13. Griffin T, Tooher R, and Nowakowski K et al. How little is enough? The evidence of postvasectomy testing. J Urol. 2005; 174(1):29-36.
Table 1. Patient, Procedural and Post-Procedural Characteristics Total PVSA No PVSA Characteristic (n=503) (n=268) (n=235)
p-value
Patient Characteristics Mean age (SD) Race, n (%) White Black Hispanic Other BMI (SD) Married (%) Fatherhood status (%) Blood thinners, n (%) Genital exam (n=499) Unremarkable Difficult vas palpation Other abnormality Mean pre-operative platelet count, n=332 (SD)
38.8 (7.6)
38.5 (7.4)
39.0 (8.2)
320 (63.6) 71 (14.1) 49 (9.7) 63 (12.5) 29.9 (5.7) 403 (84.8) 445 (88.5) 92 (18.6)
176 (65.7) 25 (9.3) 27 (10.1) 40 (14.9) 29.4 (5.4) 223 (86.1) 235 (88.0) 43 (16.3)
144 (61.3) 46 (19.6) 22 (9.4) 23 (9.8) 30.6 (5.9) 180 (83.3) 210 (92.5) 49 (21.1)
451 (90.4) 38 (7.6) 10 (2.0) 234.8 (51.8)
243 (91.7) 19 (7.2) 3 (1.1) 229.7 (47.1)
208 (88.9) 19 (8.1) 7 (3.0) 239.6 (55.6)
0.519 0.006
0.015 0.402 0.096 0.261 0.301
0.081
Procedural Variables Procedure location, n (%) Office Operating room Primary surgeon, n (%) Attending Resident Number of incisions, n (%) One Two Ligation, n (%) Suture Clip Both Cautery, n (%) Interposition, n (%)
0.047 422 (83.9) 81 (16.1)
233 (86.9) 35 (13.1)
189 (80.4) 46 (19.6)
180 (35.8) 333 (64.0)
115 (42.9) 152 (56.7)
65 (27.7) 170 (72.3)
0.001
0.215 10 (2.0) 489 (97.8)
3 (1.1) 262 (97.8)
7 (3.0) 227 (97.0)
53 (10.6) 436 (87.2) 11 (2.2) 421 (83.7) 4 (0.8)
22 (8.3) 238 (89.5) 6 (2.3) 223 (83.8) 3 (1.9)
31 (13.2) 198 (84.6) 5 (2.1) 198 (84.6) 1 (0.1)
0.811 0.248
401 (79.7)
230 (85.8)
171 (72.8)
<0.001
16 (7)
16 (7)
15.5 (7)
0.257
0.196
Post-Procedural Outcomes Post-operative follow-up, n (%) Time to follow-up, days (IQR)*
Complication, n (%) 23 (4.8) 14 (5.6) 9 (4.0) 0.417 Type of complication, n (%) 0.342 Infection 10 (2.0) 5 (1.9) 5 (2.1) Hematoma 11 (2.2) 8 (3.0) 3 (1.3) Orchalgia 1 (0.2) 1 (0.4) 0 (0) Pathology, n (%) 441 (87.7) 231 (86.2) 210 (89.4) 0.330 Vas lumen present, n (%) 0.697 Both present (favorable) 412 (93.4) 215 (93.1) 197 (93.8) Either left or right only 26 (5.9) 14 (6.1) 12 (5.7) No vas present 3 (0.1) 2 (0.1) 1 (0) *Median/IQR and corresponding Wilcox ranks sum used for data analysis given large variance and outliers PVSA=post-vasectomy semen analysis
Table 2. Post-Procedural Outcome Variables Stratified by Hospital System SDVA UCSD p-value (N=331) (N=172) Procedure location, n (%) <0.001 Office 257 (77.6%) 165 (95.9%) Operating Room 74 (22.4%) 7 (4.1%) Primary surgeon, n (%) <0.001 Attending 20 (6.0%) 161 (93.6%) Resident 311 (94.0%) 11 (6.4%) Post-operative follow-up, 255 (63.6%) 146 (84.9%) 0.038 n (%) Time to follow-up, days 18 (7) 15 (8) 0.189 (IQR) PVSA completion, n (%) 153 (46.2%) 115 (66.9%) <0.001 Time to PVSA, days (IQR) 74 (56) 86 (80) 0.391 SDVA = San Diego Veterans Administration Hospital UCSD = University of California, San Diego Health IQR = interquartile range PVSA = post-vasectomy semen analysis
Table 3: Cox Regression Multivariable Analysis of Factors Related to PVSA Completion Factor Odds Ratio (95% CI) p-value 0.950 BMI (increasing) 0.999 (0.975-1.024) 0.939 Race/Ethnicity: White 0.990 (0.755-1.297) Non-White (referent) 0.638 Age (increasing) 1.004 (0.988-1.020) 0.298 Marital Status Married 1.263 (0.813-1.963) Non-Married (referent) Fatherhood 0.007 Children 0.531 (0.335-0.843) No Children (referent) 0.469 Post-Op Clinic Attended Visit 1.145 (0.793-1.655) Did Not Attend (referent) PVSA = post-vasectomy semen analysis CI = confidence interval BMI = body mass index
POOR COMPLIANCE WITH POST-VASECTOMY SEMEN TESTING: ANALYSIS OF FACTORS AND BARRIERS Aaron Bradshaw , Eric Ballon-Landa , Richmond Owusu , Tung-Chin Hsieh PII: DOI: Reference:
S0090-4295(19)31026-X https://doi.org/10.1016/j.urology.2019.10.026 URL 21866
To appear in:
Urology
Received date: Revised date: Accepted date:
2 September 2019 3 October 2019 15 October 2019
Please cite this article as: Aaron Bradshaw , Eric Ballon-Landa , Richmond Owusu , Tung-Chin Hsieh , POOR COMPLIANCE WITH POST-VASECTOMY SEMEN TESTING: ANALYSIS OF FACTORS AND BARRIERS, Urology (2019), doi: https://doi.org/10.1016/j.urology.2019.10.026
This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2019 Published by Elsevier Inc.
POOR COMPLIANCE WITH POST-VASECTOMY SEMEN TESTING: ANALYSIS OF FACTORS AND BARRIERS
Aaron Bradshaw, Eric Ballon-Landa, Richmond Owusu, Tung-Chin Hsieh UC San Diego Health and VA San Diego Health Systems
*Correspondence Eric Ballon-Landa, M.D., M.P.H. Department of Urology UC San Diego Health 200 W. Arbor Drive #8897 San Diego, CA 92103-8897 Telephone: (619) 543-2009 Fax: (619) 543-6573 Mail: [email protected]
Key Words: Vasectomy, Semen Analysis, Patient Non-Compliance Abstract Word Count: 247 Manuscript Word Count: 2081
The authors have no financial acknowledgements or affiliations to disclose in relation to this manuscript.
ABSTRACT OBJECTIVES: To ensure procedure success, American Urological Association Guidelines recommend post-vasectomy semen analysis; however, current literature suggests poor compliance. We sought to measure post-vasectomy semen analysis compliance and assess barriers to completion.
METHODS: A retrospective review was performed of vasectomies at San Diego Veterans Administration Hospital and UC San Diego Health between 2006 and 2018. Patients received pre-procedural counseling regarding semen analysis necessity. Post-procedural management included follow-up visit within 2-4 weeks and semen analysis after 15-20 ejaculations. Demographics and periprocedural variables were collected. Telephone interviews assessed patient reported reasons for noncompliance. Multivariable analysis was performed for factors associated with semen analysis.
RESULTS: 503 men, mean age 38.8 years, underwent vasectomy at San Diego Veterans Administration Hospital (n=331) and UC San Diego (n=172). Overall, 80% completed clinical follow-up (n=401) and 53% completed semen analysis (n=268). The cohorts exhibited significantly different rates of semen analysis completion (46% vs 67%, p<0.001) and clinical follow-up (64% vs 85%, p=0.038). No difference was observed in age, fatherhood or marital
status. On multivariable analysis, fatherhood was the only factor associated with noncompliance of semen analysis (OR 0.52, 95% CI 0.33 – 0.83). Among men interviewed, the primary barriers to semen analysis completion were distance (38%), time constraints (34%), and forgetfulness (23%). 92% reported increased likelihood of completion with home-based semen testing.
CONCLUSIONS: Patients demonstrated poor post-vasectomy semen analysis compliance despite preprocedural counseling. Given that distance and time constraints limited compliance, incorporating home-based semen testing may improve the quality of care for men undergoing vasectomy.
Word count = 247
LEGEND: Standard abbreviation key: PVSA=Post-vasectomy semen analysis AUA=American Urological Association UCSD=University of California, San Diego Health SDVA=San Diego Veterans Administration Hospital FDA=Food and Drug Administration
INTRODUCTION: As one of few contraception options available exclusively for men, vasectomy is an option for permanent sterilization. Vasectomy is the most common non-diagnostic urologic surgery performed in the United States and is the primary form of contraception in up to 11% of married couples.1 Approximately 1% of American men age 25 to 49 years old undergo the operation yearly.2 A recent retrospective study estimated that between 514,000 and 588,000 American men underwent vasectomy yearly between 2007 and 2015.3 Vasectomy does not produce sterility in the immediate post-operative period, and may take weeks to months to do so.4 Clinical follow up with post-vasectomy semen analysis (PVSA) to ensure success is essential. Current American Urological Association (AUA) guidelines recommend a first PVSA at 8 to 16 weeks as decided by the surgeon, with repeat PVSA performed every four to six weeks until successful occlusion is established.1 Use of additional contraceptive methods is recommended until PVSA is completed and vasectomy success is confirmed. The published rates of compliance with PVSA vary widely. However, several larger studies show that approximately two-thirds of men return to perform PVSA (between 50% and 65%).1,5-7 Despite overall relatively poor compliance, formal studies which address barriers to post-vasectomy follow-up are scarce. Variations in sample patient populations, clinical practice setting and intensity of patient counseling regarding the necessity of follow-up may influence patient adherence. The Veterans Administration Health System provides care for a steadily growing number of Americans, up from 5 million in 2007 to 6 million in 2016.8 This system
represents the primary health system for many men of reproductive age, yet to our knowledge, no studies evaluating post-vasectomy follow-up have been performed in this population. Comparison of follow-up between a sample veteran population and community-based care may provide an opportunity for novel insight into follow-up barriers. The specific aims of this project are as follows: to assess the compliance rate for PVSA across different patient populations; to assess differences in follow-up patterns between veteran and non-veteran men; to determine barriers of post-vasectomy assessment; and to develop strategies to address patient barriers to follow-up.
MATERIAL AND METHODS: A retrospective chart review of University of California, San Diego Health (UCSD) and San Diego Veterans Administration Hospital (SDVA) patients undergoing vasectomy in the years 2006-2018 was performed. Demographics and periprocedural variables were collected. No exclusion criteria were implemented. Prior to vasectomy, patients received counseling regarding the need for confirmatory PVSA, which was repeated at the time of the procedure as well as at the post-operative visit both verbally and in printed handouts. Standard postprocedural management included follow-up visit within 2-4 weeks and PVSA after 15-20 ejaculations. PVSA was ordered as a walk-in order at the time of follow-up clinic visit. A semistructured telephone survey was performed of patients who did not complete PVSA to qualitatively analyze barriers to follow-up. The primary outcome was completion of postvasectomy semen analysis. Secondary outcomes included post-vasectomy clinic visit and patient reported barriers to follow-up.
Patient demographic and procedural data of the entire cohort was reported using mean or median, and standard deviation or interquartile range for continuous variables and frequency/proportions for categorical variables. A telephone survey was performed of SDVA and UCSD patients who failed to complete PVSA using a standard script. Patients were asked to rank primary and secondary factors contributing to lack of follow-up from the following list: time constraints related to sample delivery, distance to delivery site, and forgetfulness. Patients were then allowed to identify any additional barriers they considered to be a factor for noncompliance. Additionally, using a simple yes or no metric, we assessed the likelihood to followup if a semen test was available to be performed at home. Patient demographics, outcomes, and telephone survey results were analyzed using Chisquare and two-tailed T-tests as indicated. The PVSA-completing cohort and non-PVSAcompleting cohort were compared for demographics, pre-procedural and procedural variables as well as post-procedural outcomes. Main outcomes were compared between SDVA and UCSD cohorts. Telephone survey data recording barriers to follow-up was pooled across all responding patients. Cox regression multivariable analysis was performed for primary outcome. Analysis was performed using both Microsoft Excel and SPSS Statistics software programs. Calculations were made using a statistical significance level of p=0.05. All study procedures were reviewed and approved by our institutional review board.
RESULTS: 503 men, mean age 38.8 years, underwent vasectomy at SDVA (n=331) and UCSD (n=172) during the study period. (Table 1) From the entire cohort, 53% (268) completed PVSA
and 80% (401) completed a standard follow-up visit in clinic. No differences were observed between men completing PVSA and those who did not complete PVSA for mean age, marital status, fatherhood, or genital exam (unremarkable exam vs. difficult vas palpation vs. other abnormality). There were no differences noted in pre-operative platelet count or prescription of blood thinners between those completing PVSA and those who did not; however, differences were noted in these two groups with respect to ethnicity and body mass index (BMI). Men who completed PVSA had a lower mean BMI (29.4 vs. 30.6, p=0.015) and were more likely to be White or Other ethnicity (White: 65.7% vs. 61.3%; Other: 14.9% vs. 9.8%; overall p=0.006). Men completing PVSA were more likely to undergo an office-based procedure (87% vs. 80%, p=0.047) performed by an attending as the primary surgeon (43% vs 28%, p=0.001). (Table 1) No differences were observed in surgical techniques including number of incisions, ligation method, performance of electrocautery, and interposition. Following vasectomy, there was no difference in median time to follow-up visit, although men completing PVSA were more likely to attend a follow-up visit (85.8% vs. 72.8%, p<0.001). There were no noted differences in complication rates, types of complications, or pathologic findings. When comparing post-procedural outcomes between the SDVA and UCSD cohorts, significant differences were noted in both completion of post-operative follow-up visit and PVSA. (Table 2) UCSD patients had higher rates of post-operative follow-up (84.9% vs. 63.6%, p=0.038) and PVSA completion (66.9% vs. 46.2%, p<0.001). Similarly, UCSD patients were more likely to have an office-based procedure (95.9% vs. 77.6%, p<0.001) completed by an attending physician (93.6% vs. 6.0%, p<0.001). However, no difference was noted in the median time to follow-up or time to PVSA completion between these two groups.
In a multivariable analysis of factors affecting completion of PVSA, fatherhood was independently associated with decreased rate of PVSA completion (OR 0.531, p=0.007). (Table 3) BMI, ethnicity, age, marital status, and completion of post-operative follow-up visit were not associated with PVSA completion. 73 patients who failed to complete PVSA were interviewed via telephone; the survey response of rate was 31% (73/235). Of this group, 25 cited distance, 28 cited time constraints, and 17 cited forgetfulness as primary barrier to PVSA completion. 5 cited distance, 7 cited time constraints, and 9 forgetfulness as secondary barriers. Various other personal reasons were cited as responsible for lack of PVSA completion, including relocation to other cities and completion at an outside facility. No patients independently mentioned cost of PVSA testing as a significant consideration. 67 patients (91.7%) reported that they would be more likely to complete PVSA if it was possible to perform testing at home.
COMMENT: Similar to previous studies reporting PVSA compliance rate, our analysis revealed consistently low PVSA completion across different patient populations.5-7,9 Notably, SDVA patients did have significantly lower PVSA completion rates when compared to UCSD patients, as well as a lower rate of post-vasectomy follow-up. Possible factors underpinning the 20% difference in follow-up rates between SDVA and UCSD were not captured by statistical analysis as our sample size was limited. Counseling was performed in a similar manner in both sites and was repeated both verbally and in writing during multiple clinical encounters by physician and nursing staff. The difference may reflect socioeconomic or health literacy differences between
the two groups. Although more procedures at SDVA were performed in the operating room by trainees, patient counseling was the same at both sites and these peri-procedural factors likely have a limited effect on follow-up. Nevertheless, these particular differences may serve to limit the generalizability of the SDVA findings to a community-based population, and further analysis is warranted to explore how this gap may be narrowed. One clinical factor that differed between patients completing PVSA and those who did not, was the higher rate of post-operative follow-up visit (85.8% vs. 72.8%) in those who completed PVSA. Given that the SDVA cohort had lower rates of both follow-up visit and PVSA completion, it is possible that failure to attend a post-operative visit may be partially responsible for lower PVSA compliance in this patient population. No studies correlating postoperative follow-up with PVSA completion currently exist. Per AUA guidelines, men should wait 8-16 weeks until PVSA completion, potentially long after their recovery and post-operative visits have been completed.1 As increasing time passes following vasectomy, the likelihood of completing semen analysis dwindles. While not independently associated with PVSA completion on multivariable analysis, increased emphasis on post-operative patient tracking may still improve PVSA compliance. Clinicians looking to monitor PVSA completion rate may therefore implement tracking systems or automated reminders for patients calibrated around median post-operative follow-up (74 days SDVA, 86 days UCSD) to improve follow-up visit rate. Other social and logistical factors likely affect PVSA completion yet remain incompletely identified and may be more difficult for the clinician to address. Our study is unique in its attempt to assess these barriers to PVSA completion. Smucker et al performed a retrospective survey of 124 men who underwent vasectomy to better understand barriers to PVSA.10 The
authors found that greater than 50% of men agreed that the process of semen collection and delivery was inconvenient and embarrassing; however, they did not assess primary factors involved in noncompliance and found no difference in responses when stratified by PVSA completion status. Our analysis of men who did not submit PVSA found that time constraints and distance to delivery site were the primary barriers to PVSA compliance; however, fatherhood was the only factor negatively associated with compliance on multivariable analysis. Previous fatherhood likely is associated with reduced patient concern over a repeat pregnancy vs. those patients who have never before fathered children. Given that our analysis upheld previously established low rates of PVSA completion and identified barriers to completion, actions to specifically address these barriers could significantly improve the delivery of quality care. Our study findings are subject to a few limitations. First, the retrospective nature of data collection leads to the possibility of recall bias in the patient survey. Second, the nature of the telephone survey may have led to incomplete identification of all possible barriers to follow-up. Our low survey response rate also may have skewed the results, although this is in line with a modern population; perhaps additional interventions could have been undertaken to maximize our response rate.11 Although no men independently identified cost as a barrier to PVSA completion, the estimated self-pay out-of-pocket expense associated with completing PVSA is 227 dollars at UCSD (institutional financial data); this may serve as a significant barrier, particularly for uninsured individuals. However, the survey results generated an understanding of several domains in which to guide future inquiry regarding optimal follow-up practices.
The barriers to PVSA completion of distance and time can potentially be addressed with simple interventions. AUA guidelines recommend that patients submitting a semen sample from home ensure that it is examined within 2 hours of ejaculation.1 Increasing the availability of additional sample drop-off locations could decrease both travel time and distance, but would require increased facility and labor costs. Alternatively, improved availability of home-based semen testing not requiring sample delivery to drop-off locations would negate the geographical, logistical, and social concerns that limit some men from participating in test completion. Most men interviewed in our study reported that they would be more likely to have completed PVSA at home. In the last decade, meaningful strides have been taken in home-based fertility testing. The SpermCheck vasectomy test is FDA approved and currently available, with a single test being 96% specific for diagnosing sperm counts greater than 250,000 sperm/mL, and a sensitivity of 93%.12 According to published meta-analyses, azoospermia is achieved in a median of greater than 80% of patients after 3 months and 20 ejaculations, although 1.4% of patients do continue to have persistent nonmotile sperm following vasectomy. 13 While consecutive negative tests with the SpermCheck vasectomy test would indeed confer a high negative predictive value for sperm counts >250,000, this test does not screen for motility of the sperm present, and the cut off remains significantly higher than the standard 100,000 nonmotile sperm/mL used to declare sterility.1 Other studies intended for home semen analysis have been developed with the intention of determining overall viability of sperm for conception instead of absence of sperm for contraception. While there is potential for improved tests to be useful in the future, presently no home-based tests for post-vasectomy semen analysis are in
widespread use within the United States. A limiting factor for these commercially available tests includes cost; as these are more widely disseminated, the cost should decrease, while insurance approval would decrease the cost-sharing on the part of the individual as well.
CONCLUSIONS: Consistent with previously established analysis, we found that despite pre-procedural counseling both veteran and non-veteran patients had poor PVSA compliance. Given that distance and time constraints were identified as key barriers to compliance, addressing these factors has the potential to positively affect compliance rates. Future incorporation of homebased semen testing, increased locations for sample delivery, or post-vasectomy patient notifications scheduled around median times to PVSA completion may improve the quality of post-vasectomy care.
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REFERENCES: 1. Sharlip ID, Belker AM, and Honig S et al. Vasectomy: AUA guideline. J Urol 2012; 188(6 Suppl): 2482-91. 2. Barone MA, Hutchinson PL, and Johnson CH et al. Vasectomy in the United States, 2002. J Urol 2006; 176(1):232–6 3. Ostrowski KA, Holt SK, and Haynes B et al. Evaluation of vasectomy trends in the USA. Urology. 2018; 118:76-79. 4. Cortes M, Flick A, and Barone MA et al. Results of a pilot study of the time to azoospermia after vasectomy in Mexico City. Contraception. 1997; 56(4): 215-22. 5. Belker AM, Sexter MS, and Sweitzer SJ et al. The high rate of noncompliance for postvasectomy semen examination: medical and legal considerations. J Urol. 1990; 144(2 Pt 1): 284-6. 6. Chawla A, Bowles B, and Zini A. Vasectomy follow-up: clinical significance of rare nonmotile sperm in postoperative semen analysis. Urology. 2004; 64(6): 1212-5. 7. Maatman TJ, Aldrin L, and Carothers GG. Patient noncompliance after vasectomy. Fertil Steril. 1997; 68(3):552-5. 8. VA Utilization Profile: FY 2016. National Center for Veterans Analysis and Statistics. United States Department of Veterans Affairs. Released November 2017. 9. Duplisea J and Whelan T. Compliance with semen analysis. J Urol. 2013; 189(6):2248-2251. 10. Smucker DR, Mayhew HE, and Nordlund DJ et al. Postvasectomy semen analysis: why patients don’t follow-up. J Am Board Fam Pract. 1991; 4:5-9. 11. Weston D, Parsons V, Ntani G, et al. Mixed Contact Methods to Improve Response to a Postal Questionnaire. Occup Med (Lond) 2017; 67:305-7. 12. Klotz KL, Coppola MA, and Labrecque M et al. Clinical and Consumer Trial Performance of a Sensitive Immunodiagnostic Home Test That Qualitatively Detects Low Concentrations of Sperm Following Vasectomy. J Urol 2008; 180: 2569. 13. Griffin T, Tooher R, and Nowakowski K et al. How little is enough? The evidence of postvasectomy testing. J Urol. 2005; 174(1):29-36.
Table 1. Patient, Procedural and Post-Procedural Characteristics Total PVSA No PVSA Characteristic (n=503) (n=268) (n=235)
p-value
Patient Characteristics Mean age (SD) Race, n (%) White Black Hispanic Other BMI (SD) Married (%) Fatherhood status (%) Blood thinners, n (%) Genital exam (n=499) Unremarkable Difficult vas palpation Other abnormality Mean pre-operative platelet count, n=332 (SD)
38.8 (7.6)
38.5 (7.4)
39.0 (8.2)
320 (63.6) 71 (14.1) 49 (9.7) 63 (12.5) 29.9 (5.7) 403 (84.8) 445 (88.5) 92 (18.6)
176 (65.7) 25 (9.3) 27 (10.1) 40 (14.9) 29.4 (5.4) 223 (86.1) 235 (88.0) 43 (16.3)
144 (61.3) 46 (19.6) 22 (9.4) 23 (9.8) 30.6 (5.9) 180 (83.3) 210 (92.5) 49 (21.1)
451 (90.4) 38 (7.6) 10 (2.0) 234.8 (51.8)
243 (91.7) 19 (7.2) 3 (1.1) 229.7 (47.1)
208 (88.9) 19 (8.1) 7 (3.0) 239.6 (55.6)
0.519 0.006
0.015 0.402 0.096 0.261 0.301
0.081
Procedural Variables Procedure location, n (%) Office Operating room Primary surgeon, n (%) Attending Resident Number of incisions, n (%) One Two Ligation, n (%) Suture Clip Both Cautery, n (%) Interposition, n (%)
0.047 422 (83.9) 81 (16.1)
233 (86.9) 35 (13.1)
189 (80.4) 46 (19.6)
180 (35.8) 333 (64.0)
115 (42.9) 152 (56.7)
65 (27.7) 170 (72.3)
0.001
0.215 10 (2.0) 489 (97.8)
3 (1.1) 262 (97.8)
7 (3.0) 227 (97.0)
53 (10.6) 436 (87.2) 11 (2.2) 421 (83.7) 4 (0.8)
22 (8.3) 238 (89.5) 6 (2.3) 223 (83.8) 3 (1.9)
31 (13.2) 198 (84.6) 5 (2.1) 198 (84.6) 1 (0.1)
0.811 0.248
401 (79.7)
230 (85.8)
171 (72.8)
<0.001
16 (7)
16 (7)
15.5 (7)
0.257
0.196
Post-Procedural Outcomes Post-operative follow-up, n (%) Time to follow-up, days (IQR)*
Complication, n (%) 23 (4.8) 14 (5.6) 9 (4.0) 0.417 Type of complication, n (%) 0.342 Infection 10 (2.0) 5 (1.9) 5 (2.1) Hematoma 11 (2.2) 8 (3.0) 3 (1.3) Orchalgia 1 (0.2) 1 (0.4) 0 (0) Pathology, n (%) 441 (87.7) 231 (86.2) 210 (89.4) 0.330 Vas lumen present, n (%) 0.697 Both present (favorable) 412 (93.4) 215 (93.1) 197 (93.8) Either left or right only 26 (5.9) 14 (6.1) 12 (5.7) No vas present 3 (0.1) 2 (0.1) 1 (0) *Median/IQR and corresponding Wilcox ranks sum used for data analysis given large variance and outliers PVSA=post-vasectomy semen analysis
Table 2. Post-Procedural Outcome Variables Stratified by Hospital System SDVA UCSD p-value (N=331) (N=172) Procedure location, n (%) <0.001 Office 257 (77.6%) 165 (95.9%) Operating Room 74 (22.4%) 7 (4.1%) Primary surgeon, n (%) <0.001 Attending 20 (6.0%) 161 (93.6%) Resident 311 (94.0%) 11 (6.4%) Post-operative follow-up, 255 (63.6%) 146 (84.9%) 0.038 n (%) Time to follow-up, days 18 (7) 15 (8) 0.189 (IQR) PVSA completion, n (%) 153 (46.2%) 115 (66.9%) <0.001 Time to PVSA, days (IQR) 74 (56) 86 (80) 0.391 SDVA = San Diego Veterans Administration Hospital UCSD = University of California, San Diego Health IQR = interquartile range PVSA = post-vasectomy semen analysis
Table 3: Cox Regression Multivariable Analysis of Factors Related to PVSA Completion Factor Odds Ratio (95% CI) p-value 0.950 BMI (increasing) 0.999 (0.975-1.024) 0.939 Race/Ethnicity: White 0.990 (0.755-1.297) Non-White (referent) 0.638 Age (increasing) 1.004 (0.988-1.020) 0.298 Marital Status Married 1.263 (0.813-1.963) Non-Married (referent) Fatherhood 0.007 Children 0.531 (0.335-0.843) No Children (referent) 0.469 Post-Op Clinic Attended Visit 1.145 (0.793-1.655) Did Not Attend (referent) PVSA = post-vasectomy semen analysis CI = confidence interval BMI = body mass index