A prospective evaluation of the impact of scheduled follow-up appointments with compliance rates after vasectomy

Authors


J. Stephen Jones, Desk A100, 9500 Euclid Avenue, Cleveland, OH 44195, USA.
e-mail: Joness7@ccf.org

Abstract

OBJECTIVE

To prospectively determine the impact of scheduled follow-up appointments with compliance rates after vasectomy.

PATIENT AND METHODS

During a study period of 18 months, 228 consecutive men had a vasectomy, of whom 114 were instructed to bring a semen sample to the office and 114 were given a follow-up appointment to submit samples. All men were instructed to submit specimens at 2 months after vasectomy and at 1-month intervals until two consecutive samples were azoospermic. The mean (range) follow-up was 16 (6–24) months. Compliance rates for the appointment and no-appointment group were compared using a two-sided Fisher’s exact test. A subgroup analysis used a logistic regression model.

RESULTS

In the appointment group, 96/114 (84%) of patients complied with instructions to bring the first sample at 2 months, and in the no-appointment group, 74/114 (65%) complied (P = 0.001). In the appointment group, 43/114 (48%) of patients complied with instructions to provide two consecutive azoospermic specimens and in the no-appointment group, 23/114 (20%) complied (P = 0.005). A subgroup analysis of patients who provided a sample at 2 months indicated that, on adjusting for the results of the first test, patients with appointments were 1.17 times more likely to provide additional specimens than patients with no appointments. Adjusting for the type of appointment, patients who had sperm present in the first test were 6.72 times more likely to provide additional specimens than patients who were azoospermic on the first test.

CONCLUSION

Scheduling an appointment after vasectomy provides a statistically and clinically significant improvement in compliance.

INTRODUCTION

Vasectomy is a safe and reliable means of contraception that is used by 42 million couples worldwide [1]. As a part of the procedure, the patients and partners are counselled on the importance of follow-up semen analyses. At our institution, we traditionally require two consecutive azoospermic semen specimens after vasectomy before advising men that the vasectomy was successful. However, there are no standardized guidelines in the follow-up of these patients to assess the efficacy of the vasectomy [1].

In addition, recent reports indicate poor compliance in following instructions for determining sterility in this group of patients [2–4]. In the present study we aimed to determine prospectively the impact of scheduled follow-up appointments with compliance rates after vasectomy.

PATIENTS AND METHODS

We retrospectively noted that patients with a follow-up appointment were more likely to comply with instructions for follow-up after vasectomy and therefore we sought to verify this observation prospectively [5]. This study was approved by the Institutional Review Board and included 228 consecutive men who had a percutaneous no-scalpel vasectomy by one surgeon (J.S.J.) at the Cleveland Clinic during an 18-month accrual period, from March 2003 to September 2005. Of the 228 patients, 114 were instructed to bring a semen sample to the office during routine office hours, and 114 were scheduled a follow-up ‘nurse visit’ appointment to submit semen samples. Patients did not see the physician at this appointment. All patients were carefully instructed at both the preoperative assessment and at the time of vasectomy to submit two semen samples for analyses at 2 months after vasectomy and at consecutive 1-month intervals after this until two consecutive samples were azoospermic. Both groups received several identical reinforcements to promote compliance. Every patient had a consultation with the surgeon before vasectomy, consisting of a video explaining the risks, benefits, alternatives to the procedure, and the recommendation that two consecutive semen samples be analysed before considering the patient sterile. These factors were emphasized by the operating surgeon in person during the consultation, and were reiterated separately by the surgeon and the nurse, both before and after the procedure. In addition, before vasectomy, every patient was given a pamphlet explaining these recommendations, and signed a permit physically located within the pamphlet acknowledging their understanding of the importance of instructions for after vasectomy. The mean (range) follow-up was 16 (6–24) months.

The patients had a percutaneous no-scalpel bilateral vasectomy in the office, using the procedure previously published [6]. The subsequent semen samples were produced at home and all samples were examined as soon as possible, and always within 8 h. The surgeon who performed the vasectomy also analysed all semen samples after vasectomy in the office, using standard light microscopy (40 fields of uncentrifuged semen samples were investigated at × 200). There was no charge for the semen analysis, regardless of the number of analyses required to establish the success of vasectomy. The patient was informed of the semen analysis results by telephone or in writing, and further instructions and counselling were given at that time. Once the patient had achieved two consecutive negative semen analyses 1 month apart, he was informed that the vasectomy was successful in achieving sterility. Until that confirmation, he was instructed to use alternative contraception and to return in a month with another specimen. The follow-up recommendations remained consistent based on the group, i.e. patients initially scheduled to have appointments received scheduled repeat appointments, and those recommended to deliver a specimen at the office were recommended to leave a repeat specimen with no scheduled appointment.

To compare the compliance rates at 2 months after vasectomy between those patients who had an appointment and those who did not, the proportion of patients who provided a specimen at 2 months after vasectomy in each group was compared using a Fisher’s exact test and a significance level of 0.05. This test was also used to compare the two group rates of those complying with instructions to provide two consecutive azoospermic semen specimens within 6 months of the vasectomy. For both tests, a conditional maximum likelihood estimate of the odds ratio and 95% CI were also calculated, to describe the odds of compliance in the appointment group vs those in the no-appointment group. For those patients who submitted a sample at 2 months, a logistic regression model was used to estimate the effect of appointment type and the result of the first test on the presence of a second specimen at 3 months. Adjusted odds ratios, 95% CI and the associated P values are also given.

RESULTS

A semen analysis was requested at 2 and 3 months after vasectomy in all 228 patients. The charts of these men were reviewed to determine patient compliance in following the instructions; the results are summarized in Table 1. In the appointment group, 96/114 (84%) patients complied with instructions to bring the first sample 2 months after vasectomy, while in the no-appointment group, 74/114 (65%) complied. A comparison of these two rates using Fisher’s exact test gave P = 0.001, indicating strong evidence of a difference in compliance rates between the groups.

Table 1. 
The presence/absence of a first specimen, of a first and second specimen, and of the second specimen by the result from the first test and type of follow-up
Type of follow-up and testSpecimen, n/N (%)
PresentAbsent
First
 appointment96/114 (84)18/114 (16)
 no-appointment74/114 (65)40/114 (35)
First and second
 appointment43/114 (38)71/114 (62)
 no-appointment23/114 (20)91/114 (80)
Result from first test on specimen status at 2nd follow-up
Azoospermic
 appointment35/70 (50)35/70 (50)
 no-appointment28/50 (56)22/50 (44)
Presence of sperm
 appointment26/26 (100) 0/26
 no-appointment18/24 (75) 6/24 (25)

The conditional maximum likelihood estimate (95% CI) of the odds ratio indicated 2.87 (1.47–5.78) times greater odds of patients who had an appointment providing a specimen at 2 months than those with no appointment. Similarly, 43/114 (38%) patients in the appointment group complied with instructions to provide two consecutive azoospermic semen specimens, while in the other group, 23/114 (20%) patients complied. Fisher’s test again gave strong evidence of a difference in compliance rates between the groups (P = 0.005). The conditional maximum likelihood estimate of the odds ratio indicated 2.39 (1.27–4.56) times greater odds of patients who had an appointment providing two consecutive azoospermic semen specimens within 6 months than in the other group.

Table 1 also shows that of the 96 patients in the appointment group who provided a specimen at 2 months, 70 (73%) were azoospermic and 26 (27%) had semen containing sperm. All the latter 26 patients provided a specimen at 3 months, whereas 35 (50%) of the azoospermic patients provided a specimen at 3 months (Table 1). However, of the 74 patients in the no-appointment group who provided a specimen at 2 months, 50 (68%) were azoospermic and 24 (32%) had semen containing sperm. Only 18 patients (75%) with semen containing sperm provided a specimen at 3 months, whereas 28 (38%) of the azoospermic patients provided a specimen at 3 months (Table 1). No pregnancy was reported in the sexual partners of men in either group.

To determine if the compliance rates for obtaining a second specimen at 3 months differed between the groups, while adjusting for the results of the first test, a subgroup analysis of the data in Table 1 was done using a logistic regression model with two covariates, i.e. the presence/absence of sperm in the first test and presence/absence of an appointment. No interaction between these two covariates could be estimated due to incomplete data. On adjusting for the results of the first test, patients in the appointment group were 1.17 (0.60–2.29) times more likely to provide a specimen at 3 months than patients in the no-appointment group, indicating that no evidence of a difference in compliance rates between the groups on adjusting for the results of the first test (P = 0.64). Alternatively, adjusting for the type of appointment, patients who had sperm present in the first test were 6.72 (2.66–16.98) times more likely to provide a specimen at 3 months than patients who were azoospermic on the first test, indicating strong evidence of a difference in compliance rates between those patients who are azoospermic and those who have sperm present on their first test, on adjusting for the type of appointment the patient had (P < 0.001).

DISCUSSION

Semen analysis after vasectomy is critical to establish the success of vasectomy as a sterilization procedure. We traditionally require two consecutive azoospermic semen specimens 1 month apart before advising men that the vasectomy was successful. Studies show that up to 90% of urologists require two semen samples routinely, and that up to 95% request further semen samples if non-motile sperm were present [1] However, many patients fail to follow the instructions after vasectomy to obtain a semen analysis, and in one study, only 21% followed recommendations to have two consecutive azoospermic readings [4]. The reasons for the poor compliance are unknown and therefore adequate counselling before vasectomy is essential [4]. Smucker et al.[7] surveyed 141 patients after vasectomy because of concern about their poor response rate for semen analysis, where 29% returned one specimen, 26% returned two or more after surgery, and 45% had returned no specimens. These authors reported that 58% of patients did not return a specimen due to inconvenience, 38% through embarrassment, 29% had confidence in their sterility, 17% forgot and 4% were afraid of repeat surgery [7]. There are many other theoretical reasons why men do not return for follow-up semen analysis, such as a fear of the results of semen analyses and that the semen analyses are lost or mishandled [3].

Many patients are not aware that numerous ejaculations are required to clear the system of sperm cells, and therefore it is important for the physician to take the time to clearly explain the importance of the follow-up protocol for determining sterility [3]. If this is done, we think that the patient and the surgeon share the responsibility for determining sterility.

The present study determined the degree of patient compliance with semen analysis after vasectomy for those asked to deliver a semen sample with no appointment vs those who were provided with an appointment. The addition of an appointment improves patient compliance with the first specimen, and almost doubles the compliance with recommendations for a second specimen. Patients provided with a follow-up appointment were more likely to submit initial semen specimens (84% vs 65%, P = 0.001). These patients were almost twice as likely to provide two consecutive azoospermic semen specimens (38% vs 20%, P = 0.005). In addition, all patients with appointments who had evidence of sperm in their samples at 2 months provided a specimen at 3 months, whereas only 75% of such patients with no appointment provided additional specimens. This difference in rates was not statistically significant after adjusting for the results of the first test (P = 0.64). However, despite scheduled appointments, only 38% of such patients complied with instructions to provide two consecutive azoospermic semen specimens.

Our poor compliance rates suggest that our previous conclusion of insisting on two consecutive azoospermic semen analyses might present an unreasonable goal of follow-up [4]. The initial non-compliance rate (those returning no samples) of 16% and 35% was similar to rates of 24–36% reported previously [2,8,9]. However, non-compliance rates increased to 62% and 80% when based on the failure to produce two consecutive azoospermic specimens. Similarly, Maatman et al.[3] reported a non-compliance rate of 73% when based on failure to produce two consecutive azoospermic specimens one month apart.

Despite finding that the scheduled appointment improved the compliance rates, an unacceptable proportion of the present patients failed to comply. In addition, although the appointment improves the follow-up, it does not adequately improve the likelihood of receiving a second specimen at 3 months once a patient learns that the first specimen at 2 months was azoospermic. Based on these factors and the findings of our earlier report, we conclude that it is both unnecessary and unreasonable to require two consecutive semen analyses. Therefore, we currently recommend one semen analysis 3 months after vasectomy, and as long as there are no sperm or three or fewer immotile sperm, we inform the patient that the vasectomy has been successful. Although we do not routinely require that the specimen reach the laboratory immediately after ejaculation, we acknowledge that examination within 1 h of ejaculation might be more likely to ensure that immotile sperm indeed confirm that no live sperm persist. We also inform the patient that he must be aware of occasional reports of late re-canalization, such that sterility can be predicted with a high degree of accuracy, but can never be assumed to be 100%.

In conclusion, the simple measure of scheduling a follow-up appointment provided at the time of vasectomy significantly improves the compliance with which patients provide the first vasectomy semen specimen after vasectomy, in addition to the compliance of patients providing two consecutive azoospermic semen specimens. However, it does not adequately increase the likelihood of a patient providing a second specimen at 3 months once he has learned that the first specimen at 2 months was azoospermic. Recommendations for two consecutive negative semen analyses before assuring sterility are almost uniformly ignored, despite aggressive and redundant counselling to the contrary. In addition, there is no evidence that two consecutive specimens are superior to one specimen for predicting long-term sterility. Therefore, we recommend scheduling an appointment 3 months after vasectomy, and this is our current practice. Further efforts to increase compliance with instructions are needed.

CONFLICT OF INTEREST

None declared.

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