Efficacy of Vasectomy Reversal According to Patency for The

Home , Orchiectomy, Vasectomy reversal, Vasoepididymostomy, Vasovasostomy

ORIGINAL ARTICLE Efﬁcacy of vasectomy reversal according to patency for the surgical treatment of postvasectomy pain syndrome

JY Lee1, JS Chang1, SH Lee1, WS Ham1, HJ Cho2,TKYoo2, KS Lee3, TH Kim3, HS Moon4, HY Choi4 and SW Lee4

This study was conducted to assess outcomes (according to patency) of vasectomy reversal (VR) in qualified patients with postvasectomy pain syndrome (PVPS). A total of 32 patients with PVPS undergoing VR between January 2000 and May 2010 were examined retrospectively. Of these, 68.8% (22/32) completed a study questionnaire, either onsite at the outpatient clinic or via telephone interview. Preoperative clinical findings, preoperative and postoperative visual analogue scale (VAS) pain scores, patency and pregnancy rate and overall patient satisfaction were analyzed. For the latter, a four-point rating of (1) cure, (2) improvement, (3) no change or (4) recurrence was used. The mean age was 45.09±4.42 years and the mean period of follow-up was 3.22 years (0.74--7.41). Patency rates were 68.2% (15/22) and pregnancy rates were 36.4% (8/22). The mean VAS was 6.64±1.00 preoperatively and 1.14±0.71 postoperatively (Po0.001). The difference in the mean preoperative and postoperative VAS was 6.00±1.25 (4--8) in the patency group and 4.43±0.98 (3--6) in the no patency group (P ¼ 0.011). A significant difference in procedural satisfaction with surgical outcome was observed between patency and no patency groups (P ¼ 0.014). In conclusion, in PVPS patients requiring VR, a significant difference was observed between the patency and no patency groups in terms of pain reduction and the degree of patient procedural satisfaction.

International Journal of Impotence Research (2012) 24, 202--205; doi:10.1038/ijir.2012.17; published online 24 May 2012 Keywords: pelvic pain; treatment outcome; vasectomy; vasovasostomy

INTRODUCTION compare results of VR and assess procedural satisfaction in An estimated 40--60 million men worldwide have undergone patients stratified by patency. vasectomy, accounting for 5--10% of birth control methods currently in use.1 When a government-backed family planning project launched in 1960, the rate of vasectomy in Korea climbed. PATIENTS AND METHODS More than 100 000 fertile men had opted for this procedure by the Retrospectively, we examined patients electing VR for fertility recovery, early 1980s. However, the number of procedures has gradually performed at one of four medical institutions between January 2000 decreased since the 1990s due to changing government policy and May 2010. Patients selected for study had experienced chronic 2 and the introduction of multiple-birth family planning. epididymal pain of 43-months duration, without response to a Chronic scrotal pain following vasectomy, by definition, is conservative approach (nonsteroidal antiinflammatory drugs, tramadol, 3 persistent (either intermittent or constant) and ranges from a self- opioid, lidocaine injection, and so on) for a minimum of 3 weeks after initial limiting affliction to one that requires medical or surgical outpatient contact. The study was approved from the Ethical Review 4 intervention. First-line treatment typically entails reassurance, Committee of the hospital. scrotal support, nonsteroidal antiinflammatory drugs and nonsurgical interventions, such as local injection with lidocaine. Patients failing conservative management may turn to surgical Surgical procedure options, including testicular-sparing therapies such as spermatic A total of 331 patients underwent vasovasostomy in the specified study cord denervation (SCD), removal of sperm granuloma, epididy- period who wished to primarily recover fertility underwent VR during the mectomy and vasectomy reversal (VR)---vasovasostomy and study period. Of these, 32 (9.7%) complained of chronic scrotal pain vasoepididymostomy, or orchiectomy.5 Over the past 40 years, adjacent to epididymis on physical examination. Our postoperative research into the scope of postvasectomy chronic scrotal pain has questionnaire was completed by 68.8% (22/32) of the latter group. One increased. Alternative terms for this syndrome include congestive patient had bilateral PVPS. epididymitis,6 postvasectomy orchalgia7 and late postvasectomy Under general or spinal anesthesia, the seminal tubule was first exposed syndrome.8 More recently, the term postvasectomy pain syn- and fixed with towel clips. The vas deferens was then located and the drome (PVPS) was introduced.9 Few studies have explored vasectomy nodule dissected. Upon visualizing the lumen of the vas, its outcomes of VR, as a function of patency, for PVPS refractory to proximal and distal ends were approximated. Given detectable vasal conservative measures. The aim of this study therefore was to fluid (17 patients), bilateral modified single-layer vasovasostomy was

1Department of Urology, Urological Science Institute, Yonsei University College of Medicine, Seoul, Korea; 2Department of Urology, Eulji Hospital, Eulji University School of Medicine, Seoul, Korea; 3Department of Urology, Dong-A University College of Medicine, Busan, Korea and 4Department of Urology, Hanyang University College of Medicine, Seoul, Korea. Correspondence: Professor SW Lee, Department of Urology, Hanyang University Guri Hospital, Hanyang University College of Medicine, 153 Gyeongchun-ro, Guri 471-701, Korea. E-mail: [email protected] Received 1 August 2011; revised 5 March 2012; accepted 12 April 2012; published online 24 May 2012 Efficacy of VR for treatment of PVPS JY Lee et al 203 undertaken via microscope. If the fluid was thick, pasty and devoid of (P ¼ 0.620). In patency and no-patency groups, the mean period of sperm under a light microscope, a vasoepididymostomy was performed. postvasectomy was 9.60±2.10 years and 14.28±3.35 years, Vasoepididymostomy was otherwise performed for the remaining five respectively (P ¼ 0.006). Baseline characteristics of the study patients with no observable vasal fluid. Bilateral vasoepididymostomy was population are shown in Table 1. performed in two patients and unilateral vasoepididymosotomy and Overall, the mean preoperative and postoperative VAS scores contralateral vasovasostomy were performed in three patients. were 6.64±1.00 and 1.14±0.71, respectively (Po0.001). The mean preoperative VAS score was 6.87±0.99 (5--8) in the patency Statistical analysis group and 6.14±0.90 (5--7) for those with no-patency (P ¼ 0.133); postoperatively mean VAS scores were 0.87±0.64 (0--2) and In the study population, the following analyses were conducted: (i) the 1.71±0.49 (1--2), respectively (P 0.008). The mean change in the duration of preoperative pain, (ii) preoperative physical signs, (iii) ¼ preoperative and postoperative VAS scores was 6.00±1.25 (3--6) preoperative and postoperative visual analogue scale (VAS) pain scores, with patency and 4.43±0.98 (4--8) without patency (P 0.011). (iv) patency and pregnancy rate and (v) patient satisfaction. Outpatient ¼ Statistical significance of the preoperative and postoperative VAS clinic attendees were asked to complete a written questionnaire based on scores and of the difference in the preoperative and postoperative VAS, while those not attending could respond by phone using a verbal scores is shown in Table 1. numeric rating scale (VNRS) pain score. The severity of pain was rated Overall surgical outcomes were as follows: (i) cured, 15 patients using a scale of 0--10, with 0 indicating pain-free status and 10 (68.2%); (ii) improved, 7 patients (31.8%); (iii) no change, none representing the worst pain imaginable. A VNRS and VAS were considered (0%); and (iv) recurrence, none (0%). In the patency group, 13 equivalent. As with prior studies, surgical outcomes were rated as cure, 10--12 patients (86.7%) were reported as cured and 2 patients (13.3%) as improvement, no change or recurrence. improved, while in the no-patency group, 2 patients (28.6%) were Mann--Whitney U-test was used for age, duration of pain, mean period designated cured and 5 (71.4%) as improved. The difference in of outpatient follow-up and VAS score analyses, while treatment outcome treatment outcomes of the two groups was statistically significant was assessed with Fisher’s exact test. All statistical data relied on Open s (P 0.014; Figure 1). Of the five patients undergoing vasoepidi- Office.org Calc (Open Office.org version 3.2.0, Oracle, Redwood Shores, ¼ s dymostomy, three responded as ‘cured’ and three as ‘improved’ CA, USA) and MedCalc (MedCalc version 11.2.1.0, MedCalc Software, according to survey. Mariakerke, Belgium). A P-value of o0.05 was considered statistically significant.

RESULTS A total of 32 patients underwent VR for PVPS. Of these, 22 (68.8%) completed the study questionnaire either at the outpatient clinic (n ¼ 8) or during a telephone interview (n ¼ 14), including one respondent with bilateral PVPS. Mean age of the patient sampling was 45.09±4.42 years. The mean duration of pain was 5.18±2.02 years, while the mean period of follow-up was 3.32 years (0.74-- 7.41). The mean period of postvasectomy was 11.09±3.34 years. Analysis of semen from men achieving vasal patency was performed at month 6 after surgery, showing sperm concentra- tions of 20.1 million mlÀ1 (8.0--32.0 million mlÀ1) and sperm motilities of 35.7% (15--80%). Patency rates were 68.2% (15 out of 22) and pregnancy rates were 36.4% (8 out of 22). In the patency group (n ¼ 15), mean age was 43.80±4.20 years, while without patency (n ¼ 7), mean age was 47.86±3.76 years (P ¼ 0.033). The difference in the mean duration of pain between patency and no-patency groups was 4.80±2.21 and 5.42±1.29 Figure 1. Comparision of surgical treatment outcome according years, respectively (P ¼ 0.185), with a mean follow-up times to patency in patients with postvasectomy pain syndrome who of 3.45 years (0.74--6.48) and 3.04 years (1.68--7.41), respectively underwent vasectomy reversal.

Table 1. Characteristics of the postvasectomy pain syndrome patients and comparison of pain scale ratings in the postvasectomy pain syndrome stratiﬁed by patency

Total Patency group No patency group P-value

No. of cases 22 15 7

Age (years) 45.09±4.42 43.80±4.20 47.86±3.76 0.033

Period of vasectomy (year) 11.09±3.34 9.60±2.10 14.28±3.35 0.006

Duration of pain (years) 5.18±2.02 4.80±2.21 5.42±1.29 0.185

Duration of follow-up (years) 3.32 (0.74-7.41) 3.04 (0.74--6.48) 0.620 (1.68--7.41) 3.45

Preoperative VAS±s.d. 6.64±1.00 (4-8) 6.87±0.99 (5-8) 6.14±0.90 (5-7) 0.133 Postoperative VAS±s.d. 1.14±0.71 (3-8) 0.87±0.64 (0-2) 1.71±0.49 (1-2) 0.008 Difference VAS±s.d. 5.50±1.37 (3-8) 6.00±1.25 (3-6) 4.43±0.98 (4-8) 0.011 Abbreviation: VAS, visual analogue scale.

& 2012 Macmillan Publishers Limited International Journal of Impotence Research (2012), 202 -- 205 Efficacy of VR for treatment of PVPS JY Lee et al 204 DISCUSSION Epididymectomy is another surgical option for PVPS. Lee et al.19 The incidence of major postvasectomy complications is estimated recently reported epididymectomy outcomes in patients with at 2--3%,13 with bleeding, hematoma, superficial infection and PVPS, chronic epididymitis and painful epididymal cysts, conclud- wound separation constituting potential problems early on. PVPS, ing that it is an effective treatment for all three conditions. Hori as one form of chronic scrotal pain, is the most common late et al.20 also studied long-term results after epididymectomy for complication of vasectomy14 and may affect up to 30% of cases. PVPS.20 Of 45 patients, 42 (93.3%) were pain-free postoperatively Long-term pain, often in the epididymal region and warranting and were pleased with the results. Siu et al.21 likewise claimed surgical treatment, occurs in B0.1% of patients.3,15 100% patient satisfaction in 25 patients with PVPS undergoing The fact that PVPS typically involves areas of the genital tract epididymectomy. Furthermore, Sweeney et al.22 reported a adjacent to the vasectomy site has generated at least two satisfaction level of 87.5% with this technique, recording best pathophysiologic hypotheses. The first theory cites dilatation and overall outcomes in the PVPS group, while Chen and Ball23 obstruction of the epididymal duct, triggering interstitial fibrosis, indicated that 5 of 10 patients with PVPS (50%) were pain-free as the basis of PVPS. The other proposed mechanism is that after epididymectomy. In spite of these successes, epididymect- perineural fibrosis develops following rupture of the epididymal omy with PVPS remains controversial. Sweeney et al.24 found that duct, accompanied by extravasation of sperm near epididymal in a larger study group (n ¼ 34), only 5 of 17 patients with PVPS tubule and the vasal transection site.3 If correct, areas adjacent to (29%) responded favorably after epididymectomy. vas deferens should show histopathological evidence of vasitis Although reports are fewer than with VR or epididymectomy, and epididymitis nodosa. Although sperm granulomas (inherently and larger patient samplings are needed, SCD has been used fibrotic) may be formed in roughly 70% of all vasectomy cases, alternatively for PVPS. Heidenreich et al.25 reported outcomes they are mostly asymptomatic. Furthermore, above changes are of SCD for six patients with PVPS. The procedure involved widely reported in patients requiring no specific treatment.16 coagulation (bipolar diathermy) and transection in areas adjacent Testicular-sparing procedures commonly used for PVPS include to testicular artery, vas deferens and one or two lymphatic vasovasostomy and vasoepididymostomy, epididymectomy and vessels. All PVPS patients were pain-free postoperatively, as were SCD. However, these treatments have not been fully investigated, those evaluated in similar studies by Devine et al.26 and Levine and existing data are from small patient cohorts. Myers et al.17 et al.27 When Cadeddu et al.28 performed laparoscopic testicular performed microsurgical vasovasostomy or vasoepididymostomy denervation in six patients with PVPS, the postoperative pain-free in 32 patients with PVPS, all of whom presented with a unilateral rate was again 100%. or bilateral testicular pain exacerbated by sexual arousal, All 22 respondents undergoing VR for PVPS in this study intercourse or ejaculation. Most of them (75%) reported complete achieved statistically significant reductions in pain and were postoperative pain relief for a mean follow-up of 2.4 years, while satisfied with their treatment outcomes. Our results paralleled pain persisted or recurred for the remaining eight patients. Nangia other recent studies of VR and were comparable with outcomes et al.15 also performed vasovasostomy in 13 patients with PVPS, all following alternative testicular-sparing therapies such as epididy- of whom had failed prior nonsurgical intervention. A multilayer mectomy or SCD (Table 2). On the other hand, a significant microsurgical anastomosis technique was used. Nine of these difference in pain reduction, as measured by the VAS pain scores, patients were pain-free postoperatively, while four experienced was observed when patients with and without patency were partial pain relief. More recently, Huang et al.18 performed compared. Patency may, in fact, correlate with patient age, microsurgical vasovasostomy in four patients, three of whom postvasectomy duration, postoperative pain reduction and patient were pain-free postoperatively; but there have been no studies on procedural satisfaction. VR with patency may thus be more the efficacy of VR according to patency rate, raising the question effective in reducing pain in patients with PVPS, compared with of a selection bias when interpreting results. To our knowledge, loss of patency. Consequently, optimal use of VR may be younger this study is the first to examine patency in conjunction with PVPS patients of shorter postvasectomy status who wish to efficacy of VR in patients with PVPS. recover fertility.

Table 2. Comparison of results of postoperative outcome for vasectomy reversal, epididymectomy and spermatic cord denervation in previous studies of postvasectomy pain syndrome

Total no. Satisfaction Dissatisfaction References Surgical treatment of patients Mean Follow-up (years) orpain free ornopain relief

Present study Microsurgical vasovasostomy or vasoepididymostomy 22 3.3 22 0 Myers et al.17 Microsurgical vasovasostomy or vasoepididymostomy 32 2.4 24 8 Nangia et al.15 Microsurgical vasovasostomy 13 1.6 13a 0 Huang et al.18 Microsurgical vasovasostomy 4 Unknown 3 1 Lee et al.19 Epididymectomy 18 4.2 17 1 Hori et al.20 Epididymectomy 45 7.4 42 3 Sweeney et al.24 Epididymectomy 17 1.5 5 12 Siu et al.21 Epididymectomy 25 3.8 25 0 West et al.10 Epididymectomy 12 5.5 9 3 Sweeney et al.22 Epididymectomy 8 2.9 7 1 Chen et al.23 Epididymectomy 10 0.25 5 5 Selikowitz et al.8 Epididymectomy 20 Unknown 19 1 Devine et al.26 Spermatic cord denervation 2 Unknown 2 0 Levine et al.27 Spermatic cord denervation 7 1.4 7 0 Heidenreich et al.25 Spermatic cord denervation 6 2.83 6 0 Cadeddu et al.28 Laparoscopic testicular denervation 6 Unknown 6 0

aNine patients were pain-free and four patients experienced partial pain relief.

International Journal of Impotence Research (2012), 202 -- 205 & 2012 Macmillan Publishers Limited Efficacy of VR for treatment of PVPS JY Lee et al 205 A limitation of this study is that it was conducted retro- 5 Ahmed I, Rasheed S, White C, Shaikh NA. The incidence of post-vasectomy spectively, leaving room for recall and selection bias. All of the chronic testicular pain and the role of nerve stripping (denervation) of the patients primarily wanted recovery of fertility, so that issues of spermatic cord in its management. Br J Urol 1997; 79: 269--270. patency may have overshadowed other factors. In addition, there 6 Schmidt SS, Free MJ. The bipolar needle for vasectomy. I. Experience with the first is the possibility of placebo effect, and with all questionnaire- 1,000 cases. Fertil Steril 1978; 29: 676--680. based studies, it is possible that remarks of patients responding by 7 Shapiro EI, Silber SJ. Open-ended vasectomy, sperm granuloma, and postvasectomy orchialgia. Fertil Steril 1979; 32: 546--550. phone may have taken a more positive turn. Intraoperative vasal 8 Selikowitz SM, Schned AR. A late post-vasectomy syndrome. J Urol 1985; 134: fluid detection and postoperative recovery of fertility may also 494--497. have had some bearing on surgical outcome and patient 9 Christiansen CG, Sandlow JI. Testicular pain following vasectomy: a review of satisfaction. Although VAS is generally regarded as a valid and postvasectomy pain syndrome. J Androl 2003; 24: 293--295. reliable tool for chronic pain measurement,29 these scores could 10 West AF, Leung HY, Powell PH. Epididymectomy is an effective treatment for conceivably reflect long-term memory or other inaccuracies, and scrotal pain after vasectomy. BJU Int 2000; 85: 1097--1099. correlation between VNRS and VAS has been imperfect in previous 11 Padmore DE, Norman RW, Millard OH. Analyses of indications for and outcomes of studies.30 Results of patency may influence VAS. A cognitive epididymectomy. J Urol 1996; 156: 95--96. assessment such as a pain score may be highly influenced by 12 Calleary JG, Masood J, Hill JT. Chronic epididymitis: is epididymectomy a valid surgical treatment? Int J Androl 2009; 32: 468--472. other cognitive factors. Correlation between patency and scrotal 13 McCormack M, Lapointe S. Physiologic consequences and complications of pain might be resulted in bias. It is also the limitation of our study. vasectomy. CMAJ 1988; 138: 223--225. In addition, low patency rate of our patients should be 14 Choe JM, Kirkemo AK. Questionnaire-based outcomes study of nononcological contemplated in PVPS patients. Reason for low patency in PVPS post-vasectomy complications. J Urol 1996; 155: 1284--1286. will be turn out to be a scientific value using histological 15 Nangia AK, Myles JL, Thomas AJ. Vasectomy reversal for the post-vasectomy pain methodology or large-scale prospective study. syndrome: a clinical and histological evaluation. J Urol 2000; 164: 1939--1942. Despite these limitations, this study is the first to attempt 16 Easley S, MacLennan GT. Vasitis and epididymitis nodosa. J Urol 2006; 175: 1502. comparison of postoperative VR efficacy, stratified by patency, in 17 Myers SA, Mershon CE, Fuchs EF. Vasectomy reversal for treatment of the post- patients with PVPS. Duration of follow-up was longer and patient vasectomy pain syndrome. J Urol 1997; 157: 518--520. 18 Huang HC, Hsieh ML, Huang ST, Tsui KH, Lai RH, Chang PL. Microsurgical cohort was larger than in any previous studies of VR. As such, vasectomy reversal: ten-years0 experience in a single institute. Chang Gung Med further prospective analysis of various surgical treatments in J 2002; 25: 453--457. patients with PVPS is justified. 19 Lee JY, Lee TY, Park HY, Choi HY, Yoo TK, Moon HS et al. Efficacy of epididymectomy in treatment of chronic epididymal pain: a comparison of patients with and without a history of vasectomy. Urology 2011; 77: 177--182. 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& 2012 Macmillan Publishers Limited International Journal of Impotence Research (2012), 202 -- 205