*Number of Subjects Analysed/Total Number of Subjects Enrolled in the Study

Table 15. Characteristics of studies comparing vas occlusion techniques with and without fascial interposition

Authors Type of Study Subject’s Eligibility Criteria Sample Size* Setting Study Period Interventions Type and Number and Year of of Surgeons Publication Isolation Occlusion Method Method Schmidt 1973 Case series with Unspecified No FI: 150 Office, Between 1955 and 1961 Two lateral No FI: Double ligation with One urologist [20] historical openings cotton each end + Excision controls FI: 135 USA (10 mm) FI: Same + FI with suture (prostatic end) Rhodes et al. Case series with Unspecified No FI: 28 Unspecified, Unspecified Two lateral No FI: Vas transected Unspecified historical openings 1980 [46] controls FI: 12 USA FI: Same + FI with suture (end?) Li et al. Non-randomized Healthy volunteers who had had more No FI: 186/215 Five family Vasectomies done April NSV No FI (G): Open-end Various experienced trial. Subjects than 2 children (Group G) planning services, 1988 through March 1990 (>2,000 vasectomies) 1994 [32] divided in 7 plus two-year follow-up FI (A) Open-end + FI (end?) operators. Each groups (A to G) FI:183/200 (Group China technique done by A) No FI (B): Ligation with silk on both ends operators from 2 No FI: 427/488 different institutions FI (C): Same as B + FI (Group B) (testicular end) FI: 380/431 (Group In all groups, excision (10- C) 15 mm) De Los Rios Case series with All vasectomies performed between No FI: 550 Profamilia Male Vasectomies done between No FI: Two No FI: Ligation with At least two urologists et al. historical 1971 and 1991 Clinic in Medellin 1971 and 1991 lateral openings various suture materials + controls FI: 4,015 Colombia Excision (10 mm) (in a teaching center) 1994-2003 FI: Two lateral [25,26] openings, FI: Same + FI sutured only if bleeding (41%) and NSV (59%) Sokal et al. Randomized Healthy, sexually active men at least No FI: 422 8 research centers Recruitment from NSV No FI : Ligation with silk + Various surgeons who clinical trial 18 years old who had chosen worldwide: USA, November 1999 to May Excision (10mm) attended a 2003 [45] vasectomy for contraception FI: 419 Mexico (2 sites), El 2001 Recruitment halted standardization Salvador, Panama, after interim analyses FI : Same + FI (testicular meeting Total initially end) planned: 1,200 Sri Lanka, Nepal showing superiority of FI

*Number of subjects analysed/total number of subjects enrolled in the study. FI: fascial interposition, NSV: no-scalpel vasectomy. Table 16. Outcome measures of studies comparing vas occlusion techniques with and without fascial interposition

Authors and Effectiveness Complications Year of Publication Data Length of Post-vasectomy Semen Analysis (SA) Data Collection Length of Method of Main Outcome Measures Collection Follow-up Follow-up Follow-up Timing of SA Definition of Failure

Schmidt Retrospective Unspecified but Unspecified No number, motility nor Retrospective Unspecified but Unspecified Granuloma: leakage of sperm from the variable time specified. Sterility with variable proximal vas 1973 [20] 2 negative specimens, 1 month apart

Rhodes et al. Retrospective Unspecified but Unspecified No number, motility nor N/A N/A N/A N/A variable time specified but SA 1980 [46] results in failure described Li et al. Prospective 2 years 6 months intervals until 2 Presence of sperm two years Prospective 2 years Follow-up visits Bleeding, infection, stasis years post vasectomy after vasectomy every 6 months 1994 [32] De Los Rios et al. Retrospective At least 3 3 months or after 20 Presence of live Retrospective Unspecified Early post- Infection, bleeding, pain, granuloma, months but ejaculations spermatozoa four months vasectomy orchi-epididymitis, sexual dysfunction 1994-2003 [25,26] variable after vasectomy follow-up visit and spontaneous medical consultations Sokal et al. Prospective 12 months 2 weeks, then every 4 weeks Early: > 5 million motile Prospective 12 months Follow-up visits Surgical difficulties and adverse events: through 34 weeks or until sperm/mL at 14 weeks or at the time of SA pain, sperm granuloma, orchi- 2003 [45] success or failure, and 52 later epididymitis, hematoma, infection weeks Late: motile sperm at > 26 weeks or later (>10% motile and >100,000 sperm/mL)

N/A: not applicable, SA: semen analysis. Table 17. Quality assessment of studies comparing vas occlusion techniques with and without fascial interposition * n o n Sample Size Comparability Effectiveness Assessment Complication Assessment i g t i

r s e e a a e e a * d * * * g p * d * d l l l s t t i i e l l t t z c r e e e e a o e n u y t r r n i a i m m t i i d t t - t n e n d d l r i e i e A A t i n a r i D S o a t a t t e e l n n

e e b v i i w w p T T i i i p e n n T

i r r e y R R l l o i i o u o P m m l b u e e c S l m r d s C C s - i l B B p P P a s p d p d y t s P s

u t m t m o s r r e e f w d i u i u e e t m a a e a F a - - s s o o c c u a S s m m

l i S i S t s s P p

l l l s r r w w S r S e e o p o p o A A o o a m A

f l f l h h

x x F e l l r r o t t e e l

t t / E e o E e o t t a Y C e a a P P F F b

A A c d u u e o y y t n l q n q l l a a l l e e a i G

a a l u d d s c c p q i i r A A t t e o m a a d o h t m m A C e e u t t s s A y y S S n n e e M M Schmidt 3 285 0.32 ? No ? Yes No Yes ? No No ? Yes ? No ? No No ? ? No ? Very Low 1973 [20] Rhodes et 3 40 0.08 ? No ? ? No ± Yes No No ? Yes ? No 97.5% N/A N/A Very Low al. 1980 [46] Li et al. 2 807/ 0.70/ No Yes No No Yes Yes Yes Yes Yes ? Yes Yes Yes 88%/89%† No No Yes Yes No 88%/89%† Moderate 369† 1994 [32] 0.39† De Los Rios 3 4565 0.97 Yes No Yes No Yes No ? No Yes No Yes ? No 55% No No Yes ? No 55% Very Low et al. 1994-2003 [25,26] Sokal et al. 1 841 0.86‡ Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes No FI: 98.6% No No Yes Yes No 6 weeks High

2003 [45] FI: 97.9% 100% 12 months 89%

*Criterion used for global assessment (see Table 2, Additional file 1). FI: fascial interposition, N/A: not applicable. † group A and G / group B and C. ‡ Sample size when study halted (n=841)/sample size initially planned (n=1,200).

Table 18. Results of studies comparing vas occlusion techniques with and without fascial interposition

Authors and Effectiveness (Failure) Complications Year of Hematoma Infections Pain Granuloma Epididymitis Others Total publication Based on SA Based on Comments Comments Pregnancy Schmidt No FI: 3.3% Lower failure risk with No FI: 6.0% No other complication FI when ligation specified. Higher risk of 1973 [20] FI: 0% /excision performed FI: 9.7% granulomas defined as sperm leakage with FI Rhodes et al. No FI: 6 Similar failure risk with Complications (21.4%) and without FI when only unspecified 1980 [46] vas transected. Very FI: 2 (16.7%) small sample size P = 0.55 Li et al. No FI (G): 14 No FI (G): 1 G vs A: Lower failure Bleeding No FI (G): 1 Stasis No FI (G): 8 Higher risk of (7.5%) (0.5%) risk with FI when open- FI (A): 0 (2.2%) complications due to 1994 [32] end is performed No FI (G): 7 No FI (G): 0 bleeding in group G FI (A) :1 (0.6%) FI (A) :1 FI (A) :0 No FI (B): 2 FI (A) :0 FI (A): 0 (open-end without FI). (0.6%) B vs C: Higher failure No FI (B): 6 No FI (B):0 FI (C): 1 No FI (B):0 No FI (B): 2 Total risk of (undefined) risk with FI (testicular) complications very low (1.4%) No FI (B): 2 when ligation/excision is (0.5%) (0.5%) FI (C): 0 FI (C): 1 FI (C):10 (2.6%) performed FI (C): 2 FI (C): 6 Large variation between (0.5%) 0 (1.6%) centers De Los Rios et No FI: 94 Lower failure risk with Complications al. (29.1%) FI when ligation unspecified /excision performed 1994-2003 FI: 57 (2.6%) [25,26] Sokal et al. No FI: 53 No FI: 2 Lower failure risk with No FI: 6 No FI: 2 52 weeks No FI: 29 No FI: 6 6 weeks Non significant higher (12.7%) (0.5%) FI when ligation (1.4%) (0.5%) (6.9%) (1.4%) risk of complications due 2003 [45] /excision performed No FI: 14 No FI: 62 to granuloma and orchi- FI: 24 (5.9%) FI: 2 (0.5%) FI: 6 (1.4%) FI: 2 (0.5%) (4.3%) FI: 41 (9.8%) FI: 12 (2.9%) (14.7%) epididymitis with FI. Time to azoospermia and P < 0.0008 FI: 9 FI: 74 Same risk of hematoma to severe oligospermia and infection shorter with FI (2.6%) (17.7%) (P < 0.0001) P = 0.23

SA: semen analysis, FI: fascial interposition.