FEMALE UROLOGY Long-term Outcome of Synthetic Mesh Use in Iranian Women with Genital Prolapse Parvin Bastani1,2, Sakineh Haj-Ebrahimi1,2, Fatima Mallah1,2, Parastoo Chaichi3*, Fatemeh Sadeghi Ghiasi1,2 Purpose: To evaluate the long-term outcome of synthetic mesh use in the treatment of women with Pelvic organ prolapse (POP). Materials and Methods: We evaluated the outcome of synthetic mesh implantation by vaginal surgery method in 153 women (mean age of 9.31±53.66 years) with POP grade >2 in the anterior compartment. Demographic findings, baseline symptoms as well as subjective and objective outcome were recorded during the follow-up period of 11.33±36.89 months. Results: POP relapse occurred in %3.3 indicative of %96.7 anatomical success rate. Patients’ common baseline findings were frequency (%72.5), stress and urge incontinence (%59.5 and %47.7). Subjective outcome were vaginal pain (%13.7), dyspareunia (%9.2) and tension feeling (%8.5), while objective outcomes were mesh exposure (%3.9), urge incontinence (%11.1) and vaginal infection (%1.3). Stress incontinence was completely treated following surgery. There was significant improvement in dyspareunia, vaginal pain, urge and stress incontinence (all p < 0.001) and fecal incontinence (p = 0.02). After surgery, %88.42 were satisfied of the surgery outcome. Conclusion: POP surgery with synthetic mesh has acceptable results, considerable improvement in symptoms and high rate of satisfaction during follow-up; however, side effects are not uncommon but tolerable. Keywords: prolapse; synthetic mesh; outcome; complications INTRODUCTION Pelvic organ prolapse (POP) including genital pro-lapse is common with incidence rate of 40 % of women aged 45-85 years in general population, but only 12% of them are symptomatic (1,2). Conservative and different surgical methods have been proposed for vaginal prolapse repair(3). However, there is an in- creased risk of recurrence regarding the surgery method and the type of materials used(4,5). Transvaginal meshes have been introduced to increase the surgery efficacy and reduce the recurrence rate(6). After using synthetic meshes, studies have reported increased success rate with lower morbidity in genital prolapse surgeries(7). Although previous studies have indicated that prolapse repair surgery with synthetic meshes are very effective with low prolapse and high patient’s satisfaction, there are several complications reported regarding mesh use including mesh exposure, pelvic pain, infection, bleeding, dyspareunia and with lower incidence, organ perforation(8). Studies evaluating the long-term outcome of synthetic mesh use in vaginal prolapse surgery are few. In this study, we aim to evaluate the outcome and rate of com- plications following vaginal prolapse surgery using 1Research Center for Evidence Based Medicine (RCEBM), Health Management and Safety Promotion Research Instituted, Tabriz University of Medical Sciences, Tabriz, Iran. 2Iranian EBM Center: A Joanna Briggs Instituted Affiliated Group. 3Gynecology and obstetrics department, Ardabil University of Medical Sciences, Tabriz, Iran. *Correspondence: Women's Reproductive Health Research center, Alzahra Hospital, South Artesh Ave., Tabriz, Iran. Tel: +984135541221. Fax: +984135541221.E-mail: pt.chaichi@gmail.com. Received October 2018 & Accepted May 2019 synthetic mesh among Iranian women. PATIENTS AND METHODS In this cross-sectional study, 300 women with POP undergone vaginal surgery with synthetic meshes be- tween 2011 and 2016 in Alzahra, Taleghani and Imam Reza tertiary hospitals, Tabriz, Iran were evaluated and among them 153 patients meeting inclusion criteria and not having exclusion criteria were included. Inclusion criteria were women between 40-80 years old, with POP stage 2-4 according to simplified POP-Q scoring scale undergone surgery with synthetic mesh implan- tation (Figure 1). Patients with genital malignancies, body mass index > 40 kg/m2, infection, history of pre- vious mesh implantation, collagen vascular disease and those with psychologic disease and no cooperation for maintaining mesh were excluded. Also, those patients not returning for follow-up visits were excluded. The surgeries were performed by two experienced uro- gynecologists (PB and SH). This study was approved by ethics committee of Tabriz University of Medical Sciences. Mesh implantation was indicated when there was se- vere anterior prolapse stage >2 or accompanied with uterine or posterior prolapse. If there was concomitant Urology Journal/Vol 17 No. 1/ January-February 2020/ pp. 73-77. [DOI: 10.22037/uj.v0i0.4866] apical prolapse, sacrospinous fixation was used. Af- ter surgery, patients were followed with routine visits every six months for at least one year. In each visit, full physical examination was performed. Before implanting the mesh, a vertical incision at the anterior vaginal wall was made from the point below the bladder neck to the lowermost part of the prolapse. Diluted vasopressin solution was applied subcutane- ous to reduce bleeding. With the Allis forceps securing incision margins, full-thickness blunt dissection was done for the pubo-cervical fascia laterally until reach- ing the sacrospinous ligaments. Dissection with 1–2 finger breadths further down from the ischial spines towards sacrum was done. All used meshes were from Neomedic International Company (Madrid, Spain). For anterior prolapse, the mesh is placed by a Single Inci- sion procedure through one single vaginal incision. In its anterior part, the mesh is fixed to the internal obtura- tor muscles by its two pocket system arms, with no nee- dles and no skin perforations. For posterior prolapse, the surgeon cut the middle and anterior arms, fixating the mesh posteriorly to the sacrospinous ligament and anteriorly to the elevator anus muscles. For sacros- pinous ligament fixation, the ischial spine was palpated and taken as the reference to pinpoint the sacrospinous ligament, which extends from the ischial spine medially to the coccyx and the lower portion of the sacrum. The pararectal fascia was penetrated, and the space was en- larged using blunt dissection; the rectum was retracted to the left using two Breisky-Navratil retractors, there- by exposing the sacrospinous ligament. No 1 non-ab- sorbable suture (Prolene) was placed 2-2.5 cm medi- ally to the ischial spine, and one end of the suture was passed through the vaginal vault; surplus tissue located in the posterior vaginal wall was excised, and the upper 1/3 of the vaginal mucosa was repaired. Following the vaginal vault repair, the vaginal vault was suspended from the right sacrospinous ligament by tying together the sacrospinous sutures located proximal to the apex of the vaginal vault. Lastly, posterior repair and peri- neoplasty were performed, which marked the end of the procedure. Demographic findings, patients’ symptoms and POP grade before surgery, improvement in symptoms and complications following mesh use were all recorded. Subjective outcome was considered as pain, dyspare- unia and mass extrusion and objective outcomes were mesh exposure, tenderness and urinary incontinence. Patients’ satisfaction of the surgery was assessed using Likert scale of four (excellent, well, moderate, poor). Statistical analysis All data were analyzed using SPSS Statistics, Version 20 (IBM Corporation, New York). Results are ex- pressed as mean ± SD or percentage. McNemar test was used to evaluate the improvement in symptoms before and after surgery. p values of less than 0.05 were con- sidered statistically significant. RESULTS Patients’ baseline findings are demonstrated in Table 1. The most common symptoms were frequency, urge and stress incontinence, and dyspareunia. Posterior and uterine prolapse were mainly stage II, while anterior prolapse was mainly stage III. Patients were followed for 36.89±11.33 months (range 12-60 months). All pa- tients with fecal incontinence had posterior compart- ment prolapse and treated accordingly. During follow-up, prolapse recurrence occurred in 5 cases (3.3%), one treated with sacrocolpopexy, one with vaginal surgery and another mesh implantation and one with pessary. Two other patients were treated conservatively. In the case treated with pessary, in first surgery just small piece of mesh was used for anterior compartment repair but the relapse was related to com- Table 1. The grade of genitalia prolapse before Mesh Implantation in the study population Variables Age (years) 53.66 ± 9.61 Gravida 4.56 ± 1.94 Parity 4.18 ± 1.80 Hypertension 8 (5.2%) Diabetes mellitus 31 (20.3%) Symptoms Urge incontinence 73 (47.7%) Stress Incontinence 91 (59.5%) Urgency 73 (47.7%) Frequency 111 (72.5%) Urination problems 37 (24.2%) Dyspareunia 68 (44.4%) Vaginal pain 56 (36.4%) Fecal incontinence 5 (3.3%) Prolapse typea Stage I Stage II Stage III Stage IV Uterine 13 (8.5%) 88 (57.5%) 38 (25.18%) 14 (9.2%) Anterior 11 (7.2%) 51 (33.3%) 91 (59.5%) ------- Posterior 29 (19%) 108 (70.6%) 16 (10.5%) ------- a Data are presented as mean ± SD or number (percent) Before surgery After surgery P value Dyspareunia 68 (44.4%) 14 (9.2%) < 0.001b Vaginal pain 56 (36.6%) 21 (13.7%) < 0.001 Urge incontinence 73 (47.7%) 17 (11.1%) < 0.001 Stress incontinence 91 (59.5%) 0 < 0.001 Fecal incontinence 5 (3.3%) 0 0.02 a Data are presented as number (percent). b McNemar test was used. Table 2. Comparing the symptoms before and after mesh implantation a Figure 1. Flowdiagram of the study population. Synthetic mesh for genital prolapse. Bastani et al. Female Urology 74 Vol 17 No 01 January-February 2020 75 bined anterior and apical compartment, so we used Cap- io system with mesh and we removed the previous one as much as possible and very gently Subjective outcomes were vaginal pain in 21 (13.7%), dyspareunia in 14 (9.2%) and tension feeling in 13 (8.5%). Mass extrusion was not reported in any of the cases. This tension was present in patients with high- er prolapse grade and in the recent weeks after surgery which was later improved with no treatment in the fol- lowing visits. Of 14 dyspareunia cases after surgery, 4 persisted after surgery and 9 cases was de novo after surgery. Ten cases of vaginal pain, were persistent after surgery and the other 11 cases were de novo. Objective outcomes were mesh exposure in 6 cases (3.9%), urge incontinency in 17 cases (11.1%) and in- fection in 2 cases (1.3%). Urge incontinency persisted in 9 cases and not improved following surgery, while 8 new de novo cases occurred after surgery. All stress incontinency cases were improved after surgery. Of 6 patients with mesh exposure, symptoms occurred between 13-27 months after surgery, four cases were mild exposure and treated with vaginal estrogen. Two cases returned with delay with complete mesh expo- sure, the extruded mesh part was removed and repaired. One of the cases with complete exposure had purulent vaginal discharges and treated with proper antibiotics. At the final follow-up, all 6 patients were symptom free. Using a Likert scale, the patients reported their satis- faction of the surgery as excellent in 54 cases (35.2%), well in 81 cases (52.9%), moderate in 14 cases (9.2%) and poor in 4 cases (2.6%). Most patients had well to excellent satisfaction of surgery. Following surgery, there was significant improvement in dyspareunia, vaginal pain, urge and stress inconti- nence and fecal incontinence (Table 2). DISCUSSION In this study, we evaluated the long term outcome of using synthetic mesh in the vaginal surgery of genitalia prolapse in 153 women between 40-80 years old. There was significant improvement in prolapse stage after sur- gery with only 3.3% of recurrence indicative of 96.7% anatomical success rate. Prolapse severity, urinary symptoms and fecal incontinence was significantly im- proved after surgery. In many studies, successful treatment was considered as POP grade ≤ 1 after surgery. The reported success rate are > 80% and in the recent studies are more than 90- 95% (9-14). Similar to our findings, Hong and colleagues reported total anatomical success rate of 96.5% after 18 months follow-up (10). It is even noted that regardless of recurrence of POP in some patients, they are mostly sat- isfied of the treatment due to the considerable improve- ment in symptoms (11-14). Although some studies report that two years after mesh treatment, many women still report symptoms that negatively impact their quality of life (15). Using synthetic meshes would accompany with some side effects which would limit its use. Recent guide- lines has recommended mesh in patients after full risk evaluation and to be performed by an expert surgeon (16). Reported side effects of mesh use are mesh erosion, dyspareunia, hematoma, urinary incontinence, etc(17). Mesh exposure is a complication related to procedure, mesh type and atrophy after mesh implantation. Mesh exposure occurred in 3.9% of our patients. Four cases had mild exposure and treated with vaginal estrogen. Two cases with complete mesh exposure had the ex- truded part removed and repaired. The reported rate of mesh exposure in short and long term follow-up are variable. Meyer and colleagues re- ported mesh exposure in 6% of patients in long term follow-up(18), which was higher than 2% in midterm follow-up(19). Other studies have reported mesh expo- sure rate of 1-24% and mostly below 15% (9,18-23). Fan and colleagues reported mesh exposure in 6 patients (13%) of which three meshes were removed(20). Meyer and colleagues also reported that mesh exposure usually occurred in women with vaginal atrophy who stopped using vaginal estrogen(18). Transvaginal mesh implantation had conflicting effects on sexual function in previous studies. Meyer and col- leagues observed that this surgery has no adverse ef- fects on sexual function in long term(18). Dyspareunia occurred in 36% of their study patients. Alperin and colleagues also have reported dyspareunia in 28.9% of patients after surgery(9), while the reported rate in most studies are 2-20% (21-25). In our study, dyspareunia persisted in 2.7% and de novo dyspareunia occurred in 6.5%. The rate of dyspareunia after mesh implantation is not completely determined. The rate of new dyspareunia after surgery is reported to be between 4.4 to 20% (25-29). De novo dyspareunia could be due to mesh exposure or mesh shrinkage. Mi- lani et al. evaluated 127 patients after mesh implanta- tion with 61 of them sexually active and observed new dyspareunia in 2% of cases (26). The main cause for this difference in the rate of dys- pareunia could be due to the unwillingness of women to talk about their sexual relation in different areas, especially in religious countries such as ours. As in our study, older women did not like to talk about their sexual relations and it is possible that the real rate of new dyspareunia be higher. However, this low rate of dyspareunia is considerable and indicative of efficacy of treatment with mesh. In our study, stress incontinence was completely im- proved after surgery. Vaginal pain persisted in 6.5% and newly occurred in 7.2% and urge incontinence was persistent regardless of surgery in 5.9% and de novo in 5.2%. Patients considered their symptoms not severe and tolerable. Alperin and colleagues reported pelvic pain in 4% (9). Fan and colleagues reported stress incon- tinence in 11% of patients that were mostly mild and treated conservatively(20). We observed that 88.2% of patients were well to ex- cellent satisfied of the treatment outcome. Fan and col- leagues reported overall satisfaction of 91% (20). The satisfaction rate in Song et al. study was 84.7% (30). This study had also some limitations; One weakness of our study is that our data were collected partly retro- spectively and so some data were not available. Howev- er, this study has the power of rather good sample size and long term follow-up. CONCLUSIONS Genitalia prolapse surgery with synthetic mesh has ac- ceptable results, considerable improvement in symp- toms and high rate of satisfaction during follow-up; however, side effects are not uncommon but tolerable. Synthetic mesh for genital prolapse. Bastani et al. CONFLICTS OF INTEREST The authors declare that they have no conflict of inter- est. REFERENCES 1. Vergeldt TF, Weemhoff M, IntHout J, Kluivers KB. Risk factors for pelvic organ prolapse and its recurrence: a systematic review. Int Urogynecol J. 2015;26:1559-73. 2. Ozcan L, Polat EC, Onen E, Otunctemur A, Ozbek E, Somay A, et al. Neuronal Nitric Oxide Synthase Expression in the Anterior Vaginal Wall of Patients with Stress Urinary Incontinence. Urol J. 2018;15:280-4. 3. Oraekwe OI, Udensi MA, Nwachukwu KC, Okali UK. Genital prolapse: A 5-year review at Federal Medical Centre Umuahia, Southeastern Nigeria. Niger Med J. 2016;57:286-9. 4. Jakus SM, Shapiro A, Hall CD. Biologic and synthetic graft use in pelvic surgery: a review. Obstet Gynecol Surv. 2008;63:253–66. 5. Dällenbach P. To mesh or not to mesh: a review of pelvic organ reconstructive surgery. Int J Womens Health. 2015;7:331-43. 6. Meyer I, McGwin G, Swain TA, Alvarez MD, Ellington DR, Richter HE. Synthetic Graft Augmentation in Vaginal Prolapse Surgery: Long-Term Objective and Subjective Outcomes. J Minim Invasive Gynecol. 2016;23:614-21. 7. Abdel-Fattah M, Ramsay I. West of Scotland Study Group. Retro-spective multicentre study of the new minimally invasive mesh repair devices for pelvic organ prolapse. BJOG 2008;115:22–30. 8. Walter JE, Urogynaecology Committee, Lovatsis D, Walter JE, Easton W, Epp A, et al. Transvaginal mesh procedures for pelvic organ prolapse. J Obstet Gynaecol Can. 2011;33:168-74. 9. Alperin M, Ellison R, Meyn L, Frankman E, Zyczynski HM. Two-year outcomes after vaginal prolapse reconstruction with mesh pelvic floor repair system. Female Pelvic Med Reconstr Surg. 2013;19:72-8. 10. Hong MK, Chu TY, Wei YC, Ding DC. High success rate and considerable adverse events of pelvic prolapse surgery with Prolift: a single center experience. Taiwan J Obstet Gynecol. 2013;52:389-94. 11. De Tayrac R, Gervaise A, Chauveaud A, Fernandez H. Tension free polypropylene mesh for vaginal repair of anterior vaginal wall prolapse. J Reprod Med. 2005;50:75-80. 12. Gauruder-Burmester A, Koutouzidou P, Rohne J, Gronewold M, Tunn R. Follow-up after polypropylene mesh repair of anterior and posterior compartments in patients with recurrent prolapse. Int Urogynecol J Pelvic Floor Dysfunct. 2007;18:1059-64. 13. Rane A, Kannan K, Barry C, Balakrishnan S, Lim Y, Corstiaans A. Prospective study of the Perigee system for the management of cystocoeles—medium-term follow up. Aust N Z J Obstet Gynaecol. 2008;48:427-32. 14. Altman D, Vayrynen T, Ellstom Engh M, Axelsen S, Falconer C; Nordic Transvaginal Mesh Group. Anterior colporrhaphy versus transvaginal mesh for pelvic-organ prolapse. N Engl J Med. 2011;364:1826-36. 15. Hansen BL, Dunn GE, Norton P, Hsu Y, Nygaard I. Long-term follow-up of treatment for synthetic mesh complications. Female Pelvic Med Reconstr Surg. 2014;20:126-30. 16. Moon JW, Chae HD. Vaginal Approaches Using Synthetic Mesh to Treat Pelvic Organ Prolapse. Ann Coloproctol. 2016;32:7-11. 17. Committee Opinion no. 513. Vaginal placement of synthetic mesh for pelvic organ prolapse. Obstet Gynecol. 2011;118:1459-64. 18. Nguyen JN, Jakus-Waldman SM, Walter AJ, White T, Menefee SA. Perioperative complications and reoperations after incontinence and prolapse surgeries using prosthetic implants. Obstet Gynecol. 2012;119:539-46. 19. Wetta LA, Gerten KA, Wheeler TL 2nd, Holley RL, Varner RE, Richter HE. Synthetic graft use in vaginal prolapse surgery: objective and subjective outcomes. Int Urogynecol J Pelvic Floor Dysfunct. 2009;20:1307-12. 20. Fan HL, Chan SS, Cheung RY, Chung TK. Tension-free vaginal mesh for the treatment of pelvic organ prolapse in Chinese women. Hong Kong Med J. 2013;19:511-7. 21. Benbouzid S, Cornu JN, Benchikh A, Chanu T, Haab F, Delmas V. Pelvic organ prolapse transvaginal repair by the Prolift system: evaluation of efficacy and complications after a 4.5 years follow up. Int J Urol. 2012;19:1010- 6. 22. Abed H, Rahn DD, Lowenstein L, Balk EM, Clemons JL, Rogers RG. Systematic Review Group of the Society of Gynecologic Surgeons. Incidence and management of graft erosion, wound granulation, and dyspareunia following vaginal prolapse repair with graft materials: a systematic review. Int Urogynecol J. 2011;22:789-98. 23. de Tayrac R, Deffieux X, Gervaise A, Chauveaud-Lambling A, Fernandez H. Long- term anatomical and functional assessment of trans-vaginal cystocele repair using a tension- free polypropylene mesh. Int Urogynecol J Pelvic Floor Dysfunct. 2006;17:483-8. 24. Milani AL, Withagen MI, The HS, Nedelcu- van der Wijk I, Vierhout ME. Sexual function following trocar-guided mesh or vaginal native tissue repair in recurrent prolapse: a randomized controlled trial. J Sex Med. 2011;8:2944-53. Synthetic mesh for genital prolapse. Bastani et al. Female Urology 76 Vol 17 No 01 January-February 2020 77 25. Lowman JK, Jones LA, Woodman PJ, Hale DS. Does the Prolift system cause dyspareunia? Am J Obstet Gynecol. 2008;199:707.e1-6. 26. Milani AL, Hinoul P, Gauld JM, et al. Trocar- guided mesh repair of vaginal prolapse using partially absorbable mesh: 1 year outcomes. Am J Obstet Gynecol. 2011;204:74.e1-8. 27. Kaufman Y, Singh SS, Alturki H, Lam A. Age and sexual activity are risk factors for mesh exposure following transvaginal mesh repair. Int Urogynecol J. 2011;22:307-13. 28. Milani R, Salvatore S, Soligo M, Pifarotti P, Meschia M, Cortese M. Functional and anatomical outcome of anterior and posterior vaginal prolapse repair with prolene mesh. BJOG. 2005;112:107-11. 29. Dwyer PL, O’Reilly BA. Transvaginal repair of anterior and posterior compartment prolapse with Atrium polypropylene mesh. BJOG. 2004;111:831-6. 29. Song W, Kim TH, Chung JW, Cho WJ, Lee HN, Lee YS, et al. Anatomical and Functional Outcomes of Prolift Transvaginal Mesh for Treatment of Pelvic Organ Prolapse. Low Urin Tract Symptoms. 2016;8:159-64. Synthetic mesh for genital prolapse. Bastani et al.