Original Research

Absorbable Mesh Augmentation Compared With No Mesh for Anterior Prolapse A Randomized Controlled Trial Magali Robert, MD, MSc, Isabelle Girard, MD, Erin Brennand, Magnus Murphy, MD, and Sue Ross, PhD OBJECTIVE: To compare anatomical and patientreported outcomes at 12 months postoperatively for women who had anterior compartment pelvic organ prolapse (POP) surgery using a repair augmented with porcine small intestine submucosa mesh (Mesh Group) compared with those who had a native tissue repair (No Mesh Group). METHODS: This was a randomized controlled trial with 12 months follow-up. The surgical procedure was identical in both groups except for the placement of intervening mesh. The primary outcome was anatomical “cure” (Ba of 21 or less on Pelvic Organ Prolapse Quantification [POP-Q]). Secondary outcomes included POP-Q stage, patient-reported outcomes, and patient satisfaction. The study was powered to detect a 40% difference at 80% power (a50.05). RESULTS: Fifty-seven women were randomized (28 to Mesh Group, 29 to No Mesh Group). Forty-five (79%) underwent concomitant surgery. At the 12-month follow-up, 56% (15/27) in the Mesh Group and 61% (17/28) in the No Mesh Group were considered cured (relative risk 0.90, 95% confidence interval 0.52–1.54). From the Departments of Obstetrics and Gynecology, University of Calgary, Calgary, and University of Edmonton, Edmonton, Alberta, and University of Sherbrooke, Sherbrooke, Quebec, Canada. Supported by Cook Medical, which provided grant-in-aid funding for the study. Corresponding author: Magali Robert, MD, MSc, Department of Obstetrics and Gynecology, University of Calgary, 4th Floor, North Tower, Foothills Medical Centre, 1403-29th Street, Calgary, Alberta T2N 2T9, Canada; e-mail: magali. [email protected]. Financial Disclosure Dr. Robert has served on the advisory committee for Cook Myosite and is the Fellowship Director for a fellowship program funded by Cook Medical. Dr. Brennand completed fellowship sponsored by Cook Medical. Dr. Ross accepted grant-in-aid funding from Johnson & Johnson Medical Companies, Boston Scientific, and Cook Surgical. The other authors did not report any potential conflicts of interest. © 2014 by The American College of Obstetricians and Gynecologists. Published by Lippincott Williams & Wilkins. ISSN: 0029-7844/14

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MD,

Selphee Tang,

BSc,

Colin Birch,

MD,

There were no significant differences between groups in recurrent or persistent prolapse (7% in each group) nor in patient-reported outcomes at 12 months. Pelvic girdle pain occurred in 4 of 27 in the Mesh Group and 3 of 28 in the No Mesh Group. CONCLUSION: No significant differences were observed in anatomical or patient-reported outcomes outcome parameters at 12 months after correction of symptomatic anterior POP by mesh or no mesh repair. In our study, porcine small intestine submucosa mesh did not confer additional benefit over a native tissue repair. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www. clinicaltrials.gov, NCT0095544. LEVEL OF EVEDIENCE: I (Obstet Gynecol 2014;123:288–94) DOI: 10.1097/AOG.0000000000000105

P

elvic organ prolapse (POP) is common, thought to affect more than 40% of women aged 50–79 years, with anterior vaginal wall prolapse (cystocele) being the most common form of prolapse observed.1,2 Anatomic success rates after anterior colporrhaphy have been reported to range from as low as 27% to as high as 71%.3 An alternative is to use permanent synthetic meshes. A Cochrane Review concluded that the objective failure was higher with native tissue repair (46%) compared with fixed permanent mesh (14%), but also reported mesh erosion rates of 11.4%.4 To overcome permanent mesh complications, absorbable xenograft meshes have become an intriguing alternative.4 Porcine small intestine submucosa mesh is a xenograft that provides the scaffold for tissue ingrowth and repair5 and is replaced by organized host tissue within 4 months of implantation.6 Thus, this mesh has ideal characteristics for vaginal reconstruction surgery. One randomized controlled trial (RCT) published in 2010 compared small intestine submucosa mesh

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with traditional colporrhaphy for cystocele repair, finding a significantly higher anatomic success rate in the mesh group (82.3% compared with 59.3%, P5.03) with no difference between groups in subjective outcomes.7 However, the mesh group underwent a modified paravaginal repair, whereas the control group underwent a standard midline colporrhaphy, making the effect of the mesh alone undetermined. We carried out an RCT to compare the anatomical success and patient-reported outcomes 1 year after anterior compartment repair using a small intestine submucosa mesh-augmented procedure compared with the same anterior repair without mesh.

MATERIALS AND METHODS Our parallel-group pragmatic RCT recruited women with a cystocele requiring surgical management. They were allocated one-to-one to have either a surgical anterior prolapse repair using a small intestine submucosa mesh-augmented procedure (Mesh Group) or the same anterior repair without mesh (No Mesh Group). Anatomical success and patient-reported outcomes were measured 1 year after surgery. The study was undertaken by three surgeons working in one Calgary tertiary academic hospital. All surgeons were competent to undertake both the mesh-augmented repair and the same procedure without mesh. The study was approved by the University of Calgary Conjoint Health Research Ethics Board (Ethics ID 22217) in March 2009. Women were eligible for inclusion if they elected for surgical management of their anterior compartment prolapse, had point Ba of 0 or greater on the pelvic organ prolapse quantification (POP-Q) system,8 and provided written informed consent. Point Ba is the leading edge of the anterior vaginal wall in relation to its distance in centimeters from the hymenal ring more negative numbers indicating less prolapse to a minimum of 23 and more positive numbers indicate prolapse beyond the hymenal ring.8 With a POP-Q stage of 0 or I, most women are free of symptoms; women with stage II or more have increasing symptoms.9 Women were excluded if they preferred to have an obliterative procedure (Lefort procedure or colpocleisis), had an allergy to graft material, were immunocompromised, had a previous anterior compartment repair, were unable to understand English, or would be unavailable for follow-up. Concomitant surgery was not an exclusion criterion nor was previous nonanterior compartment prolapse surgery. Eligible patients were referred to a research nurse to receive full information about the study and give written informed consent. Preoperatively women com-

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pleted condition-specific validated patient-reported outcome questionnaires: the Pelvic Floor Distress Inventory, a 20-item measure of symptom severity and distress, the Pelvic Floor Impact Questionnaire, a seven-item measure of effects of pelvic floor disorders,10 and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, a 12-item measure of sexual function.11 The three participating surgeons developed standard surgical procedures for the anterior repair (Appendix). In patients allocated to the Mesh Group, the repair was augmented using mesh but was otherwise identical to the repair in the No Mesh Group. Surgical details were extracted from patient charts. Operative reports were screened to ensure that the standard surgical protocol was followed. Randomization to either the Mesh Group or No Mesh Group was carried out using a centralized randomization service through the data manager at the University of Calgary Department of Obstetrics and Gynaecology. The random allocation sequence was generated by the study analyst using the Proc Plan procedure in SAS 9.3 using permuted block randomization with blocks of varying size2–4 and stratified by surgeon. Randomization was carried out a few days before surgery but the operating physician was only informed in the operating room. The participant was blinded to the treatment allocation. The surgeon was blinded to the next treatment allocation. The examining physician, 1 year after surgery, was blinded to treatment allocation because they were not an operating surgeon nor involved in clinical care and had no access to operative notes. Outcomes were measured at 12 months after surgery. Baseline patient-reported outcome questionnaires were repeated and any complications since the index surgery were recorded. Physical examination, including POP-Q examination, was performed. Primary outcome was defined as anatomic success of point Ba being 21 or less (ie, less prolapse). Because there is no agreed definition of anatomical cure, this stringent end point was used to explore differences between the groups.12 Secondary objective outcomes included POP-Q staging. Secondary subjective outcomes comprised change from baseline for the patient-reported outcome questionnaires. Subjective cure at 12 months was defined as absence of bulge,12 defined by the response to question 3 of the Pelvic Floor Distress Inventory. Participants were asked if the outcome had met expectations and if they would have the same operation again under the same circumstances. Using success as defined by point Ba as 21 or less (less prolapse) at the follow-up visit, 12 months after

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surgery, we assumed an anatomic success rate of 80% for the Mesh Group and 40% in the No Mesh Group. The anatomic success rate of 80% in the Mesh Group was based on findings from our previous retrospective study (69% success)13 taking into account refinements in our anterior repair technique since that study. This estimate was later validated by Feldner’s findings.7 Anatomic success for the No Mesh Group was estimated from a trial of anterior colporrhaphy in which the overall success rate was 38.5% in women with a minimum follow-up of 1 year.14 Based on a 40% absolute difference, a trial with 23 patients per group would have 80% power (a50.05) to detect a difference of this order. The sample size was increased to a total of 50 patients to allow for a 10% loss to follow-up based on the loss to follow-up rate from our previous incontinence RCT.15 Data entry and management were carried out using Access, and analyses were carried out using SAS 9.3. The study was designed as a pragmatic RCT and therefore analyses used intention-to-treat principles. Descriptive statistics (means, standard deviations, proportions) were calculated for baseline information. The primary outcome compared the proportion of participants with success as defined by point Ba of 21 or less at 12 months using Fisher’s exact test and reporting relative risk with 95% confidence interval (CI). Analyses of secondary outcomes used similar tests to compare binomial outcomes for the two groups. Changes from baseline and group differences in the patient-reported outcome questionnaires were analyzed using the Mann-Whitney U test because the questionnaire responses and their differences were not normally distributed. Results are reported according to the Consolidated Standards of Reporting Trials (CONSORT) 2010 Statement.16

Enrolled N=58

RESULTS Fifty-eight participants were recruited from September 2009 until June 2010. One woman withdrew before randomization after choosing not to proceed to surgical correction. Figure 1 depicts the CONSORT flow diagram for the study. Twenty-eight women were allocated to the Mesh Group and 29 were allocated to the No Mesh Group. One participant from the Mesh Group did not have anterior prolapse at the time of surgery once the vault was suspended and did not receive treatment in this compartment. One participant from the No Mesh Group filled out the 12-month questionnaire but did not attend the appointment because of travel, distance logistical problems. One participant in the Mesh Group died before the 1-year appointment with the diagnosis of Hodgkin’s lymphoma. This was not diagnosed before her surgery. Postoperatively, she developed urinary retention and recurrent urinary tract infections despite not having had an incontinence sling procedure. She returned to surgery 1 month later for lysis of the mesh, which slowly relieved her retention, but she was admitted 8 months after her initial surgery with urosepsis. On this admission, abdominal lymphadenopathy and abnormal liver enzymes were identified. She died 1 week later of newly diagnosed Hodgkin’s lymphoma. Thus, the questionnaire follow-up was available for 100% of survivors, and all participants were analyzed according to their group of allocation. Baseline data are presented in Table 1. Seventy-nine percent of women in each group had a concomitant prolapse procedure performed. For this reason, operating times for the specific anterior procedure could not be separated from the total operating time and are not described.

Withdrew prior to surgery n=1

Randomized n=57

Allocated to Mesh Group: n=28 Received mesh procedure: 27 Received another procedure: 1

Allocated to No Mesh Group: n=29 Received no mesh procedure: 29 Received another procedure: 0

12-month follow-up Died: n=1 Attended clinic: n=27 Responded to questionnaire: n=27

12-month follow-up Attended clinic: n=28* Responded to questionnaire: n=29

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Fig. 1. Flow of patient recruitment and follow-up. *One patient in the No Mesh Group did not attend her 12-month study visit as a result of traveling for most of the year. Robert. Absorbable Mesh in Anterior Prolapse Repair. Obstet Gynecol 2014.

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Table 1. Patient Characteristics Characteristic* Age (y) BMI (kg/m2) Parity 1 More than 1 Postmenopausal Current hormone replacement therapy use Previous pelvic surgery Medical conditions Diabetes Cardiovascular Pulmonary Neurologic Other Concomitant procedures Anterior repair alone Anterior repair with concomitant procedure Other repair (not anterior)† Concomitant procedures Suburethral sling Hysterectomy Uterine suspension Posterior repair Other

Mesh Group No Mesh (n528) Group (n529) 58.8611.8 27.264.1 0 28 21 5

(0) (100) (75) (18)

19(68) 0 11 8 4 17

(0) (39) (29) (14) (61)

56.9612.9 27.963.9 2 27 19 5

(7) (93) (66) (17)

19 (66) 3 8 7 0 14

(10) (28) (24) (0) (48)

5 (18) 22 (79)

6 (21) 23 (79)

1 (4)

0 (0)

16 12 1 15 1

18 13 2 14 0

BMI, body mass index. Data are n (%) or n unless otherwise specified. * P.0.05 for all characteristics. t test for age and BMI and, Fisher’s exact test for all others. † Patient was randomized to mesh but did not have anterior repair; had vaginal hysterectomy, bilateral uterosacral vault suspension, posterior repair, and tension-free vaginal tape.

Two participants in the Mesh Group had intraoperative-recognized ureteric obstruction that required only release of the paravaginal apical sutures on the affected side. These sutures were not replaced. Both of these women had point Ba more than 0 at 1-year follow-up. Two participants in the Mesh Group had more than 400 mL blood loss intraoperatively but did not require transfusion; one of these women had ureteric obstruction. One participant in the No Mesh Group had a bladder perforation at the time of suburethral sling placement. One participant from each group was readmitted within 2 months of surgery. In the Mesh Group, as described previously, the woman who subsequently died of lymphoma had release of the mesh for urinary retention. In the No Mesh Group, one woman was admitted for bleeding, which was related to menorrhagia and not a surgical complication. She returned with nausea and vomiting, which responded to hydration and antiemetics.

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The 12-month follow-up is presented in Tables 2 and 3. The primary outcome of success (Ba 21 or less) was observed in 56% of the Mesh Group and 61% of the No Mesh Group (RR 0.90, 95% CI 0.52–1.54). Both groups showed improvement in the subjective outcome measures, although there were no significant differences between groups. Symptoms of bulging had decreased to 22% (78% success) in the Mesh Group and 38% (62% success) in the No Mesh Group (P5.252). Sexual activity was reported by 50% of the Mesh Group at baseline and 54% at 1 year compared with 72% in the No Mesh Group at baseline and 68% at 1 year; there was no significant between-group difference in change in sexual activity (P5.403). Pelvic pain was the most common complication seen in the subsequent year after surgery. Four women in the Mesh Group and three women in the No Mesh Group reported pain in the pelvic girdle region. One woman in the Mesh Group required two surgeries to release the sutures for ongoing pain. One woman in the No Mesh Group had spontaneous resolution at 5 months. All other women required pelvic physiotherapy to alleviate the pain. One woman in the No Mesh Group required release of the tension-free vaginal tape procedure, which relieved her urinary retention, whereas one woman in the Mesh Group required lysis of her mesh. Although intermittent catheterization was not uncommon on discharge from hospital, by 1 year, only one participant in each group had prolonged catheterization. Patient satisfaction was high in both groups: 88% (23/27) in the Mesh Group and 69% (19/29) in the No Mesh Group felt the surgery met their expectations and 96% (25/27) in the Mesh Group and 88% (23/29) in the No Mesh Group would undergo the same surgery knowing what they presently knew.

DISCUSSION This study did not find significant differences between women allocated to have a repair using porcine small intestine submucosa mesh compared with those allocated to no mesh in anatomical or patient-reported outcomes at 1-year follow-up. We used a stringent criterion for anatomic correction of POP-Q point Ba at least 21 with the aim of identifying even subtle differences between the groups. Adverse events were not statistically different between the groups. With excellent results in the No Mesh Group, the future of surgical trials should focus on technique rather than use of meshes. There is very limited evidence about the effectiveness of porcine small intestine submucosa mesh in the anterior compartment.4 Feldner et al randomized

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Table 2. Objective Outcomes: Preoperative and 12 Months Postoperatively Preoperative

12 Mo Postoperatively

Mesh No Mesh Mesh No Mesh Group (n528) Group (n529) Group (n527)* Group (n528)* Statistical Result†

POP-Q Outcomes Cure at 12 mo (primary outcome) Cure (Ba 21 or less) No cure (Ba greater than 21) Overall POP-Q stage 0 I II III IV Median (IQR) change from baseline

0 0 16 7 5

(0) (0) (57) (25) (18)

0 0 16 8 5

(0) (0) (55) (28) (17)

15 (56) 12 (44)

17 (61) 11 (39)

P5.788 RR 0.90 (95% CI 0.52–1.54)

3 5 17 0 2 22

0 1 25 2 0 22

P5.466

(11) (19) (63) (0) (7) (1)

(0) (4) (89) (7) (0) (2)

POP-Q, Pelvic Organ Prolapse Quantification; RR, relative risk; CI, confidence interval, IQR, interquartile range. Data are n (%) unless otherwise specified. * Excludes n51 in the Mesh Group who died and n51 in the No Mesh Group who did not attend the 12-month follow-up appointment. † Fisher’s exact test for all, except for Mann-Whitney U test for median change in overall POP-Q score; all tests and RRs exclude missing values.

29 women to mesh and 27 to traditional colporrhaphy, finding a significant improvement in anatomical outcome (defined as POP-Q stage II or less) in the mesh group compared with the traditional colporrhaphy group at 1 year (82% compared with 59%, P5.03).7 There were no significant differences between groups in subjective outcomes. Feldner’s surgical techniques were different for the two groups and therefore differences in anatomic success could have been related to this difference rather than being attributable to the use of mesh. Unlike Feldner’s traditional colporrhaphy group, our study participants received mesh or no mesh

repairs that addressed paravaginal, apical, midline defects or any of these combinations. This could explain why our No Mesh Group had similar results to Feldner et al’s mesh group who also received a procedure that addressed all compartments. We therefore speculate that the surgical repair itself may be more important than the mesh. Our most common complication was pain. This was evenly distributed in both groups, which suggests that the pain is likely attributable to the surgical procedure itself because both groups had similar tissue dissection and the same suture placement. Feldner

Table 3. Patient-Reported Outcomes: Preoperative and 12 Months Postoperatively Preoperative

Statistical Comparison of Mesh Group No Mesh Mesh Group No Mesh Outcomes at (n528) Group (n529) (n527) Group (n529) 12 Mo* (P)

Outcome Median pelvic floor distress Inventory (20-item) Median change from baseline Symptom of bulge, n (%) Change from yes to no,† n (%) Median pelvic floor impact Questionnaire (7-item) Median change from baseline‡ Median Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire‡ Median change from baseline

117 (87)

115 (54)

25 (89%)

28 (97%)

12 Mo Postoperatively

40 (51) 267 (65) 6 (22%) 19 (70%)

43 (57) 86 (76) 14 (33) (missing: n51) (missing: n52) 226 (62) n513, 31 (7) n521, 33 (8) n512, 38 (10) n511, 6 (6)

52 (79) 259 (60) 11 (38%) 17 (59%)

.538 .544 .252 .412

10 (90) 243 (76) n519, 38 (8)

.441 .171 .841

n519, 2 (10)

.239

Data are median (interquartile range) unless otherwise specified. * Mann-Whitney U test for questionnaire scores, Fisher’s exact test for others; all tests exclude missing values; statistical tests comparing preoperative scores were not significant, except for the Pelvic Floor Impact Questionnaire (P5.04). † Change from symptom of bulge5yes at baseline to symptom of bulge5no at 12 mo. ‡ Includes only patients who completed Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire.

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et al’s is the only other study that reported on pain as described by dyspareunia rates: 17% (5/29) in the Mesh Group and 15% (4/27) in the control group.7 These are similar rates to our results. Thus, women should be counseled that prolonged pain is a common complication of any anterior compartment surgery. Only one other RCT provides evidence of outcomes of small intestine submucosa compared with no mesh in POP.17 That trial randomized 137 women between mesh and a traditional posterior repair, finding no statistically significant differences in subjective or objective outcomes at 12 months.17 A recent Cochrane Review found insufficient rigorous evidence to support the use of any xenographic meshes in POP surgery.4 The main limitation of our study is that it was underpowered to rule out small but clinically significant differences. The success of the no mesh repair in our study was superior to what had been expected, and the outcome for the Mesh Group was less successful than expected. This unexpected finding leads us to believe that the additional cost of the porcine small intestine submucosa mesh cannot at present be justified. Most of our participants (79% in each group) had concomitant prolapse surgery. The effects of these procedures on the overall results in the anterior compartment are unknown. However, our participant population reflects a common surgical population. It is not known if tissue ingrowth with small intestine submucosa mesh differs from native tissue in the long term. Although the mesh is known to be degraded by 4 months after implantation,6 this may lead to different tissue remodeling than a native tissue repair. It is not known if follow-up longer than 1 year would change these outcomes. The strength of our study lies in the similarities between the surgeries in both groups with the exception of graft augmentation in the Mesh Group. Thus, the surgical techniques were directly comparable. We had excellent follow-up at 1 year (100% of survivors), ensuring no loss of information. Senior physicians, dedicated to the study, performed all the anterior prolapse surgeries. Thus, there was uniformity and continuity in the surgical techniques used with no surgical protocol violations. Nonpermanent mesh has theoretical advantage over permanent mesh as a result of possible lower complications. It also has theoretical advantage over native tissue repair by providing prolonged scaffolding for tissue ingrowth. This study failed to show a difference with the use of small intestine submucosa mesh 1 year after anterior compartment prolapse surgery when compared with native tissue surgery. Presently we

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cannot recommend the use of small intestine submucosa mesh to reinforce anterior compartment prolapse repair. REFERENCES 1. Jelovsek JE, Maher C, Barber MD. Pelvic organ prolapse. Lancet 2007;369:1027–38. 2. Hendrix SL, Clark A, Nygaard I, Aragaki A, Barnabei V, McTiernan A. Pelvic organ prolapse in the Women’s Health Initiative: gravity and gravidity. Am J Obstet Gynecol 2002; 186:1160–6. 3. Lee U, Wolff EM, Kobashi KC. Native tissue repairs in anterior vaginal prolapse surgery: examining definitions of surgical success in the mesh era. Curr Opin Urol 2012;22:265–70. 4. Maher C, Feiner B, Baessler K, Schmid C. Surgical management of pelvic organ prolapse in women. The Cochrane Database of Systematic Reviews 2013, Issue 4.Art No.: CD004014. DOI: 10.1002/14651858.CD004014.pub5. 5. Hodde J. Extracellular matrix as a bioactive material for soft tissue reconstruction. ANZ J Surg 2006;76:1096–100. 6. Clarke KM, Lantz GC, Salisbury KS, Badylak SF, Hiles MC, Voytik SL. Intestine submucosa and polypropylene mesh for abdominal wall repair in dogs. J Surg Res 1996;60:107–14. 7. Feldner PC, Castro RA, Cipolotti LA, Delroy CA, Sartori MG, Girão MJ. Anterior vaginal wall prolapse: a randomized controlled trial of SIS graft versus traditional colporrhaphy. Int Urogynecol J 2010;21:1057–63. 8. Bump RC, Mattiasson A, Bø K, Brubaker LP, DeLancey JO, Klarskov P, et al. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol 1996;175:10–7. 9. Swift SE, Tate SB, Nicholas J. Correlation of symptoms with degree of pelvic organ support in a general population of women: what is pelvic organ prolapse? Am J Obstet Gynecol 2003;189:372–7. 10. Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7) Am J Obstet Gynecol 2005;193:103–13. 11. Rogers RG, Coates KW, Kammerer-Doak D, Khalsa S, Qualls C. A short form of the pelvic organ prolapse/urinary incontinence sexual questionnaire (PISQ-12). Int Urogynecol J Pelvic Floor Dysfunct 2003;14:164–8. 12. Toozs-Hobson P, Freeman R, Barber M, Maher C, Haylen B, Athanasiou S, et al. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for reporting outcomes of surgical procedures for pelvic organ prolapse. Neurourol Urodyn 2012; 31:415–21. 13. Geoffrion R, Murphy M, Robert M, Birch C, Ross S, Tang S, et al. Vaginal paravaginal repair with porcine small intestine submucosa: mid-term outcomes. Female Pelvic Med Reconstr Surg 2011;17:174–9. 14. Weber AM, Walters MD, Piedmonte MR, Ballard LA. Anterior colporrhaphy: a randomized trial of three surgical techniques. Am J Obstet Gynecol 2001;185:1299–304. 15. Ross S, Robert M, Swaby C, Dederer L, Tang S, Birch C, et al. Transobturator tape compared with tension-free vaginal tape for stress incontinence–a randomized controlled trial. Obstet Gynecol 2009;114:1287–94. 16. Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting

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parallel group randomized trials. Ann Intern Med 2010;152: 726–32. 17. Sung VW, Rardin CR, Raker CA, LaSala CA, Myers DL. Porcine subintestinal submucosal graft augmentation for rectocele repair: a randomized controlled trial. Obstet Gynecol 2012; 119:125–33. 18. Mattingly RF, Thompson JD. Stress incontinence, urethrocele, and cystocele. In: Mattingly RF, Thompson JD, editors. TeLinde’s operative gynecology. 6th ed. Philadelphia (PA): Lippincott Williams & Wilkins; 1985. p. 612–6.

Appendix: Standardized Surgical Procedures for Anterior Repair Used in the Randomized Controlled Trial of Absorbable Mesh Augmentation Compared With No Mesh for Anterior Prolapse All women were placed in the modified lithotomy position, and Xylocaine with 1:100,000 epinephrine was infiltrated in the midline anterior vaginal wall extending from the urethrovesical junction to the vault (or cervix if present). A midline incision was undertaken and lateral dissection, bluntly or sharply, was performed to the level of the arcus tendineus fasciae pelvis (white line) extending along the white line from 1.5 cm lateral of the symphysis pubis to the ischial spine. 0 Vicryl sutures were used for the midline plication.18 The modified paravaginal repair was performed by placing sutures of 2-0 Prolene with the Capio suturecapturing device, 1 cm lateral to the ischial spine and 1.5 cm

from the symphysis, bilaterally. The Prolene sutures were then placed in the vaginal muscularis and endopelvic fascia complex to reapproximate the vaginal lateral sulci. If a hysterectomy had been performed with the surgery, the superior Prolene stitches were brought lateral to the cuff with incorporation of the uterosacral ligaments. To provide apical support, the superior margin muscularis and endopelvic fascia complex were fixed to the vaginal cuff or cervix (if present) using 0 Vicryl sutures. The mucosa was not trimmed and was closed in the midline with 2-0 Vicryl running interlocking closure. Any concomitant reconstruction surgery was carried out at the operating surgeon’s discretion. However, no other apical support procedure was performed at the time because the apical sutures of the anterior prolapse repair were considered adequate. In patients allocated to the Mesh Group, the repair was augmented using mesh but was otherwise identical to the no mesh procedure. The fixed Prolene sutures were placed along the edge of the trapezoidal mesh. From the superior edge along the lateral edge, a 1-cm wide strip was cut for 2–3 cm to form leg extensions that could reach lateral to the ischial spines. The mesh was placed along the anterior wall and trimmed proximally. The superior and inferior margins were fixed to the muscularis and endopelvic fascia complex with interrupted sutures of 2-0 Vicryl both in the midline and lateral to ensure that it remained flat. Cystoscopy was carried out at the completion of the procedure. At the completion of the repair, the vagina was packed with gauze lubricated with Premarin vaginal cream for 24 hours and an indwelling catheter was placed.

Obstetrics & Gynecology and Public Access A number of research-funding agencies now require or request authors to submit the postprint (the article after peer review and acceptance but not the final published article) to a repository that is accessible online by all without charge. Within medical research, three funding agencies in particular have announced such policies:

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The National Institutes of Health (NIH)1 2 The Howard Hughes Medical Institute (HHMI) 3 The WellcomeTrust

As a service to our authors, the journal’s publisher (Lippincott Williams & Wilkins; LWW) will identify to the National Library of Medicine (NLM) articles that require deposit. The journal’s author agreement form (available at http://www.greenjournal.org/misc/agreementform.pdf)provides the mechanism for identifying such articles. LWW will transmit the postprint of an article based on research funded in whole or in part by one or more of these three agencies to PMC.

References: 1. U.S. Departmentof Health and Human Services. National Institutes of Health public access. Availableat http://publicaccess.nih.gov/. Retrieved July 10, 2008. 2. Howard Hughes Medical Institute. HHMI & public access publishing. Available at: http://www.hhmi.org/about/research/journals/main?action=search. Retrieved July 10, 2008. 3. Wellcome Trust. Position statement in support of open and unrestricted access to published research. Available at: http://www.wellcome.ac.uk/About-us/Policy/Policy-and-position-statements/WTD002766.htm. Retrieved July 10, 2008.

Questions? Contact the Editorial Office at [email protected] or 202-314-2317. rev 7/2013

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Absorbable mesh augmentation compared with no mesh for anterior prolapse: a randomized controlled trial.

To compare anatomical and patient-reported outcomes at 12 months postoperatively for women who had anterior compartment pelvic organ prolapse (POP) su...
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