Objective
The objective of the study was to compare anterior colporrhaphy with and without a mesh.
Study Design
Two hundred two women with anterior prolapse were assigned to undergo colporrhaphy alone or reinforced with a tailored polypropylene mesh. Before and 2, 12, 24, and 36 months after surgery, the outcome was assessed by examination and standard questions. The primary endpoint was anatomic recurrence of anterior vaginal prolapse. Secondary outcomes were symptom resolution, reoperation, and mesh exposure.
Results
Recurrences of anterior vaginal prolapse were noted in 40 of the 97 (41%) in the colporrhaphy group and 14 of 105 (13%) in the mesh group ( P < .0001). The number needed to treat was thus 4. The proportion of symptomatic patients, including those with dyspareunia, did not differ between the groups. The mesh erosion rate was 19%.
Conclusion
At 3 year follow-up, anterior colporrhaphy with mesh reinforcement significantly reduced anatomic recurrences of anterior vaginal prolapse, but no difference in symptomatic recurrence were noted and the mesh erosion rate was high. The use of mesh was not associated with an increase in dyspareunia.
Almost 10% of women need surgery for pelvic organ prolapse, urinary incontinence, or both during their lifetime, and 30% of them will undergo 2 or more surgical procedures. Prolapse of the anterior vaginal wall (cystocele) is the most common and typical segment requiring surgical repair. It has traditionally been treated with anterior colporrhaphy, which entails central plication of the fibromuscular layer of the anterior vaginal wall. Recurrent anterior vaginal wall prolapse after conventional repair has occurred in more than 30% of the cases.
In an effort to improve outcomes in transvaginal prolapse repair, a number of biologic and synthetic graft materials have been introduced to complement, reinforce, or replace native tissue in reconstructive surgical procedures. The use of synthetic graft material for repair of the anterior vaginal wall prolapse has been limited by possible adverse events related to the mesh (ie, graft erosion, dyspareunia, pelvic pain, and urinary incontinence). The literature on graft use is increasing, but there are few randomized controlled trials comparing the efficacy of transvaginal prolapse repair with or without graft material.
We here conducted a prospective randomized study with a 3 year follow-up to determine whether reinforcement of traditional anterior colporrhaphy with a synthetic polypropylene mesh would reduce the frequency of recurrences in women with anterior vaginal wall prolapse and to explore whether synthetic mesh is associated with any adverse effects. The outcomes of 12 and 24 month follow-up have been reported previously.
Materials and Methods
Participants were recruited from the Departments of Obstetrics and Gynecology at 4 central hospitals and 1 university hospital in Finland between April 2003 and May 2005. The institutional review board approved the study protocol in each hospital.
Women with symptomatic anterior vaginal wall prolapse to the hymen or beyond and referred for reconstructive pelvic surgery were eligible for inclusion. Patients requiring concomitant vaginal vault suspension such as sacrospinous ligament fixation or sacrocolpopexy for vaginal prolapse or uterine procidentia or surgery for stress urinary incontinence or laparotomy or laparoscopy for any reason were excluded. Undergoing other prolapse repairs did not preclude study participation and did not affect group assignment.
Each patient accepted the study protocol and treatment allocation, including the possible placement of the synthetic mesh, and gave written informed consent before being randomly assigned.
Details of the study methods have been published elsewhere. Patients’ symptoms were evaluated by both standard questions put by the examining physician and a questionnaire filled in by the patients. The details of our nonvalidated questionnaire and the scoring of the answers were as in the appendix of our previously published article. The questionnaire included questions concerning sensation of vaginal bulge, pelvic pressure, difficulties in emptying the bladder or bowel, coital frequency, satisfaction, ability to reach orgasm, and dyspareunia. All the answers were given points from 1 to 5, 1 equaling normal or good and 5 poor or abnormal situation.
Each participant underwent a comprehensive physical examination, including assessment of prolapse by pelvic organ prolapse quantification (POP-Q) as recommended by the International Continence Society. The postvoidal residual urine volume was measured by catheterization.
A study nurse in Tampere University Hospital randomized the patients by taking a card from an opaque envelope, and the surgeons obtained the randomization group by telephone call. A statistician drew up a computer-generated randomization list used. The patients were allocated to 1 of the 2 groups. The first underwent traditional anterior colporrhaphy and the second anterior colporrhaphy reinforced with a polypropylene mesh.
Details of the operative procedures have been described previously. Briefly, anterior colporrhaphy was performed through a midline vaginal dissection, involving separation of the vaginal epithelium from the fibromuscular layer, midline plication of the fibromuscular layer using horizontal stitches, excision of excess vaginal mucosa, and closure with continuous suture.
In the mesh group, after plication of the fibromuscular layer, a monofilament polypropylene patch of 6 × 11 cm (Parietene light; Sofradim Co, Trévoux, France) self-tailored with 4 arms extending toward the retropubic space and the ischial spines, was placed subepithelially. Concurrent surgery such as vaginal hysterectomy, resection of the enterocele, culdoplasty, or posterior colporrhaphy was performed if indicated. At the close of the procedure, a Foley catheter and vaginal packing were inserted for 20 hours.
The patients were evaluated 2, 12, 24, and 36 months postoperatively in the same manner as preoperatively: standard questions on symptoms, a questionnaire, gynecologic examination including assessment of prolapse by the POP-Q system, and postvoidal residual urine measurement. Blinding of outcome assessment was not done. Patients who had been reoperated no longer attended the follow-up visits thereafter, and the data recorded at their last visit prior to reoperation were included in the analysis and likewise data on patients who did not complete the 3 year follow-up.
The patient was regarded as having completed the follow-up if she attended the 36 month visit with both POP-Q assessment and the questionnaires. The analysis of the follow-up was assessed by the intent-to-treat method.
The primary outcome in the trial was anatomic recurrence of anterior vaginal wall prolapse within 3 years after repair. The outcome was considered an anatomic failure if either point Aa or Ba was at stage II or beyond (–1 cm or greater) by the POP-Q system. Secondary outcomes included symptom resolution, reoperation rate, mesh exposure, and postvoidal urine residual.
Power calculations were initially made with recurrent anterior vaginal wall prolapse reaching stage II in the POP-Q classification as the primary endpoint. The recurrence rate was assumed to be 20% with the traditional and 5% with the mesh technique, and the dropout rate 15%. With 80% power and a 5% type I error, the total number of patients was 202. The Student t test was used for continuous data and the χ 2 test for nominal or ordinal data. Kaplan-Meier estimates of time until failure were made and compared with log rank test. An SPSS 17.0 for Windows (SPSS Inc, Chicago, IL) software package was used for statistical analysis.
Results
Two hundred two women were assigned to either the traditional anterior colporrhaphy group or the group with anterior colporrhaphy reinforced with mesh. Figure 1 shows the stages of the trial with patient follow-up. One patient in the no-mesh group did not attend the 12 month visit and could not be contacted thereafter; in the mesh group, 1 patient could not attend the 36 month visit because of severe illness and another refused examination without specifying the reason. None of the 6 deaths were related to the operation, and the minimum time period between operation and time of death was 22 months. Eighty-nine percent of the patients in the no-mesh and 92% in the mesh group completed the 36 month follow-up ( Figure 1 ).
Demographic and clinical features and concomitant surgery were similar in the groups ( Table 1 ). A total of 16 patients in the no-mesh group (16%) and 13 in the mesh group (12%) underwent anterior repair only, without concomitant surgery. Details of the index surgery and short-term complications and outcomes have been reported elsewhere.
| Characteristics | No mesh (n = 97) | Mesh (n = 105) |
|---|---|---|
| Age, y | 65 ± 9 | 66 ± 9 |
| Parity | 2 (1-10) | 3 (0-11) |
| Coexisting condition, total | 68 (70) | 78 (74) |
| Coronary heart disease | 9 (9) | 10 (10) |
| Hypertension | 41 (41) | 48 (46) |
| Pulmonary disease | 6 (6) | 17 (16) |
| Diabetes | 6 (6) | 9 (9) |
| Smokers | 14 (14) | 14 (13) |
| Others | 22 (23) | 21 (20) |
| Body mass index, kg/m 2 | 27.2 ± 4.1 | 26.5 ± 3.5 |
| With estrogen treatment | 81 (84) | 90 (86) |
| Previous hysterectomy | 27 (28) | 23 (22) |
| Previous hysterectomy for prolapse | 7 (7) | 6 (6) |
| Previous anterior repair | 14 (14) | 12 (11) |
| Previous posterior repair | 12 (12) | 13 (12) |
| Previous incontinence operation | 7 (7) | 4 (4) |
| Concomitant procedures | ||
| Hysterectomy | 47 (48) | 63 (61) |
| Enterocele repair | 35 (36) | 35 (34) |
| Posterior colporrhaphy | 67 (69) | 75 (72) |
Three years after surgery, a total of 40 of 97 patients in the no-mesh (41%) and 14 of 105 in the mesh group (13%) were diagnosed as having had a recurrent anatomic anterior vaginal wall prolapse ( P < .0001). The number needed to treat for benefit was thus 4. Nine patients in the no-mesh group (9%) and 16 in the mesh group (15%) suffered apical or posterior prolapse during the follow-up period ( P = .21). For all types of recurrence, including anterior, posterior, and apical prolapse, the figures were 49 (51%) vs 30 (29%) ( P = .002).
Figure 2 shows the Kaplan-Meier curves of the recurrent prolapses of the anterior vaginal wall and recurrent prolapses of the vaginal apex and posterior vaginal wall. The mean estimated time interval to recurrence of the anterior vaginal wall prolapse was 26 months for the no-mesh group and 34 months for the mesh group ( P < .0001), whereas for other prolapse types, it was 34 vs 33 months ( P = .54), respectively.
The pre- and postoperative POP-Q values for the anterior vaginal wall (points Aa and Ba) were statistically significantly closer to normal in the mesh group, whereas those for prolapses of posterior vaginal wall, vaginal apex, genital hiatus, or perineal body did not differ significantly between the groups ( Table 2 ). Sixty-three patients in the no-mesh group (65%) had anterior vaginal wall (points Aa and Ba) above the 0 point (hymen) and 95 (91%) in the mesh group ( P < .0001).
| POP-Q measurements, cm | Variable | No mesh (n = 97) | Mesh (n = 104) | P value |
|---|---|---|---|---|
| Aa | Preoperative | 1.7 ± 1.0 | 1.5 ± 1.1 | .4 |
| Postoperative | –1.4 ± 1.5 | –2.4 ± 0.9 | < .0001 | |
| Ba | Preoperative | 2.3 ± 1.7 | 2.1 ± 1.8 | .5 |
| Postoperative | –1.5 ± 1.8 | –2.4 ± 0.9 | < .0001 | |
| C | Preoperative | –3.2 ± 3.0 | –2.9 ± 3.3 | .4 |
| Postoperative | –6.9 ± 2.3 | –7.5 ± 2.1 | .07 | |
| gh | Preoperative | 4.6 ± 0.9 | 4.6 ± 0.9 | .6 |
| Postoperative | 3.6 ± 0.8 | 3.5 ± 1.0 | .4 | |
| pb | Preoperative | 3.3 ± 0.8 | 3.1 ± 0.8 | .12 |
| Postoperative | 3.6 ± 1.1 | 3.5 ± 0.7 | .5 | |
| tvl | Preoperative | 8.7 ± 3.2 | 8.9 ± 2.6 | .7 |
| Postoperative | 8.3 ± 2.7 | 8.4 ± 2.7 | .8 | |
| Ap | Preoperative | –1.4 ± 1.1 | –1.5 ± 1.0 | .6 |
| Postoperative | –2.2 ± 1.2 | –2.3 ± 1.0 | .2 | |
| Bp | Preoperative | –1.6 ± 1.3 | –1.5 ± 1.3 | .5 |
| Postoperative | –2.2 ± 1.2 | –2.3 ± 1.1 | .9 |
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