Tension-free vaginal mesh procedure for pelvic organ prolapse: A single-center experience of 310 cases with 1-year follow up
Satoru Takahashi md, Department of Urology, Nihon University School of Medicine, 30-1, Oyaguchikamimachi, Itabashi-ku, Tokyo 173-8610, Japan. Email: email@example.com
Objective: To prospectively evaluate the efficacy of a tension-free vaginal mesh (TVM) procedure for pelvic organ prolapse (POP).
Methods: Between December 2005 and April 2008, 310 female patients (mean age 67.2 years, range 42–84) with POP underwent TVM procedures at our institute. Fifty-six individuals were qualified as stage 2 according to the POP quantification system and 162 and 92 were stage 3 and 4, respectively. One hundred ninety-one patients underwent anterior TVM, and seven underwent posterior TVM. One hundred twelve cases underwent both anterior and posterior TVM procedures. Each patient was systematically assessed at 1, 3, 6 and 12 months after surgery. Quality of life (QOL) was also assessed by using the Short Form-36 and the prolapse-QOL questionnaires.
Results: Perioperative complications were the following: five bladder injuries (1.6%), no rectal injuries and three hemorrhages greater than 400 mL (1.0%). The anatomical cure rate (% stage 0 cases) at 3, 6 and 12 months after surgery were 94.1%, 93.5%, and 92.3%, respectively. Short Form-36 and prolapse-QOL parameters were significantly improved, and maintained during the follow-up period. Postoperative complications were the following: five pelvic hematomas (1.6%), one wound infection (0.3%), 10 vaginal mesh extrusions (3.2%), and three cases of pelvic pain (1.0%). Complications concerning lower urinary tract function were: eight cases of postoperative stress urinary incontinence (2.6%), three cases of transient urinary retention (1.0%), and two cases of de novo overactive bladder (0.6%).
Conclusions: The TVM procedure provides a good outcome at 1 year with a low incidence of surgical complications and recurrence. Further evaluation with a longer follow up is needed.
Pelvic organ prolapse (POP) is a major health-care problem that will increase as the population ages. It has been reported that 11% of women in the USA have surgery for POP or a related condition (e.g. urinary incontinence) by the age of 80 years.1 However, surgical treatment of POP is exposed to failure. Olsen et al. reported that there was a large proportion of repeat procedures for recurrence (29.2% of cases) and the time interval between repeat procedures decreased with each successive repair.1 The treatment failures could be attributable to the use of weak native tissues. Today, abdominal sacral colpopexy using synthetic mesh over the anterior and/or posterior vaginal wall seems to be the more reliable procedure for the cure of vaginal vault prolapse.2,3 Nevertheless, recurrence of cystocele after vaginal prolapse surgery is very common4 and some authors have suggested the transvaginal use of reinforcement mesh to improve anatomical results. Early experience showed that synthetic material could reduce the recurrence prolapse rate, but with notable adverse effects.5,6
The new surgical technique, known as the tension-free vaginal mesh (TVM) procedure, involves the implantation without suture of a synthetic mesh in areas of vesicovaginal and rectovaginal dissection spaces.7 We treated 310 cases with the TVM procedure, and prospectively evaluated its clinical efficacies during 1 year of follow up.
Between December 2005 and April 2008, 310 female patients with POP underwent the TVM procedure. The mean age was 67.2 years (range, 42–84). Fifty-six individuals were qualified as stage 2 in the POP quantification (POP-Q) system,8 and 162 and 92 were stage 3 and 4, respectively. After written informed consent was obtained, 191 patients with cystocele underwent anterior TVM (A-TVM), and seven patients with rectocele underwent posterior TVM (P-TVM). One hundred twelve cases with prolapse of the apical compartment underwent both anterior and posterior TVM (A & P-TVM) procedures. Among them, 26 cases with vault prolapse after hysterectomy were treated with a one-piece prosthesis (total TVM) (Table 1). Two hundred eight cases (67.1%) underwent a concomitant transobturator tape (TOT) sling procedure because of concurrent clinical or occult stress urinary incontinence (SUI) (121 and 87 cases, respectively). The occult SUI was confirmed using a 1-h pad test and/or a stress test with prolapse correction.
Table 1. Types of TVM surgeries and operating time and blood loss (n = 310)
|Anterior TVM†||57||29–122 (48.6)||3–120 (36.0)|
|A-TVM+TOT||134||25–142 (70.5)||3–432 (71.7)|
|Posterior TVM||5||35–130 (56.6)||19–145 (97.0)|
|P-TVM+TOT‡||2||27–165 (96.0)||7–49 (28.0)|
|A & P-TVM§||30||50–143 (83.0)||5–429 (66.8)|
|Total TVM||10||44–122 (71.6)||7–335 (59.6)|
|A & P/T-TVM+TOT§||72||58–215 (112.0)||5–440 (79.6)|
|Total||310||25–215 (74.8)||3–440 (63.7)|
The TVM surgical technique has been described previously.7 Briefly, a macroporous, monofilament polypropylene mesh (Gynemesh PS; Ethicon, Somerville, NJ, USA; 25 × 25 cm) is used in surgery. The mesh is cut into a similar shape as that used in the Prolift system (Ethicon; Somerville, NJ, USA). The procedure for the A-TVM begins with an anterior colpotomy. Cystocele correction warrants bilateral trans-obturator passage of the mesh in order to suspend it. On either side, both arms of the mesh are passed into the paravesical region using a modified Emmet needle. The anterior, sub-vesical strap is inserted in the arcus tendineus fasciae pelvis and the posterior, sub-vesical strap into the arcus tendineus 1 cm from the sciatic spine. As for the P-TVM to correct the rectocele and/or uterine prolapse, posterior colpotomy is performed longitudinally. The mesh is then transperineal. On either side, one strap of the mesh is passed into the pararectal space through the sacrosciatic ligament to become exteriorized in incisions located outside and below the anus. The mesh is pre-cut, and then adjusted according to the type of correction required. Traction over the exteriorized arms of the sling ensures correct positioning. After cystoscopy and digital examination of the rectum, the colpotomy is closed with a 2-0 Vicryl running suture without additional colpectomy. In case of a concomitant TOT procedure, additional 2-cm anterior colpotomy is placed at the mid-urethral portion, and a standard outside-in TOT procedure is applied.9 Finally, a vaginal compress is inserted for 24 h. Menopausal patients receive perioperative topical estriol treatment for 3 months.
In the outpatient unit, before and after surgery, all patients underwent a physical examination, including a urogynecological examination in the lithotomy position using the POP-Q system.8 The efficacies and complications of each patient were systematically assessed at 1, 3, 6 and 12 months after surgery. Patient QOL was also assessed with the Short Form (SF)-36 and prolapse-QOL (P-QOL) questionnaires at 6 and 12 months after surgery.10,11 The P-QOL questionnaire is a condition-specific instrument to assess QOL in women with POP conditions. The P-QOL questionnaire contains nine multi-item domains: General health perceptions, Prolapse impacts, Role limitations, Physical limitations, Personal relationships, Social limitations, Emotions, Sleep/energy, and Severity measures. Possible P-QOL scores range from 0 (best health perception) to 100 (worst health perception).11 At the time of this study, no validated P-QOL questionnaire in the Japanese version was present. The P-QOL questionnaire consists of questions that are quite similar in style to King's Health Questionnaire (KHQ).11,12 Therefore, we carefully translated the original P-QOL questionnaire into the Japanese version, according to the Japanese version of the KHQ12 and a conditionally Japanese-translated P-QOL questionnaire previously reported.13
The Wilcoxon rank-test was carried out to test for differences in the domains of the P-QOL questionnaire between the two points of assessment (before vs 6 and 12 months after surgery). P-values < 0.05 were considered statistically significant.
Mean operation time was 74.8 min (25–215) in all 310 cases. Mean operation time for A-TVM, A & P-TVM and total TVM were 48.6, 83.0 and 71.6 min, respectively (Table 1). Mean intraoperative blood loss was 63.7 mL (3–440). Three cases (1.0%) experienced significant bleeding (>400 mL), but no blood transfusion was required (Table 1). We experienced five bladder injuries (1.6%) and no rectal injuries. All bladder injuries were identified intraoperatively, and cautiously repaired with a 3-0 Vicryl running suture followed by mesh insertion as usual.
Anatomical cure rate (% stage 0 cases) at 3, 6 months and 1 year after surgery were 94.1%, 93.5%, and 92.3%, respectively (Table 2). During 1 year of follow up, 24 cases (7.7%) experienced recurrence of prolapse (15 stage 1, seven stage 2, and two stage 3) (Table 2). Among nine cases with stage 2 or 3 prolapse, seven required surgical repairs (five hysterectomies for uterine prolapse and two additional TVM procedures for untreated vaginal compartments). All the domains of the SF-36 and P-QOL questionnaires (General health perception, Prolapse impact, Role limitations, Physical limitations, Social limitations, Personal relationships, Emotions, Sleep/Energy, and Severity measures) were significantly improved at 6 months after surgery, and maintained during the 1-year follow-up period (all domains in the SF-36: P < 0.001, Personal relationships in P-QOL: P < 0.05, and others in P-QOL: P < 0.0001) (Figs 1,2). Less of an improvement in the Personal relationships domain seemed to be due to deterioration of sexual function within a relatively short-term period after surgery.
Table 2. Surgical outcomes of the tension-free vaginal mesh procedures during the 1-year follow up (n = 310)
|Preop. (n = 310)||0||0||56||162||92||—|
|3 months (n = 310)||292||10||7||1||0||94.1|
|6 months (n = 304)‡||290||12||2||0||0||93.5|
|1 year (n = 303)§||286||15||2||0||0||92.3|
Post-surgical complications were: five pelvic hematomas (1.6%), one wound infection (0.3%), 10 vaginal mesh extrusions (3.2%), and three cases of pelvic pain possibly due to mesh retractions (1.0%) (Table 3). Pelvic hematoma was identified with a postoperative decrease of hematocrit, and confirmed by pelvic computed tomography. However, no cases required blood transfusions or any interventions. Among 10 cases with vaginal mesh extrusion, two patients with minor lesions were cured with the removal of the extruded mesh and with topical estriol treatment at the outpatient unit. Eight cases required surgical repair consisting of mesh excision and vaginal suture under spinal anesthesia. Intermittent or consistent pelvic pain (not dyspareunia) were identified in three cases without any abnormal laboratory or image findings. All cases could be managed conservatively with administration of NSAIDs.
Table 3. Perioperative and postoperative complications of tension-free vaginal mesh procedures during 1-year follow up (n = 310)
|Bladder injury||5 (1.6)|
|Rectal injury||0 (0)|
|Vaginal hematoma||5† (1.6)|
|Mesh extrusion||10 (3.2)|
|Pain (mesh retraction)||3 (1.0)|
|Urinary retention||3‡ (1.0)|
|Postoperative SUI||8 (2.6)|
|De novo OAB||2 (0.6)|
Complications concerning lower urinary tract function were: eight cases of postoperative SUI (2.6%), three cases of transient urinary retention (1.0%), and two cases of de novo overactive bladder (OAB) (0.6%) (Table 3). As for stress urinary incontinence, seven of 102 cases (6.9%) who underwent TVM alone showed de novo SUI postoperatively. Of these, two underwent the TOT procedure 1 year after surgery. In contrast, 207 of 208 cases (99.5%) who underwent the TOT concomitant with TVM experienced a cure of SUI (no significant complaint of SUI and less than 2 g in a 1-h pad test), and no patients experienced deterioration of SUI. De novo OAB was found in one case in each of the groups, but symptoms were temporary and resolved within 3 months after surgery. Only three cases with concomitant TOT sling experienced postoperative voiding difficulty, which required a transient catheterization for 1–2 weeks and was resolved promptly. No cases without concomitant TOT needed the catheterization for voiding difficulty after surgery.
This 1-year evaluation in a single institute has shown favorable results of the TVM procedure with regard to restoration of anatomical support and disease-specific quality of life. The present study has also demonstrated that TVM techniques can be performed with a relatively low rate of complications following the standardized protocol. The overall anatomical cure rate was 92.3% at 1 year, and comparable to the results of a recent, randomized, controlled trial (RCT) using non-standardized polypropylene mesh at anterior repair.14 This RCT demonstrated significant superiority of the non-absorbable mesh repair, compared with conventional anterior colporrhaphy (anatomical cure rate: 93.3% vs 61.5% at 1 year, respectively, P < 0.001). Very recently, Cosson et al. reported 3-year outcomes of total TVM with 81% of anatomical cure rate.15 Further studies are necessary to prospectively determine if the high success rates achieved at short/medium term are sustainable for the longer follow-up periods. Some recurrent prolapses can occur after mesh reinforcement: shrinkage or displacement of the mesh may cause weakness of a given area of the vaginal wall. The wide positioning of the synthetic mesh overlay is necessary to prevent excessive folding and to reduce such complications.16 Also we experienced five cases with recurrent uterine prolapse, which required vaginal hysterectomy. Recently-published clinical guidelines on vaginal graft use from the Society of Gynecologic Surgeons indicated that nonabsorbable synthetic mesh may improve anatomical outcomes of anterior vaginal wall repair. However, there are no comparative studies to guide any recommendation on the use of it in posterior vaginal wall (or multiple compartment) repair when compared with native tissue repair.17 Because the uterine prolapses possibly attributed to suture detachment between meshes and uterine cervix, we have recently reinforced attachment of anterior and posterior meshes to the uterine cervix with three sutures each. Subsequently, recurrences of the apical compartment have not been observed. Longer follow up is needed to prove the usefulness of this technical modification.
Perhaps even more important than the anatomical outcomes were the major improvements in all QOL domains measured with the SF-36 and P-QOL questionnaires. The improvements were sustained until 1 year after surgery. The present study demonstrated that TVM induced rapid and persistent improvements of QOL in women with POP. Reduced improvement of the Personal relationships domain seemed to be due to deterioration of sexual function within relatively short-term periods after surgery.11 Patients were instructed to abstain from sexual intercourse during the first 3 months after surgery, which might have influenced the patients' sexual behaviors.
In the present study, the incidence of perioperative and postoperative complications were comparable with that of previous reports, and no serious complications have been observed.18 The combined data from recent large studies suggest that pelvic organ injury occurs in 3–4.5% of transvaginal mesh procedures, and particular care should be taken to avoid and detect pelvic organ perforation at the time of operation.7,15,18–20 When using surgical techniques involving permanent biomaterials, specific mesh-related complications, such as mesh extrusion, infection and retraction, must be considered. We experienced 10 cases (3.2%) with mesh extrusion. Because of high incidence of mesh extrusion in the initial 100 cases, we have changed a dissecting plane of the vaginal wall, from submucosal into fully thick vaginal wall. Subsequently, no mesh extrusions have been identified in the last 100 cases. Collinet et al. reported that the incidence of mesh exposure was 12.3%.7 Other risk factors of mesh exposure were concomitant hysterectomy and inverted T colpotomy.7,15 Polypropylene mesh retraction is considered to be due to fibrosis of the surrounding tissues rather than a diminution of the mesh itself.19 A retrospective study with 684 cases recently reported 11.7% of mesh retraction with pain.20 They found a significant correlation between retraction and vaginal extrusion (P = 0.01), suggesting that early care of vaginal extrusion could prevent secondary retraction.
The present study demonstrated that postoperative complications related with lower urinary tract function, such as urinary retention and de novo OAB, were rare. Furthermore, a concomitant TOT sling may prevent postoperative SUI. Huang et al. reported favorable results of concomitant traditional POP surgeries (without mesh augmentation) with the TVT procedure for the treatment of POP concurrent with SUI.21 Of 310 cases in the present study, we performed concomitant TOT sling in 121 patients (39%) with clinical SUI and 87 cases (28%) with occult SUI confirmed by a 1-h pad test and/or stress test with prolapse correction. Very recently, a retrospective review of 335 women with stage 2 or worse vaginal prolapse who had undergone Prolift surgery, demonstrated a postoperative de novo SUI rate of 24.3%.22 Arriola et al. reported that a preoperative urodynamic study identified occult SUI in 24 of 38 cases (63.2%) with stage 3 or 4 vaginal prolapse. Subsequently, these patients underwent mid-urethral sling concomitant with Prolift surgery, and 23 of them (96%) experienced no postoperative SUI.23 At present, no standard criteria for indication of concomitant anti-incontinence surgery with the TVM procedure have been established. Further studies remain necessary.
In conclusion, TVM reconstruction for POP is associated with satisfactory subjective and objective clinical outcomes at 1 year after surgery. However, our study revealed a certain number of mesh-related complications and recurrence of uterine prolapse. Further evaluations with longer follow up and technical modifications to prevent complications and recurrence of prolapse are needed.