Objective
The objective of the study was to compare recurrence and complication rates for sacrospinous fixation (SSF) and prolene mesh techniques for the primary treatment of posthysterectomy vaginal vault prolapse.
Study Design
Patients undergoing surgery for vault prolapse were included in a multicenter, randomized, controlled study comparing SSF or total mesh (Prolift; Gynecare/Ethicon, Somerville, NJ). The examination included pelvic organ prolapse quantification, urodynamics, ultrasound, and quality-of-life (QoL) questionnaires before and 3 and 12 months after surgery.
Results
Of 168 randomized patients, 83 underwent SSF and 85 mesh repair. Prolapse recurrence after 12 months occurred in 39.4% of the SSF group and in 16.9% of the mesh group ( P = .003). The mesh exposure rate was 20.8%. No difference in QoL improvement as well as of de novo stress urinary incontinence and overactive bladder onset was found.
Conclusion
Mesh exposure occurrence was balanced against a lower prolapse recurrence rate in the patients undergoing mesh surgery compared with those undergoing SSF.
Increasing life expectancy has resulted in a growing number of older women seeking gynecological care. According to Babalola et al, pelvic organ prolapse (POP) is the most frequent gynecological pathology leading to hysterectomy in women older than 55 years of age. In an epidemiological study, Olsen et al estimated that 11% of all women will undergo surgery for POP during their lifetime and that 30% of these women will require reoperation for prolapse recurrence.
Studies on etiology and genetic influence that are aimed at elucidating this problem are still ongoing. Vaginal vault prolapse after previous hysterectomy represents a distressing condition not only for the patient but also for the surgeon. The abdominal sacrocolpopexy has become the standard abdominal procedure to correct POP; in the past century the Amreich-Richter sacrospinous fixation (SSF) has been used widely as a vaginal surgical approach.
In the past decade, different heterologous meshes for the treatment of prolapse have been introduced in an effort to improve long-term results with vaginal POP surgery. The use of artificial meshes has a long tradition in abdominal wall surgery. Ulmsten and Petros demonstrated the successful use of polypropylene vaginal tape for the treatment of urinary incontinence, and monofilament macroporous prolene has become the most widely recommended material also for POP correction. This material should reinforce weak suspension structures and generate neofibrosis.
In 2004, the US Food and Drug Administration (FDA) approved the first commercially available system of polypropylene mesh for introduction into vesicovaginal and rectovaginal spaces (Prolift; Gynecare/Ethicon, Somerville, NJ). Currently, only a few randomized trials comparing classical methods with artificial meshes have been reported. Therefore, this study was designed to compare the clinical efficacy and complication rates between traditional techniques and meshes in a prospective randomized study.
The primary objective of our study was to compare prospectively a mesh technique (Prolene surgical kit Prolift) with the sacrospinous fixation in terms of prolapse recurrence. Secondary objectives were to compare the sacrospinous fixation and mesh procedures with respect to complications and changes in quality of life (QoL).
Materials and Methods
In January 2007, a multicenter, prospective, randomized, comparative study in 5 tertiary, accredited urogynecological centers in the Czech Republic was approved by the Ethical Committee of Charles University in Prague and registered with the FDA (evidence no. NCT00572702 ). The study was planned to be consistent with the Consort recommendations. At each department, 2 experienced surgeons participated after previous central standardization and control of the techniques. Informed consent, including information regarding the random allocation to different surgical techniques, was obtained from all patients scheduled for surgery for vaginal prolapse with objectively verified symptoms by pelvic organ prolapse quantification (POP-Q) stage II or greater according to the International Continence Society standard. Patients who had a pelvic malignancy, who were younger than 18 years of age, who had a history of radiotherapy of the pelvis, or were requiring hysterectomy were excluded.
The cohort of 180 consecutive patients with central posthysterectomy vaginal vault prolapse was assessed for eligibility and 168 patients underwent randomization into 2 groups: the SSF group (n = 83), treated with the sacrospinous fixation, and the mesh group (n = 85), treated using the total Prolift mesh.
Baseline assessments before surgery included a history and physical examination (including POP-Q examinations on maximum Valsalva effort in the lithotomy position and urodynamic testing). For urodynamics, the bladder was filled to 200 mL when urethral profilometry was performed, followed by perineal and vaginal ultrasound (5 MHz curved array probe and 7.5 MHz curved array probe) both at rest and with Valsalva to measure the p distance (distance between lower edge of symphysis and urethrovesical junction) and the γ angle (angle between the urethral and pubic axis). Finally, condition-specific QoL and the effect of complications (eg, protruding vaginal wall, dyspareunia, pain, voiding, and bowel dysfunction), were assessed using validated QoL questionnaires. Sexual life satisfaction, impact of urinary dysfunction, bowel dysfunction, and harmful effects of prolapse on QoL were assessed by the Prolapse Impact Sexual Questionnaire (PISQ–short form), the Urinary Impact Questionnaire (UIQ), the Colorectoanal Impact Questionnaire (CRAIQ), and the Pelvic Organs Prolapse Impact Questionnaire (POPIQ), respectively. The QoL instruments and the physical examination were repeated at 3 and 12 months after surgery.
Standardized guidelines based on the literature and manufacturers’ recommendations for both surgical procedures were provided to all the participating centers, and the main investigator (M.H.) intermittently monitored (via personal visits) the surgeries every 6 months. All participating surgeons were experienced in pelvic surgery and performed at least 20 of each of the 2 procedures before the start of the study.
SSF group
The surgical procedure begins with anterior and posterior median colpotomy and dissection of urethrovesical/rectovaginal spaces. Reconstruction of the anterior compartment (anterior repair) was followed by visualization of a right sacrospinous ligament: 2 nonabsorbable stitches (Nurolon; Gynecare/Ethicon) were anchored here and fixed to the vaginal cuff apex. A moderate excision of the redundant vaginal wall followed. If necessary, posterior repair with approximation of the levator muscles was performed. The suturing of the colpotomy with subsequent knotting of the SSF stitches elevated the vagina into its final position.
SSF group
The surgical procedure begins with anterior and posterior median colpotomy and dissection of urethrovesical/rectovaginal spaces. Reconstruction of the anterior compartment (anterior repair) was followed by visualization of a right sacrospinous ligament: 2 nonabsorbable stitches (Nurolon; Gynecare/Ethicon) were anchored here and fixed to the vaginal cuff apex. A moderate excision of the redundant vaginal wall followed. If necessary, posterior repair with approximation of the levator muscles was performed. The suturing of the colpotomy with subsequent knotting of the SSF stitches elevated the vagina into its final position.
Mesh group
An iodoform gauze wick was inserted into the anus and rectum and left until the end of the surgery. Hydrodissection of the vaginal wall and underlying pubocervical fascia was followed by the blunt preparation of the arcus tendineus fasciae pelvis and sacrospinous ligament. Next, we inserted Prolift cannulas (original Prolift; Gynecare/Ethicon) with retrieval loops. Surgical drapes and gloves were changed before the placement of mesh straps. Both anterior and posterior dissections for insertion of the total mesh were performed preserving the integrity of the vaginal cuff apex, and also against the peritoneal cavity, creating a tunnel for the proximal part of the implant. The mesh was then pushed through this tunnel, and the arms were verified and inserted. Distal edges of the mesh were fixed by sutures of PDS 2-0 to the pubocervical fascia and vaginal wall. Colpotomy was closed using single-knotted stitches. The tension of the mesh arms was carefully adjusted and finally the skin incision sutures followed. Prophylactic application of second-generation cephalosporin as well as vaginal packing with estrogen cream applied for 48 hours was administered to both groups.
Operation time and blood loss (measured by volumometry and weighing of towels) and intraoperative and postoperative complications were recorded, including excessive bleeding during the operation (>500 mL), bladder and bowel injury, hematoma, abscess, fistula creation, lower urinary tract infection, mesh exposure (defined as any occurrence of prolene mesh in the vagina or adjacent organs), prolapse recurrence, de novo stress urinary incontinence (SUI), de novo urgency, pelvic pain, and dyspareunia. Prolapse recurrence was defined as stage II or greater descent according to the International Continence Society pelvic organ prolapse quantification system.
Random allocation to surgery was performed by one person (O.S.) using a computer-generated random sequence of zeros and ones.
Based on previous experience, the prolapse recurrence rate after surgery was estimated to be 10-40%. Thus, to detect (Fisher exact test, 2-sided alternative) a difference of 20% between the 2 procedures, a sample size of 140 patients (70 in each group) was required for a power of 0.70. Statistical evaluation of the data included descriptive statistics (sample mean and SD), parametric analysis (2-sample Student t tests, paired Student t tests, analysis of variance) for normal data and nonparametric analysis (Wilcoxon test and Kruskall-Wallis test) for nonnormal data. Analysis in the contingency tables (χ 2 test and Fisher exact test for tables with small counts) was used to assess categorical variables.
To ensure statistical power for the 2-sample Student t test sample sizes in the study, 2-sided alternatives 0.26 for small effects (defined by 20% of the variance) and 0.91 for moderate effects (defined by 50% of the variance) were calculated. Very similar values could be estimated for the χ 2 test (Fisher test) for a moderate effect (0.24) and for a medium effect (0.96). Statistical analysis was performed using SAS for Windows, version 9.0 (SAS Institute, Cary, NC).
Results
A cohort of 180 patients was assessed for eligibility; of these 180 patients, 168 were randomized to the 2 surgical groups ( Figure 1 ). At the 3-month and 12 month follow-up visits, 152 patients and 151 patients, respectively, were assessed. Table 1 presents demographic and occupational characteristics of the cohort. There were no statistically significant differences in demographic and occupational characteristics between the SSF and mesh groups. Most of the patients were in their 60s (the mean age of both groups was 66.4 years) and of similar body mass (body mass index of 27.3 and 26.8 kg/m 2 in the SSF and mesh groups, respectively). Concerning workload, although there were no significant differences between the 2 groups, there was a trend for patients in the mesh group to more often be engaged in hard physical work than for those in the SSF group.
| Variable | SSF | MESH | P value |
|---|---|---|---|
| Number of patients | 83 | 85 | |
| Age (SD) | 66.41 (9.62) | 63.37 (10.12) | .48 |
| Body mass index (SD) | 27.62 (3.80) | 26.81 (3.73) | .15 |
| Parity (SD) | 2.32 (0.68) | 2.08 (0.71) | .37 |
| Headwork, % | 32.4 | 33.3 | .08 |
| Light physical work, % | 35.1 | 24.4 | |
| Hard physical work, % | 32.4 | 42.2 |
Table 2 presents the rates of prolapse recurrence and complications by groups. The prolapse recurrence rate was significantly higher at 12 months in the SSF group (39.4%) than in the mesh group (16.9%; P = .003). The most common location of recurrence in the SSF group was the anterior compartment (16 of 28, 57.1 %). However, only 1 patient in this subgroup was symptomatic and required reoperation using anterior Prolift. Two more reoperations were required after apical prolapse recurrence, which was seen in 3 of 28 (10.7%) cases. These recurrences were treated by total Prolift or colpocleisis.
| Variable | 3 months | 12 months | ||||
|---|---|---|---|---|---|---|
| SSF | MESH | P value | SSF | MESH | P value | |
| Number of patients | 73 | 79 | 72 | 79 | ||
| Severe bleeding | 6 (8.2%) | 10 (12.7%) | .44 | |||
| Hematoma | 0 | 1 (1.3%) | 1 | |||
| Bladder injury | 1 (1.4%) | 3 (3.8%) | .62 | |||
| Bowel injury | 0 | 0 | 0 | |||
| Abscess | 0 | 1 (1.3%) | 1 | |||
| LUT infections a | 5 (6.9%) | 1 (1.3%) | .11 | 5 (6.9%) | 3 (3.8%) | .48 |
| Mesh exposure a | NA | 12 (15.6%) | NA | NA | 16 (20.8%) | NA |
| Prolapse recurrence a | 13 (18.3%) | 6 (7.8%) | .08 | 28 (39.4%) | 13 (16.9%) | .003 |
| De novo SUI a | 18 (25.4%) | 21 (27.3%) | .85 | 18 (25.4%) | 27 (35.1%) | .16 |
| De novo OAB b | 9 (12.7%) | 7 (9.1%) | .60 | 8 (14.5%) | 8 (10.8%) | .60 |
| Dyspareunia b | 2 (2.8%) | 7 (9.1%) | .17 | 2 (3.7%) | 6 (8.0%) | .47 |
| Pelvic pain b | 3 (4.2%) | 8 (10.4%) | .21 | 3 (5.5%) | 6 (8.1%) | .73 |
Stay updated, free articles. Join our Telegram channel
Full access? Get Clinical Tree
