Background: The use of standardized mesh kits for repair of pelvic-organ prolapse has spread rapidly in recent years, but it is unclear whether this approach results in better outcomes than traditional colporrhaphy. Methods: In this multicenter, parallel-group, randomized, controlled trial, we compared the use of a trocarguided, transvaginal polypropylene-mesh repair kit with traditional colporrhaphy in women with prolapse of the anterior vaginal wall (cystocele). The primary outcome was a composite of the objective anatomical designation of stage 0 (no prolapse) or 1 (position of the anterior vaginal wall more than 1 cm above the hymen), according to the Pelvic Organ Prolapse Quantification system, and the subjective absence of symptoms of vaginal bulging 12 months after the surgery. Results: Of 389 women who were randomly assigned to a study treatment, 200 underwent prolapse repair with the transvaginal mesh kit and 189 underwent traditional colporrhaphy. At 1 year, the primary outcome was significantly more common in the women treated with transvaginal mesh repair (60.8%) than in those who underwent colporrhaphy (34.5%) (absolute difference, 26.3 percentage points; 95% confidence interval, 15.6 to 37.0). The surgery lasted longer and the rates of intraoperative hemorrhage were higher in the mesh-repair group than in the colporrhaphy group (P < 0.001 for both comparisons). Rates of bladder perforation were 3.5% in the mesh-repair group and 0.5% in the colporrhaphy group (P = 0.07), and the respective rates of new stress urinary incontinence after surgery were 12.3% and 6.3% (P = 0.05). Surgical reintervention to correct mesh exposure during follow-up occurred in 3.2% of 186 patients in the mesh-repair group. Conclusions: As compared with anterior colporrhaphy, use of a standardized, trocar-guided mesh kit for cystocele repair resulted in higher short-term rates of successful treatment but also in higher rates of surgical complications and postoperative adverse events. (Funded by the Karolinska Institutet and Ethicon; ClinicalTrials. gov number, NCT00566917.).

Background: The use of standardized mesh kits for repair of pelvic-organ prolapse has spread rapidly in recent years, but it is unclear whether this approach results in better outcomes than traditional colporrhaphy. Methods: In this multicenter, parallel-group, randomized, controlled trial, we compared the use of a trocarguided, transvaginal polypropylene-mesh repair kit with traditional colporrhaphy in women with prolapse of the anterior vaginal wall (cystocele). The primary outcome was a composite of the objective anatomical designation of stage 0 (no prolapse) or 1 (position of the anterior vaginal wall more than 1 cm above the hymen), according to the Pelvic Organ Prolapse Quantification system, and the subjective absence of symptoms of vaginal bulging 12 months after the surgery. Results: Of 389 women who were randomly assigned to a study treatment, 200 underwent prolapse repair with the transvaginal mesh kit and 189 underwent traditional colporrhaphy. At 1 year, the primary outcome was significantly more common in the women treated with transvaginal mesh repair (60.8%) than in those who underwent colporrhaphy (34.5%) (absolute difference, 26.3 percentage points; 95% confidence interval, 15.6 to 37.0). The surgery lasted longer and the rates of intraoperative hemorrhage were higher in the mesh-repair group than in the colporrhaphy group (P < 0.001 for both comparisons). Rates of bladder perforation were 3.5% in the mesh-repair group and 0.5% in the colporrhaphy group (P = 0.07), and the respective rates of new stress urinary incontinence after surgery were 12.3% and 6.3% (P = 0.05). Surgical reintervention to correct mesh exposure during follow-up occurred in 3.2% of 186 patients in the mesh-repair group. Conclusions: As compared with anterior colporrhaphy, use of a standardized, trocar-guided mesh kit for cystocele repair resulted in higher short-term rates of successful treatment but also in higher rates of surgical complications and postoperative adverse events. (Funded by the Karolinska Institutet and Ethicon; ClinicalTrials. gov number, NCT00566917.).

II.

The objective of this study is to report on shortterm outcomes after pelvic organ prolapse repair using Prolift transvaginal mesh. A 3-year multicenter prospective cohort study was performed in 28 centers. Assessment preoperatively and at 2 months postoperatively included the condition-specific pelvic organ prolapse quantification system (POP-Q) and a macroscopic inflammatory scale. Subjective outcome was measured using the urogenital distress inventory (UDI) and the incontinence impact questionnaire (IIQ-7). Surgical characteristics and adverse events during follow-up were registered in a separate protocol. The evaluation is based on the interim safety analysis and includes 2-month evaluations of 123 cases. Pelvic organ perforation occurred in four cases (3.2%), three bladder injuries and one case of rectal perforation. At the 2-month follow-up, there were two cases of mesh exposure, an increase of mild-moderate granuloma formation in the operated areas (P < 0.003) but no cases of serious adverse tissue reactions related to the polypropylene mesh. Postoperative anatomical cure (defined as POP-Q stage 0-1) was 87% after anterior repair, 91% after posterior repair and 88% after total repair. All quality of life aspects measured by the IIQ-7 improved 2 months after surgery. Pelvic heaviness, vaginal bulging, and vaginal protrusion all decreased considerably (P < 0.001). There was also a significant improvement in several lower urinary tract symptoms and a decreased need for manually assisted defecation. This first report from an ongoing multicenter study suggests that transvaginal mesh surgery with the Prolift system is associated with satisfactory outcomes 2 months after surgery. There were no severe adverse events attributed to the polypropylene mesh.

The overlap technique should be adopted as the method of choice for primary sphincter repair after obstetric tear.

The results show that the primary overlap technique in the repair of anal sphincter rupture following vaginal delivery is highly successful.