Patient population
This was a retrospective, single-center based cohort study with 574 women who were underwent anterior pelvic floor repair surgeries between January 1, 2019 and October30, 2020. The inclusion criteria were as follows: (1) primary diagnosis of III or IV grade anterior vaginal wall prolapse; (2) complete data acquisition; (3) no other systemic diseases. Volunteers who met the following were excluded: (1) had other procedures during surgery, such as tension free vaginal tape (TVT) surgery, etc.; (2) company with stage III or IV apical or posterior vaginal wall prolapse; (3) had pelvic surgeries or hysterectomy before. 299 patients met the criteria and after checking complete follow-up data and signed informed consent, 285 participants were recruited finally. According to the different procedure, they were divided into 2 groups. Those are anterior pelvic floor repair (TVM) group(n = 181), and modified anterior pelvic floor repair(M-TVM) group(n = 104) (see Fig. 1).
Clinical Procedures
All enrolled patients had no absolute contraindications to these two surgical methods. After being fully informed of the relevant advantages and disadvantages of these two surgical methods by surgeons, patients chose the surgical procedures by themselves according to their own considerations.
For TVM, the procedure was performed with the patient in the lithotomy position under general anesthesia. A 0.5cm incision was made at the inner folds of both thighs at the horizontal level of the urethral orifice. Another 0.5cm incision was made 1cm laterally and 2cm below the former incision as the second puncture point. A puncture device was used to penetrate from the above puncture points, respectively near the inner corner of the obturator foramen and above the ischial spine. With this procedures, 4 arms of mesh were suspended to the bilateral obturator muscle and arcus tendineus fascia pelvis (see Fig. 2A)
M-TVM procedure the protocol was almost the same at the beginning until cutting the 4 incisions. A 0.5cm incision was made at the inner folds of both thighs at the horizontal level of the urethral orifice. Another 0.5cm incision was made 4cm laterally and 4cm below the former incision as the second puncture point.4 arms polypropylene mesh (TiLOOP total 4, pfm, Nṻrnberg, Germany) was penetrated from the first puncture point with a curved hook puncture device (same as above). Near the inner corner of the obturator, the upper limb band of the mesh was led out of the skin through the Vicryl 2/0, and the mesh head was fixed at the bottom of the urethral mouth with no. 4 silk wire. With deep puncture device via the puncture point to the pelvic cavity puncture, via anus levator and siatic rectal fossa, ischial spine on both sides of finger guided through the inside of the sacrospinous ligament, the lower two arms of mesh were hanging in the sacral spine ligament midpoint. (See Fig. 2B)
The POP-Q classification was used to evaluate level of POP according to the International Continence Society [11]. Examination of the women was performed in the dorsal lithotomy position. Following inspection of the vulva and perineum, the labia were separated and prolapse was noted. Women were asked to perform Valsalva maneuver (women were asked to pinch the nose, close the mouth, and exhale like as inflating the balloon, bear down for 10 to 15 seconds) for measurement of Aa, Ba, C, Ap, Bp, D, gh, pb, tvl.
3/4 dimensional transperineal ultrasound was performed 6 months after operation with 3 senior sonographers. Width and length of meshes were measured in vesicovaginal gap follow Dietz methods [12] (supplemental Fig. 1).
All patients came to out-patient department for postoperative examination at 3, 6, and 12 months after surgeries. Pelvic examinations were taken including symptom checklist, a stress test, POP-Q test and transperineal ultrasound.
Follow-up
Complications directly related to the surgeries were acquired by analyzing questionnaires that women taken at each visit when we follow up, which include pelvic floor function (PFDI20, PFIQ7), sexual function (PISQ-12), quality of life (EQ5D-3L main score and visual analogic scale (VAS), and improvement (PGII). Vaginal examinations were conducted to check for mesh erosion and assess vaginal support according to the POP-Q evaluation. To evaluate recurrence, we included a composite outcome defined by either anatomical recurrence (any point Ba, C, or Bp > 0 cm beyond the hymen), and/or retreatment (reintervention for prolapse recurrence).
Data Collection
All patient data were complete and collected from hospital medical records, which include general condition, detailed medical history, surgical characteristics, and all information concerning postoperative complications.
Statistical analysis
Sample size was calculated according to the formula as follows:
According to the literatures[5, 6],the expected population rate was 0.0288, we estimated σ = 5, \(\delta\)= 0.03, α = 0.05, then the sample size was at least 120. In consideration of 10% of lost to follow-up, the sample size would be 132.
Statistical analysis was performed after normality testing (Kolmogorov-Smirnov and Shapiro-Wilk testing). Continuous variables are expressed as means with SDs. For categorical variables, counts and percentages are presented. One-way ANOVA was used to compare normally distributed continuous, Kruskal-Wallis test was used in the event of abnormal distributions. Contingency tables with Chi-squared test were used to assess the relationship between quantitative variables. Statistical analyses were performed using SPSS 20.0 software for windows.
Ethics Approval
This retrospective study was approved by the ethical committee of Chongqing Health Center for Women and Children (Trial registration number: NO.(2021) EC (D) 036). Informed consents were obtained from all individual participants included in the study and Patients signed informed consent regarding publishing their data