As human life expectancy increases, the prevalence of pelvic floor disfunction (PFD) is increasing year by year, seriously affecting the quality of life of middle-aged and elderly women. The traditional surgical treatment for pelvic organ prolapse (POP) is mainly transvaginal hysterectomy and simple anterior and posterior vaginal wall repair, with a high recurrence rate after surgery. With the advancement of research on the etiology and pelvic anatomy of POP and the development of surgical instruments and repair materials, the results of surgical treatment of POP have been significantly improved. However, the complications associated with transvaginal use of polypropylene mesh and the indications for surgery using mesh are still urgent clinical issues that need to be addressed. It has been suggested that mesh complications and postoperative recurrence are related to mesh wrinkling. The clinical outcomes of 70 cases of severe POP treated with transvaginal PROSIMA mesh combined with High Uteroligament Suspension ( HUS ) and the follow-up results of mesh measurement under ultrasound in our hospital are reported.
Data and Methods
I. Basic information
The mean age of the 70 patients was 66 ± 10.42 years (44-80 years), the mean body mass index was 23.59 ± 2.28 kg/m2, and the mean number of pregnancies and deliveries was 4 (1). Fifty-six cases (80%) had medical comorbidities, including 45 cases of hypertension, 16 cases of diabetes mellitus, 21 cases of coronary heart disease, 7 cases of cerebrovascular disease, old cerebral infarction and cerebral white matter lesions, 2 cases of bronchiectasis, and 1 case each of other complications, including uterine fibroids and uterine pus.
The degree of pelvic organ prolapse was determined by the pelvic organ prolapse quantitative staging method (POP-Q). 68 of the 70 cases had POP Q stage III, 2 had POP Q stage IV, 20 had combined urinary incontinence, and 1 had mild fecal incontinence. 70 cases were all first-time POP patients. According to the site of prolapse, there were 70 cases of uterine prolapse and severe bulging of the anterior vaginal wall, 15 cases of severe bulging of the posterior vaginal wall, and 60 cases of old II degree perineal laceration. The clinical diagnosis of SUI was made if the patient had a history of urinary leakage prior to prolapse, one of the following: coughing, sneezing, laughing, exercising, leaking when bending or standing, coughing, swab, pad test, urinary diary, and urodynamic examination after prolapse correction suggested stress urinary incontinence (SUI). Preoperative ultrasound of the pelvis and urinary tract is routinely performed to exclude the presence of pelvic pathology and urinary tract obstruction. Preoperative cervical cytology smears were routinely performed. Preoperative estrogen ointment was applied along with oiled gauze rolls to return the uterus for 7-14 days and daily sitz baths with douching to prepare the vagina. Routine bowel cleansing preparation was given preoperatively.
II. Surgical methods
1. Anesthesia: Except for 5 cases with general anesthesia, all of them were anesthetized by combined epidural + subarachnoid block. Ceftriaxone sodium 1g or azithromycin 0.5g was injected intravenously 0.5 h before anesthesia.
2. Surgical method: The surgery was performed by the same chief physician and 2 to 3 deputy chief physicians. All patients underwent transvaginal hysterectomy followed by HUS [1] and then closure of the peritoneum. Prosima mesh was placed before suturing the vaginal stump, and the method of placement is described in the literature [2]. Anterior Prosima combined with high sacral ligament suspension is performed in patients with predominantly anterior and middle pelvic defects, while full Prosima combined with HUS suspension is performed in patients with posterior wall bulge stage III or higher. Anti-SUI surgery: In 20 patients with SUI, after completion of Prosima mesh and HUS, a classical retropubic TVT (tension-free vaginal tape, TVT ) and a total of 20 cases of transobturator TVT-O (tranobturator transvaginal tape, TVT-O) (Gynecare TVT TM Obturator System) were performed on the anterior vaginal wall mucosa of the mid-urethra according to the method introduced by de Leval [3]. After surgery, the total vaginal length (TVL), vaginal volume (calculated by fingers), genital hiatus (GH) and perineal body length (PB) were measured, and the Vaginal Support Device (VSD) was placed according to the TVL length, which was 8 cm or more. After placement, the VSD was fixed with two stitches to both anal levator muscles and then inflated.
3. Postoperative management: The vaginal balloon was removed 24 hours after surgery. After 4 weeks of VSD placement, the VSD was removed on an outpatient basis. 3 months of heavy lifting (≥5 kg) and heavy physical labor were avoided to avoid increasing abdominal pressure.
4. postoperative follow-up: VSD was removed one month after surgery on an outpatient basis. and clinical gynecological examination was performed on the patient. The objective criteria for successful surgery were ≤0 cm (hymen level) at the most distal end of prolapse, ≤0 cm was defined as successful anatomical repositioning, and >0 cm was defined as failure of anatomical repositioning [4]. The vaginal volume and TVL, GH and PB data during exertion were also measured, and urination, incontinence and defecation and tolerance to VSD after placement were asked. The improvement of patients’ symptoms and quality of life was also evaluated by the preoperative and postoperative PFIQ-7 and PFDI-20 questionnaires [5].
5. ultrasonography: at 1 month and 2-3 months postoperatively, the position and length of the anterior mesh of the patients were measured by trans-perineal ultrasound using the American Zowie color ultrasound diagnostic system (ZONARE 4.0) with a C6-2/CH3-6 MHZ probe, respectively. After the patient’s bladder was moderately filled and lying in the truncated position, the probe surface was covered with coupling agent and then the probe was covered with protective film, and the coupling agent was applied again outside the protective film and placed on the patient’s perineum, and a median sagittal view was taken to show the pubic symphysis, bladder, urethra and vagina, and the position of the mesh at the posterior bladder wall was observed and its length was measured.
III. Statistical methods
SPSS 10.0 software was used for statistical analysis, and paired t-test was used for normally distributed data.
RESULTS
I. Surgery
A total of 70 cases of PROSIMA mesh combined with HUS were performed, including 55 cases with anterior mesh only (PROSIMA A) and 15 cases with full mesh (PROSIMA C). Hysterectomy was performed in 70 cases, bilateral adnexal resection in 10 cases, perineal body repair in 60 cases, and TVT and TVT-O in 20 cases. All patients underwent intraoperative cystoscopy to confirm bilateral ureteral patency and no damage to the bladder wall. The mean operative time was 195±46.57 min (135-210 min), 189 min for PROSIMA A plus HUS and 210 min for PROSIMA C plus HUS. the mean bleeding volume was 160±63.70 ml (80-300 ml), and no blood transfusion was required. there were no surgical side injuries in 70 cases, and the postoperative disease rate was 1.4%. The mean postoperative indwelling urinary catheter was 7.0±0.94 d, and the mean hospitalization was 10.1±2.9 d. The residual urine was routinely measured after removal of the urinary catheter and was >50 ml.
II. Subjective and objective efficacy and follow-up
The average postoperative follow-up was 13 months (2-19 months). At the time of follow-up, the most distal end of the prolapse was above the hymenium in all cases, the average vaginal depth was about 8.5 cm, the average capacity was 2 fingers, the pubic cleft was reduced from 6.1 cm before surgery to 3.3 cm after surgery, and the perineal body was increased from 2.3 cm before surgery to 4.3 cm after surgery, achieving 100% objective cure rate, see Table 1. （Seven cases (10%), all less than 1 cm in area, were classified as small local exposure according to the 2011 IUGA and UCS classification of vaginal mesh complications, 1-2A-B/T2-3/S1-2. All were cured after outpatient estrogen medication and local excision of the exposed patch, and no postoperative lower extremity pain was required. Among the 70 cases followed up at 4 weeks after surgery, 68 cases were placed for 4 weeks, except for 2 cases in which the VSD was placed for less than 4 weeks and fell off, and none of them had to be removed earlier due to discomfort. 10 of the 68 cases complained of excessive vaginal discharge, but there was no obvious local infection or wound infection on examination. 20 cases showed significant improvement in urinary leakage 1 year after anti-SUI surgery, and 2 cases had mild leakage after coughing, but did not require a second anti-SUI surgery. One case had a new onset of mild SUI, and no SUI was found in the preoperative evaluation, which is still under observation. The results of the subjective symptom questionnaire showed that the PFIQ-7 and PFDI-20 questionnaire scores of 70 cases with severe POP were 53.57 and 51.43 preoperatively and 19.20 and 18.55 postoperatively, respectively. 70 cases had transperineal ultrasound recordings of anterior mesh located in the lower bladder and mid-upper vagina, and the mean anterior-posterior mesh diameter was 3.5 cm measured at 1 month postoperatively and 2-3 months postoperatively. The anterior-posterior diameter of the mesh was 2.8 cm, and there was no statistical difference between the 1 month and 2-3 month measurements.
Table 1 Changes in POP-Q indexes before and after surgery in 70 patients (cm)
Indication point Preoperative 13 months postoperative P
Aa 2.0±0.5 -3.0±0.00 ＜0.05
Ba 4.0±0.5 -3.0±0.00 ＜0.05
C 3.5±1.0 -8.5±0.5 ＜0.05
GH 6.1±0.4 3.3±0.4 ＜0.05
PB 2.3±0.4 4.3±0.5 ＜0.05
TVL 7.7±0.3 8.5±0.4 ＜0.05
Ap -1.5±0.5 -3.0±0.00 ＜0.05
Bp -1.8±0.3 -3.0±0.00 ＜0.05
D -1.5±0.5 – –
Discussion
I. Characteristics of Prosima mesh repair system
In the last 20 years or so, the application of polypropylene mesh to the treatment of POP has compensated for the high recurrence rate of traditional autologous tissue repair of POP, with an overall success rate of 71-100% [6]. The uncut synthetic mesh needs to be laid flat and fixed on the surface of the bladder and rectum, and the anterior wall is sutured up to the pelvic fascial tendon arch on both sides, and the posterior wall needs to be cut and fixed according to the degree of rectal distention, which requires high anatomical knowledge and surgical skills of the operator, and the operation is difficult and time-consuming, and the mesh is not easy to be placed flat. 2004 saw the invention of Prolift, which is represented by the requirement of pelvic floor repair, where the mesh is The total pelvic floor mesh repair system, which is pre-cut, punctured by multiple guide needles and anchored in the body surface skin, has greatly simplified the operation and achieved an objective cure rate of 87% (75-94%) on average in the treatment of patients with POPQ stage III-IV. However, such body skin-anchored pelvic floor repair cassettes with large mesh areas and blind needle guiding puncture also bring corresponding complications such as vaginal wall stiffness, mesh exposure, and pain at the hip and thigh puncture sites. To further reduce the trauma and complication rate, the GYNECARE PROSIMA TM Pelvic Floor Repair System without body piercing holes was invented and reported by Prof. Marcus Carrey from Australia in 2007. The system is designed with two identical meshes, one bifurcated at one end and one trapezoidal at the other, with an overall “Y” shape, for anterior and posterior vaginal wall repair. For anterior wall repair, the trapezoidal portion of the mesh is placed from the surface of the bladder to the internal muscles of the foramen ovale and the pelvic fascia tendon arch, with the two branches placed anterior to the sciatic spine, and for posterior wall repair, the trapezoidal portion of the mesh is placed anterior to the rectum, with the two branches placed immediately lateral to the sacrospinous ligament. The clever design of both sides of the branch is deep and strong compared to the cut and stitch fixed mesh placement method. Although compared with Prolift-type repairs with anchoring points on the body surface, it may be slightly weaker in fixing the pelvic floor due to the shallow puncture site and is not suitable for heavy POP treatment, its unique advantages are obvious, such as less separation area in the surgical area, the anterior and posterior walls only need to be separated up to the anterior superior sciatic spine and sacrospinous ligament, and the “Y”-shaped mesh is inserted using the supporting auxiliary anterior and posterior inserter. The “Y”-shaped mesh can be inserted, avoiding complications such as bleeding, infection and postoperative pain caused by blind puncture and skin puncture, and it is simple to learn and easy to promote.
II. Indications for Prosima pelvic repair system and Prosima combined with high sacral ligament suspension
Theoretically and by design, the PROSIMA mesh pelvic floor repair system is mainly aimed at those with POPQ stage II-III and predominantly anterior and posterior vaginal wall bulge, and is not recommended for severe POP, especially for those with mid-pelvic defects. Although there are reports in the literature of a 2 cm improvement in the position of the posterior fornix with PROSIMA anterior and posterior lobe repair [4], there is a lack of evidence whether this surgical approach also provides adequate support for severe apical prolapse. The clinical use of the PROSIMA patch pelvic floor repair system is limited by the fact that the number of patients with POP with pure anterior and posterior wall bulging is small and mostly young, and surgical treatment with the patch is not generally preferred due to mesh complications. In view of the fact that most of the patients requiring surgery for POP are stage III-IV patients with anterior and posterior vaginal wall bulge and varying degrees of uterine prolapse, this study concluded that the application of the Prosima repair system for the treatment of anterior and posterior vaginal wall bulge along with accurate and reliable treatment of mid-pelvic defects would greatly expand the indications for the Prosima procedure, and would also achieve a reduction in trauma and mesh-related The aim is to reduce trauma and mesh-related complications. Based on the above concept, the present study combined Prosima with high sacral ligament suspension for the treatment of severe POP, expanding the indications for Prosima surgery and achieving satisfactory clinical results.
III. Analysis of the efficacy of Prosima mesh combined with high sacral ligament
Sacral ligament suspension (US), sacrospinous ligament fixation (SSLF) and sacrocolpopexy (SC) are considered to be the three surgical procedures with the best results in the treatment of mid-pelvic defects. Transvaginal HUS is reliable for severe uterine prolapse, with an objective medium- to long-term success rate of 98%-100% for the procedure, and also has the effect of enhancing the anterior and posterior vaginal wall repair, with which the authors have accumulated extensive clinical experience and longer-term clinical evidence-based results [1]. In this study, we innovated a combined Prosima and HUS procedure for severe POP, combining the advantages of both Prosima and HUS procedures, with a concept comparable to that of total pelvic reconstruction, treating mid-pelvic defects by HUS and suspending the pelvic floor from the first level, while using the PROSIMA mesh repair system to treat anterior/posterior pelvic defects and the second level, while using a transvaginal With a single surgical route, a comprehensive repair of the anterior/middle/posterior pelvis, first and second levels was achieved. In the present study, Prosima mesh combined with HUS for 70 patients with severe POP achieved excellent subjective and objective results, with an overall objective cure rate of 100% during a mean follow-up of 13 months, an outcome that was also higher than the cure rate of 64-97% with sacrospinous ligament fixation for apical prolapse [7-10]. The one-year cure rate of transvaginal mesh in the treatment of fornix prolapse after hysterectomy was reported in the literature as 85.7% [11,12], and the results of this study were significantly better than those reported in the literature.T. Sayer reported interim follow-up results of 29 months (mean 24-34 months) for Prosima mesh alone, and if POP Q stage 0-I was used as the cure criterion, the anatomical cure rate was only 69.1 However, the most distal part of the prolapse was above the hymen in 84.5% of the cases, indicating that the success rate could reach 84.5% if stage II was used as the anatomical cure criterion, while pelvic symptoms and sexual function were significantly improved (p<0.01). The literature reports a mesh exposure rate of 9.1%, new onset incontinence in 5%, and 3.3% of recurrent prolapse requiring further prolapse surgery [13]. The literature reports that pelvic reconstruction with preservation of the uterus may carry a risk of cervical lengthening and higher fornix prolapse [14, 15], which explains the concomitant hysterectomy in all patients in our study. 1-year follow-up of PROSIMA pelvic floor repair showed a PROSIMA mesh exposure rate of 8.0% [4], which is significantly lower than other finished mesh repair systems and 10% in this study . Because the mesh anterior page can be fixed to the sciatic spine, it can be laid flat tension-free on the bladder surface, the submucosa of the vagina, and is not limited by the patient's occlusal anatomy or the operator's surgical level, as is the posterior wall mesh. The mesh is assisted by an anterior and posterior inserter to flatten it into place. The curved anterior inserter is uniquely designed to assist the left and right lateral branches of the patch to reach the sciatic spine and adhere well, as indicated by the direction of the arrow on the inserter. The posterior inserter also ensures that the lateral branches of the mesh reach the sciatic spine from the pararectal area. There is a consensus that the area of the mesh is significantly correlated with the erosion rate, and the mesh for anterior and posterior vaginal wall repair is discontinuous with two separate lobes, so that the anterior and posterior vaginal walls are repaired separately and the tip of the vagina is not covered by the mesh, thus avoiding the most likely apical erosion. The long operative time in this study was related to the hysterectomy, the number of steps and the intraoperative cystoscopy. In conclusion, Prosima mesh in combination with HUS is reasonably effective in the treatment of severe prolapse, restoring anatomy and thus improving the function of the pelvic floor organs, as reflected by the subjective questionnaire scores in this study.
IV. Advantages of the vaginal support device (VSD) in PROSIMA
Given the design of the mesh of the Prosima repair system, VSD placement is an important step in conjunction with surgical use and in ensuring surgical efficacy. It provides continuous support to the vagina during early tissue ingrowth, prevents displacement of the patch by abdominal pressure and activity, etc., and prevents wrinkling of the mesh during early fusion with the tissue. It is also critical to place the appropriate size VSD according to the length of the vagina. If the VSD is placed too large, the edges will extend beyond the hymen, causing discomfort to the patient and thus interfering with her normal life. If the VSD is too small, it will not provide good intravaginal support and may fall out of the vagina as the patient moves around and the absorbable thread breaks, which will not facilitate the fusion of the mesh with the tissue. In our 70 patients with postoperative VSD placement, 15 were large, 46 were medium, and 9 were small. The high proportion of large and medium placement was related to the fact that we did HUS at the same time and the vagina was deeper. The non-absorbable polypropylene mesh is able to fuse stably with the tissue for approximately 28 days [16]. Animal studies have shown that the time to reach maximum tension after mesh implantation is 25 days [17]. Therefore, the recommended time of VSD placement for the Prosima system is 3-4 weeks. In the literature with a 1-year follow-up, only 52.9% of patients with VSD placement <21 days were able to maintain POP at stage 0/I. In contrast, 80.5% of patients with VSD placement >21 days were able to achieve POP stage 0/I [4]. The intravaginal balloon provides more uniform pressure to the vaginal wall than the gauze roll. And the inflation of the balloon can be adjusted moderately according to the size of the patient’s vaginal volume, resulting in a more moderate intravaginal pressure.
V. Crumpling of the mesh under ultrasound
In animal studies polypropylene mesh causes a severe inflammatory response within the tissue associated with mesh crumpling, with approximately 16% shortening in mesh diameter and approximately 28% reduction in area in animal models [18].Tunn et al [19] reported that 6 weeks after anterior wall Perigee mesh repair in 13 cases, the mesh was only 45% of the original mesh length and suggested that the reasons for the different degrees of measured mesh shortening There may be a reason for the surgical technique and also a different tension on the caudal side of the mesh resulting in wrinkling of the mesh. lo et al. observed changes 3 years after polypropylene sling implantation, with an increase in the thickness and width of the suburethral sling over time [20]. This may be related to the concomitant occurrence of thickening and fibrosis of the mesh, so that the mesh covers a smaller area than expected. Some scholars also prefer that intraoperative mesh not spreading and causing mesh folding is the main reason for shorter mesh under ultrasound. kamil et al. reported in the literature after ultrasound examination of intraoperative and postoperative lengths of Prolift anterior lobe mesh suggested that intraoperative mesh folding was the reason for the discrepancy between the two mesh measurements, suggesting that the surgical technique may need further improvement. In his article, he reported a significant difference in the length of the mesh measured transvaginally on the fourth postoperative day compared to the preoperative mesh length, 57.1 vs. 90.3 mm, and a smaller difference in the length of the mesh compared to the ultrasound at 3-5 months postoperatively, 57.1 vs. 48.3 mm, leading to the conclusion that the mesh shortening may be due to intraoperative folding [21]. The limitations of this study are that the measurement of the mesh under ultrasound was not taken immediately postoperatively but was put to one month postoperatively, and the tracking of the mesh thickness was not performed, so it was not possible to reveal whether the real cause of the mesh wrinkling was due to intraoperative mesh not spreading or postoperatively with tissue fibrosis. Although the present study found 53% wrinkling of the prosima anterior lobe at 2-3 months postoperatively, it did not affect the objective results of surgical reconstruction, which we believe is related to our surgical design, with apical suspension ensuring first level pelvic support and anterior wall mesh preventing the most recurrent bladder bulge.
In conclusion, the Prosima mesh repair system reinforces the pelvic floor fascial tissues through mechanical support, is simple to operate, has a high cure rate for moderate pelvic organ prolapse, is less invasive surgically, and can treat severe POP if combined with HUS for total pelvic repair, with positive efficacy at 1-year follow-up, this combined procedure expands the clinical indications for Prosima and is worth promoting its application, and the long-term efficacy is still under observation The long-term efficacy is still under observation.