BACKGROUND: It has been a global trend that increasing complications related to pelvic floor surgeries have been reported over time. The current study aimed to outline the development of Chinese pelvic floor surgeries related to pelvic organ prolapse (POP) over the past 14 years and investigate the potential influence of enhanced monitoring conducted by the Chinese Association of Urogynecology since 2011. METHODS: A total of 44,594 women with POP who underwent pelvic floor surgeries between October 1, 2004 and September 30, 2018 were included from 22 tertiary academic medical centers. The data were reported voluntarily and obtained from a database. We compared the proportion of each procedure in the 7 years before and 7 years after September 30, 2011. The data were analyzed by performing Z test (one-sided). RESULTS: The number of different procedures during October 1, 2011-September 30, 2018 was more than twice that during October 1, 2004-September 30, 2011. Regarding pelvic floor surgeries related to POP, the rate of synthetic mesh procedures increased from 38.1% (5298/13,906) during October 1, 2004-September 30, 2011 to 46.0% (14,107/30,688) during October 1, 2011-September 30, 2018, whereas the rate of non-mesh procedures decreased from 61.9% (8608/13,906) to 54.0% (16,581/30,688) (Z = 15.53, P < 0.001). Regarding synthetic mesh surgeries related to POP, the rates of transvaginal placement of surgical mesh (TVM) procedures decreased from 94.1% (4983/5298) to 82.2% (11,603/14,107) (Z = 20.79, P < 0.001), but the rate of laparoscopic sacrocolpopexy (LSC) procedures increased from 5.9% (315/5298) to 17.8% (2504/14,107). CONCLUSIONS: The rate of synthetic mesh procedures increased while that of non-mesh procedures decreased significantly. The rate of TVM procedures decreased while the rate of LSC procedures increased significantly. TRIAL REGISTRATION NUMBER NCT03620565, https://register.clinicaltrials.gov.
China ; Female ; Gynecologic Surgical Procedures/adverse effects* ; Humans ; Pelvic Floor/surgery* ; Pelvic Organ Prolapse/surgery* ; Surgical Mesh/adverse effects* ; Treatment Outcome ; Vagina

PURPOSE: This study aimed to investigate the surgical outcomes and safety of robotic sacrocolpopexy (RSC) in patients with uterine/vaginal vault prolapse. METHODS: Between January 2009 and June 2015, 16 women with apical prolapse underwent RSC. Pelvic organ prolapse quantification (POP-Q) examination was performed, and treatment success was defined as the presence of grade 0 or I apical prolapse upon POP-Q examination at the final follow-up. Pelvic floor distress inventory-short form 20 (PFDI-SF 20) was administered at every follow-up. A treatment satisfaction questionnaire was administered by telephone to evaluate patient satisfaction with the operation. RESULTS: Median age was 65 years (interquartile range [IQR], 56–68 years), and follow-up duration was 25.3 months (IQR, 5.4–34.0 months). Thirteen women (81.3%) had ≥grade III apical prolapse. Operation time was 251 minutes (IQR, 236–288 minutes), and blood loss was 75 mL (IQR, 50–150 mL). Median hospital stay was 4 days (IQR, 3–5 days). At the final follow-up, treatment success was reported in all patients, who presented grade 0 (n=8, 57.1%) and grade I (n=6, 42.9%) apical prolapse. Dramatic improvements in PFDI-SF 20 scores were noted after RSC (from 39 to 4; P=0.001). Most patients (12 of 13) were satisfied with RSC. An intraoperative complication (sacral venous plexus injury) was reported in 1 patient, and there was no conversion to open surgery. Mesh erosion was not reported. CONCLUSIONS: RSC is an efficient and safe surgical option for apical prolapse repair. Most patients were satisfied with RSC. Thus, RSC might be one of the best treatment options for apical prolapse in women.
Conversion to Open Surgery ; Female ; Follow-Up Studies ; Humans ; Intraoperative Complications ; Length of Stay ; Patient Satisfaction ; Pelvic Floor ; Pelvic Organ Prolapse* ; Prolapse ; Robotic Surgical Procedures ; Telephone ; Uterine Prolapse

BACKGROUNDMesh exposure after surgery continues to be a clinical challenge for urogynecological surgeons. The purpose of this study was to explore the risk factors for polypropylene (PP) mesh exposure after transvaginal mesh (TVM) surgery.

METHODSThis study included 195 patients with advanced pelvic organ prolapse (POP), who underwent TVM from January 2004 to December 2012 at the First Affiliated Hospital of Chinese PLA General Hospital. Clinical data were evaluated including patient's demography, TVM type, concomitant procedures, operation time, blood loss, postoperative morbidity, and mesh exposure. Mesh exposure was identified through postoperative vaginal examination. Statistical analysis was performed to identify risk factors for mesh exposure.

RESULTSTwo-hundred and nine transvaginal PP meshes were placed, including 194 in the anterior wall and 15 in the posterior wall. Concomitant tension-free vaginal tape was performed in 61 cases. The mean follow-up time was 35.1 ± 23.6 months. PP mesh exposure was identified in 32 cases (16.4%), with 31 in the anterior wall and 1 in the posterior wall. Significant difference was found in operating time and concomitant procedures between exposed and nonexposed groups (F = 7.443, P = 0.007; F = 4.307, P = 0.039, respectively). Binary logistic regression revealed that the number of concomitant procedures and operation time were risk factors for mesh exposure (P = 0.001, P = 0.043).

CONCLUSIONConcomitant procedures and increased operating time increase the risk for postoperative mesh exposure in patients undergoing TVM surgery for POP.

Adult ; Aged ; Aged, 80 and over ; Female ; Humans ; Middle Aged ; Operative Time ; Pelvic Organ Prolapse ; surgery ; Polypropylenes ; therapeutic use ; Postoperative Period ; Retrospective Studies ; Risk Factors ; Surgical Mesh ; adverse effects ; Vagina ; surgery

BACKGROUNDPelvic organ prolapse (POP) is a major health concern that affects women. Surgeons have increasingly used prosthetic meshes to correct POP. However, the most common used is synthetic mesh, and absorbable mesh is less reported. This research aimed to evaluate the clinical effectiveness of porcine small intestinal submucosa (SIS).

METHODSConsecutive forty POP patients who met the inclusion criteria underwent pelvic reconstruction surgery with SIS between March 2012 and December 2013. The patients' clinical characteristics were recorded preoperatively. Surgical outcomes, measured by objective and subjective success rates, were investigated. We evaluated the quality of life (QOL) using the Pelvic Floor Distress Inventory-20 (PFDI-20) and the Pelvic Floor Impact Questionnaire-7 (PFIQ-7). Sexual QOL was assessed by the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire-12 (PISQ-12).

RESULTSAt postoperative 12 months, the subjective recurrence rate (7.5%) was much lower than the objective recurrence rate (40.0%). Postoperatively, no erosion was identified. One underwent a graft release procedure because of urinary retention, and one had anus sphincter reconstruction surgery due to defecation urgency. Another experienced posterior vaginal wall infection where the mesh was implanted, accompanied by severe vaginal pain. Estrogen cream relieved the pain. One patient with recurrence underwent a secondary surgery with Bard Mesh because of stage 3 anterior vaginal wall prolapse. Scoring system of PFDI-20 was from 59.150 ± 13.143 preoperatively to 8.400 ± 4.749 postoperatively and PFIQ-7 was from 73.350 ± 32.281 to 7.150 ± 3.110, while PISQ-12 was from 15.825 ± 4.050 to 12.725 ± 3.471.

CONCLUSIONSQOL and the degree of subjective satisfaction were significantly improved postoperatively. Anterior repair deserves more attention because of the higher recurrence rate. The long-term follow-up of the patient is warranted to draw firm conclusion.

Aged ; Animals ; Female ; Humans ; Intestinal Mucosa ; transplantation ; Male ; Middle Aged ; Pelvic Organ Prolapse ; surgery ; Prospective Studies ; Surgical Mesh ; Swine ; Tissue Scaffolds

OBJECTIVETo explore the efficacy and safety of laparoscopic tunnel-like peri-anterior superior iliac spine suspension(L-TASISS) or combined with stapled transanal rectal resection (STARR) in the treatment of pelvic organ prolapse (POP) with outlet obstructive constipation (OOC).

METHODSA total of 119 POP patients complicated with OOC( II( to IIII( stage evaluated by POP-Q) received L-TASISS or combined with STARR in the First Affiliated Hospital of Zhengzhou University from August 2010 to January 2015. Clinical and follow-up data of these patients were analyzed retrospectively and compared before and after operation.

RESULTSAmong 119 cases, 51 cases(42.9%) underwent L-TASISS alone, and 68 cases (57.1%) received L-TASISS combined with STARR. All the 119 patients were successfully operated without conversion to open surgery. The operation time was (67.8±10.9) minutes, the intra-operative blood loss was (10.3±3.8) ml, the indwelling catheter time was (3.6±1.1) days, and hospital stay was (5.1±1.8) days. One month after operation, abdominal wall pain or stress occurred in 15 cases, of whom 3 cases were improved by local block injection, 1 case by incision stitches release, the rest ameliorated spontaneously within 3 months after surgery. No potential ureterostenosis, hydroureterosis, internal iliac vascular thrombosis resulting from compression of the mesh and other complications related to the mesh were found. One year after operation, all the patients were followed up. The OOC remission rate was 78.2%(93/119), of whom 76 cases were satisfied and 17 patients were completely satisfied. One case(0.8%) with stress urinary incontinence did not improve. Fifteen cases(12.6%) with algopareunia or dyspareunia did not achieve remission, but there was no new algopareunia or dyspareunia case. Eleven patients (9.2%) presented recurrence of symptoms, of whom 9 cases(7.6%) complained of sensation of incomplete evacuation. Two cases(1.7%) were graded as POP-Q II(, and 1 case (0.8%) as POP-Q III( after surgery. Constipation Score of all the patients was 1.4±0.9 (compared to 7.8±3.6 preoperatively) according to Rome III( criteria. Enterocele occurred in 53 cases (44.5%) preoperatively corresponded with only 1 case (0.8%) after operation (χ(2)=64.77, P=0.000). One hundred and six cases (86.6%) with defecation difficulties and 87 cases (73.1%) with sensation of incomplete evacuation before operation were significantly improved after surgery, corresponding with 7(5.9%) and 9 (7.6%) symptomatic cases respectively (χ(2)=155.78, P=0.000). Three cases (2.5%) with preoperative fecal incontinence symptoms were improved after operation as well.

CONCLUSIONThe procedure of L-TASISS or combined with STARR for POP patients with OCC has good short-term efficacy, and is safe and feasible.

Constipation ; Digestive System Surgical Procedures ; methods ; Fecal Incontinence ; Humans ; Laparoscopy ; Middle Aged ; Operative Time ; Pelvic Organ Prolapse ; surgery ; Rectal Prolapse ; Retrospective Studies ; Treatment Outcome

BACKGROUNDAlthough repair augmented with mesh has been proved its priority in anatomical and functional recovery after anterior compartment reconstruction, the data about posterior compartment are scarce. The aim of this study was to compare bowel functional outcome of posterior vaginal compartment repair with and without mesh in patients with pelvic organ prolapse (POP).

METHODSThis was a prospective, double-blind, clinical pilot study of 22 postmenopausal women with symptomatic POP (overall POP-quantification [POP-Q] Stage III-IV) who underwent total pelvic floor reconstruction. Patients were grouped according to the use of mesh for posterior vaginal compartment repair: A mesh group and a nonmesh group. POP-Q stage, the pelvic floor impact questionnaire short form-7 (PFIQ-7) and anorectal manometry were evaluated before and 3 months after surgery. Anatomical success was defined as POP-Q Stage II or less. A t-test was used to compare preoperative with postoperative data in the two groups.

RESULTSTotally, 17 (71%) were available for the follow-up. POP-Q measurements improved significantly compared to baseline (P < 0.05) in both groups. No recurrence was observed. Subjects in both groups reported improvement in pelvic floor symptoms, and there was no significant difference in the PFIQ-7 score between groups at follow-up (P > 0.05). Compared with baseline, the nonmesh group exhibited a statistically significant decrease in anal residual pressure, a significant increase in the anorectal pressure difference during bowel movement, and a reduced rate of dyssynergia defecation pattern (P < 0.05).

CONCLUSIONSProvided there is sufficient support for the anterior wall and apex of vagina with mesh, posterior compartment repair without mesh may be as effective as repair with mesh for anatomical recovery while providing better anorectal motor function.

Aged ; Constipation ; diagnosis ; etiology ; Double-Blind Method ; Female ; Humans ; Manometry ; Middle Aged ; Pelvic Organ Prolapse ; surgery ; Surgical Mesh ; adverse effects

BACKGROUNDFood and Drug Administration announcements have highlighted the standard rate of mesh-related complications. We aimed to report the short-term results and complications of tension-free polypropylene mesh (PROSIMA™) surgical repair of pelvic organ prolapse (POP) using the standard category (C), timing (T), and site (S) classification system.

METHODSA prospective cohort study of 48 patients who underwent PROSIMA™ mesh kit-related surgical repairs were followed for two years at Peking Union Medical College Hospital. Recurrence was defined as symptomatic POP quantification (POP-Q) Stage II or higher (leading edge ≥ -1 cm). The Patient Global Impression of Change Questionnaire, the Chinese version of the Pelvic Floor Impact Questionnaire short-form-7 and POP/Urinary Incontinence Sexual Questionnaire short-form-12 were used to evaluate the self-perception and sexual function of each patient. Mesh-related complications conformed to the International Urogynecological Association/International Continence Society joint terminology. The paired-sample t-test, one-way analysis of variance, Fisher's exact test, Kaplan-Meier survival analysis and log-rank test were used to analyze data.

RESULTSAll patients were followed up for ≥12 months; 30 (62.5%) patients completed the 24 months study. We observed a 93.8% (45/48) positive anatomical outcome rate at 12 months and 90.0% (27/30) at 24 months. Recurrence most frequently involved the anterior compartment (P < 0.05). Pelvic symptoms improved significantly from baseline (P < 0.05), although the patients' impressions of change and sexual function were not satisfying. Vaginal complication was the main complication observed (35.4%, 17/48). The survival analysis did not identify any relationship between vaginal complication and anatomical recurrent prolapse (POP-Q ≥ Stage II) (P = 0.653).

CONCLUSIONSTension-free polypropylene mesh (PROSIMA™ )-related surgical repair of POP has better short-term anatomical outcomes at the apical and posterior compartments, but a low patient satisfaction rate. The mesh complications were not the definitive cause of recurrence.

Aged ; Cohort Studies ; Humans ; Kaplan-Meier Estimate ; Male ; Middle Aged ; Pelvic Organ Prolapse ; surgery ; Polypropylenes ; chemistry ; Prospective Studies ; Quality of Life ; Surgical Mesh

PURPOSE: The aim of this study was to evaluate the effect of surgical repair of pelvic organ prolapse on female sexual function and to assess correlations between the two using two current standardized questionnaires. MATERIALS AND METHODS: From October 2009 to September 2010, 143 patients with posterior compartment or combined vaginal prolapse were included. We assessed surgical outcomes according to anatomical change in the vagina and results of the Female Sexual Function Index (FSFI) and Pelvic Organ Prolapse/Urinary Incontinence Sexual Function questionnaire (PISQ-12) both pre- and postoperatively. RESULTS: Among the 143 preoperative patients, 99 and 84 patients responded to the PISQ-12 and FSFI, respectively. The mean PISQ-12 score increased after surgery (p<0.001). Specifically, postoperative scores for questions 8 and 12 were higher than their respective preoperative scores (p<0.001). Postoperatively, mean FSFI score changed only slightly (p=0.76), and only the score for the satisfaction domain was improved (p=0.023). In regards to vaginal anatomy, vaginal length was significantly greater postoperatively (6.99+/-0.18 vs. 7.56+/-1.08, p<0.001), and postoperative vaginal caliber was narrowed to a two-finger width. CONCLUSION: In this study, surgery for pelvic organ prolapse was shown to affect female sexual function. Moreover, menopause was associated with a change in postoperative sexual function.
Aged ; Female ; Humans ; Middle Aged ; Pelvic Organ Prolapse/*physiopathology/*surgery ; Questionnaires ; Sexual Behavior/*physiology

BACKGROUNDDuring the past decade, graft materials have been widespread used in the vagina in order to correct pelvic organ prolapse. The aim of this study was to describe and compare the exact anatomical position of the puncture devices and their relations to the relevant anatomical structures in the Prolift(TM) and a modified pelvic reconstructive surgery with mesh.

METHODSTwelve fresh cadavers were allocated randomly to either the Prolift(TM) or the modified pelvic reconstructive surgery group. Each group had six fresh cadavers. Relevant distances between the puncture devices and anatomical structures were recorded in both minimally invasive puncture surgeries.

RESULTSThe mean distances from the posterior puncture points of the obturator membrane to the posterior branch of obturator arteries were shorter ((0.60 ± 0.36) cm and (0.78 ± 0.10) cm) when compared with the distances to the anterior branch of obturator arteries ((1.53 ± 0.46) cm and (1.86 ± 0.51) cm) for the reconstruction of the anterior compartment in both surgeries (all P < 0.05). The distance from the puncture points of the pelvic floor through the ischiorectal fossa to the coccygeal and inferior gluteal arteries in the Prolift(TM) technique ((0.88 ± 0.10) cm) and ((1.59 ± 0.36) cm)) were much shorter than that in the modified pelvic reconstructive surgery ((2.95 ± 0.09) cm) and ((3.40 ± 0.36) cm)) for the reconstruction of the middle and posterior compartments (all P < 0.05).

CONCLUSIONSCompared with the Prolift(TM) technique, the modified pelvic reconstructive surgery with mesh would be safer not to cause great damage to the inferior gluteal arteries and the coccygeal arteries. The posterior branch of obturator arteries would be easier to be injured than the anterior branch of obturator arteries during anterior compartment reconstruction in both surgeries.

Aged ; Aged, 80 and over ; Cadaver ; Female ; Gynecologic Surgical Procedures ; methods ; Humans ; Pelvic Organ Prolapse ; surgery ; Postoperative Complications ; Reconstructive Surgical Procedures ; methods ; Surgical Mesh ; Treatment Outcome

Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Surgical mesh has been used since the 1950s to repair abdominal hernias. In the 1970s, gynecologists began using surgical mesh products to indicate the repair of pelvic organ prolapse (POP), and in the 1990s, gynecologists began using surgical mesh for POP. Then the U.S. Food and Drug Administration (FDA) approved the first surgical mesh product specifically for use in POP. Surgical mesh materials can be divided into several categories. Most surgical mesh devices cleared for POP procedures are composed of non-absorbable synthetic polypropylene. Mesh can be placed in the anterior vaginal wall to aid in the correction of cystocele (anterior repair), in the posterior vaginal wall to aid in correction of rectocele (posterior repair), or attached to the top of the vagina to correct uterine prolapse or vaginal apical prolapse (apical repair). Over the past decades, surgical mesh products for transvaginal POP repair became incorporated into "kits" that included tools to aid in the delivery and insertion of the mesh. Surgical mesh kits continue to evolve, adding new insertion tools, tissue fixation anchors, surgical techniques, and ab- sorbable and biological materials. This procedure has been performed popularly. It was also performed increased in China. But this new technique met some trouble recently and let shake in urogynecology.
China ; Female ; Humans ; Pelvic Organ Prolapse ; surgery ; Surgical Mesh ; United States ; United States Food and Drug Administration ; Vagina ; surgery