A 14-year multi-institutional collaborative study of Chinese pelvic floor surgical procedures related to pelvic organ prolapse.

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.

Risk Factors for Mesh Exposure after Transvaginal Mesh Surgery.

BACKGROUND: Mesh 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. METHODS: This 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. RESULTS: Two-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). CONCLUSION: Concomitant procedures and increased operating time increase the risk for postoperative mesh exposure in patients undergoing TVM surgery for POP.

[Long-term outcomes of the high vaginal uterosacral ligament suspension in treatment of the severe pelvic organ prolapse].

OBJECTIVE: To investigate the long-term objective and subjective outcomes of the transvaginal high uterosacral ligament suspension(HUS) in treatment of severe pelvic organ prolapse (POP) . METHODS: From Jun. 2003 to Mar.2013, 136 patients with severe POP quantitation (POP-Q) stage III-IV underwent transvaginal hysterectomy and HUS operation in the First Affiliated Hospital, General Hospital of People's Liberation Army. And 125 patients (91.9%, 125/136) were followed up at a mean of 5.4 years (range of 4.2-9.2 years) . Anterior colporrhaphy (79.2%, 99/125), posterior colporrhaphy (64.0%, 80/125), the perineorrhaphy (96.0%, 120/125) and tension-free suburethral slings (37.6%, 47/125) were performed concurrently, in which 53 (65%, 53/81) patients with severe cystocele and 5 patients (15%, 5/34) with rectocele were augmented with mesh, respectively. Concurrent operation and complications were studied. The objective success of the operation was defined as the leading vaginal edge above hymen.Subjective results were obtained quality-of-life questionnaires, including pelvic floor distress inventory short form (PFDI-20) and pelvic floor impact questionnaire short form (PFIQ-7). RESULT: The mean interval of following up was (5.4 ± 1.2) years.Four patients presented mild anterior vaginal wall prolapse, and the recurrence rate were 3.2% (4/125), but no reoperation and pessary treatment were needed. Therefore, the subjective and objective satisfaction rate was 94.4% (118/125) and 96.8% (121/125). The mean scores of PFDI-20 and PFIQ-7 at 5 years after the operations were 8, 7, significantly lower than 62, 64 (P < 0.01). There were 3 cases of ureter obstruction. Tension-free vaginal tape was performed on 47 cases with stress urinary incontinence (SUI) as indicated. The symptom of 2 patients was not improved significantly after the operation, but one was improved after 6 months. The rate of denovo SUI was in 2(1.6%, 2/125) patients, but no further treatment was needed. CONCLUSIONS: The transvaginal HUS was then conformed to be a safe, minimal traumatic, highly successful and durable procedure for severe POP, so it is worthy of being popularized for clinical application.

[Transvaginal Prosima mesh and high uterosacral ligament suspension in the treatment of severe pelvic organ prolapsey].

OBJECTIVE: To study the efficacy of performing transvaginal Prosima mesh with high uterosacral ligament suspension (HUS) in treatment of severe pelvic organ prolapse (POP). METHODS: From July 2010 to February 2011, 70 patients with severe POP underwent transvaginal prosima mesh with HUS in First Affiliated Hospital, General Hospital of People's Liberation Army. Clinical parameters of perioperation were collected. After 1 month and 2 - 3 months, perineal two-dimensional ultrasound examination was performed to measure mesh length in midsagittal plane. Validated prolapse quality of life questionnaires, pelvic floor distress inventsry short form 20 (PFDI-20) and pelvic floor impact questionnaire short form 7 (PFIQ-7) were used to evaluate the therapeutic effect. The mean results of pre-operative PFIQ-7 and PFDI-20 was 54 and 51, respectively. RESULTS: Median operation time was (195 ± 47) min and median blood loss was (160 ± 64) ml. All the patients were followed for a mean time of 13 months (2 - 19 months). Seven cases were found with mesh exposure with less than 1 cm(2). The objective cure rate was 100%. The mean score of post-operative PFIQ-7 and PFDI-20 were both 19, which were significantly lower than those of pre-operation (P < 0.05). Anterior Prosima mesh was 3.5 cm at 1 month by ultrasound examination, and the second result of ultrasound scans was 2.8 cm at 2 - 3 month, which were both shortened 2.5 cm and 3.2 cm when compared with that of original size. CONCLUSIONS: Transvaginal Prosima mesh placement with HUS is a safe and efficient surgery with less complication. Although mesh became shorter after 2 - 3 month, it did not affect surgery efficacy.

[Impact of vaginal mesh exposure on quality of life in patients undergoing transvaginal reconstructive pelvic surgery with polypropylene mesh].

OBJECTIVE: To study the impact of vaginal mesh exposure on quality of life in patients undergoing transvaginal reconstructive pelvic surgery (RPS) with polypropylene mesh. METHODS: From May 2004 to March 2011, 114 patients with severe pelvic organ prolapse (POP) undergoing transvaginal RPS with polypropylene mesh were enrolled in this study, which were divided into exposure and non-exposure group according to appearing vaginal mesh exposure at 2 months, 6 months and 1 year after operation. At the same time, pelvic floor distress inventory short form 20 (PFDI-20) and pelvic floor impact questionnaire short form 7 (PFIQ-7) were completed in those patients. RESULTS: At 2 months after operation, 96 patients were followed up, including 19 patients in exposure group and 77 patients in non-exposure group, and the rate of exposure was 19.8% (19/96); At 6 months after operation, 85 patients were followed up, including 13 patients in exposure group and 72 patients in non-exposure group, and the rate of exposure was 15.3% (13/85); At 1 year after operation, 77 patients were followed up, including 6 patients in exposure group and 71 patients in non-exposure group, and the rate of exposure was 7.8% (6/77). Mean score of PFDI-20 and PFIQ-7 in exposure group before operation was 39.6 and 57.1, which was statistically improved to 8.3 and 9.5 at 2 months after operation, 8.3 and 9.5 at 6 months after operation, 2.1 and 0 in 1 year after operation (P < 0.01). Mean score of PFDI-20 and PFIQ-7 of non-exposure group before operation was 54.2 and 66.7, which was improved to 8.3 and 4.8 at 2 months after operation, 0 at 6 months and 1 year after operation, but there was no significant difference in mean score of PFDI-20 and PFIQ-7 between the two groups (P > 0.05). CONCLUSION: Vaginal mesh exposure was common after transvaginal RPS with polypropylene mesh, however, most of them were moderate, and there was no significant impact on patients' qualifies of life.

[Validation of incontinence impact questionnaire short form in Chinese population].

OBJECTIVE: To study reliability and validity of incontinence impact questionnaire short form (IIQ-7) in the Chinese population. METHODS: IIQ-7 form was translated into Chinese; 74 patients with urinary incontinence completed the IIQ-7 simplified Chinese version and short-form 12-item health survey (SF-12) questionnaires. The urinary incontinence patient also ran a 1 hour pad test. Then, reliability and validity of those forms were analyzed. RESULTS: The Cronbach's alpha of IIQ-7 simplified Chinese version was 0.824 (P<0.01). The intra-class correlation coefficient of IIQ-7 simplified Chinese version was 0.749 (P<0.01). IIQ-7 simplified Chinese version scores were negatively correlated with SF-12 scores (Spearman correlation coefficient: -0.570, P<0.01), IIQ-7 simplified Chinese version scores were positively correlated with 1 hour pad test (Spearman correlation coefficient: 0.461, P<0.01), IIQ-7 simplified Chinese version scores were also positively correlated with the course of disease (Spearman correlation coefficient: 0.235, P<0.05). Factor analysis of IIQ-7 simplified Chinese version showed good construct validity. CONCLUSIONS: The simplified Chinese version of IIQ-7 has higher reliability and validity in the Chinese population. They are highly recommended for clinical treatment and research.

[Impact of colpocleisis on body image in women with severe pelvic organ prolapse].

OBJECTIVE: To investigate the impact of colpocleisis on body image in women with severe pelvic organ prolapse (POP). METHODS: From Oct. 2005 to Feb. 2010, 60 POP patients with stage III and IV by POP quantitation system underwent total or partial colpocleisis. Patients received body image evaluation before and 1 year after operation. RESULTS: One year after operation, 52 (87%, 52/60) patients completed body image evaluation. Before and 1 year after operation, the ratio of answer "Not at all" of questions such as "Have you felt less physically attractive as a result of your vaginal prolapse?", "Have you been feeling less feminine as a result of your vaginal prolapse?", "Did you find it difficult to look at yourself naked?", "Have you been feeling less sexually attractive as a result of your vaginal prolapse?", "Have you felt dissatisfied with your body?" were 25% and 96% (P < 0.01), 21% and 96% (P < 0.01), 37% and 67% (P = 0.018), 29% and 96% (P < 0.01), 12% and 83% (P < 0.01), respectively, indicating significant improvement on body image after operation for patients treated by colpocleisis. CONCLUSION: Women underwent colpocleisis for severe POP could not decrease their body image as a result of the disability of vaginal intercourse.

[Prevalence of fecal incontinence among adult women in Beijing district].

OBJECTIVE: To investigate the prevalence of fecal incontinence (FI) among adult women in Beijing area, and to analysis risk factors associated with FI. METHODS: A stratified multiple-cluster systemic method was used to recruit women ≥ 20 years old in 6 districts of Beijing. A self-administrated questionnaire was used to collect information about FI and possible risk factors. RESULTS: There were three thousand and 58 women participated in the survey, the average age was (48 ± 16) years (range 20-79 years). The prevalence of FI was 1.28% (39/3058), which was related to age. There were five factors entered the logistic regress model, which were included age ≥ 40 years old (OR = 3.3, 95%CI: 1.7-6.8), urinary incontinence (OR = 3.0, 95%CI: 1.5-6.1), vaginal delivery (OR = 2.4, 95%CI: 1.2-4.9), household per capita income ≤ 2000 RMB per month (OR = 3.3, 95%CI: 1.6-6.5), and feeling fatigue (OR = 3.0, 95%CI: 1.5-5.8). CONCLUSION: Prevalence of FI is low among adult women in Beijing area, while risk factors associated with FI are complicated and further studies are necessary to be conducted.

[Colpocleisis in elderly patients with severe pelvic organ prolapse].

OBJECTIVE: To study the objective and subjective therapeutic effect of total and partial (LeFort) colpocleisis in treatment of severe pelvic organ prolapsed (POP) in selected elderly patients. METHODS: From Oct. 2005 to Feb. 2010, 63 severe POP patients [59-87 years, median age (75+/-6) years] with stage III and IV by POP-Q system underwent total and partial colpocleisis. The mean age was (75+/-6) years (59-87 years). Fifty-eight patients (58/63, 92%) present more than one kind of medical disease. There were 53 cases with uterus prolapse, 1 case with cervix prolapse and 9 cases with vaginal vault prolapse. Seven patients were recurrent POP from previous surgery. Twenty-three patients (36%) presented voiding difficulty. Seven patients (17%) presented obstructive bowel symptom. Three patients (5%) presented fecal incontinence, and 28 patients (44%) presented either had urinary incontinence or history of that. Among 63 patients, 48 patients (76%) underwent total colpoclesis, and 15 (24%) patients partial colpoclesis. Meanwhile, 58 (92%) patients underwent levator myorrhaphy plus perineorrhaphy and 20 (32%) patients underwent anti-urinary incontinence procedure (TVT-O), respectively. Patients were followed up to evaluate therapeutic effect at 2 months and 1 year after surgery. Objective evaluation included the POP-Q and the length of vagina, genital hiatus, perineal body. A nonvalidated Body Image and Satisfaction Questionnaire was completed for subjective evaluation. RESULTS: The mean operating time of 63 patients was (105+/-48) minutes, which was (128+/-58) in total and (82+/-26) minutes partial procedures, which exhibited significant difference (P<0.05). The mean blood loss was (187+/-128) ml (50-600 ml), total and partial procedures caused (232+/-159) and (101+/-54) ml, respectively, which also showed significant difference (P<0.05). No intraoperative injury or death occurred. The rate of postoperative complications was 5% (3/63). Mean follow-up time of 63 patients was 22.5 months (1-51 months). All patients had POP-Q staging score

[High vaginal uterosacral ligament suspension for treatment of uterine prolapse].

OBJECTIVE: To evaluate the physiological and anatomic basis,indications,surgical skills, prevention of ureter injury and clinic outcomes of using high uterosacral ligament suspension (HUS) for correction of advanced uterine prolapse by the vaginal route. METHODS: Fifty women with advanced uterine prolapse underwent transvaginal HUS after vaginal hysterectomy with reconstruction of pubocervical and rectovaginal fascia to correct their uterine prolapse between June 2003 and September 2007. The average age of the women was 60.1 years. The mean follow-up period was 24 months (range 4-51 months). The degree of pelvic organ prolapse preoperatively and anatomic outcomes postoperatively were assessed with pelvic organ prolapse quantification system (POP-Q). RESULTS: The remnants of the uterosacral ligaments were clearly identified and palpated posterior and medial to the ischial spines by traction with a 24 cm long Allis clamp and used for successful vaginal vault suspension and reconstruction in all 50 consecutive advanced uterine prolapse patients. The ureter injury was avoided by complete knowledge of the ureter's course from the cervix/apex toward its insertion in the sacral region and how far outside of the uterosacral ligament, by uteri palpation and by suturing purposefully placed "deep" dorsally and posteriorly toward the sacrum, as well as by cystoscopy examination of the spillage of urine from both ureters. Mean POP-Q point C improved from 1.5 to -7.5 cm with a median follow-up of 24 months. If the successful HUS was defined as point C < or = stage I prolapse, both the objective and subjective cure rates were as high as 100% with a maximum follow-up of 51 months. None of the 50 patients had repeat operation for recurrence of prolapse. There was no major intra-or postoperative complications, such as ureter and other pelvic organ injury. CONCLUSION: HUS with fascial reconstruction seems to be a safe, minimal traumatic, tolerable and highly successful procedure for vaginal repair of advanced uterine prolapse. Because of the use of native tissue as suspension site HUS is more physiologic and cost effective.

[Vaginal paravaginal repair in treatment of severe anterior vaginal prolapse and cystocele].

OBJECTIVE: To explore the rationality, efficacy and safety of vaginal paravaginal repair (VPVR) in treating anterior vaginal prolapse and cystocele. METHODS: Twenty-five consecutive women with stage II to IV and grade II-III anterior vaginal prolapse and cystocele evaluated by pelvic organ prolapse quantification (POP-Q) and Baden-Walker half way system were treated by VPVR. One hundred and one concomitant procedures for reconstructive pelvic surgery were also performed. The VPVR consisted of a thorough entry from the vesicovaginal space under the inferior pubic ramus into the retropubic space, exposing the area of the arcus tendineus fascia pelvis (ATFP), placing nonabsorbable sutures around ATFP on either side and fixed to appropriate locations on the bladder fascia and anterior vaginal walls. Tying of these sutures resulted in dramatic elevation of the lateral superior sulci, as well as prolapsed vesica. Patients were followed up after operation. The cure rate was estimated subjectively and objectively, according to POP-Q and Baden-Walker half way system. RESULTS: All patients had their surgery completed by VPVR. The average operative time was 40 min and estimated blood loss was 70 ml. Two minor intraoperative hemorrhage occurred during dissection of retropubic space and there were no other complications. No morbidity after operation was observed either. Postoperatively, two patients developed obstructive voiding and urinary retention. One recovered completely in a few days, the other has improved slowly for 2 months. Patients were followed up for 2 - 14 months. Two patients with asymptomatic stage I or grade I cystocele were found by examination between 2 and 6 months after operation. Our objective cure rate was 92% and subjective cure rate was 100% respectively at a mean of 6 months after operation. CONCLUSIONS: Since VPVR can restore the normal lateral attachment of the pubocervical fascia to pelvic side wall at ATFP, it is a reasonable, safe and effective procedure to correct severe anterior vaginal prolapse and cystocele.