Transvaginal mesh or grafts or native tissue repair for vaginal prolapse.

BACKGROUND: Pelvic organ prolapse is the descent of one or more of the pelvic organs (uterus, vaginal apex, bladder, or bowel) into the vagina. In recent years, surgeons have increasingly used grafts in transvaginal repairs. Graft material can be synthetic or biological. The aim is to reduce prolapse recurrence and surpass the effectiveness of traditional native tissue repair (colporrhaphy) for vaginal prolapse. This is a review update; the previous version was published in 2016. OBJECTIVES: To determine the safety and effectiveness of transvaginal mesh or biological grafts compared to native tissue repair or other grafts in the surgical treatment of vaginal prolapse. SEARCH METHODS: We searched the Cochrane Incontinence Group Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and two clinical trials registers (March 2022). SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing different types of vaginal repair (mesh, biological graft, or native tissue). DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials, assessed risk of bias, and extracted data. The primary outcomes were awareness of prolapse, repeat surgery, and recurrent prolapse on examination. MAIN RESULTS: We included 51 RCTs (7846 women). The certainty of the evidence was largely moderate (ranging from very low to moderate). Transvaginal permanent mesh versus native tissue repair Awareness of prolapse at six months to seven years was less likely after mesh repair (risk ratio (RR) 0.83, 95% confidence interval (CI) 0.73 to 0.95; I2 = 34%; 17 studies, 2932 women; moderate-certainty evidence). This suggests that if 23% of women are aware of prolapse after native tissue repair, between 17% and 22% will be aware of prolapse after permanent mesh repair. Rates of repeat surgery for prolapse were lower in the mesh group (RR 0.71, 95% CI 0.53 to 0.95; I2 = 35%; 17 studies, 2485 women; moderate-certainty evidence). There was no evidence of a difference between the groups in rates of repeat surgery for incontinence (RR 1.03, 95% CI 0.67 to 1.59; I2 = 0%; 13 studies, 2206 women; moderate-certainty evidence). However, more women in the mesh group required repeat surgery for the combined outcome of prolapse, stress incontinence, or mesh exposure (RR 1.56, 95% CI 1.07 to 2.26; I2 = 54%; 27 studies, 3916 women; low-certainty evidence). This suggests that if 7.1% of women require repeat surgery after native tissue repair, between 7.6% and 16% will require repeat surgery after permanent mesh repair. The rate of mesh exposure was 11.8% and surgery for mesh exposure was 6.1% in women who had mesh repairs. Recurrent prolapse on examination was less likely after mesh repair (RR 0.42, 95% CI 0.32 to 0.55; I2 = 84%; 25 studies, 3680 women; very low-certainty evidence). Permanent transvaginal mesh was associated with higher rates of de novo stress incontinence (RR 1.50, 95% CI 1.19 to 1.88; I2 = 0%; 17 studies, 2001 women; moderate-certainty evidence) and bladder injury (RR 3.67, 95% CI 1.63 to 8.28; I2 = 0%; 14 studies, 1997 women; moderate-certainty evidence). There was no evidence of a difference between the groups in rates of de novo dyspareunia (RR 1.22, 95% CI 0.83 to 1.79; I2 = 27%; 16 studies, 1308 women; moderate-certainty evidence). There was no evidence of a difference in quality of life outcomes; however, there was substantial heterogeneity in the data. Transvaginal absorbable mesh versus native tissue repair There was no evidence of a difference between the two methods of repair at two years for the rate of awareness of prolapse (RR 1.05, 95% CI 0.77 to 1.44; 1 study, 54 women), rate of repeat surgery for prolapse (RR 0.47, 95% CI 0.09 to 2.40; 1 study, 66 women), or recurrent prolapse on examination (RR 0.53, 95% CI 0.10 to 2.70; 1 study, 66 women). The effect of either form of repair was uncertain for bladder-related outcomes, dyspareunia, and quality of life. Transvaginal biological graft versus native tissue repair There was no evidence of a difference between the groups at one to three years for the outcome awareness of prolapse (RR 1.06, 95% CI 0.73 to 1.56; I2 = 0%; 8 studies, 1374 women; moderate-certainty evidence), repeat surgery for prolapse (RR 1.15, 95% CI 0.75 to 1.77; I2 = 0%; 6 studies, 899 women; moderate-certainty evidence), and recurrent prolapse on examination (RR 0.96, 95% CI 0.71 to 1.29; I2 = 53%; 9 studies, 1278 women; low-certainty evidence). There was no evidence of a difference between the groups for dyspareunia or quality of life. Transvaginal permanent mesh versus any other permanent mesh or biological graft vaginal repair Sparse reporting of primary outcomes in both comparisons significantly limited any meaningful analysis. AUTHORS' CONCLUSIONS: While transvaginal permanent mesh is associated with lower rates of awareness of prolapse, repeat surgery for prolapse, and prolapse on examination than native tissue repair, it is also associated with higher rates of total repeat surgery (for prolapse, stress urinary incontinence, or mesh exposure), bladder injury, and de novo stress urinary incontinence. While the direction of effects and effect sizes are relatively unchanged from the 2016 version of this review, the certainty and precision of the findings have all improved with a larger sample size. In addition, the clinical relevance of these data has improved, with 10 trials reporting 3- to 10-year outcomes. The risk-benefit profile means that transvaginal mesh has limited utility in primary surgery. Data on the management of recurrent prolapse are of limited quality. Given the risk-benefit profile, we recommend that any use of permanent transvaginal mesh should be conducted under the oversight of the local ethics committee in compliance with local regulatory recommendations. Data are not supportive of absorbable meshes or biological grafts for the management of transvaginal prolapse.

Surgery for women with apical vaginal prolapse.

BACKGROUND: Apical vaginal prolapse is the descent of the uterus or vaginal vault (post-hysterectomy). Various surgical treatments are available, but there are no guidelines to recommend which is the best. OBJECTIVES: To evaluate the safety and efficacy of any surgical intervention compared to another intervention for the management of apical vaginal prolapse. SEARCH METHODS: We searched the Cochrane Incontinence Group's Specialised Register of controlled trials, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings and ClinicalTrials.gov (searched 14 March 2022). SELECTION CRITERIA: We included randomised controlled trials (RCTs). DATA COLLECTION AND ANALYSIS: We used Cochrane methods. Our primary outcomes were awareness of prolapse, repeat surgery and recurrent prolapse (any site). MAIN RESULTS: We included 59 RCTs (6705 women) comparing surgical procedures for apical vaginal prolapse. Evidence certainty ranged from very low to moderate. Limitations included imprecision, poor methodology, and inconsistency. Vaginal procedures compared to sacral colpopexy for vault prolapse (seven RCTs, n=613; six months to f four-year review) Awareness of prolapse was more common after vaginal procedures (risk ratio (RR) 2.31, 95% confidence interval (CI) 1.27 to 4.21, 4 RCTs, n = 346, I2 = 0%, moderate-certainty evidence). If 8% of women are aware of prolapse after sacral colpopexy, 18% (10% to 32%) are likely to be aware after vaginal procedures. Surgery for recurrent prolapse was more common after vaginal procedures (RR 2.33, 95% CI 1.34 to 4.04; 6 RCTs, n = 497, I2 = 0%, moderate-certainty evidence). The confidence interval suggests that if 6% of women require repeat prolapse surgery after sacral colpopexy, 14% (8% to 25%) are likely to require it after vaginal procedures. Prolapse on examination is probably more common after vaginal procedures (RR 1.87, 95% CI 1.32 to 2.65; 5 RCTs, n = 422; I2 = 24%, moderate-certainty evidence). If 18% of women have recurrent prolapse after sacral colpopexy, between 23% and 47% are likely to do so after vaginal procedures. Other outcomes: Stress urinary incontinence (SUI) was more common after vaginal procedures (RR 1.86, 95% CI 1.17 to 2.94; 3 RCTs, n = 263; I2 = 0%, moderate-certainty evidence). The effect of vaginal procedures on dyspareunia was uncertain (RR 3.44, 95% CI 0.61 to 19.53; 3 RCTs, n = 106, I2 = 65%, low-certainty evidence). Vaginal hysterectomy compared to sacral hysteropexy/cervicopexy (six RCTS, 554 women, one to seven year review) Awareness of prolapse - There may be little or no difference between the groups for this outcome (RR 1.01 95% CI 0.10 to 9.98; 2 RCTs, n = 200, very low-certainty evidence). Surgery for recurrent prolapse - There may be little or no difference between the groups for this outcome (RR 0.85, 95% CI 0.47 to 1.54; 5 RCTs, n = 403; I2 = 9%, low-certainty evidence). Prolapse on examination- there was little or no difference between the groups for this outcome (RR 0.78, 95% CI 0.54 to 1.11; 2 RCTs n = 230; I2 = 9%, moderate-certainty evidence). Vaginal hysteropexy compared to sacral hysteropexy/cervicopexy (two RCTs, n = 388, 1-four-year review) Awareness of prolapse - No difference between the groups for this outcome (RR 0.55 95% CI 0.21 to 1.44; 1 RCT n = 257, low-certainty evidence). Surgery for recurrent prolapse - No difference between the groups for this outcome (RR 1.34, 95% CI 0.52 to 3.44; 2 RCTs, n = 345; I2 = 0%, moderate-certainty evidence). Prolapse on examination- There were little or no difference between the groups for this outcome (RR 0.99, 95% CI 0.83 to 1.19; 2 RCTs n =367; I2 =9%, moderate-certainty evidence). Vaginal hysterectomy compared to vaginal hysteropexy (four RCTs, n = 620, 6 months to five-year review) Awareness of prolapse - There may be little or no difference between the groups for this outcome (RR 1.0 95% CI 0.44 to 2.24; 2 RCTs, n = 365, I2 = 0% moderate-quality certainty evidence). Surgery for recurrent prolapse - There may be little or no difference between the groups for this outcome (RR 1.32, 95% CI 0.67 to 2.60; 3 RCTs, n = 443; I2 = 0%, moderate-certainty evidence). Prolapse on examination- There were little or no difference between the groups for this outcome (RR 1.44, 95% CI 0.79 to 2.61; 2 RCTs n =361; I2 =74%, low-certainty evidence). Other outcomes: Total vaginal length (TVL) was shorter after vaginal hysterectomy (mean difference (MD) 0.89cm 95% CI 0.49 to 1.28cm shorter; 3 RCTs, n=413, low-certainty evidence). There is probably little or no difference between the groups in terms of operating time, dyspareunia and stress urinary incontinence. Other analyses There were no differences identified for any of our primary review outcomes between different types of vaginal native tissue repair (4 RCTs), comparisons of graft materials for vaginal support (3 RCTs), pectopexy versus other apical suspensions (5 RCTs), continuous versus interrupted sutures at sacral colpopexy (2 RCTs), absorbable versus permanent sutures at apical suspensions (5 RCTs) or different routes of sacral colpopexy. Laparoscopic sacral colpopexy is associated with shorter admission time than open approach (3 RCTs) and quicker operating time than robotic approach (3 RCTs). Transvaginal mesh does not confer any advantage over native tissue repair, however is associated with a 17.5% rate of mesh exposure (7 RCTs). AUTHORS' CONCLUSIONS: Sacral colpopexy is associated with lower risk of awareness of prolapse, recurrent prolapse on examination, repeat surgery for prolapse, and postoperative SUI than a variety of vaginal interventions. The limited evidence does not support the use of transvaginal mesh compared to native tissue repair for apical vaginal prolapse. There were no differences in primary outcomes for different routes of sacral colpopexy. However, the laparoscopic approach is associated with a shorter operating time than robotic approach, and shorter admission than open approach. There were no significant differences between vaginal hysteropexy and vaginal hysterectomy for uterine prolapse nor between vaginal hysteropexy and abdominal hysteropexy/cervicopexy. There were no differences detected between absorbable and non absorbable sutures however, the certainty of evidence for mesh exposure and dyspareunia was low.

Surgery for women with posterior compartment prolapse.

BACKGROUND: Posterior vaginal wall prolapse (also known as 'posterior compartment prolapse') can cause a sensation of bulge in the vagina along with symptoms of obstructed defecation and sexual dysfunction. Interventions for prevention and conservative management include lifestyle measures, pelvic floor muscle training, and pessary use. We conducted this review to assess the surgical management of posterior vaginal wall prolapse. OBJECTIVES: To evaluate the safety and effectiveness of any surgical intervention compared with another surgical intervention for management of posterior vaginal wall prolapse. SEARCH METHODS: We searched the Cochrane Incontinence Group Specialised Register of controlled trials, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) (searched April 2017). We also searched the reference lists of relevant articles, and we contacted researchers in the field. SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing different types of surgery for posterior vaginal wall prolapse. DATA COLLECTION AND ANALYSIS: We used Cochrane methods. Our primary outcomes were subjective awareness of prolapse, repeat surgery for any prolapse, and objectively determined recurrent posterior wall prolapse. MAIN RESULTS: We identified 10 RCTs evaluating 1099 women. Evidence quality ranged from very low to moderate. The main limitations of evidence quality were risk of bias (associated mainly with performance, detection, and attrition biases) and imprecision (associated with small overall sample sizes and low event rates).Transanal repair versus transvaginal repair (four RCTs; n = 191; six months' to four years' follow-up)Awareness of prolapse is probably more common after the transanal approach (risk ratio (RR) 2.78, 95% confidence interval (CI) 1.00 to 7.70; 2 RCTs; n = 87; I2 = 0%; low-quality evidence). If 10% of women are aware of prolapse after transvaginal repair, between 10% and 79% are likely to be aware after transanal repair.Repeat surgery for any prolapse: Evidence is insufficient to show whether there were any differences between groups (RR 2.42, 95% CI 0.75 to 7.88; 1 RCT; n = 57; low-quality evidence).Recurrent posterior vaginal wall prolapse is probably more likely after transanal repair (RR 4.12, 95% CI 1.56 to 10.88; 2 RCTs; n = 87; I2 = 35%; moderate-quality evidence). If 10% of women have recurrent prolapse on examination after transvaginal repair, between 16% and 100% are likely to have recurrent prolapse after transanal repair.Postoperative obstructed defecation is probably more likely with transanal repair (RR 1.67, 95% CI 1.00 to 2.79; 3 RCTs; n = 113; I2 = 10%; low-quality evidence).Postoperative dyspareunia: Evidence is insufficient to show whether there were any differences between groups (RR 0.32, 95% CI 0.09 to 1.15; 2 RCTs; n = 80; I2 = 5%; moderate-quality evidence).Postoperative complications: Trials have provided no conclusive evidence of any differences between groups (RR 3.57, 95% CI 0.94 to 13.54; 3 RCTs; n = 135; I2 = 37%; low-quality evidence). If 2% of women have complications after transvaginal repair, then between 2% and 21% are likely to have complications after transanal repair.Evidence shows no clear differences between groups in operating time (in minutes) (mean difference (MD) 1.49, 95% CI -11.83 to 8.84; 3 RCTs; n = 137; I2 = 90%; very low-quality evidence).Biological graft versus native tissue repairEvidence is insufficient to show whether there were any differences between groups in rates of awareness of prolapse (RR 1.09, 95% CI 0.45 to 2.62; 2 RCTs; n = 181; I2 = 13%; moderate-quality evidence) or repeat surgery for any prolapse (RR 0.60, 95% CI 0.18 to 1.97; 2 RCTs; n = 271; I2 = 0%; moderate-quality evidence). Trials have provided no conclusive evidence of a difference in rates of recurrent posterior vaginal wall prolapse (RR 0.55, 95% CI 0.30 to 1.01; 3 RCTs; n = 377; I2 = 6%; moderate-quality evidence); if 13% of women have recurrent prolapse on examination after native tissue repair, between 4% and 13% are likely to have recurrent prolapse after biological graft. Evidence is insufficient to show whether there were any differences between groups in rates of postoperative obstructed defecation (RR 0.96, 95% CI 0.50 to 1.86; 2 RCTs; n = 172; I2 = 42%; moderate-quality evidence) or postoperative dyspareunia (RR 1.27, 95% CI 0.26 to 6.25; 2 RCTs; n = 152; I2 = 74%; low-quality evidence). Postoperative complications were more common with biological repair (RR 1.82, 95% CI 1.22 to 2.72; 3 RCTs; n = 448; I2 = 0%; low-quality evidence).Other comparisonsSingle RCTs compared site-specific vaginal repair versus midline fascial plication (n = 74), absorbable graft versus native tissue repair (n = 132), synthetic graft versus native tissue repair (n = 191), and levator ani plication versus midline fascial plication (n = 52). Data were scanty, and evidence was insufficient to show any conclusions about the relative effectiveness or safety of any of these interventions. The mesh exposure rate in the synthetic group compared with the native tissue group was 7%. AUTHORS' CONCLUSIONS: Transvaginal repair may be more effective than transanal repair for posterior wall prolapse in preventing recurrence of prolapse, in the light of both objective and subjective measures. However, data on adverse effects were scanty. Evidence was insufficient to permit any conclusions about the relative effectiveness or safety of other types of surgery. Evidence does not support the utilisation of any mesh or graft materials at the time of posterior vaginal repair. Withdrawal of some commercial transvaginal mesh kits from the market may limit the generalisability of our findings.

Can the Learning Curve of Laparoscopic Sacrocolpopexy Be Reduced by a Structured Training Program?

OBJECTIVE: The aim of this study was to establish whether the learning curve for laparoscopic sacral colpopexy (LSC) could be significantly reduced in a structured learning program. METHODS: We conducted a prospective study aimed at mapping the learning curve of LSC in the setting of a structured learning program for a urogynecology fellow at the Royal Brisbane and Women's Hospital.The fellow was laparoscopic suturing and dissection naive at the commencement of her fellow position and was required to assist in 20 LSCs, video-edit 2 procedures, and undertake laparoscopic suturing and knot tying training on a laparoscopic trainer for 2 h/wk during the trial period.After the completion of this structured learning program, the fellow began performing LSC as the primary surgeon.Symptomatic assessment of pelvic organ prolapse and pelvic floor dysfunction was undertaken preoperatively and 12 months postoperatively using the Australian Pelvic Floor Questionnaire.Objective success at 12 months was defined as less than stage 2 prolapse in any compartment. Subjective success was defined as no prolapse on Q 28 to 31 on the Australian Pelvic Floor Questionnaire, and patient-determined success was defined as "much" or "very much better" on the Patient Global Impression of Improvement at 12 months. RESULTS: Five consecutive LSC in 90 minutes or less without intraoperative or postoperative complications was achieved by case 18. Overall objective success at 12 months was 91%, and subjective and patient-determined success was 95%. CONCLUSION: Previous studies on LSC that report a similar learning curve have recorded much longer operating times. We believe that the shorter operating time, without compromise to outcomes and complication rates, is a result of the structured learning program.

A descriptive study on the efficacy and complications of the Capio (Boston Scientific) suturing device for sacrospinous ligament fixation.

BACKGROUND: Sacrospinous colpopexy is an effective vaginal apical support operation. Due to morbidity associated with traditional approaches which require wide dissection, slim-line suture delivery devices have been introduced in the hope of reducing morbidity without compromise to outcomes. AIM: The aim of our series was to report outcomes and complications (particularly buttock pain and blood loss) of the sacrospinous colpopexy using the Capio suturing device and evaluate it against published results using the Miya hook. METHODS: This is a prospective, multi-centre descriptive study. The primary outcome is objective success at 12 months. Secondary outcomes include subjective success at 12 months, patient-reported outcomes at 12 months, operating time, estimated blood loss and post-operative buttock pain. RESULTS: Fifty-one consenting patients undergoing sacrospinous colpopexy were recruited at four Queensland hospitals. Objective success at 12 months was 95% (41/43) and subjective success at 12 months was 92% (44/48). Eighty-four percent of patients reported buttock pain at one week, reducing to 16% by six weeks, of which 7% required analgesia. CONCLUSIONS: At a mean of 17 months follow up, we found that the sacrospinous colpopexy using the Capio suturing device provided excellent apical support with a low requirement for blood transfusion and an average operating time of seven minutes. We found a high rate of buttock pain immediately post-operatively, but our rates became consistent with previous reports by six weeks post-operation.

Surgical outcomes for low-volume vs high-volume surgeons in gynecology surgery: a systematic review and meta-analysis.

OBJECTIVE: The aim of this study was to determine the impact of gynecological surgeon volumes on patient outcomes. DATA SOURCES: Eligible studies were selected through an electronic literature search from database inception up until September 2015 and references in published studies. Search terms included surgical volume, surgeon volume, low-volume or high-volume, and gynecology or hysterectomy or sling or pelvic floor repair or continence procedure. STUDY ELIGIBILITY: The literature search was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We defined a low-volume surgeon (LVS) as one performing the procedure once a month or less, and studies were excluded if their definition of LVS was > ±33% of our definition. Primary outcomes were total complications, intraoperative complications, and postoperative complications. STUDY APPRAISAL AND SYNTHESIS METHODS: All outcome data for individual studies were entered into systematic review software. When 2 or more studies evaluated a designated outcome, a meta-analysis of the entered data was undertaken as per the Cochrane database methodology. Data analysis was entered into a software product, which generated a summary of findings table that included structured and qualified grading (very low to high) of the quality for the evidence of the individual outcomes and provided a measure of effect. RESULTS: Fourteen peer-reviewed studies with 741,760 patients were included in the systematic review. For gynecology the LVS group had an increased rate of total complications (odds ratio [OR], 1.3, 95% confidence interval [CI], 1.2-1.5), intraoperative complications (OR, 1.6, 95% CI, 1.2-2.1), and postoperative complications (OR, 1.4 95% CI, 1.3-1.4). In gynecological oncology, the LVS group had higher mortality (OR, 1.9, 95% CI, 1.3-2.6). In the urogynecology group, a single study reported that the LVS group had a higher rate of any complication (risk ratio [RR], 1.4, 95% CI, -1.2-1.6). Another single study found that LVS had higher rates of reoperation for mesh complications after midurethral sling procedures (RR, 1.4, 95% CI, 1.2-1.5). The evidence is of moderate to very low quality. CONCLUSION: Gynecologists performing procedures approximately once a month or less were found to have higher rates of adverse outcomes in gynecology, gynecological oncology, and urogynecology, with higher mortality in gynecological oncology.

Adenoma malignum presenting as urinary incontinence.

Adenoma malignum is a rare malignancy of the cervix that often presents, as in this case, as urinary incontinence (UI). Due to this symptomatology, women with adenoma malignum are often referred to urogynecologists for investigation and management. Without a high degree of suspicion, the diagnosis is easy to overlook due to the atypical presentation for a gynecological malignancy and the deceptively benign histopathology. Adenoma malignum is highly malignant, and a late diagnosis is often fatal. An early diagnosis is therefore crucial for curative management, and the following paper provides a timely reminder of this rare but potentially devastating condition.