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.

Do or Don't: Results of a Multinational Survey on Antibiotic Prophylaxis in Urodynamics.

Antibiotic prophylaxis contributes substantially to the increase in antibiotic resistance rates worldwide. This investigation aims to assess the current standard of practice in using antibiotic prophylaxis for urodynamics (UDS) and identify barriers to guideline adherence. An online survey using a 22-item questionnaire designed according to the Checklist for Reporting Results of Internet E-Surveys (CHERRIES) was circulated among urologists and gynecologists in Austria, Germany, and Switzerland between September 2021 and March 2022. A total of 105 questionnaires were eligible for analysis. Out of 105 completed surveys, most responders (n = 99, 94%) regularly perform dipstick urine analysis prior to urodynamics, but do not perform a urine culture (n = 68, 65%). Ninety-eight (93%) participants refrain from using antibiotic prophylaxis, and sixty-eight (65%) use prophylaxis if complicating factors exist. If asymptomatic bacteriuria is present, approximately 54 (52%) participants omit UDS and reschedule the procedure until antimicrobial susceptibility testing is available. Seventy-eight (78%) participants do not have a standard procedure for antibiotic prophylaxis in their department. Part of the strategy against the development of bacterial resistance is the optimized use of antibiotics, including antibiotic prophylaxis in urodynamics. Establishing a standard procedure is necessary and purposeful to harmonize both aspects in the field of urological diagnostics.

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.

Urinary Incontinence and Pelvic Organ Prolapse in Women.

BACKGROUND: Pelvic floor disorders are common, especially in pregnancy and after delivery, in the postmenopausal period, and old age, and they can significantly impact on the patient's quality of life. METHODS: This narrative review is based on publications retrieved by a selective search of the literature, with special consideration to original articles and AWMF guidelines. RESULTS: Pelvic floor physiotherapy (evidence level [EL] 1), the use of pessaries (EL2), and local estrogen therapy can help alleviate stress/urge urinary incontinence and other symptoms of urogenital prolapse. Physiotherapy can reduce urinary incontinence by 62% during pregnancy and by 29% 3-6 months post partum. Anticholinergic and ß-sympathomimetic drugs are indicated for the treatment of an overactive bladder with or without urinary urge incontinence (EL1). For patients with stress urinary incontinence, selective serotonin-noradrenaline reuptake inhibitors can be prescribed (EL1). The tension-free tape is the current standard of surgical treatment (EL1); in an observational follow-up study, 87.2% of patients were satisfied with the outcome 17 years after surgery. Fascial reconstruction techniques are indicated for the treatment of primary pelvic organ prolapse, and mesh-based surgical procedures for recurrences and severe prolapse (EL1). CONCLUSION: Urogynecological symptoms should be specifically asked about by physicians of all relevant specialties; if present, they should be treated conservatively at first. Structured surgical techniques with and without mesh are available for the treatment of urinary incontinence and pelvic organ prolapse. Preventive measures against pelvic floor dysfunction should be offered during pregnancy and post partum.

Summary: 2021 International Consultation on Incontinence Evidence-Based Surgical Pathway for Pelvic Organ Prolapse.

(1) Background: There is wide variation in the reported prevalence rates for pelvic organ prolapse (POP). There is also wide variation in the rate at which surgical interventions for pelvic organ prolapse are performed, as well as the type of interventions undertaken. As part of the International Consultation on Incontinence (ICI), our committee was tasked to produce evidence-based pathways for the surgical management of POP, any associated stress urinary incontinence (SUI), and bowel dysfunction. (2) Methods: To enable us to generate such evidence, we undertook a thorough search for the POP surgery-related, English-language scientific literature published up to April 2021. (3) Results: The committee evaluated the literature and made recommendations based on the Oxford grading system. (4) Conclusions: This review serves to provide a summary of the 2021 ICI surgical management of an evidence-based prolapse pathway and outline the evidence used to inform this guidance.

Aspects of Pelvic Floor Protection in Spontaneous Delivery - a Review.

The necessity of increasingly addressing aspects of pelvic floor protection, i.e., prevention of the most frequent female pelvic floor disorders, such as urinary incontinence, faecal incontinence and pelvic organ prolapse, is the result of the steadily improving understanding of the association of pregnancy and delivery with the prevalence of these disorders. About a quarter of all women experience one or more such symptoms during their life. Apart from age and weight, pregnancies and births play an important part. While initial discussion of pelvic floor protection often focused very rapidly on the mode of delivery and elective caesarean section as a possible protective intervention, it has become apparent in the last few decades how varied and wide-ranging the options are that can be used to protect against pelvic floor disorders. The mode of delivery as such is "only" one element among numerous other considerations and has diminished markedly in importance. Interprofessionality and interdisciplinarity undoubtedly represent an important development as resulting recommendations must always be incorporated in an overall context that considers mother and child at the same time. Considering the pelvic floor only certainly does not make sense. This review article will analyze in greater detail important pre-, intra- and postpartum aspects that in their entirety can provide insight into the various aspects of pelvic floor protection. The authors regard the following article as an additional basis for discussion on achieving a sustained reduction in the incidence and prevalence of female pelvic floor disorders.

Summary: 2017 International Consultation on Incontinence Evidence-Based Surgical Pathway for Pelvic Organ Prolapse.

OBJECTIVE: The aim of this article is to summarize the relevant findings that inform the 2017 International Consultation on Incontinence pathway for surgical treatment of pelvic organ prolapse (POP). METHODS: We conducted an evidence-based review of the English-language peer-reviewed literature relating to POP surgery published prior to December 2016. Level 1 evidence (randomized controlled trials [RCTs] or systematic reviews of RCTs) was preferred; however, level 2 (poor-quality RCT, prospective cohort studies) or 3 evidence (case series or retrospective studies) has been included if level 1 data were lacking. The committee evaluated the literature and made recommendations based on the Oxford grading system summarized as follows: grade A recommendation usually depends on consistent level 1 evidence; grade B recommendation usually depends on consistent level 2 and/or 3 studies, or "majority evidence" from RCTs; grade C recommendation usually depends on level 3 studies or "majority evidence" from level 2/3 studies or Delphi-processed expert opinion; grade D, "no recommendation possible," would be used where the evidence is inadequate or conflicting. RESULTS: The recommendations from each chapter of the review are presented and serve to inform an evidence-based pathway for the surgical treatment of prolapse. A Web-based interactive application of the pathway is presented. CONCLUSIONS: The 2017 International Consultation on Incontinence pathway on surgery for POP is designed as an adjunct to transparent consultation and consent relating to POP surgery. The final decision regarding surgical intervention can be made only after a shared decision-making process between the patient and the clinician that will evaluate a variety of individual factors that cannot be assessed in the pathway.

The minimal important difference of the Australian Pelvic Floor Questionnaire.

INTRODUCTION AND HYPOTHESIS: The aim of this study was to establish the minimal important difference (MID) of the Australian Pelvic Floor Questionnaire (APFQ) in women undergoing surgery for stress urinary incontinence or symptomatic pelvic organ prolapse. A further aim was to estimate dysfunction scores dependent on the bothersomeness in a community cohort. METHODS: The APFQ was completed before and 6 weeks after pelvic floor surgery by 183 women (n = 80 suburethral tape insertion; n = 103 laparoscopic sacrocolpopexy). Distribution and anchor-based methods were used to establish the effect size, standardised response mean and MID (calculated as the difference between women who stated no change or a little better in the Patient Global Impression of Improvement [PGI-I]). In a community cohort of 470 women aged 42-80 years, the APFQ was analysed according to disclosed bothersomeness. RESULTS: For the suburethral tape group, the effect size in the bladder domain was 1.5 and the PGI-I-based MID 1.3. For the POP surgery, group the effect size in the prolapse domain was calculated at 2.2 and the PGI-I-based MID at 1.0. The domain scores for women who declared no bother were significantly different from those who were a little bothered (bladder domain 2.2 vs 4.0, bowel 0.6 vs 1.7, POP 0.1 vs 3.2, sex 1.8 vs 3.0) with wide variations. CONCLUSIONS: The MID of the APFQ ranged from 1.0 to 1.3 in the domains after POP or continence surgery respectively. This is corroborated by the differences in domain scores from community-based women who were bothered versus not bothered by pelvic floor symptoms.

Surgery for women with pelvic organ prolapse with or without stress urinary incontinence.

BACKGROUND: Pelvic organ prolapse (POP) is common in women and is frequently associated with stress urinary incontinence (SUI). In many cases however, SUI is present only with the prolapse reduced (occult SUI) or may develop after surgical treatment for prolapse (de novo SUI). OBJECTIVES: To determine the impact on postoperative bladder function of surgery for symptomatic pelvic organ prolapse with or without concomitant or delayed two-stage continence procedures to treat or prevent stress urinary incontinence. SEARCH METHODS: We searched the Cochrane Incontinence Group Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE-In-Process, ClinicalTrials.gov, WHO ICTRP, handsearching journals and conference proceedings (searched 11 November 2017) and reference lists of relevant articles. We also contacted researchers in the field. SELECTION CRITERIA: Randomised controlled trials (RCTs) including surgical operations for POP with or without continence procedures in continent or incontinent women. Our primary outcome was subjective postoperative SUI. Secondary outcomes included recurrent POP on examination, overactive bladder (OAB) symptoms, and voiding dysfunction. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures as expected by Cochrane. MAIN RESULTS: We included 19 RCTs (2717 women). The quality of the evidence ranged from low to moderate. The main limitations were risk of bias (especially blinding of outcome assessors), indirectness and imprecision associated with low event rates and small samples.POP surgery in women with SUIVaginal repair with vs without concomitant mid-urethral sling (MUS)A concomitant MUS probably improves postoperative rates of subjective SUI, as the evaluated clinical effect appears large (risk ratio (RR) 0.30, 95% confidence interval (CI) 0.19 to 0.48; 319 participants, two studies; I² = 28%; moderate-quality evidence), and probably decreases the need for further continence surgery (RR 0.04, 95% CI 0.00 to 0.74; 134 participants, one study; moderate-quality evidence). This suggests that if the risk of SUI with POP surgery alone is 39%, the risk with an MUS is between 8% and 19%.Rates of recurrent POP on examination, OAB, and voiding dysfunction were not reported.Vaginal repair with concomitant vs delayed MUSEvidence suggested little or no difference between groups in reporting postoperative SUI (RR 0.41, 95% CI 0.12 to 1.37; 140 participants, one study; moderate-quality evidence).Rates of recurrent POP on examination, OAB, and voiding dysfunction and the need for further surgery were not reported.Abdominal sacrocolpopexy with vs without Burch colposuspensionAn additional Burch colposuspension probably has little or no effect on postoperative SUI at one year (RR 1.38, 95% CI 0.74 to 2.60; 47 participants, one study; moderate-quality evidence), OAB symptoms (RR 0.85, 95% CI 0.61 to 1.18; 33 participants, one study; moderate-quality evidence), or voiding dysfunction (RR 0.96, 95% CI 0.06 to 14.43; 47 participants, one study; moderate-quality evidence). Rates of recurrent POP and the need for further surgery were not reported.POP surgery in women with occult SUIVaginal repair with vs without concomitant MUSMUS probably improves rates of subjective postoperative SUI (RR 0.38, 95% CI 0.26 to 0.55; 369 participants, five studies; I² = 44%; moderate-quality evidence). This suggests that if the risk with surgery alone is 34%, the risk with a concomitant MUS is between 10% and 22%. Evidence suggests little or no difference between groups in rates of recurrent POP (RR 0.86, 95% CI 0.34 to 2.19; 50 participants, one study; moderate-quality evidence), OAB symptoms (RR 0.75, 95% CI 0.52 to 1.07; 43 participants, one study; low-quality evidence), or voiding dysfunction (RR 1.00, 95% CI 0.15 to 6.55; 50 participants, one study; low-quality evidence). The need for further surgery was not reported.POP surgery in continent women Vaginal repair with vs without concomitant MUSResearchers provided no conclusive evidence of a difference between groups in rates of subjective postoperative SUI (RR 0.69, 95% CI 0.47 to 1.00; 220 participants, one study; moderate-quality evidence). This suggests that if the risk with surgery alone is 40%, the risk with a concomitant MUS is between 19% and 40%. Rates of recurrent POP, OAB, and voiding dysfunction and the need for further surgery were not reported.Abdominal sacrocolpopexy with vs without Burch colposuspensionWe are uncertain whether there is a difference between groups in rates of subjective postoperative SUI (RR 1.31, 95% CI 0.19 to 9.01; 379 participants, two studies; I² = 90%; low-quality evidence), as RCTs produced results in different directions with a very wide confidence interval. We are also uncertain whether there is a difference between groups in rates of voiding dysfunction (RR 8.49, 95% CI 0.48 to 151.59; 66 participants, one study; low-quality evidence) or recurrent POP (RR 0.98, 95% CI 0.74 to 1.30; 250 participants, one study; moderate-quality evidence. No study reported OAB symptoms and need for further surgery.Vaginal repair with armed anterior vaginal mesh repair vs anterior native tissue Anterior armed mesh repair may slightly increase postoperative de novo SUI (RR 1.58, 95% CI 1.05 to 2.37; 905 participants, seven studies; I² = 0%; low-quality evidence) but may decrease recurrent POP (RR 0.29, 95% CI 0.22 to 0.38; 848 participants, five studies; I² = 0%; low-quality evidence). There may be little or no difference in rates of voiding dysfunction (RR 1.65, 95% CI 0.22 to 12.10; 125 participants, two studies; I² = 0%; low-quality evidence). Rates of OAB and the need for further surgery were not reported.Adverse events were infrequently reported in all studies; cost was not studied in any trial. AUTHORS' CONCLUSIONS: In women with POP and SUI (symptomatic or occult), a concurrent MUS probably reduces postoperative SUI and should be discussed in counselling. It might be feasible to postpone the MUS and perform a delayed (two-stage) continence procedure, if required.Although an abdominal continence procedure (Burch colposuspension) during abdominal POP surgery in continent women reduced de novo SUI rates in one underpowered trial, another RCT reported conflicting results. Adding an MUS during vaginal POP repair might reduce postoperative development of SUI.An anterior native tissue repair might be better than use of transobturator mesh for preventing postoperative SUI; however, prolapse recurrence is more common with native tissue repair.

Perioperative interventions in pelvic organ prolapse surgery.

BACKGROUND: Pelvic organ prolapse (POP) affects as many as 50% of parous women, with 14% to 19% of women undergoing a surgical correction. Although surgery for the treatment of POP is common, limited supportive data can be found in the literature regarding the preoperative and postoperative interventions related to these procedures. The main goal of perioperative interventions is to reduce the rate of adverse events while improving women's outcomes following surgical intervention for prolapse. A broad spectrum of perioperative interventions are available, and although the benefits of interventions such as prophylactic antibiotics before abdominal surgery are well established, others are unique to women undergoing POP surgeries and as such need to be investigated separately. OBJECTIVES: The aim of this review is to compare the safety and effectiveness of a range of perioperative interventions versus other interventions or no intervention (control group) at the time of surgery for pelvic organ 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, MEDLINE In Process, ClinicalTrials.gov, WHO ICTRP, handsearching of journals and conference proceedings (searched 30 November 2017), and reference lists of relevant articles. We also contacted researchers in the field. SELECTION CRITERIA: We included randomised controlled trials (RCTs) of women undergoing surgical treatment for symptomatic pelvic organ prolapse that compared a perioperative intervention related to pelvic organ prolapse surgery versus no treatment or another intervention. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures recommended by Cochrane. Our primary outcomes were objective failure at any site and subjective postoperative prolapse symptoms. We also measured adverse effects, focusing on intraoperative blood loss and blood transfusion, intraoperative ureteral injury, and postoperative urinary tract infection. MAIN RESULTS: We included 15 RCTs that compared eight different interventions versus no treatment for 1992 women in five countries. Most interventions were assessed by only one RCT with evidence quality ranging from very low to moderate. The main limitation was imprecision, associated with small sample sizes and low event rates.Pelvic floor muscle training (PFMT) compared with no treatment (three RCTs) - peri-operative intervention The simplest of the PFMT programmes required women to attend six perioperative consultations in the three months surrounding prolapse surgery. Trial results provided no clear evidence of a difference between groups in objective failure at any site at 12 to 24 months (odds ratio (OR) 0.93, 95% confidence interval (CI) 0.56 to 1.54; two RCTs, 327 women; moderate-quality evidence). With respect to awareness of prolapse, findings were inconsistent. One RCT found no evidence of a difference between groups at 24 months (OR 1.07, 95% CI 0.61 to 1.87; one RCT, 305 women; low-quality evidence), and a second small RCT reported symptom reduction from the Pelvic Organ Prolapse Symptom Questionnaire completed by the intervention group at 12 months (mean difference (MD) -3.90, 95% CI -6.11 to -1.69; one RCT, 27 women; low-quality evidence). Researchers found no clear differences between groups at 24-month follow-up in rates of repeat surgery (or pessary) for prolapse (OR 1.92, 95% CI 0.74 to 5.02; one RCT, 316 women; low-quality evidence).Other interventionsSingle RCTs evaluated the following interventions: preoperative guided imagery (N = 44); injection of vasoconstrictor agent at commencement of vaginal prolapse surgery (N = 76); ureteral stent placement during uterosacral ligament suspension (N = 91); vaginal pack (N = 116); prophylactic antibiotics for women requiring postoperative urinary catheterisation (N = 159); and postoperative vaginal dilators (N = 60).Two RCTs evaluated bowel preparation (N = 298), and four RCTs assessed the method and timing of postoperative catheterisation (N = 514) - all in different comparisons.None of these studies reported our primary review outcomes. One study reported intraoperative blood loss and suggested that vaginal injection of vasoconstrictors at commencement of surgery may reduce blood loss by a mean of about 30 mL. Another study reported intraoperative ureteral injury and found no clear evidence that ureteral stent placement reduces ureteral injury. Three RCTs reported postoperative urinary tract infection and found no conclusive evidence that rates of urinary tract infection were influenced by use of a vaginal pack, prophylactic antibiotics, or vaginal dilators. Other studies did not report these outcomes. AUTHORS' CONCLUSIONS: There was a paucity of data about perioperative interventions in pelvic organ prolapse surgery. A structured programme of pelvic floor muscle training before and after prolapse surgery did not consistently demonstrate any benefit for the intervention; however, this finding is based on the results of two small studies. With regard to other interventions (preoperative bowel preparation and injection of vasoconstrictor agent, ureteral stent placement during uterosacral ligament suspension, postoperative vaginal pack insertion, use of vaginal dilators, prophylactic antibiotics for postoperative catheter care), we found no evidence regarding rates of recurrent prolapse and no clear evidence that these interventions were associated with clinically meaningful reductions in adverse effects, such as intraoperative or postoperative blood transfusion, intraoperative ureteral injury, or postoperative urinary tract infection.

Submaximal pelvic floor muscle contractions: similar bladder-neck elevation, longer duration, less intra-abdominal pressure.

INTRODUCTION AND HYPOTHESIS: An adequate pelvic floor muscle contraction (PFMC) elevates the bladder neck (BN) and stabilizes it during increased intra-abdominal pressure (IAP). A maximal PFMC may increase the IAP and thereby prevent BN elevation. The aim of this study was to assess BN elevation during submaximal and maximal PFMC and their achievable duration. METHODS: We recruited 68 women with stress urinary incontinence and 14 vaginally nulliparous continent controls who were able to perform a PFMC on vaginal palpation. Women were upright and performed a maximal PFMC as long as possible, followed by a submaximal PFMC, controlled by vaginal electromyogram (EMG). BN position was measured with perineal ultrasound, IAP and urethral pressure with a microtip catheter, and breathing with a circular thorax sensor. RESULTS: A submaximal PFMC elevated the bladder neck 4 mm in continent and incontinent women (p = 0.655) and 4.5 vs. 5 mm during maximal PFMC (0.528). Submaximal PFMC was maintained significantly longer than a maximal PFMC (33 vs 12 s) with no difference between groups. A maximal PFMC resulted in BN descent in 29% of continent and 28% of incontinent women, which was not observed during submaximal PFMC. Breathing was normal in 70% of continent and 71% of incontinent women during submaximal PFMC but stopped completely in 21 and 50%, respectively, during maximal PFMC (p = 0.011). IAP increase was significantly greater with maximal PFMC in both groups (24 vs. 9.6 cmH2O and 17 vs. 9 cmH2O, respectively). CONCLUSION: Submaximal PFMC are sufficient to elevate the bladder neck, can be maintained longer, and breathing was not influenced.

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.

Traditional Gymnastic Exercises for the Pelvic Floor Often Lead to Bladder Neck Descent - a Study Using Perineal Ultrasound.

BACKGROUND: The aims of physiotherapy in stress incontinent women are to improve pelvic floor function and the continence mechanism including bladder neck support and urethral closure pressure. In Germany, traditional conservative treatment often includes gymnastic exercises with unclear effects on the bladder neck. The aim of this study was to sonographically assess bladder neck movements during selected exercises. METHODS: Fifteen healthy, continent women without previous vaginal births, who were able to voluntarily contract their pelvic floor muscels performed the shoulder bridge, the abdominal press, tiptoe and the Pilates clam exercises. The first set was performed without any additional instructions. During the second set directions were given to activate the pelvic floor before beginning each exercise and to maintain the contraction throughout the exercise. Bladder neck movement was measured on perineal ultrasound using a validated method with the pubic symphysis as a reference point. RESULTS: The median age of participants was 32 years, median BMI was 23. Eight women were nulliparous and seven had given birth to 1 - 2 children via caesarean section. When exercises were performed without voluntary pelvic floor contraction the bladder neck descended on average between 2.3 and 4.4 mm, and with pelvic floor contraction prior to the exercise only between 0.5 and 2.1 mm (p > 0.05 except for abdominal press p = 0.007). The Pilates clam exercise and toe stand stabilised the bladder neck most effectively. DISCUSSION: Bladder neck descent often occurs during pelvic floor gymnastic exercises as traditionally performed in Germany, and a voluntary pelvic floor contraction during the exercises does not necessarily prevent this.

Self-Reported Long-Term Autonomic Function After Laparoscopic Total Mesometrial Resection for Early-Stage Cervical Cancer: A Multicentric Study.

OBJECTIVES: This multicentric retrospective study investigates the early and long-term self-reported urinary, bowel, and sexual dysfunctions in early-stage cervical cancer patients who submitted to laparoscopic total mesometrial resection (L-TMMR), total laparoscopic radical hysterectomy, vaginal-assisted laparoscopic radical hysterectomy, and laparoscopic-assisted radical vaginal hysterectomy. METHODS: Cervical cancer patients, FIGO (International Federation of Gynecology and Obstetrics) stage IA2-IB1/IIA1 who submitted to nerve-sparing radical hysterectomy were recruited. Pelvic functions were assessed within 30 days (early outcome) and 12 months after surgery (long-term outcome). RESULTS: Two hundred thirteen subjects receiving nerve-sparing radical hysterectomy were enrolled. Laparoscopic total mesometrial resection was performed in 46 patients (21.6%), total laparoscopic radical hysterectomy in 65 patients (30.5%), vaginal-assisted laparoscopic radical hysterectomy in 54 patients (25.4%), and laparoscopic-assisted radical vaginal hysterectomy in 48 women (22.5%). Operative time was significantly lower in the L-TMMR group (240 minutes; range, 120-670 minutes; P = 0.001). The overall perioperative complication rate was 11.3%, with no statistically significant differences among the 4 groups. Stress incontinence and sensation of bladder incomplete emptying were detected, respectively, in 54 patients (25.6%) and 65 patients (30.7%) with a significantly lower prevalence among those in the L-TMMR group, which resulted, respectively, in 11.1% (P = 0.022) and 13.3% (P = 0.036). The prevalence rates of constipation, sensation of incomplete bowel emptying, and effort during evacuation were significantly higher among those in the L-TMMR group, resulting in, respectively, 37% (P = 0.001), 42.3% (P = 0.012), and 50% (P = 0.039). One hundred forty-nine patients (70%) were sexually active. Fifty-eight women (38.9%) reported low enjoyment, 83 women (55.7%) medium enjoyment, and 8 women (5.4%) reported high enjoyment, without statistically significant differences among the 4 groups. CONCLUSIONS: Laparoscopic total mesometrial resection is associated with improved long-term urinary autonomic functions and worse gastrointestinal autonomic outcome. Further larger prospective trials are needed to evaluate both the oncological and functional outcomes in order to establish the most appropriate surgical approach for early-stage cervical cancer patients.

Development and Validation of a Questionnaire for the Assessment of Pelvic Floor Disorders and Their Risk Factors During Pregnancy and Post Partum.

Introduction The aim of this study was to develop and validate a questionnaire for the assessment of pelvic floor disorders, their symptoms and risk factors in pregnancy and after birth including symptom course, severity and impact on quality of life. Methods The validated German pelvic floor questionnaire was modified and a new risk factor domain developed. The questionnaire was initially completed by 233 nulliparous women in the third trimester of pregnancy and at six weeks (n = 148) and one year (n = 120) post partum. Full pyschometric testing was performed. The clinical course of symptoms and the influence of risk factors were analysed. Results Study participants had a median age of 31 (19-46) years. 63 % had spontaneous vaginal deliveries, 15 % operative vaginal deliveries and 22 % were delivered by caesarean section. Content validity: Missing answers never exceeded 4 %. Construct validity: The questionnaire distinguished significantly between women who reported bothersome symptoms and those who did not. Reliability: Cronbach's alpha values exceeded 0.7 for bladder, bowel and support function, and 0.65 for sexual function. The test-retest analysis showed moderate to almost complete concordance. The intraclass coefficients for domain scores (between 0.732 and 0.818) were in acceptable to optimal range. Reactivity: The questionnaire was able to track changes significantly with good effect size for each domain. Risk factors for pelvic floor symptoms included familial predisposition, maternal age over 35 years, BMI above 25, nicotine abuse, subjective inability to voluntarily contract the pelvic floor musculature and postpartum wound pain. Conclusion This pelvic floor questionnaire proved to be valid, reliable and reactive for the assessment of pelvic floor disorders, their risk factors, incidence and impact on quality of life during pregnancy and post partum. The questionnaire can be utilised to assess the course of symptoms and treatment effects using a scoring system.