Transobturator Versus Minisling for Urinary Incontinence: A Randomized Controlled Trial.

IMPORTANCE: The comparison between single-incision slings (SISs) and midurethral slings has been documented in the literature, but results vary according to the SIS device. OBJECTIVES: The purpose of this study is to assess whether SIS (Solyx) is noninferior to transobturator (TOT) (Obtryx) sling for treating women with confirmed stress-predominant urinary incontinence. STUDY DESIGN: A prospective, parallel, nonblinded, multicenter, noninferiority, randomized controlled study with 114 patients were randomized and followed 6 and 12 months after surgery. Interventions were midurethral TOT sling (Obtryx-halo; n = 58) or SIS (Solyx; n = 56). The primary outcome was improvement in the Patient Global Impression of Improvement (PGI-I). Secondary outcomes were the Kings Health Questionnaire (KHQ) instruments after treatment, subjective improvement, and surgical outcomes. RESULTS: Both groups were homogeneous ( P = NS) regarding sociodemographic and clinical variables. There was improvement in the PGI-I after 6 ( P = 0.001) and 12 months ( P = 0.001) of treatment for women who underwent TOT sling. After 6 months, KHQ scores improved in the TOT group for the following domains: role limitations ( P = 0.026) and physical limitations ( P = 0.006). After 12 months, the TOT group presented better KHQ scores that were statistically significant from the SIS group in incontinence impact ( P = 0.012), physical limitations ( P = 0.001), and severity measures ( P = 0.017). Moreover, the TOT group presented higher subjective improvement after 6 months ( P = 0.006) than the SIS group. Mesh erosion was higher in the SIS group ( P = 0.006). Reoperations were not statistically different between groups. CONCLUSION: There were higher scores in the PGI-I score and higher subjective improvement for the TOT sling after 6 and 12 months of treatment when compared with the SIS group.

Risk Factors for Dislodgment of Vaginal Pessaries in Women With Pelvic Organ Prolapse: A Cohort Study.

OBJECTIVE: The aim of the study was to evaluate the associated factors associated with pessary dislodgment in women with advanced pelvic organ prolapse (POP). METHODS: A cohort study with women (N = 98) with advanced POP who chose conservative treatment with ring pessary between December 2016 and 2018 identified by screening. Demographic data, history of POP, urinary, and/or bowel symptoms were collected. A medical visit was scheduled 3 and 6 months after pessary insertion to evaluate symptoms (vaginal discharge, bleeding, pain, discomfort, new-onset urinary, or fecal problems) and any pessary dislodgment. Two groups were created (women who were able to retain the pessary versus who were not able), and univariate and multivariate analysis were performed to look for risk factors for pessary dislodgment. Women who requested to have their pessaries removed during the 6-month follow-up were excluded. RESULTS: Ninety-three women included in the study, 78 successfully continued to use the pessary at 6 months, and 15 had pessary dislodgment (16.1%). Demographic characteristics were similar between the treatment group and the control group. After multivariate analysis, women who had their pessaries dislodged presented higher rates of previous surgery (odds ratio = 8.11; 95% confidence interval = 2.09-31.58; P = 0.003) with advanced Pelvic Organ Prolapse Quantification system staging (odds ratio, 13.41; confidence interval, 1.97-91.36; P = 0.008). CONCLUSIONS: The presence of advanced apical POP and previous POP surgery are risk factors for ring pessary dislodgment. This information should guide physicians for counseling patients before pessary insertion.

Vaginal hysterectomy with bilateral sacrospinous fixation plus an anterior mesh versus abdominal sacrocervicopexy for the treatment of primary apical prolapse in postmenopausal women: a randomized controlled study.

INTRODUCTION AND HYPOTHESIS: We compared vaginal hysterectomy with bilateral sacrospinous fixation plus an anterior polyvinylidene fluoride mesh versus abdominal sacrocolpopexy for the treatment of primary apical prolapse in postmenopausal women. METHODS: A prospective, randomized, single-blind, parallel study [Registro Brasileiro de Ensaios Clinicos (REBEC) trial register code RBR-7t6rg2] was performed from October 2015 to May 2016. A total of 71 postmenopausal women with advanced pelvic organ prolapse (POP) and undergoing surgery were randomized to the abdominal sacrocolpopexy (ASC) (n = 36) or the vaginal sacrospinous fixation with anterior mesh (VSF-AM) (n = 35) groups. Pelvic Organ Prolapse Quantification (POP-Q) system classification was performed for objective assessment, and the International Consultation on Incontinence Questionnaire-Vaginal Symptoms (ICIQ-VS), International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), and International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB) questionnaires were filled out for subjective evaluation by women before and 1 year after surgery. All procedures were performed by a single surgeon. RESULTS: Both groups had improvement in almost POP-Q points (except for vaginal length in the VSF-AM group) and all ICIQ scores. The ASC group had a longer operative time (129 versus 117 min, p = 0.0038) and duration for return to activities (103 versus 57 days, p < .05). Four women (11%) in the VSF-AM group were reoperated versus none from the ASC group (p = .05). CONCLUSIONS: Although the study did not achieve the planned recruitment, after 12 months of follow-up, ASC did not differ from VSF-AM in objective and subjective scores (ICIQ questionnaires; POP-Q measurements). Recovery time was longer after open abdominal surgery.

Vaginal axis after abdominal sacrocolpopexy versus vaginal sacrospinous fixation-a randomized trial.

AIMS: To compare postoperative vaginal axis (VA) following vaginal sacrospinous fixation (VSF) or abdominal sacrocolpopexy (ASC) using magnetic resonance imaging (MRI) at postoperative period, in a randomized sample. METHODS: Seventy-one patients randomized to VSF with an anterior mesh or ASC were recruited with a mean 27-month follow-up for pelvic MRI; 40 patients underwent the examination. VA was calculated in relation to the pelvic inclination correction line. All patients were submitted to physical examination according to the pelvic organ prolapse quantification system, subjective impression questionnaires and quality of life (QoL) questionnaires (International Consultation on Incontinence Questionnaire, ICIQ). Objective failure was defined as points Ba, Bp, or C > 0. Subjective cure was defined as questions 5a and 6a from the ICIQ-VS questionnaire equal to zero. RESULTS: VA exhibited two portions (inferior and medium). Mean medium axis was equally more obtuse in VSF (85.9° ± 9.9°; P < 0.001) and ASC (87.1° ± 14.7°; P < 0.001) groups, with no difference between them. Mean inferior axis was more acute for both groups (VSF, 72.5° ± 19.1°, P < 0.001; ASC, 75.7° ± 15.5°, P < 0.001). All women had normal medium axes and 47.5% had inferior axis values above the 95th or below the fifth percentile, without differences regarding type of surgery performed. Women with abnormal vs normal VA did not present any difference regarding pre or postoperative physical examination, demographic characteristics, objective or subjective cure, patient satisfaction, QoL scores, or sexuality. CONCLUSIONS: Both VSF and ASC deviate the physiological VA, both in its medium and inferior portions, where values fall outside normality percentiles. However, this alteration was not associated with worse objective, subjective, QoL, or sexual outcomes.

Does the Vaginal Flora Modify When a Synthetic Mesh is Used for Genital Prolapse Repair in Postmenopausal Women? A Pilot, Randomized Controlled Study.

OBJECTIVE: The vaginal flora from postmenopausal women with pelvic organ prolapse (POP) is different from younger women. We hypothesized that the decision of a surgical route using a mesh would modify the vaginal flora. The purpose of this study was to analyze the vaginal flora from postmenopausal women that were submitted to abdominal sacrocervicopexy or vaginal sacrospinous fixation. METHODS: A pilot, randomized controlled study with 50 women aged 55 to 75 years (n = 25; abdominal sacrocervicopexy + subtotal hysterectomy; n = 25 vaginal sacrospinous fixation + vaginal hysterectomy) was performed. A polyvinylidene mesh was used in both arms. The vaginal content analysis was collected before and 60 days after the surgery. The type of flora, the presence of lactobacilli/leukocytes, and the Nugent criteria were analyzed. RESULTS: Most of the women were white (80%), with at least 1 comorbidity (69.9%), did not present sexual activity (60%), and presented advanced stage 4 POP. Two thirds of women presented a type 3 flora, and half of them did not present lactobacilli (48.3%). About the Nugent criteria, 51.7% presented normal flora, 46.6% found altered flora, and 1.7% had bacterial vaginosis. There were no differences about the type of flora (P = 1), number of lactobacilli (P = 0.9187), Nugent criteria (P = 0.4235), inflammation (P = 0.1018), and bacterial vaginosis (P = 0.64) before and after surgery in both groups. CONCLUSIONS: In this pilot study, the use of synthetic mesh by vaginal or abdominal route did not affect the vaginal flora in postmenopausal women operated on by POP surgery.

Female pelvic organ prolapse using pessaries: systematic review.

INTRODUCTION AND HYPOTHESIS: The purpose of this systematic review is to assess the impact of pessary use on the quality of life of women with pelvic organ prolapse, and to determine the satisfaction rate and rationale for discontinuation. METHODS: This review is recorded in the PROSPERO database under number CRD42015023384. The criteria for inclusion were observational study; cross section; cohort study; randomized controlled trial; study published in English, Portuguese, and Spanish; and study whose participants are women with female pelvic organ prolapse treated using a pessary. We did not include limitations on the year of publication. The criteria for exclusion included studies that did not include the topic, bibliographic or systematic reviews and articles that did not use validated questionnaires. The MeSH terms were "Pelvic Organ Prolapse AND Pessaries AND Quality of Life" OR "Pessary AND Quality of Life" OR "Pessaries". RESULTS: We found 89 articles. After the final analyses, seven articles were included. All articles associated pessary use with improved quality of life, and all used only validated questionnaires. Over half of the women continued using the pessary during the follow-up with acceptable levels of satisfaction. The main rationales for discontinuation were discomfort, pain in the area, and expulsion of the device. CONCLUSION: This systematic review demonstrates that the pessary can produce a positive effect on women's quality of life and can significantly improve sexual function and body perception.

Impact of Sacrospinous Colpopexy Associated with Anterior Colporrhaphy for the Treatment of Dome Prolapse on all Three Vaginal Compartments.

OBJECTIVE: To evaluate the results of sacrospinous colpopexy surgery associated with anterior colporrhaphy for the treatment of women with post-hysterectomy vaginal vault prolapse. METHODS: This prospective study included 20 women with vault prolapse, Pelvic Organ Prolapse Quantification System (POP-Q) stage ≥ 2, treated between January 2003 and February 2006, and evaluated in a follow-up review (more than one year later). Genital prolapse was evaluated qualitatively in stages and quantitatively in centimeters. Prolapse stage < 2 was considered to be the cure criterion. Statistical analysis was performed using the Wilcoxon test (paired samples) to compare the points and stages of prolapse before and after surgery. RESULTS: Evaluation of the vaginal vault after one year revealed that 95% of subjects were in stage zero and that 5% were in stage 1. For cystocele, 50% were in stage 1, 10% were in stage 0 (cured) and 40% were in stage 2. For rectocele, three women were in stage 1 (15%), one was in stage 2 (5%) and 16 had no further prolapse. The most frequent complication was pain in the right buttock, with remission of symptoms in all three cases three months after surgery. CONCLUSIONS: In this retrospective study, the surgical correction of vault prolapse using a sacrospinous ligament fixation technique associated with anterior colporrhaphy proved effective in resolving genital prolapse. Despite the low complication rates, there was a high rate of cystocele, which may be caused by posterior vaginal shifting due to either the technique or an overvaluation by the POP-Q system.