IMPORTANCE:Despite evidence emphasizing the necessity of routine care for women with pelvic organ prolapse (POP) using pessaries, the frequency of follow-up is unclear. OBJECTIVE:The aim of this study was to compare the presence of complications in women with POP using vaginal pessaries with cleaning and gynecological examination every 3 or 6 months. STUDY DESIGN:This pilot study was a randomized clinical trial of women with advanced POP using a ring pessary. The women were randomized into 2 groups ("3-month group" and a "6-month group") that returned for evaluation by a health care professional that monitored the vagina, removed the pessary, cleaned it, and reinserted it. Sociodemographic and clinical data were collected. During their follow-up, the women answered a questionnaire regarding the presence of vaginal symptoms and had a physical examination and vaginal sampling for microbiological analysis. RESULTS:A total of 38 women were randomized into 2 groups: the 3-month group (n = 18) and the 6-month group (n = 20). Baseline characteristics of the groups were similar except for age, which was 70.7 (±7.4) years in the 3-month group and 74.7 (±6.6) years in the 6-month group ( P  = 0.022). Regarding physical examination, after 12 months of follow-up, 4 women in each group presented erosions or ulcers in each group, but without difference ( P  = 1). The presence of bacterial vaginosis was more frequent in the group with cleaning every 6 months ( P  = 0.026). CONCLUSIONS:The prevalence of ulcerations was similar in both groups with cleaning every 3 or 6 months, but the group with cleaning every 6 months showed a higher prevalence of bacterial vaginosis.

Objective:To compare the efficacy of a traditional open ASC technique (ASC-T) to an open modified technique (ASC-M). Methods:Retrospective cohort study with stage 3 or 4 apical prolapse women, who operated on using one of the two techniques were included in the study: ASC-T (vaginal mesh is secured with eight sutures) and ASC-M (four sutures). The POP-Q was used to objectively assess anatomical improvement. Women with less than one year of follow-up, without POP-Q classification, or with incomplete data were excluded. Results:A total of 223 women underwent ASC: 120 in ASC-T and 103 in ASC-M. The average age was 65.3 (±6.5) years in the ASC-T group and 65 (±8.5) years in the ASC-M group, with no difference between them (p=0.706). There was no difference in intraoperative increased bleeding (p=1.000) and bladder injury (p=0.706) in both groups. Comparing the POP-Q points pre- and postoperatively, we observed improvement in all points in both groups (p<0.001) without difference between them. The analysis of variance for repeated measures was used to compare the outcomes between the two groups. The postoperative prolapse stage was similar between the two groups in the apical (p=0.251) and anterior (p=0.052) vaginal compartments. In the subjective evaluation, we observed a high rate of cure and improvement in both groups, respectively 81.7% and 16.7% in the ASC-T group, and 91.3% and 8.7% in the ASC-M group (p=0.100). Conclusion:Both sacrocolpopexy techniques were effective in treating apical prolapse, as evidenced by both objective and subjective cure rates, with a low complication rate.

(Abstracted from Urogynecology 2024;30:443–451) Urinary incontinence affects roughly 25% of women between the ages of 15 and 64 years and more than half of patients seen at geriatric clinics. It is typically treated using surgical and other methods.

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.

Study Objective To assess whether single-incision sling (SIS) is non-inferior to transobturator (TOT) sling regarding efficacy for treating women with confirmed stress-predominant urinary incontinence (SUI). Design Prospective, parallel, non-blinded, multicenter, randomized controlled study. Setting Two tertiary, academic hospitals. Patients or Participants Ninety-nine patients were followed 6 and 12 months after surgery. Interventions Mid-urethral TOT sling (Obtryx II® – Halo; n=50) with regional anesthesia or SIS (Solyx®; n=49) with local anesthesia. Intention-to-treat analysis was performed. Measurements and Main Results The primary outcome was improvement in the Patient Global Improvement (PGI-I) and Kings Health Questionnaire (KHQ) instruments after treatment. Secondary outcomes were subjective improvement (improved/cured), number of reoperations, estimated blood loss (EBL), operative room (OR) time, post-op complications. Both groups were homogeneous (p=NS) regarding age(p=0.728), race(p=0.112), body mass index(p=0.082), menopausal status(p=0.359), vaginal deliveries(p=0.839), tobacco use(p=0.385) and sexual activity(p=0.605). There was no difference in the PGI after 6(p=0.067) and 12 months(p=0.128) of treatment between the groups. KHQ scores were better improved in the TOT group for the following domains: role limitations(p=0.049), physical limitations(p=0.0105) and severity measures(p=0.0416). The other domains (general health, incontinence impact, personal relationships, emotions, sleep/energy) were not different between the groups. After 12 months, TOT group was only superior to SIS in the general health domain(p=0.0189). However, the TOT group presented higher subjective improvement after 6 months (93.62 vs 75%; p=0.013) than SIS group, with no significant difference after 12 months. Six patients from the SIS group were reoperated versus three from the TOT group(p=0.309). The SIS group presented a smaller EBL (17.95 vs 33.9 ml; p=<0.005) and shorter OR time (16 vs 40.3 min; p<0.005) than the TOT group. Erosion rate was higher in the SIS group(p=0.059). No major complications occurred in both groups. Conclusion TOT and SIS groups were equally effective after 6 and 12 months after treatment according to the PGI-I and KHQ instruments. Subjective improvement was higher in the TOT group after 6 months, with no difference after 12 months. To assess whether single-incision sling (SIS) is non-inferior to transobturator (TOT) sling regarding efficacy for treating women with confirmed stress-predominant urinary incontinence (SUI). Prospective, parallel, non-blinded, multicenter, randomized controlled study. Two tertiary, academic hospitals. Ninety-nine patients were followed 6 and 12 months after surgery. Mid-urethral TOT sling (Obtryx II® – Halo; n=50) with regional anesthesia or SIS (Solyx®; n=49) with local anesthesia. Intention-to-treat analysis was performed. The primary outcome was improvement in the Patient Global Improvement (PGI-I) and Kings Health Questionnaire (KHQ) instruments after treatment. Secondary outcomes were subjective improvement (improved/cured), number of reoperations, estimated blood loss (EBL), operative room (OR) time, post-op complications. Both groups were homogeneous (p=NS) regarding age(p=0.728), race(p=0.112), body mass index(p=0.082), menopausal status(p=0.359), vaginal deliveries(p=0.839), tobacco use(p=0.385) and sexual activity(p=0.605). There was no difference in the PGI after 6(p=0.067) and 12 months(p=0.128) of treatment between the groups. KHQ scores were better improved in the TOT group for the following domains: role limitations(p=0.049), physical limitations(p=0.0105) and severity measures(p=0.0416). The other domains (general health, incontinence impact, personal relationships, emotions, sleep/energy) were not different between the groups. After 12 months, TOT group was only superior to SIS in the general health domain(p=0.0189). However, the TOT group presented higher subjective improvement after 6 months (93.62 vs 75%; p=0.013) than SIS group, with no significant difference after 12 months. Six patients from the SIS group were reoperated versus three from the TOT group(p=0.309). The SIS group presented a smaller EBL (17.95 vs 33.9 ml; p=<0.005) and shorter OR time (16 vs 40.3 min; p<0.005) than the TOT group. Erosion rate was higher in the SIS group(p=0.059). No major complications occurred in both groups. TOT and SIS groups were equally effective after 6 and 12 months after treatment according to the PGI-I and KHQ instruments. Subjective improvement was higher in the TOT group after 6 months, with no difference after 12 months.

Abstract Objective Magnetic resonance imaging (MRI) has been considered another tool for use during the pre- and postoperative periods of the management of pelvic-organ prolapse (POP). However, there is little consensus regarding its practical use for POP and the association betweenMRI lines of reference and physical examination.We aimedto evaluate the mid- to long-term results of two surgical techniques for apical prolapse. Methods In total, 40 women with apical POP randomized from 2014 to 2016 underwent abdominal sacrocolpopexy (ASC group; n = 20) or bilateral vaginal sacrospinous fixation with an anterior mesh (VSF-AM group; n = 20). A physical examination using the POP Quantification System (POP-Q) for staging (objective cure) and the International Consultation on Incontinence Questionnaire-Vaginal Symptoms (ICIQ-VS: subjective cure), were applied and analyzed before and one year after surgery respectively. All MRI variables (pubococcigeous line [PCL], bladder base [BB], anorectal junction [ARJ], and the estimated levator ani subtended volume [eLASV]) were investigated one year after surgery. Significance was established at p < 0.05. Results After a mean 27-month follow-up, according to the MRI criteria, 60% of the women were cured in the VSF-AM group versus 45% in ASC group (p= 0.52). The POP-Q and objective cure rates by MRI were correlated in the anterior vaginal wall (p= 0.007), but no correlationwas foundwith the subjective cure. The eLASVwas largeramongthe patients with surgical failure, and a cutoff of ≥ 33.5mm3 was associated with postoperative failure (area under the receiver operating characteristic curve [ROC]: 0.813; p= 0.002). Conclusion Both surgeries for prolapse were similar regarding theobjective variables (POP-Q measurements and MRI cure rates). Larger eLASV areas were associated with surgical failure.

Objective In this study, we present a series of 2 cases of rectovaginal fistula (RVF) due to the use of a ring-type pessary in the conservative treatment of pelvic organ prolapse and a literature review on the management of RVF related to the use of pessaries. Methods Two patients were selected from the medical records of the urogynecology service, and their demographic and clinical data were retrieved. An updated literature review was included presenting cases of RVF induced by or after use of a pessary. Results Both patients evolved with removal of the pessary and correction of the fistula. The surgical procedures of choice were Le Fort Colpocleisis and posterior colporraphy without major complications. In the literature review, we selected 17 studies with a total of 23 cases reporting RVFs induced or followed by the use of pessaries. Conclusions Although the pessary is commonly indicated for the conservative treatment of pelvic organ prolapse, this device is not exempt from generating complications.

An 80-year-old female patient with advanced pelvic organ prolapse underwent vaginal hysterectomy with unilateral sacrospinous fixation and anterior/posterior correction through repair of the paravaginal defect and perineorrhaphy. Within less than a year after the first procedure, the patient presented with stage 4 uterovaginal prolapse, and a Le Fort colpocleisis with perineorrhaphy was performed.

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.

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.

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 degrees +/- 9.9 degrees; P < 0.001) and ASC (87.1 degrees +/- 14.7 degrees; P < 0.001) groups, with no difference between them. Mean inferior axis was more acute for both groups (VSF, 72.5 degrees +/- 19.1 degrees, P < 0.001; ASC, 75.7 degrees +/- 15.5 degrees, 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.

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. 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. 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). 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.

OBJECTIVE:The use of pessary is an option for the conservative treatment of pelvic organ prolapse (POP). However, here are few studies assess the quality of life (QoL) after inserting the pessary for POP. We have hypothesized that the use of pessary would modify QoL in women with POP.METHODS:A prospective, observational study was performed that included 19 women with advanced POP. Pessary was introduced, and the SF-36 (general quality of life) and ICIQ-VS (vaginal symptoms and quality of life subdomain) questionnaires were applied before the introduction and after six months. A single question about the satisfaction regarding the use of the device was presented (subjective impression).RESULTS:The mean age of the women included was 76 years. Most of them were non-caucasian (52.6%), with no prior pelvic surgery (57.5%), with urinary symptoms (78.9%). A third of the patients reported sexual activity. After treatment, 22.2% of them presented vaginal infection, and 27.7% increased vaginal discharge. Urinary symptoms remained unaltered. Women reported 100% satisfaction after using the pessary (77.7% partial improvement; 22.3% total improvement). SF-36 had significant improvement in three specific domains: general state of health (p=0.090), vitality (p=0.0497) and social aspects (p=0.007). ICIQ-VS presented a reduction in the vaginal symptoms (p < 0.0001) and an improvement in QoL (P < 0.0001).CONCLUSION:The use of pessary for six months improved the QoL and reduced vaginal symptoms for women with advanced POP.