Management Of Pelvic Organ Prolapse Research Articles

Effectiveness and safety of a novel, collapsible pessary for management of pelvic organ prolapse.

Pessaries are an effective treatment for pelvic organ prolapse, yet currently available pessaries can cause discomfort with removal and insertion. An early feasibility trial of an investigational, collapsible pessary previously demonstrated mechanical feasibility during a brief 15-minute office trial. Longer-term, patient-centered safety and efficacy data is needed. To assess the effectiveness and safety of the investigational vaginal pessary for pelvic organ prolapse at three months. This was a prospective, seven-center, open-label equivalence study with participants serving as their own controls. Subjects were current users of a Gellhorn or ring pessary with ≥ Stage II prolapse. Baseline subjective and objective data were collected for one month using their current pessary, and then data were collected through a three-month treatment phase with use of the study pessary. The primary outcome was change in Pelvic Floor Distress Inventory-20 score. Secondary outcome measures included objective assessment of prolapse support, changes in the Pelvic Floor Impact Questionnaire-7, and pain with insertion and removal measured on a Visual Analog Scale. Subjects fitted with study pessary were analyzed as intention to treat and those who dropped out were assigned scores at the upper limit of the predefined equivalence limits. Secondary per protocol analyses included subjects who completed treatment. The study was powered to 80% with a minimal important change equivalence limit of 18.3 points on the Pelvic Floor Distress Inventory-20 scale. Square root transformations were used for non-parametric data and p-values adjusted for multiple comparisons. Seventy-eight subjects were enrolled, though 16 withdrew prior to study pessary placement. Sixty-two subjects (50 ring and 12 Gellhorn pessary users) were fitted with the study pessary, and 48 (62%) completed the three-month intervention. The change in Pelvic Floor Distress Inventory-20 scores at three months demonstrated equivalence compared to the subjects' baseline scores, (mean difference -3.96 (improvement), 90% confidence interval (CI) [-11.99, 4.08], p=0.002). Per protocol analysis of the Pelvic Floor Distress Inventory-20, equivalence was not demonstrated with scores favoring the study pessary (mean difference -10.45, 90% CI, [-20.35, 0.54] (p=0.095)). Secondary outcomes included: objective measures of support which were similar, mean difference Ba=0.54 cm, Bp=0.04 cm, favoring study pessary; improvement in mean Pelvic Floor Impact Questionnaire-7 scores for those who completed the trial (pre=32.23, post=16.86, p=0.019); and pain with insertion and removal, which was lower with the study pessary compared to subject's own pessary (mean difference Visual Analogue Scale insertion=9.91 mm (p=0.019), removal=11.23 mm (p=0.019)). No serious adverse events related to the pessary were reported. Equivalence was demonstrated in the study pessary primary outcome compared to current non-collapsible pessaries for change in severity and bother of pelvic floor symptoms. In participants who completed the trial, the Pelvic Floor Impact Questionnaire-7 improved with the study pessary and change in Pelvic Floor Distress Inventory-20 scores were non-equivalent, favoring the study pessary. Subjects reported significantly lower pain scores with both pessary insertion and removal with the novel collapsible pessary compared with their standard pessary.

Trends and focal points in pelvic floor reconstruction for pelvic organ prolapse: A bibliometric analysis.

This study aims to investigate the current research trends and focal points in the field of pelvic floor reconstruction for the management of pelvic organ prolapse (POP). To achieve this objective, a bibliometric analysis was conducted on relevant literature using the Citespace database. The analysis led to the creation of a knowledge map, offering a comprehensive overview of scientific advancements in this research area. The study included a total of 607 publications, revealing a consistent increase in articles addressing pelvic floor reconstruction for POP treatment. Most articles originated from the United States (317 articles), followed by Chinese scholars (40 articles). However, it is important to note that the overall number of articles remains relatively low. The organization with the highest publication frequency was the Cleveland Clinic in Ohio, where Matthew D. Barber leads the academic group. Barber himself has the highest number of published articles (18 articles), followed by Zhu Lan, a Chinese scholar (10 articles). Key topics with high frequency and mediated centrality include stress urinary incontinence, quality of life, impact, and age. The journal with the largest number of papers from both domestic and international researchers is INT UROGYNECOL J. The study's hotspots mainly focus on the impact of pelvic floor reconstruction on the treatment and quality of life of POP patients. The United States leads in this field, but there is a lack of cooperation between countries, institutions, and authors. Moving forward, cross-institutional, cross-national, and cross-disciplinary exchanges and cooperation should be strengthened to further advance the field of pelvic floor reconstructive surgery for POP research.

Effect of Intravaginal Application of Palasha Udumbaradi Ointment on Pelvic Organ Prolapse

Prolapse is a downward descent of the female pelvic organs as a result of weakness of the structures that normally retain them in position. The main symptoms of pelvic organ prolapse include micturition disturbances like stress incontinence, imperfect control of micturition, a feeling of lump coming down, postural low back ache, constipation and leucorrhoea. The management of pelvic organ prolapse includes preventive conservative and surgical measures. Surgery is indicated when conservative management fails. The three different conditions like Phalini, Prasramsini and Mahayoni vyapath mentioned by different Acharyas explain the prolapsed condition according to the stage and part prolapsed out. Palasha udumbaradi yoga mentioned in Bhaishajya Ratnavali containing ingredients such as Palasha beeja, Udumbara phala, Thilathaila and Madhu was taken for this study. The Lepa was applied in the modified form of an ointment. The study is an attempt to assess the effect of Palasha udumbaradi ointment on uterine prolapse. The ointment was applied intra vaginally. The presence of dense blood vasculature makes the vagina a potential site for local and systemic drug administration. The key advantages of vaginal drug delivery over oral administration is that this is able to circumvent the harsh gastric environment and also bypass hepatic first-pass metabolism. A 38 year woman with complaints of increased frequency of micturition, stress incontinence, burning micturition, low back ache and dyspareunia consulted the OPD of Govt. Ayurveda Medical College, Tripunithura. Palasha udumbaradi ointment was self-applied intra-vaginally. Administration of ointment was advised for 60 consecutive days excluding the days of menstruation with follow up on 90th day. Assessment was done on 0th, 30th and 60th day and follow up was done on 90th day using POP-Q Scale, urinary incontinence scale, and visual analogue scale.

Vaginal Hysterectomy and Pelvic Organ Prolapse: History and Recent Developments.

Vaginal hysterectomy (VH) was described as far back as 120 CE. However, it was not till the mid-1900s when reconstructive procedures were introduced to mitigate the risk of, or treat, pelvic organ prolapse in relation to VH. Furthermore, routine hysterectomy, particularly VH, has long been advocated in prolapse surgery. However, this indication is now questionable. Literature review to provide an overview of current evidence and experts' opinion regarding the relationship between VH and pelvic organ prolapse. The review presents a historical perspective on the role of VH in the management of pelvic organ prolapse, the current debate on the usefulness of the procedure in this context, a practical guide on operative techniques used during VH and the impact of recent surgical developments on its use. Vaginal hysterectomy is a well-established technique that is still superior to laparoscopic hysterectomy for benign gynecological disease, although more surgically challenging. However, it is possible that some contemporary techniques, such as vaginal natural orifice transluminal endoscopic surgery, may overcome some of these challenges, and hence increase the number of hysterectomies performed via the vaginal route. Although patients should be counselled about uterine-sparing reconstructive surgery, vaginal hysterectomy continues to be a major surgical procedure in reconstructive pelvic floor surgery. Therefore, it is prudent to continue to train residents in vaginal surgical skills to ensure that they continue to provide safe, cost-effective, and comprehensive patient care.

Self-care of vaginal pessary for pelvic organ prolapse: a systematic review and meta-analysis.

There is no evidence about the efficacy of self-care of vaginal pessary in women with symptomatic pelvic organ prolapse (POP). The aim of this systematic review and meta-analysis is to assess the adherence to pessary treatment among women who engage in self-management of their pessary. We performed a systematic review and meta-analysis, according to PRISMA 2020 guidelines, and selected seven publications for inclusion in the analysis. Pooled continuation rate of self-cared vaginal pessary was the 76% (95%CI: 66-85%) with a I2-test of 93.3% (p < 0.001). Pooled conversion to POP surgery was the 12% (95%CI: 1-23%) with a I2-test of 96% (p < 0.001). Continuation rate was not statistically different between women who were treated by self-care and non-self-care management of vaginal pessary (RR 1.11, 95%CI 0.96-1.27; p = 0.15), with a related I2-test of 37% (p = 0.21). Self-care vaginal pessary management presented a high continuation rate in women affected by pelvic organ prolapse at a long follow-up. The rate of conversion to surgical management of POP was low. No significant difference in continuation rate were highlighted between women who adopted the self-care or the clinical-based management of pessary.

Social Vulnerability Index and Surgical Management of Pelvic Organ Prolapse.

The aim of this study was to determine whether the Social Vulnerability Index (SVI) is associated with the type of surgery for pelvic organ prolapse (POP) focusing on sacrocolpopexy (SCP) and uterosacral ligament suspension (USLS). This was a retrospective case-control study that included patients from 8 hospitals within a large academic health system in New York between January 1, 2018 and January 1, 2023. All patients 15-85 years of age with a preoperative diagnosis of POP who underwent a hysterectomy with an SCP or USLS were included. Home addresses were linked to census tracts and SVI scores. Multiple logistic regression analyses were performed to evaluate the association between SVI quartiles and POP surgical management (SCP vs USLS). Six hundred one patients who underwent reconstructive surgery for POP were included in the study. The Social Vulnerability Index was not statistically significantly associated with POP surgical management (P = 0.26). After adjusting for potential confounders, there continued to be no association between SVI and POP management (P = 0.40). The adjusted model illustrated that age 65 years or greater was associated with decreased odds (adjusted odds ratio, 0.24; 95% confidence interval, 0.14-0.40) of SCP (P < 0.0001), whereas patients with hypertension were found to be at increased odds (adjusted odds ratio, 2.60; 95% confidence interval, 1.01-6.71). There was no statistically significant association between SVI and POP surgical management for SCP versus USLS. However, advanced patient age (65 years and greater) was associated with decreased odds, and hypertension was associated with greater odds of SCP.

Effectiveness & safety of a novel, collapsible pessary for management of pelvic organ prolapse

Effectiveness & safety of a novel, collapsible pessary for management of pelvic organ prolapse

Complications of obliterative versus reconstructive vaginal surgery for pelvic organ prolapse in octogenarians: A retrospective cohort study.

Women of advanced age may choose between restorative or obliterative surgery for surgical management of pelvic organ prolapse. Obliterative surgery is traditionally reserved for a subset of older women with more severe medical comorbidities, since obliterative approaches are generally considered to be less morbid and older individuals have higher rates of perioperative complications than younger cohorts. This study compared perioperative complications amongst octogenarians undergoing obliterative versus reconstructive approaches. This data will help to inform perioperative counselling as previous studies have not been powered to evaluate complications in this population. The National Surgical Quality Improvement Program database was used to identify patients that had Pelvic organ prolapse surgery between 2012 and 2021, aged 80 years or older. Single-compartment procedures, vaginal mesh procedures, and oncologic surgery were excluded. The primary outcome was any complication within the first 30 days excluding urinary tract infection (UTI). UTI, readmission, and severe complications were secondary outcomes. Of the 4149 patients identified, 2514 (60.6%) underwent reconstructive surgery and 1635 (39.4%) underwent obliterative surgery. Patients undergoing reconstructive surgery were more likely to have an American Society of Anesthesiologists (ASA) class of 1 or 2 (46.1% vs. 31.3%, p = 0.002) and were less likely to be on antihypertensive medication (72.0% vs. 75.8%, p = 0.006). Further, there was an increased length of stay (1.47 ± 1.84 vs. 1.03 ± 1.31 days, p < 0.001) in hospital for reconstructive surgery which was more often performed as an inpatient (45.7% vs. 37.9%, p < 0.001). There was no difference in the primary outcome: any complication excluding UTIs. However, UTI was more common in the reconstructive group (aOR 0.48; 95% confidence interval 0.34-0.0). The rate of serious complications (Clavien-Dindo Class IV) was low overall and not different between reconstructive and obliterative approaches (1.3% vs. 1.0%, respectively). Both vaginal reconstructive and obliterative approaches have low complication rates in octogenarians, with only UTIrate being different between cohorts. When choosing surgical approach, we suggest a case-based, patient center discussion on the anatomic outcomes, durability and patient satisfaction.

Implication of Neighborhood Deprivation Index on Pelvic Organ Prolapse Management.

Differences in the rate of diagnosis of POP have been described based on race and ethnicity; however, there are few data available on the management and treatment patterns of POP based on multiple factors of socioeconomic status and deprivation. The objective of this study was to investigate the association between pelvic organ prolapse (POP) management and the Neighborhood Deprivation Index (NDI), a standardized multidimensional measure of socioeconomic status. This retrospective cohort study included female members of a large integrated health care delivery system who were 18 years or older and had ≥4 years of continuous health care membership from January 1, 2015, to December 31, 2019. Demographic, POP diagnosis, urogynecology consultation, and surgical treatment of POP were obtained from the electronic medical record. Neighborhood Deprivation Index data were extrapolated via zip code and were reported in quartiles, with higher quartiles reflecting greater deprivation. Descriptive, bivariate, and logistic regression analyses were conducted by NDI. Of 1,087,567 patients identified, 34,890 (3.2%) had a POP diagnosis. Q1, the least deprived group, had the highest prevalence of POP (26.3%). Most patients with POP identified as White (57.3%) and represented approximately a third of Q1. Black patients had the lowest rate of POP (5.8%) and comprised almost half of Q4, the most deprived quartile. A total of 13,730 patients (39.4%) had a urogynecology consultation, with rates ranging from 23.6% to 26.4% (P < 0.01). Less than half (12.8%) of patients with POP underwent surgical treatment, and the relative frequencies of procedure types were similar across NDI quartiles except for obliterative procedures (P = 0.01). When controlling for age, no clinically significant difference was demonstrated. Differences in urogynecology consultation, surgical treatment, and surgical procedure type performed for prolapse across NDI quartiles were not found to be clinically significant. Our findings suggest that equitable evaluation and treatment of prolapse can occur through a membership-based integrated health care system.

Association of Neighborhood-Level Socioeconomic Status With Prolapse Management Decision.

This study identifies how neighborhood-level socioeconomic status (SES) may affect patients' treatment decisions for pelvic organ prolapse (POP). This study aimed to evaluate the association of neighborhood-level SES with the decision of surgical versus conservative POP management. This was a retrospective cohort study of patients newly diagnosed with POP at a tertiary medical center between 2015 and 2021. Patients lost to follow-up or poor surgical candidates were excluded. Patient characteristics, demographics, and treatment selection were abstracted from the electronic health record. Conservative management was defined as expectant, pessary, and/or pelvic floor physical therapy. Five-digit zip codes were linked to the Area Deprivation Index and used as a surrogate for neighborhood-level SES. Area Deprivation Indices were dichotomized at or below the sample median (less disadvantaged area) and above the sample median (more disadvantaged area). Logistic regression models estimated the odds of choosing surgical versus conservative management as a function of the Area Deprivation Index. A total of 459 patients met the eligibility criteria (non-Hispanic White, 88.2%). The median age was 63 years (interquartile range, 52-70 years), and the majority had stage 2 POP (65.7%). Of all patients, 59.3% had Medicare/Medicaid, 39.9% were privately insured, and 0.9% were uninsured. Furthermore, 74.7% selected surgical management, and 25.3% chose conservative management. Increasing age and higher Pelvic Organ Prolapse Quantification System stage were significantly associated with selecting surgery (P = 0.01). Women residing in a more disadvantaged area had a 67% increased odds of choosing surgical over conservative management (adjusted odds ratio, 1.67; 95% confidence interval, 1.06-2.64) after adjusting for age, race/ethnicity, body mass index, and Pelvic Organ Prolapse Quantification System stage. Residing in a more disadvantaged zip code was associated with 67% increased odds of choosing surgical versus conservative POP management.

Surgical and Functional Outcome of Laparoscopic Vaginal Suspension Combined with Suture Rectopexy for Management of Pelvic Organ Prolapse

Abstract Purpose Laparoscopic techniques to treat pelvic organ prolapse are gaining popularity around the globe due to their low recurrence rates and better functional results compared to perineal techniques. However, the optimum surgical procedures are not yet determined. In the current research, we suggest a novel surgical approach, laparoscopic vaginal suspension with suture rectopexy, to treat multiorgan pelvic prolapse. Methods This prospective cohort trial was conducted from March 2018 to March 2022 and comprised 35 females with multiorgan pelvic organ prolapse with obstructed defecation symptoms. A residual rectal prolapse was still present despite the manual reduction of uterine prolapse. Patients' conditions before and after the operation were monitored regarding the obstructed defecation score, sexual function, need for laxatives, anorectal manometry pressures, anorectal sensations, and recurrence. The mean follow-up duration was one year. Results Modified Longo score for obstructed defecation significantly decreased at six and twelve months after surgery. Additionally, a significant reduction was reported in the number of patients who needed laxatives at six and twelve months after surgery. Anorectal manometry pre- and post-surgery showed a significant elevation in the mean squeeze pressure and a decline in all rectal sensations. All parameters of the female sexual function scoring system increased postoperatively. No recurrence was reported during follow-up. Conclusion For multiorgan pelvic prolapse, laparoscopic vaginal suspension combined with suture rectopexy has excellent functional outcomes, minimal morbidity, and low cost.

Effect of pelvic floor status on the outcome of pelvic organ prolapse surgery.

Pelvic organ prolapse (POP) is a common diagnosis with an incidence in the population of up to 50%. POP causes restrictions in everyday life and reduces patients' quality of life. Therapy is either conservative in the form of physiotherapy or the use of different types of pessaries, possibly. in case of inappropriateness or failure of conservative treatment, an operative solution is chosen. Avulsion injury of the levator ani muscle (MLA) is a strong factor in the development of POP. Some patients undergo repeated surgeries for POP, negatively impacting their quality of life. Studies show that the stage of POP and avulsion injury is associated with an increased risk of recurrence after index prolapse surgery. Ultrasound diagnosis of MLA injuries might help in predicting the risk of recurrence. Assessment of pelvic floor function is crucial for the success of surgical management of POP.

Surgical management practice of pelvic organ prolapse among Ethiopian gynecologists, 2021: a descriptive study

IntroductionPelvic Organ Prolapse is the descent of one or more of the anterior vaginal wall, posterior vaginal wall, the uterus, or the apex of the vagina. Surgical intervention addresses both anatomical defect and associated symptoms. The landscape of prolapse surgery has been evolving constantly over years. Emerging evidences either support or challenge existing surgical treatment options, making urogynecology a dynamic field. In Ethiopia, the surgical management of pelvic organ prolapse has transitioned from abdominal to vaginal hysterectomy, supplemented later by McCall’s culdoplasty. Disparities exist in the national uniformity of surgical approaches, linked to the establishment of Urogynecology centers in certain institutions.ObjectivesThis study was done to assess the surgical management practice of Ethiopian gynecologists on pelvic organ prolapse.MethodsA cross-sectional study encompassing all Gynecologists in Ethiopia took place between January to June 2021. Information was gathered through online Google forms crafted in English. Subsequently, the collected data underwent verification, coding, and entry into Epi info 7 before being exported to SPSS version 22 software for descriptive statistical analysis.ResultsWe reached 280 gynecologists out of the 450 practicing in the Ethiopia making 62% response rate. Anterior colporrhaphy (98.6%), vaginal hysterectomy with McCall’s cul-do-plasty (51.8%), and Posterior colporrhaphy (97.5%) were the most commonly performed surgical procedures for anterior vaginal wall prolapse, apical prolapse (uterine/cervical), and posterior vaginal wall prolapse respectively. Only 3.2% and 0.7% of the gynecologists conducted abdominal and vaginal paravaginal repair for anterior vaginal wall prolapse. Sacrospinous ligament fixation and sacrocolpopexy for apical prolapse were carried out by 32.9% and 9.3% of the gynecologists respectively. Site-specific posterior repair for posterior vaginal wall prolapse was performed only by 23.9% of the gynecologists. The main reasons mentioned not to perform paravaginal repair, sacrocolpopexy, sacrospinous ligament fixation, and site-specific posterior repair were lack of skill and lack of appropriate materials.Conclusion and recommendationMost gynecologists in Ethiopian continue to perform vaginal hysterectomy and colporrhaphy procedures for treatment of pelvic organ prolapse due primarily to lack of skill and appropriate materials to perform the alternative procedures. Implementing short term training on alternative surgical treatment options of pelvic organ prolapse with provision of suitable materials and increasing the number of urogynecologists in the country in the long run holds the potential to enhance the standard of care of women with the condition.

#359 : Impact of Genitourinary Prolapse on Quality of Life and Sexual Function in Women at Their Midlife

Background and Aims: Pelvic organ prolapse (POP) is a common condition affecting women during their midlife, leading to various symptoms and decreased quality of life (QoL). This study aimed to assess the association of POP severity with QoL and sexual function in women at their midlife, with the objective of providing valuable insights for comprehensive care and effective management of POP. Method: A cross-sectional study included 130 symptomatic GUP women aged 40-60 years from Sir Salimullah Medical College &amp; Mitford Hospital in Dhaka. Group 1 (85 women) had stage 1 GUP, while the remaining were in group 2. Face-to-face interviews and POP-Q staging were conducted, followed by statistical analysis using Chi-Square, Mann-Whitney U, and Spearman rank correlation tests to examine the association of GUP severity with QoL and sexual function between the groups. Results: The mean age of the participants was 51.24 years (SD=5.5). The majority of the respondents were above 50 years of age (56%), and 65.38% of the study population were in group 2. One-third of the respondents (35.38%) had stage III GUP whereas only 4.62% were in stage IV. The frequency of urinary symptoms was most commonly occurring (70%) where dribbling of urine was least frequent (38%). Sexual and bowel symptoms were correlated with advanced stage of disease where urinary symptoms were not associated with GUP severity. Sexual dysfunction symptoms were positively associated with uterine descent. Regarding quality of life, all nine domains of QoL scores had positive correlation with severity of GUP. Conclusion: This study reveals the correlation between POP and urinary, bowel, and sexual symptoms. Clinicians should assess these symptoms for comprehensive care, and further research is required to determine effective treatment options for women with POP.

Pelvic floor symptoms among premenopausal women with pelvic organ prolapse in the Democratic Republic of the Congo.

Most of the literature on pelvic organ prolapse (POP) has been generated from postmenopausal patients in high-income countries. In the Democratic Republic of the Congo (DRC), a significant proportion of patients who present for surgical management of POP are premenopausal. Little is known about the impact of POP on pelvic floor symptoms in this population. The objective was to describe pelvic floor symptoms and sexual function among premenopausal patients presenting for POP surgery in DRC. We performed a prospective cohort study of symptomatic premenopausal patients undergoing fertility-sparing POP surgery at a large referral hospital in the DRC. Pelvic floor symptoms were evaluated with the Pelvic Floor Distress Inventory Questionnaire and sexual function with the Pelvic organ prolapse/urinary Incontinence Sexual Questionnaire. Data are presented as means with standard deviations or counts with percentages. A total of 107 patients were recruited between April 2019 and December 2021. All had either stage III (95.3%) or stage IV (4.7%) prolapse. Ages were 34.2 ± 6.7 years; 78.5% were married. A majority of patients experienced low abdominal pain (82.2%), heaviness or dullness (95.3%), and bulging or protrusion of the prolapse (92.5%). Almost two-thirds of patients reported no longer being sexually active, and 80% stated that they were not sexually active because of POP. Of the 37 sexually active patients (34.6%), nearly all reported significant sexual impairment because of the prolapse, with only 4 reporting no sexual impairment. This study represents one of the largest prospective series of patients with premenopausal POP. Our results highlight the severity of pelvic floor symptoms and the negative effects on sexual function among this patient population with POP.

Techniques in the Surgical Management of Pelvic Organ Prolapse

Pelvic organ prolapse is a common condition affecting women worldwide, significantly impacting their quality of life. Surgical management plays a vital role in addressing the associated discomfort and dysfunction. This bibliographic review explores the epidemiology, significance, theoretical framework, encompassing definition, risk factors, complications, and management of pelvic organ prolapse. The discussion delves into emerging techniques and sheds light on the future of this critical aspect of surgical practice.

Vaginal Cancer: Association with long term use of Pessary in Pelvic Organ Prolapse

Vaginal cancer, rarest form of gynaecological cancer (0.6%) has been found to be associated with long term use of vaginal ring pessary, which have long been used in alternative management of pelvic organ prolapse (POP) other than surgery. A through survey was done in remote areas of Cox’s bazar, refugee camp where out of 52 cases of pelvic organ prolapse, 7 cases found to use vaginal ring pessary for long and out of 7, vaginal cancer developed in 4 cases. All of them were aged women above 60 and had defaulted follow up presented with vaginal bleeding, varying discharge and pain of varying intensity. One patient had only local lesion was treated by surgical removal followed by radiotherapy. The 2 nd one, 68 years, received neo-adjuvant therapy and died before planned surgery. The 3 rd one, aged 79, did not come for follow up after diagnosis of vaginal cancer done and advised for definitive surgical treatment, family refused operation and she passed away after 2 years at 81 years. The 4 th one declined further investigations and any form of treatment once diagnosed with vaginal cancer. So, all patients of pelvic organ prolapse should be informed thoroughly (both verbal and written informed consent) before inserting pessary for potential long term serious consequences where strict compliance must be ensured for subsequent regular follow up and biopsy should be mandatory for any suspicious chronic vaginal ulcers among them. Bangladesh J Obstet Gynaecol, 2022; Vol. 37(1): 75-77

A randomized controlled study comparing the objective efficacy and safety of a novel self-inserted disposable vaginal prolapse device and existing ring pessaries.

ProVate is a novel, disposable, collapsible self-inserted vaginal device for the nonsurgical management of pelvic organ prolapse (POP). We assessed possible vaginal microflora changes and POP reduction using ProVate and a commercially available ring pessary (control). We performed post-hoc analysis of data obtained from an interventional, prospective, multicenter, open-label, randomized, controlled, statistically powered (noninferiority), home-use, cross-over study conducted at seven sites. Safety and performance data collected for both devices were analyzed to compare objective POP reduction (employing the Pelvic Organ Prolapse Quantification System [POP-Q]), safety (assessed by the incidence of adverse events [AEs]), and the rates of certain AEs. Eighty-five women with symptomatic POP were screened; 71 were randomized, and 58 completed the study per protocol. Forty-nine (90.7%) ProVate users experienced complete prolapse reduction (stage 0), 3 (5.6%) experienced reductions to POP-Q stage 1, and 2 (3.7%%) experienced reductions to stage 2. Collectively, 52/54 (96.3%) ProVate users experienced prolapse reduction to stage 0 or 1. In all, 47/57 (82.5%) control users experienced complete prolapse reduction, while 5 (8.8%), 4 (7.0%), and 1 (1.8%) experienced reductions to stage 1, 2, and stage 3, respectively. Collectively, 52/57 (91.2%) control users experienced reductions to either stage 0 or 1. In 53/54 (98.1%) ProVate and 55/57 (96.5%) control users, there was at least 1 POP-Q stage prolapse reduction, and in 32 (91.4%) ProVate and 31 (83.8%) control users who had stage ≥3 prolapse, there were at least three POP-Q stage reductions. In total, 26/71 (36.6%) ProVate and 22/64 (34.4%) control users in the safety population experienced AEs. The incidence of device-related AEs was 17/71 (23.9%) for ProVate and 13/64 (20.3%) for the control. Most AEs were minor, mild, and anticipated. Our analysis demonstrated that ProVate and the control are highly effective in reducing POP, and both are associated with comparably low numbers of AEs. However, ProVate has the advantage of being more user-friendly, suitable for home use, and expected to allow women with POP to practice better and easier self-care.

Does adding estrogen to surgery for the management of pelvic organ prolapse (POP) in postmenopausal women have any benefits?

Does adding estrogen to surgery for the management of pelvic organ prolapse (POP) in postmenopausal women have any benefits?

Pessary management for pelvic organ prolapse: a review of clinical practice and Australian medical device regulations

Pessary management for pelvic organ prolapse: a review of clinical practice and Australian medical device regulations