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Cureus Dec 2023Hysterectomy is an effective management approach for uterovaginal prolapse. However, the decision to undergo hysterectomy is a complex matter, influenced not only by...
BACKGROUND
Hysterectomy is an effective management approach for uterovaginal prolapse. However, the decision to undergo hysterectomy is a complex matter, influenced not only by medical factors but also cultural beliefs, societal norms, and individual attitudes. In Saudi Arabia, a nation with its distinctive cultural and social norms, the understanding of women's attitudes toward hysterectomy is of utmost importance. Unfortunately, such related attitudes have not been explored.
OBJECTIVE
This first-ever study aimed to investigate the attitudes toward hysterectomy among Saudi Arabian women undergoing evaluation for uterovaginal prolapse, by exploring the factors influencing their decision-making process and treatment choices, with a particular focus on the potential impact of cultural beliefs and societal norms.
METHODS
A survey was conducted among 404 women referred for uterovaginal prolapse evaluation. The participants completed a self-administered questionnaire, which included demographic information, perceptions on hysterectomy's impact on well-being, and factors affecting decision-making.
RESULTS
The mean ± standard deviation of participants was 51.07 ± 11.1 years. Most participants were currently married (n=327, 81%), were unemployed (n=309, 76.5%), and had an "excellent" self-rated general health status (n=138, 34%). Current prolapse management methods included Kegel exercises (n=103, 25.5%), pessary use (n=32, 8%), physical therapy (n=12, 3%), planned surgery (n=75, 18.5%), and no specific treatment (n=182, 45%). Overall, the study revealed diverse findings on the potential perceived impact of hysterectomy on different aspects of well-being. Notably, for pain symptoms, 152 participants (38%) reported potential improvement, while 123 participants (30%) predicted worsening, and 129 participants (32%) anticipated no change. Moreover, the study unveiled insights into the factors influencing patients' decision-making between hysterectomy and uterine-sparing procedures. Remarkably, 97 respondents (24%) considered the doctor's opinion to be "very Important," while 91 respondents (22%) rated the impact on surgical complication risk as "very important." Furthermore, the desire to preserve all healthy organs was deemed "very important" by 106 respondents (26%). The resources of information women depended on when making a decision to undergo hysterectomy varied and included a second opinion from another physician (n=68, 17%), social media (n=81, 20%), opinion from spouse/partner (21%), second opinion from female family members (n=99, 25%), and opinion from friends (n=70, 17%). Regarding preferences for decision-making, the responses varied substantially. Overall, 65 participants (16%) indicated a preference for their doctor to make the decision entirely, 81 participants (20%) preferred shared decision-making with their doctor, 89 participants (22%) wanted their doctor to make the decision after considering their input, 77 participants (19%) wished to make the final decision after discussing it with their doctor, and 93 participants (23%) expressed a preference for independently making the final decision. Lastly, correlations between women's responses and some demographic factors were identified.
CONCLUSION
This pioneering study provides valuable insights into Saudi Arabian women's attitudes toward hysterectomy, emphasizing the need for patient-centered care and culturally sensitive approaches in managing uterovaginal prolapse.
PubMed: 38179401
DOI: 10.7759/cureus.49967 -
Revista Brasileira de Ginecologia E... Dec 2023The aim of the present study is to compare the effectiveness of Arabin pessary and McDonald cervical cerclage on preterm delivery.
OBJECTIVE
The aim of the present study is to compare the effectiveness of Arabin pessary and McDonald cervical cerclage on preterm delivery.
METHODS
We conducted a retrospective analysis of data from patients who underwent either Arabin pessary or McDonald cerclage between January 1, 2019, and January 1, 2023. A total of 174 patients were included in the study, with 31 undergoing Arabin pessary and 143 receiving cervical cerclage using the McDonald technique in singleton pregnant women with cervical insufficiency, which applied between 14 and 22 gestational weeks. We included singleton pregnant women with normal morphology, and with normal combined test. The primary outcome was the impact of each method on preterm delivery (< 34 gestational weeks).
RESULTS
The weeks of cervical cerclage or pessary application were compatible with each other ( < 0.680). The pessary group had a statistically significant longer time to delivery compared with the Cerclage group (cerclage group mean 30.8 c 7.1 standard deviation [SD] versus pessary group mean 35.1 ± 4.4 SD; < 0.002). A statistically significant difference was found between the pessary and cerclage groups in terms of delivery at < 34 weeks ( = 0.002). In patients with cervical length between 25 and 15mm and < 15mm, no significant difference was found between the pessary and cerclage groups in terms of delivery week ( < 0.212; < 0.149). Regardless of the technique applied, no statistically significant difference was observed between cervical length and birth < 34 weeks.
CONCLUSION
Our study found that pessary use for cervical insufficiency is statistically more effective than cervical cerclage surgery in preventing preterm births < 34 weeks in singleton pregnancy.
Topics: Infant, Newborn; Pregnancy; Female; Humans; Premature Birth; Pessaries; Retrospective Studies; Uterine Cervical Incompetence; Cervix Uteri
PubMed: 38141596
DOI: 10.1055/s-0043-1776033 -
EClinicalMedicine Dec 2023Prolapse affects 30-40% of women. Those using a pessary for prolapse usually receive care as an outpatient. This trial determined effectiveness and cost-effectiveness of...
BACKGROUND
Prolapse affects 30-40% of women. Those using a pessary for prolapse usually receive care as an outpatient. This trial determined effectiveness and cost-effectiveness of pessary self-management (SM) vs clinic-based care (CBC) in relation to condition-specific quality of life (QoL).
METHODS
Parallel-group, superiority randomised controlled trial, recruiting from 16 May 2018 to 7 February 2020, with follow-up to 17 September 2021. Women attending pessary clinics, ≥18 years, using a pessary (except Shelf, Gellhorn or Cube), with pessary retained ≥2 weeks were eligible. Limited manual dexterity; cognitive deficit; pregnancy; or requirement for non-English teaching were exclusions. SM group received a 30-min teaching session; information leaflet; 2-week follow-up call; and telephone support. CBC group received usual routine appointments. The primary clinical outcome was pelvic floor-specific QoL (PFIQ-7), and incremental net monetary benefit for cost-effectiveness, 18 months post-randomisation. Group allocation was by remote web-based application, minimised on age, user type (new/existing) and centre. Participants, intervention deliverers, researchers and the statistician were not blinded. The primary analysis was intention-to-treat based. Trial registration: https://doi.org/10.1186/ISRCTN62510577.
FINDINGS
The requisite 340 women were randomised (169 SM, 171 CBC) across 21 centres. There was not a statistically significant difference between groups in PFIQ-7 at 18 months (mean SM 32.3 vs CBC 32.5, adjusted mean difference SM-CBC -0.03, 95% CI -9.32 to 9.25). SM was less costly than CBC. The incremental net benefit of SM was £564 (SE £581, 95% CI -£576 to £1704). A lower percentage of pessary complications was reported in the SM group (mean SM 16.7% vs CBC 22.0%, adjusted mean difference -3.83%, 95% CI -6.86% to -0.81%). There was no meaningful difference in general self-efficacy. Self-managing women were more confident in self-management activities. There were no reported suspected unexpected serious adverse reactions, and 31 unrelated serious adverse events (17 SM, 14 CBC).
INTERPRETATION
Pessary self-management is cost-effective, does not improve or worsen QoL compared to CBC, and has a lower complication rate.
FUNDING
National Institute for Health and Care Research, Health Technology Assessment Programme (16/82/01).
PubMed: 38078194
DOI: 10.1016/j.eclinm.2023.102326 -
American Journal of Obstetrics and... Nov 2023Miscarriage and preterm birth are leading causes of loss and disability in monochorionic twins after laser treatment of twin-twin transfusion syndrome.
The Arabin cervical pessary for the prevention of preterm birth in twin-to-twin transfusion syndrome treated by fetoscopic laser coagulation: a multicenter randomized controlled trial.
BACKGROUND
Miscarriage and preterm birth are leading causes of loss and disability in monochorionic twins after laser treatment of twin-twin transfusion syndrome.
OBJECTIVE
This study aimed to investigate the use of cervical pessary to reduce preterm birth before 32 weeks of gestation in monochorionic diamniotic twin pregnancies after fetal surgery for twin-twin transfusion syndrome.
STUDY DESIGN
In this open-label multicenter randomized trial, pregnant women carrying monochorionic diamniotic twins requiring fetoscopic laser coagulation for twin-twin transfusion syndrome were randomly assigned in a 1:1 ratio to pessary placement or conservative management. The primary outcome was birth before 32 weeks of gestation. The secondary outcomes were birth before 28, 30, 34, or 37 weeks of gestation; preterm premature rupture of membranes; fetal and neonatal survival; and a composite of maternal and neonatal complications. The estimated sample size was 364 patients, with 182 cases in each arm of the study. The analysis was performed according to the intention-to-treat principle. Moreover, 2 interim analyses were planned.
RESULTS
The trial was stopped prematurely after the first planned interim analysis for futility. Overall, 137 women were included in the analysis, 67 in the pessary group and 70 in the conservative management group. Preterm birth before 32 weeks of gestation occurred in 27 of 67 women (40.3%) in the pessary group and in 25 of 70 women (35.7%) in the conservative management group (adjusted odds ratio, 1.19; 95% confidence interval, 0.58-2.47; P=.63). No differences between groups was observed in the rate of deliveries before 28, 30, 34, and 37 weeks of gestation. Overall survival to delivery was 91.2% (125/137) for at least 1 twin, and 70.8% (97/137) for both twins, with no difference between groups. Neonatal survival at 30 days was 76.5% (208/272). There was no difference between the groups in maternal or neonatal morbidity.
CONCLUSION
In monochorionic diamniotic twin pregnancies requiring fetal therapy for twin-twin transfusion syndrome, routine use of cervical pessary did not reduce the rate of preterm birth before 32 weeks of gestation.
PubMed: 38036166
DOI: 10.1016/j.ajog.2023.11.1245 -
The Medical Journal of Malaysia Nov 2023Pelvic organ prolapse (POP) is a condition involving weakened pelvic floor muscles causing organs to protrude. Conservative POP treatment comprises pelvic floor...
INTRODUCTION
Pelvic organ prolapse (POP) is a condition involving weakened pelvic floor muscles causing organs to protrude. Conservative POP treatment comprises pelvic floor exercises and vaginal pessaries. Besides conservative care, surgery is offered. However, surgery is invasive, risky and unsuitable for those with serious medical conditions. This study aims to assess the acceptance, success and outcomes of the Gellhorn pessary for POP treatment, especially in advanced cases.
MATERIALS AND METHODS
The present study is a retrospective cohort study using hospital medical records (patient files) from October 2019 to November 2021 (for 2 years). This study was performed in Malaysian women (n=53) suffering from advanced stages of POP, in which Gellhorn pessaries of diameter (44-76mm) were inserted by trained personnel. Pelvic Floor Distress Inventory-20 (PFDI-20) and Pelvic Floor Impact Questionnaire-7 (PFIQ-7) were used to measure patients' symptoms and quality of life before and after Gellhorn pessary fitting. Patients were reassessed every three months for two years and their satisfaction scores were recorded.
RESULTS
We observed a significant difference in pre-test (pre-fitting) and post-test (three months post-fitting) scores on all three subscales and the PFIQ-7 total score. Twentyeight (52.83%) patients continued the use of Gellhorn pessary for at least 24 months, whereas 25 (47.20%) patients discontinued during this period. A retrospective analysis of the patients who discontinued Gellhorn pessary showed that 13 (24.52%) patients gave up the use of pessary for definitive surgery. It is noteworthy to mention here that only one out of the 13 patients who were awaiting surgery, chose surgery and the remaining 12 changed their mind after being fitted with the Gellhorn pessary. Seven (13.20%) patients declined reinsertion due to discomfort and voiding difficulties and refused further intervention, whereas three (5.66%) patients requested a ring pessary. Two (3.77%) patients, requested the removal of pessary due to vesicovaginal fistula and rectovaginal fistula (caused by an impacted pessary). The rate of continued use was 79.24% (42 patients) after 1st year and 52.83% (28 patients) at the end of two years.
CONCLUSION
In the current study, the Gellhorn pessary was used to treat stage 3 and 4 POP with significant symptom reduction post-fitting. More than half of the patients continued to use the pessary after 24 months of fitting. Therefore, the Gellhorn pessary can be used as a treatment strategy for stage 3 and 4 POP with reasonable acceptance in the Malaysian population.
Topics: Humans; Female; Retrospective Studies; Pessaries; Quality of Life; Pelvic Organ Prolapse; Pelvic Floor
PubMed: 38031210
DOI: No ID Found -
Archives of Gynecology and Obstetrics Feb 2024To investigate whether ProVate, a novel, disposable, self-inserted vaginal device for pelvic organ prolapse management, clinically affects the vaginal microflora, as... (Randomized Controlled Trial)
Randomized Controlled Trial
Vaginal microflora following the use of a disposable home-use vaginal device and a commercially available ring pessary for pelvic organ prolapse management: a randomized controlled trial.
PURPOSE
To investigate whether ProVate, a novel, disposable, self-inserted vaginal device for pelvic organ prolapse management, clinically affects the vaginal microflora, as compared with a commercially available ring pessary, to assess its microbiological safety.
METHODS
This interventional, prospective, multi-center, open-label, randomized, controlled, statistically powered (noninferiority), home-use, crossover study was conducted at seven sites. Participants were randomized into either group A (using ProVate and then a new reusable commercially available ring pessary [control]) or B (using control device and then ProVate) with a 1:1 ratio. Noninferiority of ProVate over the control was evaluated for the primary endpoint, which was based on meeting one of the failure criteria: significant change in Lactobacillus spp., Gardnerella vaginalis, Candida morphotypes, or Staphylococcus aureus levels compared to the baseline (significant change: Nugent score ≥ 7 or > 1 scale unit increase in S. aureus or Candida morphotype), bothersome vaginal infection symptoms, or symptoms requiring treatment for infection.
RESULTS
The study included 58 participants (mean age: 64.5 years, 91.4% postmenopausal). There were no significant microfloral changes in terms of the four microorganisms mentioned above, the rate of Nugent score ≥ 7 after use was low and comparable between the two devices, and the rate of patients with a > 1 unit-scale change (increase or decrease) from the baseline to the end-of-use phase in any studied microorganism was comparable between the devices. The failure rate was 15.5% for ProVate and 15.5% for control while using 383 ProVate devices over 1647 days or one control device throughout the study. Two patients had bothersome vaginal complaints and one had overt vaginal infection in the control group, but no such cases were observed in the ProVate group.
CONCLUSION
The primary endpoint of possible vaginal microbial changes, bothersome vaginal symptoms, or treatment-requiring vaginal complaints while using ProVate was successfully met. Our findings show that the vaginal microflora is comparable when using either ProVate or commercially available ring pessary (control) with a relatively low rate of vaginal infections. Trial registration details: ClinicalTrials.gov; URL: https://www.
CLINICALTRIALS
gov/ct2/show/NCT03345121?term=NCT03345121&draw=2&rank=1 ; No. NCT03345121; Registration date, November 17, 2017; initial enrollment started on August 20, 2017.
Topics: Female; Humans; Middle Aged; Pessaries; Prospective Studies; Cross-Over Studies; Staphylococcus aureus; Pelvic Organ Prolapse
PubMed: 37882871
DOI: 10.1007/s00404-023-07260-w -
Scientific Reports Oct 2023Pelvic organ prolapse (POP) is a benign gynecological disease in which the pelvic organ descends into the vagina and causes voiding, and defecatory dysfunction, mainly...
Pelvic organ prolapse (POP) is a benign gynecological disease in which the pelvic organ descends into the vagina and causes voiding, and defecatory dysfunction, mainly occurs in older women. This study aimed to investigate the vaginal microbiome of POP and associated changes after anatomical restorative pessary or reconstructive pelvic operation. We analyzed the vaginal microbiome using 16S ribosomal RNA gene sequencing and compared the results among patient groups with POP, pessary, and postoperation. We also measured 10 inflammation-related cytokines in vaginal swab samples using multiplex immunoassay. In pelvic organ prolapse, vaginal community status type IV was the most prevalent, which showed a low abundance of Lactobacillus with increased diversity and abundance of anaerobic species. The alpha diversity of species richness was highest in the POP group. The beta diversity distance differed significantly between the three groups (p = 0.001). While human intestinal taxa-associated bacteria were reduced after pessary or operation, vaginitis-associated bacterial composition was altered but vaginal microbiome homeostasis was not improved. IFN-γ, IL-10, IL-12p70, IL-1β, IL-4 and TNF-α levels increased in the pessary group. Therefore, in addition to anatomical restorative treatment, supplementary treatment focusing on the recovery of the vaginal microbiome may be needed to maintain the health of gynecological organs in old age.
Topics: Female; Humans; Aged; Pelvic Organ Prolapse; Vagina; Pelvic Floor; Pessaries; Microbiota
PubMed: 37845312
DOI: 10.1038/s41598-023-44988-6 -
Frontiers in Medicine 2023ProVate is a novel, disposable, collapsible self-inserted vaginal device for the nonsurgical management of pelvic organ prolapse (POP). We assessed possible vaginal...
INTRODUCTION
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).
METHODS
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.
RESULTS
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.
CONCLUSION
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.
PubMed: 37822469
DOI: 10.3389/fmed.2023.1252612 -
Frontiers in Reproductive Health 2023Catamenial products like menstrual tampons for managing menses and vaginal pessaries for managing urinary incontinence and uterine prolapse are products that can be...
Catamenial products like menstrual tampons for managing menses and vaginal pessaries for managing urinary incontinence and uterine prolapse are products that can be inserted and removed from the vagina repeatedly over a woman's lifetime. In the United States (US), these products are considered to be medical devices and are regulated by the Center for Devices & Radiological Health (CDRH) of the Food and Drug Administration (FDA). As such, they are subject to both premarket and postmarket regulatory controls. Both tampons and pessaries have a long history of safe and effective use, and FDA applies a risk-based approach to both premarket entry as well as continued postmarket regulatory controls. Practicing clinicians are often the initial source of ideas for medical device improvements. This article is intended to help such clinicians to understand the regulatory challenges faced by development teams who seek to introduce these kinds of products to the US market. It explains FDA's risk-based classification of medical devices and the 510(k) premarket notification as the primary regulatory mechanism for market entry. It also highlights key FDA guidance documents and encourages early engagement with FDA when appropriate.
PubMed: 37795520
DOI: 10.3389/frph.2023.1224421 -
Cureus Sep 2023Pelvic organ prolapse (POP) is a common condition mainly affecting postmenopausal women, characterized by the descent of pelvic organs through the vaginal canal. While...
Pelvic organ prolapse (POP) is a common condition mainly affecting postmenopausal women, characterized by the descent of pelvic organs through the vaginal canal. While often asymptomatic, POP can manifest with various symptoms such as a painless bulge or pressure sensation, abdominal pain, urinary complaints, and discomfort during intercourse. Severe cases can lead to urinary tract obstruction, hydronephrosis, and renal dysfunction. This case study presents an elderly female with bilateral severe hydronephrosis and pyelonephritis due to undiagnosed POP. Imaging revealed obstructive uropathy resulting from bilateral ureteric compression caused by cystocele and uterine prolapse. The patient's condition improved with antibiotics and supportive management. A vaginal hysterectomy was performed, which led to the resolution of the urinary tract obstruction. This case emphasizes the importance of considering POP in elderly women with urinary symptoms and the need for proactive screening. It highlights the significance of appropriate management to prevent irreversible renal damage. Different treatment modalities, including surgery and pessaries, are discussed, to emphasize the significance of tailoring treatments to individual patient characteristics.
PubMed: 37790056
DOI: 10.7759/cureus.44513