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Ethiopian Journal of Health Sciences Sep 2023In the female population, pelvic organ prolapse is a common problem that lowers people's quality of life in terms of their health. Depending on the severity of the...
BACKGROUND
In the female population, pelvic organ prolapse is a common problem that lowers people's quality of life in terms of their health. Depending on the severity of the prolapse and the symptoms, there are many treatment options. Simple observation, vaginal pessaries, or surgical management are all possible treatments. Reconstructive pelvic surgery with or without mesh augmentation and obliterative surgery are two surgical treatments that are available. Due to the contentious concerns surrounding the use of mesh and the rising demand for uterine preservation, surgical practices are currently shifting.
METHODS
Just two cases are included in this study due to the rarity of this condition. In this study, I introduce a new technique to the literature (Mostafa Maged sling technique) which will be challenging. This technique depends on round ligaments and ovarian ligament to hitch up the whole uterus.
RESULTS
There were no difficulties following the procedure. None of the patients required blood transfusions, and there were no signs of dehiscence or incision infection. Non-steroidal antiinflammatory medications were administered to both patients as analgesia. On the first postoperative day, the foley catheters were removed from both patients.
CONCLUSION
A simple and new manueuver is applied in the literature to treat the uterine prolapse. It is easy to learn and easy to perform. We need further studies to compare different techniques including Mostafa Maged sling operation to manage uterine prolapse.
Topics: Humans; Female; Uterine Prolapse; Middle Aged; Suburethral Slings; Uterus; Gynecologic Surgical Procedures; Pelvic Organ Prolapse; Surgical Mesh
PubMed: 38784517
DOI: 10.4314/ejhs.v33i5.22 -
Health Technology Assessment... May 2024Pelvic organ prolapse is common, causes unpleasant symptoms and negatively affects women's quality of life. In the UK, most women with pelvic organ prolapse attend... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Pelvic organ prolapse is common, causes unpleasant symptoms and negatively affects women's quality of life. In the UK, most women with pelvic organ prolapse attend clinics for pessary care.
OBJECTIVES
To determine the clinical effectiveness and cost-effectiveness of vaginal pessary self-management on prolapse-specific quality of life for women with prolapse compared with clinic-based care; and to assess intervention acceptability and contextual influences on effectiveness, adherence and fidelity.
DESIGN
A multicentre, parallel-group, superiority randomised controlled trial with a mixed-methods process evaluation.
PARTICIPANTS
Women attending UK NHS outpatient pessary services, aged ≥ 18 years, using a pessary of any type/material (except shelf, Gellhorn or Cube) for at least 2 weeks. Exclusions: women with limited manual dexterity, with cognitive deficit (prohibiting consent or self-management), pregnant or non-English-speaking.
INTERVENTION
The self-management intervention involved a 30-minute teaching appointment, an information leaflet, a 2-week follow-up telephone call and a local clinic telephone helpline number. Clinic-based care involved routine appointments determined by centres' usual practice.
ALLOCATION
Remote web-based application; minimisation was by age, pessary user type and centre.
BLINDING
Participants, those delivering the intervention and researchers were not blinded to group allocation.
OUTCOMES
The patient-reported primary outcome (measured using the Pelvic Floor Impact Questionnaire-7) was prolapse-specific quality of life, and the cost-effectiveness outcome was incremental cost per quality-adjusted life-year (a specifically developed health Resource Use Questionnaire was used) at 18 months post randomisation. Secondary outcome measures included self-efficacy and complications. Process evaluation data were collected by interview, audio-recording and checklist. Analysis was by intention to treat.
RESULTS
Three hundred and forty women were randomised (self-management, = 169; clinic-based care, = 171). At 18 months post randomisation, 291 questionnaires with valid primary outcome data were available (self-management, = 139; clinic-based care, = 152). Baseline economic analysis was based on 264 participants (self-management, = 125; clinic-based care, = 139) with valid quality of life and resource use data. Self-management was an acceptable intervention. There was no group difference in prolapse-specific quality of life at 18 months (adjusted mean difference -0.03, 95% confidence interval -9.32 to 9.25). There was fidelity to intervention delivery. Self-management was cost-effective at a willingness-to-pay threshold of £20,000 per quality-adjusted life-year gained, with an estimated incremental net benefit of £564.32 and an 80.81% probability of cost-effectiveness. At 18 months, more pessary complications were reported in the clinic-based care group (adjusted mean difference 3.83, 95% confidence interval 0.81 to 6.86). There was no group difference in general self-efficacy, but self-managing women were more confident in pessary self-management activities. In both groups, contextual factors impacted on adherence and effectiveness. There were no reported serious unexpected serious adverse reactions. There were 32 serious adverse events (self-management, = 17; clinic-based care, = 14), all unrelated to the intervention. Skew in the baseline data for the Pelvic Floor Impact Questionnaire-7, the influence of the global COVID-19 pandemic, the potential effects of crossover and the lack of ethnic diversity in the recruited sample were possible limitations.
CONCLUSIONS
Self-management was acceptable and cost-effective, led to fewer complications and did not improve or worsen quality of life for women with prolapse compared with clinic-based care. Future research is needed to develop a quality-of-life measure that is sensitive to the changes women desire from treatment.
STUDY REGISTRATION
This study is registered as ISRCTN62510577.
FUNDING
This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/82/01) and is published in full in ; Vol. 28, No. 23. See the NIHR Funding and Awards website for further award information.
Topics: Humans; Female; Pessaries; Pelvic Organ Prolapse; Cost-Benefit Analysis; Self-Management; Middle Aged; Quality of Life; Aged; United Kingdom; Quality-Adjusted Life Years; Adult
PubMed: 38767959
DOI: 10.3310/NWTB5403 -
Translational Andrology and Urology Apr 2024Patients with cystocele of pelvic organ prolapse quantification (POP-Q) stage II and below can be treated conservatively, but there are few reports on non-surgical...
BACKGROUND
Patients with cystocele of pelvic organ prolapse quantification (POP-Q) stage II and below can be treated conservatively, but there are few reports on non-surgical treatment for these patients. This study aimed to present the real-world clinical effectiveness of nonsurgical treatment, including pelvic floor muscle training (PFMT), PFMT combined with pessary (PFMT + P), or non-ablative radiofrequency (PFMT + RF) for female with POP-Q stage II cystocele.
METHODS
We retrospectively analyzed females with POP-Q stage II cystocele between January 2020 and January 2022 who received PFMT, PFMT + P, or PFMT + RF treatment and were followed up for 12 months. Clinical parameters including Pelvic Floor Distress Inventory-20 questionnaire (PFDI-20), Persian version urinary incontinence quality of life questionnaire (I-QOL), POP-Q, pelvic floor Glazer evaluation, and trans-labial ultrasound at different time points were analyzed.
RESULTS
There were 147 participants enrolled. PFDI-20 and I-QOL scores were improved in all groups, but the mean decrement in the PFDI-20 scores (-14.28±8.57 and -9.78±8.25) was higher in the PFMT + P group than in the PFMT group and PFMT + RF group at both 6 and 12 months (P<0.05), and the mean I-QOL score (3.82±23.43 and 3.47±22.06) was higher in the PFMT + RP group at both 6 months and 12 months (P<0.05). The PFMT + P group also showed higher improvement rate (43.3%, P=0.03) in terms of changing the severity of cystocele (point Ba) and delta bladder neck-symphyseal distance (ΔBSD) (P<0.05) than the other 2 groups at 12 months. No statistical difference was found in the type-I and type-II myofiber function-based Glazer assessment among 3 groups.
CONCLUSIONS
The combination of 2 treatment strategies seems to be superior to PFMT only for stage-II cystocele. Specific prolapse-related symptoms and objective indicators did improve more in the PFMT + P group, whereas stress urinary incontinence (SUI) symptoms and quality of life were improved in the PFMT + RP group.
PubMed: 38721295
DOI: 10.21037/tau-23-486 -
BMJ Open May 2024To evaluate the cost-effectiveness of pessary therapy as an initial treatment option compared with surgery for moderate to severe pelvic organ prolapse (POP) symptoms in... (Randomized Controlled Trial)
Randomized Controlled Trial Comparative Study
Cost-effectiveness of pessary therapy versus surgery for symptomatic pelvic organ prolapse: an economic evaluation alongside a randomised non-inferiority controlled trial.
OBJECTIVE
To evaluate the cost-effectiveness of pessary therapy as an initial treatment option compared with surgery for moderate to severe pelvic organ prolapse (POP) symptoms in secondary care from a healthcare and a societal perspective.
DESIGN
Economic evaluation alongside a multicentre randomised controlled non-inferiority trial with a 24-month follow-up.
SETTING
21 hospitals in the Netherlands, recruitment conducted between 2015 and 2022.
PARTICIPANTS
1605 women referred to secondary care with symptomatic prolapse stage ≥2 were requested to participate. Of them, 440 women gave informed consent and were randomised to pessary therapy (n=218) or to surgery (n=222) in a 1:1 ratio stratified by hospital.
INTERVENTIONS
Pessary therapy and surgery.
PRIMARY AND SECONDARY OUTCOME MEASURES
The Patient Global Impression of Improvement (PGI-I), a 7-point scale dichotomised into successful versus unsuccessful, with a non-inferiority margin of -10%; quality-adjusted life-years (QALYs) measured by the EQ-5D-3L; healthcare and societal costs were based on medical records and the institute for Medical Technology Assessment questionnaires.
RESULTS
For the PGI-I, the mean difference between pessary therapy and surgery was -0.05 (95% CI -0.14; 0.03) and -0.03 (95% CI -0.07; 0.002) for QALYs. In total, 54.1% women randomised to pessary therapy crossed over to surgery, and 3.6% underwent recurrent surgery. Healthcare and societal costs were significantly lower in the pessary therapy (mean difference=-€1807, 95% CI -€2172; -€1446 and mean difference=-€1850, 95% CI -€2349; -€1341, respectively). The probability that pessary therapy is cost-effective compared with surgery was 1 at willingness-to-pay thresholds between €0 and €20 000/QALY gained from both perspectives.
CONCLUSIONS
Non-inferiority of pessary therapy regarding the PGI-I could not be shown and no statistically significant differences in QALYs between interventions were found. Due to significantly lower costs, pessary therapy is likely to be cost-effective compared with surgery as an initial treatment option for women with symptomatic POP treated in secondary care.
TRIAL REGISTRATION NUMBER
NTR4883.
Topics: Humans; Pessaries; Female; Cost-Benefit Analysis; Pelvic Organ Prolapse; Middle Aged; Netherlands; Aged; Quality-Adjusted Life Years; Treatment Outcome; Quality of Life
PubMed: 38692718
DOI: 10.1136/bmjopen-2023-075016 -
Medicina (Kaunas, Lithuania) Mar 2024Pelvic organ prolapse (POP) is a common condition in women, with its prevalence increasing with age, and can significantly impact the quality of life (QOL) of many... (Observational Study)
Observational Study
Pelvic organ prolapse (POP) is a common condition in women, with its prevalence increasing with age, and can significantly impact the quality of life (QOL) of many individuals. The objective of this study was to assess the overall improvement, quality of life, and continuation of primary treatment for POP over a 24-month period in a real-world setting. This is a prospective, observational, follow-up study of women with symptomatic POP who, as a primary treatment, opted for recommendations (lifestyle changes and pelvic floor muscle training), pessary therapy, or surgery. The primary outcome measure was a subjective improvement at the 24-month follow-up, measured with the Patient Global Impression of Improvement (PGI-I) scale. Secondary outcome measures were the continuation rate of the primary treatment method, reason for discontinuation, and the quality of life evaluated with the P-QoL questionnaire. We included 137 women, with 45 women (32.8%) in the recommendations group, 39 (28.5%) in the pessary group, and 53 women (38.7%) in the surgery group. After 24 months, surgery, in comparison with pessary treatment and recommendations, resulted in significantly more women reporting a subjective improvement: 89.6%, 66.7%, and 22.9% ( < 0.001), respectively. Overall, 52% of women from the recommendations group and 36.4% from the pessary group switched to another treatment or discontinued the primary treatment within 24 months. However, women who continued the primary treatment, pessary use, and surgery showed similar subjective improvements (90.5% and 89.6%, respectively) and quality-of-life improvement. The chance of significant improvement was higher following surgery. However, after 24 months, both vaginal pessaries and surgery showed an important quality-of life improvement and can be proposed as primary treatment methods for pelvic organ prolapse.
Topics: Humans; Quality of Life; Female; Pelvic Organ Prolapse; Pessaries; Prospective Studies; Middle Aged; Aged; Follow-Up Studies; Surveys and Questionnaires; Treatment Outcome
PubMed: 38674193
DOI: 10.3390/medicina60040547 -
AJOG Global Reports May 2024The incidence of preterm delivery is much higher in twin pregnancies than in singletons and even higher if a short cervical length is detected in the second trimester.... (Review)
Review
The effect of cervical pessary on increasing gestational age at delivery in twin pregnancies with asymptomatic short cervix: a systematic review and meta-analysis of randomized controlled trials.
OBJECTIVE
The incidence of preterm delivery is much higher in twin pregnancies than in singletons and even higher if a short cervical length is detected in the second trimester. Studies are contradictory regarding the efficacy of a cervical pessary to decrease preterm birth in twin pregnancies and short cervical length. To conduct a systematic review and meta-analysis investigating the efficacy of cervical pessary in prolonging gestation, preventing preterm birth, and reducing adverse neonatal outcomes in twin pregnancies with an asymptomatic short cervix.
DATA SOURCES
PubMed, Scopus, Web of Science, and ClinicalTrials.org were searched for randomized controlled trials from inception to June 2023.
STUDY ELIGIBILITY CRITERIA
In this study, randomized controlled trials comparing the cervical pessary to expectant management in the pregnant population with twin gestations and asymptomatic short cervix were included.
METHODS
The Cochrane risk-of-bias-2 tool for randomized controlled trials was used for the evaluation of the risk of bias in included studies. A meta-analysis was performed by calculating risk ratio and mean difference with their 95% confidence interval using the random effects model or fixed effect model on the basis of heterogeneity and accounting for potential covariates among the included randomized controlled trials.
RESULTS
A total of 6 randomized controlled trials were included in the analysis. Cervical pessary did not significantly increase the gestational age at delivery in twin pregnancies with asymptomatic patients (mean difference, 0.36 weeks [-0.27 to 0.99]; =.270; I=72.0%). Moreover, the cervical pessary use did not result in a reduction of spontaneous or all-preterm birth before 37 weeks of gestation (risk ratio, 0.88 [0.77-1.00]; =.061; I=0.0%). There was no statistically significant difference in the composite neonatal adverse outcomes (risk ratio, 1.001 [0.86-1.16]; =.981; I=20.9%), including early respiratory morbidity, intraventricular hemorrhage, necrotizing enterocolitis, and confirmed sepsis.
CONCLUSION
The use of cervical pessary in twin pregnancies with asymptomatic short cervix does not seem to be effective in increasing the gestational age at delivery, preventing preterm birth, or reducing adverse neonatal outcomes. This indicates that alternative interventions should be sought for the management of this patient population.
PubMed: 38655568
DOI: 10.1016/j.xagr.2024.100347 -
American Journal of Obstetrics &... May 2024Preterm birth is a major cause of perinatal morbidity and mortality. It is unclear whether the introduction of a universal transvaginal ultrasound cervical length... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Preterm birth is a major cause of perinatal morbidity and mortality. It is unclear whether the introduction of a universal transvaginal ultrasound cervical length screening program in women at low risk for preterm delivery is associated with a reduction in the frequency of preterm birth.
OBJECTIVE
To test the hypothesis that the introduction of a midtrimester universal transvaginal ultrasound cervical length screening program in asymptomatic singleton pregnancies without prior preterm delivery would reduce the rate of preterm birth at <37 weeks of gestation.
STUDY DESIGN
This study was a multicenter nonblinded randomized trial of screening of asymptomatic singleton pregnancies without prior spontaneous preterm birth, who were randomized to either cervical length screening program (ie, intervention group) or no screening (ie, control group). Participants were randomized at the time of their routine anatomy scan between 18 0/7 and 23 6/7 weeks of gestation. Women randomized in the screening group received cervical length measurement. Those who were found to have cervical length ≤25 mm were offered 200 mg vaginal progesterone daily along with cervical pessary. The primary outcome was preterm birth at <37 weeks. The risk of primary outcome was quantified by the relative risk with 95% confidence interval, and was based on the intention-to-screen principle.
RESULTS
A total of 1334 asymptomatic women with singleton pregnancies and without prior preterm birth, were included in the trial. Out of the 675 women randomized in the transvaginal ultrasound cervical length screening group, 13 (1.9%) were found to have transvaginal ultrasound cervical length ≤25 mm during the screening. Preterm birth at <37 weeks of gestation occurred in 48 women in the transvaginal ultrasound cervical length screening group (7.5%), and 54 women in the control group (8.7%) (relative risk, 0.86; 95% confidence interval, 0.59-1.25). Women randomized in the transvaginal ultrasound cervical length screening group had no significant differences in the incidence of preterm birth at less than 34, 32, 30, 28, and 24 weeks of gestation.
CONCLUSION
The introduction of a universal transvaginal ultrasound cervical length screening program at 18 0/6 to 23 6/7 weeks of gestation in singleton pregnancies without prior spontaneous preterm birth, with treatment for those with cervical length ≤25 mm, did not result in significant lower incidence of preterm delivery than the incidence without the screening program.
Topics: Pregnancy; Infant, Newborn; Female; Humans; Premature Birth; Risk; Cervix Uteri; Incidence
PubMed: 38642994
DOI: 10.1016/j.ajogmf.2023.101267 -
European Journal of Obstetrics &... Jun 2024We aimed to identify the incidence and risk factors of spontaneous preterm birth in pessary carriers with singleton pregnancies and a short cervix in the mid-trimester...
INTRODUCTION
We aimed to identify the incidence and risk factors of spontaneous preterm birth in pessary carriers with singleton pregnancies and a short cervix in the mid-trimester of pregnancy.
MATERIAL AND METHODS
Patient data were obtained from the PECEP Trial. We analyzed singleton pregnancies in pessary carriers with a short cervix (≤25 mm) between 18 and 22 gestational weeks. Demographics and obstetric history were compared to identify risk factors for spontaneous preterm birth < 34 gestational weeks. Each demographic and obstetric variable was compared between spontaneous preterm birth < 34 and ≥ 34 weeks of gestation.Regression analysis was used to identify risk factors. A risk score model was generated using the odds ratio for significant factors. The risk score model and spontaneous preterm birth risk were assessed using the receiver operating characteristic curve. Perinatal outcomes were compared by risk score.
RESULTS
Among 190 pregnant individuals, 12 (6.3%) had spontaneous preterm birth < 34 gestational weeks. In the bivariate analysis, statistically significant differences between those with and without spontaneous preterm birth were only observed for mean cervical length at diagnosis and mean cervical length after pessary placement. By multiple logistic regression analysis, maternal age (OR 0.818; 95% CI 0.69-0.97; 0.020), cervical length at diagnosis (OR 0.560; 95% CI 0.43-0.73; < 0.001) and smoking status (OR 7.276; 95% CI 1.02-51.80; 0.048) remained significantly associated with spontaneous preterm birth.The ROC curve from the multiple logistic regression analysis, including cervical length, maternal age and smoking status, had an area under the curve (AUC) of 0.952 0.001). The ROC curve for the risk score model incorporating all three variables had an AUC of 0.864 (95% CI 0.77-0.96; < 0.001). A high-risk score was predictive of spontaneous preterm birth with a sensitivity of 75%, specificity of 84%, positive predictive value of 24%, and negative predictive value of 98%.Women with a high-risk score had a significantly reduced latency to delivery and poorer neonatal outcomes than those with a low-risk score.
CONCLUSIONS
Patients at a high risk for spontaneous preterm birth despite pessary therapy may be identified using cervical length at diagnosis added to maternal age and smoking status.
PubMed: 38595705
DOI: 10.1016/j.eurox.2024.100305 -
Cureus Mar 2024Preterm birth is the delivery of a live fetus before the 37th week of gestation. Preterm birth may stem from various factors, including premature rupture of membranes,... (Review)
Review
Preterm birth is the delivery of a live fetus before the 37th week of gestation. Preterm birth may stem from various factors, including premature rupture of membranes, spontaneous preterm labor, or medically induced circumstances. Premature delivery can result in serious and long-lasting difficulties even for infants who survive, as it is the leading cause of death for infants under five years old. Numerous nations have implemented initiatives to detect and track pregnant women who may give birth before their due date. Numerous therapies are available to protect these at-risk groups from the devastating effects of premature delivery, given the complex nature of preterm birth risk factors. Among the preventive measures, prophylactic progesterone appears to hold significant promise, while cervical cerclage proves effective in cases of cervical insufficiency. Conversely, pessaries show no discernible beneficial effects in reducing the risk of preterm birth. Regular antenatal visits are imperative for frequent patient evaluation and screening for potential risk factors. Adopting a healthy lifestyle can influence the risk of developing preeclampsia, with regular physical activity, a fiber-rich diet, and smoking cessation serving to mitigate the risk of preterm birth. The efficacy of bed rest in preventing preterm birth remains inconclusive due to insufficient evidence. This study aims to explore various preventive strategies for averting premature birth in high-risk women.
PubMed: 38586732
DOI: 10.7759/cureus.55737 -
Maturitas Jul 2024The efficacy and tolerability of a non-hormonal pessary (that forms an oil-in-water emollient with the vaginal fluid) were assessed for the treatment of symptoms of... (Clinical Trial)
Clinical Trial
OBJECTIVES
The efficacy and tolerability of a non-hormonal pessary (that forms an oil-in-water emollient with the vaginal fluid) were assessed for the treatment of symptoms of vaginal dryness associated with menopause.
STUDY DESIGN
Seventy-nine postmenopausal women (mean age 60.8 ± 6.5 years) with mild to moderate symptoms of vaginal dryness (including dyspareunia) were enrolled in this open-label, prospective, post-market clinical follow-up trial, conducted in 2022 by one research center in Germany. The investigational pessary was applied for the first 7 days once daily and the subsequent 31 days twice a week, at bedtime. A treatment-free period of 6 days completed the trial.
MAIN OUTCOME MEASURES
During the trial, participants filled out questionnaires that enabled the calculation of a total severity score for subjective symptoms of atrophy-related vaginal dryness and impairment of daily as well as sexual life. Furthermore, vaginal health index and safety were studied.
RESULTS
A rapid and significant reduction in the severity scores for symptoms was observed over the 38-day course of treatment and beyond. Quality of life assessed by DIVA (day-to-day impact of vaginal aging) questionnaire, dyspareunia and vaginal health index also clearly improved. The tolerability was mainly rated as "good to very good" by the investigator and 94.9 % of participants. The vast majority were very satisfied with the simple and pleasant handling. No serious adverse events occurred.
CONCLUSION
Overall, the presented data suggest that the investigated non-hormonal pessary is an effective and well tolerated treatment option for vaginal symptoms associated with dryness, thus improving quality of life for women, even those who are sexually active.
CLINICALTRIALS
gov identifier NCT05211505.
Topics: Humans; Female; Middle Aged; Vaginal Diseases; Quality of Life; Aged; Prospective Studies; Dyspareunia; Vagina; Menopause; Pessaries; Surveys and Questionnaires; Severity of Illness Index; Postmenopause; Treatment Outcome
PubMed: 38583316
DOI: 10.1016/j.maturitas.2024.107978