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Saudi Pharmaceutical Journal : SPJ :... Feb 2024Preterm labor is a growing health problem that causes newborn death, and safe and effective therapy is significantly needed. Arabin pessaries and progesterone are...
Preterm labor is a growing health problem that causes newborn death, and safe and effective therapy is significantly needed. Arabin pessaries and progesterone are preventive and therapeutic approaches that can be applied to managing the short cervix; hence, reducing the risk of preterm labor. The main goal of current work is to fabricate a novel nanofiber formulation based on polycaprolactone (PCL) and loaded with progesterone to coat for Arabin pessaries to be used as dual preventive and therapeutic approaches for local vaginal delivery. Several important criteria were considered in this study to assess the prepared nanofibers (i.e.; nanofiber diameter, progesterone loading efficiency, progesterone release profiles and cytotoxicity assessment). The results showed a dimeter of 397 ± 88 nm, drug loading of 142 ± 3 µg/mg and encapsulation efficiency of 99 ± 2 % for the progesterone-loaded nanofibers. Approximately, 17 % of progesterone was released from the nanofibers after 90 days. The assessment showed that the application of progesterone is safe upon 24 and 48-hours incubation on HFF-1 cell line at concentrations ≤ 32 µg/mL and within 72-hours at a dose of ≤ 8 µg/mL. To conclude, the data recommended that progesterone-loaded nanofibers can coat the Arabin pessaries with the potential of being a safe and effective dual preventive and therapeutic tool for preterm labor.
PubMed: 38223205
DOI: 10.1016/j.jsps.2023.101929 -
Obstetrics and Gynecology Mar 2024Our objective was to perform a cost-effectiveness analysis comparing polyacrylamide hydrogel urethral bulking with other surgical and nonsurgical treatments for stress...
Our objective was to perform a cost-effectiveness analysis comparing polyacrylamide hydrogel urethral bulking with other surgical and nonsurgical treatments for stress urinary incontinence (SUI). We created a cost-effectiveness analysis using TreeAge Pro, modeling eight SUI treatments. Treatment with midurethral sling (MUS) had the highest effectiveness (1.86 quality-adjusted life-years [QALYs]), followed by polyacrylamide hydrogel (1.82 QALYs), with a difference (Δ 0.02/year) less than the minimally important difference for utilities of 0.03 annually. When the proportion of polyacrylamide hydrogel urethral bulking procedures performed in the office setting is greater than 58%, polyacrylamide hydrogel is a cost-effective treatment for SUI, along with pessary, pelvic floor physical therapy, and MUS. Although MUS is more effective and, therefore, the preferred SUI treatment, polyacrylamide hydrogel is a reasonable alternative depending on patient preferences and treatment goals.
Topics: Humans; Urinary Incontinence, Stress; Cost-Effectiveness Analysis; Acrylic Resins; Urethra; Treatment Outcome; Suburethral Slings
PubMed: 38207326
DOI: 10.1097/AOG.0000000000005503 -
Case Reports in Women's Health Mar 2024Uterine prolapse is a rare condition in pregnancy that may lead to serious antepartum, intrapartum and postpartum complications for the mother and fetus. This is the...
Uterine prolapse is a rare condition in pregnancy that may lead to serious antepartum, intrapartum and postpartum complications for the mother and fetus. This is the case of a 30-year-old woman who presented at 38 weeks of gestation of her third pregnancy with spontaneous rupture of membranes and labor pain. Pelvic examination in dorsal lithotomy position revealed a stage 3 uterine prolapse, with a 3 cm dilated thick edematous cervix and rupture of membranes with clear liquor. Four hours after admission, the cervix became more edematous and there had been no change in cervical dilatation. Therefore, advanced apical prolapse (negatively affecting labor) was diagnosed, and the obstetric team decided on a cesarean delivery because a lack of progression of cervical dilatation. A live female baby weighing 3400 g was delivered and no abnormal findings or complications were reported. The patient had uneventful postoperative course with a significant reduction in uterine prolapse. Six weeks post-delivery, assessment in the urogynecology outpatient clinic revealed spontaneous resolution of the prolapse. The woman was advised to perform pelvic floor muscle exercises and to seek medical advice if the condition recurred. Obstetricians should be aware of this rare condition in pregnancy, as proper early diagnosis is crucial for a safe, uneventful pregnancy.
PubMed: 38192520
DOI: 10.1016/j.crwh.2023.e00578 -
Archives of Gynecology and Obstetrics May 2024To evaluate long-term continuation rates, adverse events of ring pessary use at a minimum of 5 years follow-up, and factors associated with discontinuation in...
PURPOSE
To evaluate long-term continuation rates, adverse events of ring pessary use at a minimum of 5 years follow-up, and factors associated with discontinuation in symptomatic pelvic organ prolapse (POP).
METHODS
Women with symptomatic POP who were treated with vaginal ring pessary and had successful fittings were included. Adverse events and reasons for discontinuation of pessary use were recorded. Patients who were lost to follow-up were defined as discontinuation.
RESULTS
During 12 year-period, 239 of 329 POP patients (72.6%) had successful fittings with ring pessary. The mean age was 67.8 ± 8.9 years (range 27-86) and 70% of patients had advanced stage. The cumulative probability of continued ring pessary use was 84.1%, 64.4%, 49.3%, and 33.5%, at 1, 3, 5, and 10 years, respectively. Most common reason for discontinuation was frequent expulsion (21.6%), followed by vaginal erosion (16.5%), no prolapse improvement (12.4%), and inability or inconvenience to do self-care (9.3%). However, 9 patients (9.3%) had improvement of prolapse and were able to discontinue pessary insertion. Age above 70 years, wide introitus, and incapability of self-care are independent factors associated with long-term discontinuation. Adverse events occurred in 23.4% of patients, 18.8% of them had vaginal erosion, 11.7% vaginal discharge/infection, and 18.4% de novo SUI. However, no statistical significance existed between those who continued and discontinued pessary use due to these adverse events.
CONCLUSION
Ring pessary is an effective treatment in symptomatic POP, with acceptable long-term continuation rates and minor adverse events. Self-care of pessary is very important aiming to minimize adverse events. Advanced age, wide introitus and incapability of self-care were associated factors for long-term discontinuation.
Topics: Humans; Female; Adult; Middle Aged; Aged; Aged, 80 and over; Pessaries; Vagina; Treatment Outcome; Pelvic Organ Prolapse; Contraceptive Devices, Female
PubMed: 38189963
DOI: 10.1007/s00404-023-07299-9 -
Cureus Jan 2024Preterm births are a significant concern, as they can have serious consequences for both infants and mothers. It is crucial to identify risk factors associated with... (Review)
Review
Preterm births are a significant concern, as they can have serious consequences for both infants and mothers. It is crucial to identify risk factors associated with preterm birth and to implement effective interventions, such as progesterone, cervical pessary, and cervical cerclage, to prevent it. This systematic review aims to evaluate the efficacy of cervical pessary in reducing spontaneous preterm delivery. However, cervical pessaries have limited research and conflicting findings when compared to other interventions for preventing preterm labor. Therefore, this review seeks to analyze various studies to evaluate their overall effectiveness and better understand their role in treating this vulnerable population. The literature search was conducted using PubMed between January and September 2023, and the systematic review adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The results of this review highlight the importance of continued research into mitigation strategies for preterm birth. There is some evidence that indicates that using cervical pessaries before 34 weeks can be effective. While some studies have reported positive outcomes when cervical pessaries are combined with other treatments like progesterone, there is no solid statistical evidence to support this claim. Furthermore, additional research is needed to comprehend the impact of singleton pregnancies and long-term outcomes for both mothers and infants.
PubMed: 38187016
DOI: 10.7759/cureus.51775 -
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 -
Ceska Gynekologie 2023Pelvic 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'...
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.
Topics: Humans; Pelvic Floor; Quality of Life; Pelvic Organ Prolapse; Ultrasonography
PubMed: 38171922
DOI: 10.48095/cccg2023463 -
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 -
International Journal of Biological... Feb 2024The research aimed to develop novel bioadhesive sodium alginate (Na-Alg) microspheres laden pessaries for intravaginal delivery of tenofovir disoproxil fumarate (TDF),...
The research aimed to develop novel bioadhesive sodium alginate (Na-Alg) microspheres laden pessaries for intravaginal delivery of tenofovir disoproxil fumarate (TDF), to overcome limitations of conventional dosage forms. Twelve batches of microspheres formulated by emulsification gelation method indicated that drug-polymer ratios and polymer type affected particle size, drug release, and entrapment efficiency (%EE). Microspheres of batch EH-8 with drug: polymer ratio of 1:4 containing equal amounts of Na-Alg and HPMC K100M displayed optimal %EE (62.09 ± 1.34 %) and controlled drug release (97.02 ± 4.54 % in 12 h). Particle size analysis in Matersizer indicated that microspheres (EH-8) displayed a surface-mean diameter of 11.06 ± 0.18 μm. Ex-vivo mucoadhesion studies on rabbit mucosa indicated that microspheres (EH-8) adhered well for 12 h. Microspheres integrated into pessaries displayed a sustained release profile (95.31 ± 1.37 % in 12 h) in simulated vaginal fluid. In vivo studies in rabbits indicated that pessaries displayed a significantly higher C (41.18 ± 3.57 ng/mL) (P < 0.005) and reduced T (1.00 ± 0.01 h) (P < 0.0001) of TDF concentrations in vaginal fluid compared to oral tablets. The microparticulate pessaries with the ability to elicit higher vaginal fluid levels in the crucial initial hours of insertion demonstrates a potential novel platform to offer better self-protection to HIV-negative women against HIV during sexual intercourse.
Topics: Animals; Female; Humans; Rabbits; Tenofovir; Microspheres; Alginates; Pessaries; Administration, Intravaginal; HIV Infections; Polymers
PubMed: 38114000
DOI: 10.1016/j.ijbiomac.2023.128816 -
American Journal of Obstetrics &... Feb 2024
Topics: Humans; Female; Premature Birth; Cervix Uteri
PubMed: 38104942
DOI: 10.1016/j.ajogmf.2023.101255