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BMJ Case Reports Apr 2024Vaginal pessaries are widely considered to be a safe and effective non-surgical management option for women with pelvic organ prolapse. Complications may occur, and are...
Vaginal pessaries are widely considered to be a safe and effective non-surgical management option for women with pelvic organ prolapse. Complications may occur, and are more frequent with improper care and certain device designs and materials. It is imperative to provide information to patients about potential complications. We present the case of a woman in her 70s who presented to the Emergency Department with increasing groin and abdominal pain following a vaginal pessary insertion 2 days prior for grade 3 vaginal vault prolapse. On presentation, her abdomen was markedly distended with guarding. Laboratory investigations showed a significant acute kidney injury with a metabolic acidosis. An initial non-contrast CT showed fluid and inflammatory changes surrounding the bladder, and bladder perforation was suspected. A subsequent CT cystogram showed extravasation of contrast from the bladder into the peritoneal cavity, in keeping with an intraperitoneal bladder rupture. The patient underwent an emergency bladder repair in theatre.
Topics: Humans; Female; Pessaries; Urinary Bladder; Pelvic Organ Prolapse; Urinary Bladder Diseases; Vagina; Abdominal Injuries
PubMed: 38569734
DOI: 10.1136/bcr-2023-257233 -
Value in Health : the Journal of the... Mar 2024Pelvic organ prolapse is the descent of one or more reproductive organs from their normal position, causing associated negative symptoms. One conservative treatment...
OBJECTIVES
Pelvic organ prolapse is the descent of one or more reproductive organs from their normal position, causing associated negative symptoms. One conservative treatment option is pessary management. This study aimed to to investigate the cost-effectiveness of pessary self-management (SM) when compared with clinic-based care (CBC). A decision analytic model was developed to extend the economic evaluation.
METHODS
A randomized controlled trial with health economic evaluation. The SM group received a 30-minute SM teaching session, information leaflet, 2-week follow-up call, and a local helpline number. The CBC group received routine outpatient pessary appointments, determined by usual practice. The primary outcome for the cost-effectiveness analysis was incremental cost per quality-adjusted life year (QALY), 18 months post-randomization. Uncertainty was handled using nonparametric bootstrap analysis. In addition, a simple decision analytic model was developed using the trial data to extend the analysis over a 5-year period.
RESULTS
There was no significant difference in the mean number of QALYs gained between SM and CBC (1.241 vs 1.221), but mean cost was lower for SM (£578 vs £728). The incremental net benefit estimated at a willingness to pay of £20 000 per QALY gained was £564, with an 80.8% probability of cost-effectiveness. The modeling results were consistent with the trial analysis: the incremental net benefit was estimated as £4221, and the probability of SM being cost-effective at 5 years was 69.7%.
CONCLUSIONS
Results suggest that pessary SM is likely to be cost-effective. The decision analytic model suggests that this result is likely to persist over longer durations.
PubMed: 38492924
DOI: 10.1016/j.jval.2024.03.004 -
Clinics (Sao Paulo, Brazil) 2024Internal vaginal pessary is among the leading treatments for pelvic organ prolapse (POP); however, it has a high adverse event rate. An external pessary was recently... (Randomized Controlled Trial)
Randomized Controlled Trial
INTRODUCTION AND HYPOTHESIS
Internal vaginal pessary is among the leading treatments for pelvic organ prolapse (POP); however, it has a high adverse event rate. An external pessary was recently developed as an alternative. The study's objective was to compare the efficacy of external and internal pessaries in treating POP in postmenopausal women.
METHODS
This parallel randomized (1:1 ratio) open-blind study included 40 symptomatic women with stage 2 or 3 POP. They were randomized into two groups: group 1 (internal pessary) and group 2 (external pessary) (n = 20 in each); and evaluated at the start of and 3 months after the treatment. Statistical analysis was performed to compare the results within and between the groups before and after the 3-month treatment.
RESULTS
The groups were homogeneous, except for the variables previous pregnancies (p = 0.030) and POP-Q score of apical prolapse (p = 0.023) whose values were higher in group 2. A significant improvement in quality of life was observed in both groups after 3 months of follow-up; however, internal pessaries were found to be more effective (p < 0.001). In group 1 there were differences between the initial and final POP-Q scores of anterior (0.004) and apical prolapse (p = 0.005). The complication rate associated with internal pessary use was high (p = 0.044).
CONCLUSIONS
The present data suggested that external pessaries have a similar effect to internal ones for the treatment of POP and improvement of the quality of life of postmenopausal women.
Topics: Female; Humans; Middle Aged; Pelvic Organ Prolapse; Pessaries; Pilot Projects; Postmenopause; Quality of Life; Treatment Outcome; Aged
PubMed: 38484583
DOI: 10.1016/j.clinsp.2024.100335 -
Reproductive Biomedicine Online May 2024Is there a difference between the proportion of patients with serum progesterone <8.8 ng/ml on the day of embryo transfer when micronized vaginal progesterone (MVP) for...
RESEARCH QUESTION
Is there a difference between the proportion of patients with serum progesterone <8.8 ng/ml on the day of embryo transfer when micronized vaginal progesterone (MVP) for luteal phase support (LPS) is given as pessaries versus capsules?
DESIGN
This retrospective, matched-cohort, single-centre study compared pessaries (Cyclogest) versus capsules (Utrogestan, Progeffik) for LPS in hormone replacement treatment-embryo transfer (HRT-ET) cycles. Patients under 50 years old with a triple-layer endometrial thickness of ≥6.5 mm underwent transfer of one or two blastocysts. Serum progesterone concentrations were measured on the day of transfer; patients with concentrations <8.8 ng/ml received a single 'rescue' dose of additional progesterone by subcutaneous injection.
RESULTS
In total 2665 HRT-ET cycles were analysed; 663 (24.9%) used pessaries for LPS and 2002 (75.1%) used capsules. Mean serum progesterone concentrations with standard deviations on the day of embryo transfer were significantly higher in the group using MVP pessaries compared with those using capsules (14.5 ± 5.1 versus 13.0 ± 4.8 ng/ml; P = 0.000). The percentage of participants with suboptimal serum progesterone concentrations on the day of embryo transfer (<8.8 ng/ml) was significantly lower in the pessary group than the capsule group (10.3%, 95% confidence interval [CI] 7.9-12.6% versus 17.9%, 95% CI 16.2-19.6%; adjusted odds ratio 0.426, 95% CI 0.290-0.625; P = 0.000). No differences in pregnancy outcome were observed between the groups.
CONCLUSIONS
Using MVP pessaries rather than capsules for LPS resulted in significantly fewer patients having suboptimal serum progesterone concentrations on the day of embryo transfer. Consequently, almost 50% fewer patients in the pessary group needed rescue treatment.
Topics: Humans; Female; Progesterone; Retrospective Studies; Luteal Phase; Adult; Pregnancy; Administration, Intravaginal; Embryo Transfer; Pessaries; Pregnancy Rate; Capsules
PubMed: 38484430
DOI: 10.1016/j.rbmo.2023.103638 -
Journal of Family Medicine and Primary... Jan 2024Vaginal pH has been suggested to be one of the causative factors, responsible for variation in prostaglandin efficacy for induction of labour. The purpose of this study...
OBJECTIVE
Vaginal pH has been suggested to be one of the causative factors, responsible for variation in prostaglandin efficacy for induction of labour. The purpose of this study was to analyse the effect of vaginal douching with normal saline before insertion of dinoprostone vaginal insert for induction of labour.
METHODS
This randomised controlled study was done in the Department of Obstetrics and Gynaecology for a period of 1 year. Using a computer-generated random number table, subjects were allocated in two groups. In group A (study group), vaginal douching was done with 20 cc of sterile 0.9% NaCl and vaginal pH was again measured with pH paper strips just before inserting dinoprostone pessary. Dinoprostone pessary was inserted without douching in group B (control group).
RESULTS
There was a significant increase in the vaginal pH after douching with normal saline (4.91 vs 5.52, < 0.001). Mean intrinsic vaginal pH (pH before inserting dinoprostone insert) in women who delivered vaginally was significantly higher than that of the women who had a caesarean section (5.10 vs 4.63, < 0.001). Time interval between dinoprostone insertion to active phase of labour, duration of active phase of labour, time interval between dinoprostone insertion, and complete cervical dilatation and mode of delivery were not significantly different between the two groups.
CONCLUSION
Although douching with normal saline increases vaginal pH, douching does not help in increasing the chances of vaginal delivery because it gives a transient effect. Rather, it is intrinsic vaginal pH, which is a better decisive factor for successful vaginal delivery.
PubMed: 38482325
DOI: 10.4103/jfmpc.jfmpc_1108_23 -
Geburtshilfe Und Frauenheilkunde Mar 2024To compare three conservative treatment options, standard care, pelvic floor muscle training (PFMT), and vaginal pessaries, for postpartum urinary incontinence (UI) that...
INTRODUCTION
To compare three conservative treatment options, standard care, pelvic floor muscle training (PFMT), and vaginal pessaries, for postpartum urinary incontinence (UI) that are accessible to most patients and practitioners in a generalizable cohort.
MATERIALS AND METHODS
A multicenter, open-label, parallel group, pragmatic randomized controlled clinical trial comparing standard care, PFMT, and vaginal cube pessary for postpartum urinary incontinence was conducted in six outpatient clinics. Sample size was based on large treatment effects (Cramers' V > 0.35) with a power of 80% and an alpha of 0.05 for a 3 × 3 contingency table, 44 patients needed to be included in the trial. Outcomes were analyzed according to the intention-to-treat principle. Group comparisons were made using analysis of variance (ANOVA), Kruskal-Wallis, and chi-square test as appropriate. P < 0.05 was considered statistically significant.
RESULTS
Of the 516 women screened, 111 presented with postpartum UI. Of these, 52 were randomized to one of three treatment groups: standard care (n = 17), pelvic floor muscle training (n = 17), or vaginal cube pessary (n = 18). After 12 weeks of treatment, treatment success, as measured by patient satisfaction, was significantly higher in the vaginal pessary group (77.8%, n = 14/18), compared to the standard care group (41.2%, n = 7/17), and the PFMT (23.5%, n = 4/17; χ = 14.55; p = 0.006, Cramer-V = 0.374). No adverse events were reported. SUI and MUI accounted for 88.4% of postpartum UI.
CONCLUSION
Vaginal pessaries were superior to standard care or PFMT to satisfyingly reduce postpartum UI symptoms. No complications were found.
PubMed: 38455997
DOI: 10.1055/a-2243-3784 -
Urology Case Reports Mar 2024We present the case of a patient with pyelonephritis secondary to urinary tract obstruction caused by uterine prolapse. An 80-year-old woman with uterine prolapse...
We present the case of a patient with pyelonephritis secondary to urinary tract obstruction caused by uterine prolapse. An 80-year-old woman with uterine prolapse (pelvic organ prolapse stage 4) was treated with a pessary at an outside hospital due to her high perioperative risk. However, the pessary prolapsed. The patient developed pyelonephritis with hydronephrosis. A pessary was inserted to resolve the blockage of the urinary tract, antibiotic treatment was initiated, and the patient's condition improved. A total vaginal hysterectomy was ultimately performed. Challenges remain in the treatment of pelvic organ prolapse stage 4 for which a pessary cannot be used.
PubMed: 38444617
DOI: 10.1016/j.eucr.2024.102692 -
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 -
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 -
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