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  1. Ramanujam S, Balakrishnan S
    Med J Malaysia, 2023 Nov;78(6):705-710.
    PMID: 38031210
    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.

    Matched MeSH terms: Pessaries*
  2. Thangatorai R, Lim FC, Nalliah S
    J Matern Fetal Neonatal Med, 2018 Jun;31(12):1638-1645.
    PMID: 28412851 DOI: 10.1080/14767058.2017.1319930
    BACKGROUND: Preterm births occur frequently in multiple pregnancies with a short cervix. The cervical pessary is a potential intervention for prevention of preterm births.

    OBJECTIVE: To assess the effectiveness of cervical pessary in the prevention of preterm births in multiple pregnancies with a short cervix (<25 mm).

    SEARCH STRATEGY: Major databases from 2006 to 20th November 2016 were searched for relevant terms.

    SELECTION CRITERIA: We included randomized controlled trials that assessed the effectiveness of cervical pessary on pregnancy outcomes in multiple pregnancies with a short cervix.

    DATA COLLECTION AND ANALYSIS: Risk ratio was used as the summary measure with random effects model. We assessed heterogeneity between studies using the I2 index. Quality assessment was done based on Cochrane Handbook Method.

    MAIN RESULTS: Pooled data showed no benefit of using cervical pessary in the prevention of preterm births, birth weights less than 1500 g, less than 2500 g, adverse neonatal events and fetal/neonatal deaths in twin pregnancies with a short cervix.

    CONCLUSION: We are unable to show benefit of using cervical pessary in preventing preterm births in twin pregnancies with a short cervix. However, as cervical pessary is a reasonable intervention, there is a need for more randomized controlled trials in this area.

    Matched MeSH terms: Pessaries*
  3. Lim BK, Collaris RR
    J Obstet Gynaecol Res, 2008 Jun;34(3):436-8.
    PMID: 18588622 DOI: 10.1111/j.1447-0756.2008.00786.x
    A 62-year old para 4 with a history of a radical hysterectomy followed by radiotherapy for endometrial carcinoma was seen shortly after insertion of a pessary for a total vault prolapse. On follow-up the pessary couldn't be retrieved. An abdominal X-ray revealed the pessary in the abdominal cavity and it had to be removed by means of a laparotomy. Fistula and defects have been reported both in longstanding pessary use and as long-term complication in radical surgery with radiotherapy. In view of potential - though rare - serious complications, adequate follow-up in pessary use is therefore mandatory. Adequate diagnostic investigations are essential in deciding on an appropriate approach for rare cases like these.
    Matched MeSH terms: Pessaries*
  4. Rahman RA, Atan IK, Ali A, Kalok AM, Ismail NAM, Mahdy ZA, et al.
    BMC Pregnancy Childbirth, 2021 May 10;21(1):368.
    PMID: 33971828 DOI: 10.1186/s12884-021-03838-x
    BACKGROUND: Spontaneous preterm birth is a global issue that contributed to perinatal morbidities and mortalities worldwide. The study aimed to describe the experience at UKM Medical Center in managing women at high risk for spontaneous preterm birth using the Arabin pessary.

    METHODS: This is a retrospective observational study involving 58 pregnancies from 1st January 2013 to 31st December 2019. Inclusion criteria were previous mid-trimester miscarriage and/or preterm birth, previous cervical surgery or short cervical length on routine sonogram. The demographic data, characteristics of each pregnancy and details of outcomes and management were described.

    RESULTS: The majority of women were Malay with mean age and body mass index of 32.9 ± 4.2 years and 27.1 ± 6.3 kg/m2 respectively. The most frequent indications for Arabin pessary insertion were previous mid-trimester miscarriage (46.4%) and early preterm birth (17.2%). A total of 73.4% of these women had the pessary inserted electively at a mean cervical length of 31.6 ± 9.1 mm at median gestation of 15.0 weeks. They were managed as outpatient (56.9%), inpatient (24.1%) or mixed (19.0%) with combination of progestogen (81.0%) and 53.4% received antenatal corticosteroids. Spontaneous preterm birth at or more than 34 weeks gestation occurred in 74.1% with birthweight at or more than 2000 g (82.4%). Despite cervical funneling in 12 women (20.7%), 66.7% delivered at or later than 34 weeks gestation and 2 (16.7%) resulted in miscarriage.

    CONCLUSIONS: Insertion of the Arabin pessary is beneficial to prevent spontaneous preterm birth in pregnant women who are at high risk. In particular, early insertion and close monitoring allows the best possible outcomes.

    TRIAL REGISTRATION: This study was retrospectively registered with ClinicalTrials.gov ( NCT04638023 ) on 20/11/2020.

    Matched MeSH terms: Pessaries/statistics & numerical data*
  5. Tan PC, Valiapan SD, Tay PY, Omar SZ
    BJOG, 2007 Jul;114(7):824-32.
    PMID: 17506788
    To compare concurrent oxytocin with dinoprostone pessary versus dinoprostone pessary in labour induction for nulliparas with an unfavourable cervix.
    Matched MeSH terms: Pessaries
  6. Grace Ng YH, Aminuddin AA, Tan TL, Kuppusamy R, Tagore S, Yeo GSH
    Arch Gynecol Obstet, 2021 May 11.
    PMID: 33973051 DOI: 10.1007/s00404-021-06090-y
    OBJECTIVE: To evaluate the safety in the first 12 h, efficacy and maternal satisfaction of a double balloon catheter (DBC) with vaginal prostaglandin (PGE) for induction of labour (IOL).

    METHODS: We conducted a multicentre randomised controlled study of 420 patients from 1st January 2016 to 31st December 2017 to evaluate the use of DBC in IOL in an Asian population looking at the adverse effects in the first 12 h after insertion. Women were assigned randomly to cervical ripening with either a DBC or a prostaglandin pessary. The adverse events in the 12 h after DBC or first prostaglandin inserted, the efficacy of a DBC to a prostaglandin in labour induction and maternal satisfaction were evaluated.

    RESULTS: There were significantly less women with uterine hyperstimulation in the DBC (2 vs 24, p ≤ 0.0001) compared to the prostaglandin group. There were no women with uterine hyperstimulation and non-reassuring foetal status in the DBC while there were 5 women with uterine hyperstimulation and foetal distress in the prostaglandin group. Use of entonox was significantly less in the DBC group (p = 0.009). There were no significant differences in both groups in caesarean section, vaginal deliveries and time to delivery, although significant less time was needed to achieve cervical os dilation more than 4 cm in the DBC group (p ≤ 0.0001). Neonatal birth outcomes were similar. Women's pain scores were similar for both methods. 80.1% of women allocated the DBC and 76.8% of women allocated the PGE were keen to recommend their method of induction.

    CONCLUSION: Double balloon catheter remains a good alternative method for inducing women in view of a good safety profile with low risk of hyperstimulation and high maternal satisfaction.

    CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02620215.

    Matched MeSH terms: Pessaries
  7. Lo TS, Jaili S, Uy-Patrimonio MC, Karim NB, Ibrahim R
    J Obstet Gynaecol Res, 2017 Mar;43(3):543-550.
    PMID: 28160508 DOI: 10.1111/jog.13234
    AIM: The aim of this study was to evaluate the management outcomes of advanced pelvic organ prolapse (POP) in nulliparous women.

    METHODS: Eight nulliparous women diagnosed with POP ≥ stage 3 between January 2005 and August 2013, according to the Pelvic Organ Quantification System (POPQ), were reviewed. Seven were managed surgically and one was managed with pessary. Primary outcome was surgical objective cure (POP-Q ≤ 1) and subjective cure, defined as negative response to questions 2 and 3 on Pelvic Organ Prolapse Distress Inventory 6. Secondary outcomes were complications, symptoms' severity and quality of life according to validated questionnaires.

    RESULTS: A total of 1275 prolapse patients with POP-Q ≥ stage 3 were managed surgically, among whom seven (0.55%) were nulliparous. Each woman had at least one risk factor associated with POP. Risk factors identified were history of pelvic trauma, obesity, menopause, chronic cough, hard physical labor and constipation. Five patients underwent surgical correction (vaginal hysterectomy with sacrospinous fixation) with mesh (Perigee, n = 3; Avaulta, n = 2). Two patients had uterine preservation without mesh (hysteropexy with sacrospinous ligament fixation). One patient preferred treatment with pessary. The total cure rate (objective and subjective cure rates) was 86% after surgical reconstructive surgery.

    CONCLUSION: Management of nulliparous advanced POP poses significant challenges with regard to uterine preservation, future pregnancy and childbirth. Conservative management with pessary insertion should be offered followed by surgical correction. Reconstructive surgery with mesh may improve prolapse symptoms objectively and subjectively.

    Matched MeSH terms: Pessaries
  8. Jibril AH, Norlelawati Ab Latip, Ng, PY, Jegasothy, R
    MyJurnal
    De novo stress urinary incontinence (SUI) may occur in up to 80% of clinically continent women following genitourinary prolapse surgery. This had resulted in an increase in the rate of concurrent continence surgery during prolapse repair from 38% in 2001 to 47% in 2009 in the United States. To date, there is no local data available to estimate the prevalence of occult SUI (OSUI) among Malaysian women awaiting surgery. Therefore, this study was conducted to elicit the prevalence of occult SUI and its associated risks factors in patients awaiting prolapse surgery. We retrospectively studied the records of 296 consecutive women with significant pelvic organ prolapse awaiting reconstructive repair. All patients attended the Urogynaecology Unit in Hospital Kuala Lumpur Malaysia between October 2007 and September 2011. They had undergone standardized interviews, clinical examinations and urodynamic studies. During the urodynamic testings, all prolapses were reduced using ring pessaries to elicit OSUI. Primary outcome was the prevalence of OSUI with prolapse reduction to predict possibility of developing de novo SUI following prolapse surgery. Secondary outcome was the assessment of potential risk factors for OSUI. Among the 296 women studied, 121 (40.9%) were found to have OSUI. The risk factors associated with OSUI included age, BMI, numbers of SVD, recurrent UTI, reduction of urinary flow symptoms and grade 2 to 4 central compartment prolapses. We concluded that preoperative urodynamic testing with reduction of prolapse is useful to identify women with OSUI. This is important for preoperative counselling as well as planning for one step approach of prophylactic concomitant anti-incontinence procedures during prolapse surgery in order to avoid postoperative de novo SUI.
    Matched MeSH terms: Pessaries
  9. Tan PC, Daud SA, Omar SZ
    Obstet Gynecol, 2009 May;113(5):1059-1065.
    PMID: 19384121 DOI: 10.1097/AOG.0b013e3181a1f605
    OBJECTIVE: : To estimate the effect of concurrent vaginal dinoprostone and oxytocin infusion against oxytocin infusion for labor induction in premature rupture of membranes (PROM) on vaginal delivery within 12 hours and patient satisfaction.

    METHODS: : Nulliparas with uncomplicated PROM at term, a Bishop score less than or equal to 6, and who required labor induction were recruited for a double-blind randomized trial. Participants were randomly assigned to 3-mg dinoprostone pessary and oxytocin infusion or placebo and oxytocin infusion. A cardiotocogram was performed before induction and maintained to delivery. Dinoprostone pessary or placebo was placed in the posterior vaginal fornix. Oxytocin intravenous infusion was commenced at 2 milliunits/min and doubled every 30 minutes to a maximum of 32 milliunits/min. Oxytocin infusion rate was titrated to achieve four contractions every 10 minutes. Primary outcomes were vaginal delivery within 12 hours and maternal satisfaction with the birth process using a visual analog scale (VAS) from 0 to 10 (higher score, greater satisfaction).

    RESULTS: : One hundred fourteen women were available for analysis. Vaginal delivery rates within 12 hours were 25 of 57 (43.9%) for concurrent treatment compared with 27/57 (47.4%) (relative risk 0.9, 95% confidence interval 0.6-1.4, P=.85) for oxytocin only; median VAS was 8 (interquartile range [IQR] 2) compared with 8 (IQR 2), P=.38. Uterine hyperstimulation was 14% compared with 5.3%, P=.20; overall vaginal delivery rates were 59.6% compared with 64.9%, P=.70; and induction to vaginal delivery interval 9.7 hours compared with 9.4 hours P=.75 for concurrent treatment compared with oxytocin, respectively. There was no significant difference for any other outcome.

    CONCLUSION: : Concurrent vaginal dinoprostone and intravenous oxytocin for labor induction of term PROM did not expedite delivery or improve patient satisfaction.

    CLINICAL TRIAL REGISTRATION: : Current Controlled Trials, www.controlled-trials.com, ISRCTN74376345

    LEVEL OF EVIDENCE: : I.

    Matched MeSH terms: Pessaries
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