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Investigative and Clinical Urology Mar 2022We compared the degree of pelvic floor symptom improvement between pessary use and prolapse surgery.
PURPOSE
We compared the degree of pelvic floor symptom improvement between pessary use and prolapse surgery.
MATERIALS AND METHODS
Pessary-naïve women who elected prolapse surgery were enrolled and used a pessary preoperatively (for ≥7 days and ≤30 days). Pelvic floor symptoms were assessed at baseline, after pessary use, and at 3 months postoperatively. The primary outcome was concordance in the degree of symptoms improvement between pessary use and surgery, as assessed by Patient Global Impression of Improvement (PGI-I). Secondary outcomes were related to prolapse specific symptoms on validated questionnaires (POPDI-6, PFIQ-7). The McNemar test was used for comparisons of discordant pairs for comparisons of the PGI-I ratings after pessary use and surgery.
RESULTS
Sixty-one participants were enrolled (March 2016 through April 2019) and 58 patients used a pessary. Mean±standard deviation age was 60.7±10.7 years; 24.1% had prior hysterectomy, and 13.8% had prior prolapse surgery. While both treatments demonstrated symptomatic improvement, concordance in the degree of overall improvement on the PGI-I score was poor (n=40); responses significantly favored more improvement postoperatively (p<0.001). Pessary use and surgery were associated with significant improvements in prolapse symptoms from baseline on POPDI-6 (both p<0.001) and POPIQ-7 (pessary, p=0.002; surgery, p<0.001). The degree of improvement was larger postoperatively compared to post-pessary use on POPDI-6 (p<0.001) and PFIQ-7 (p=0.004).
CONCLUSIONS
Both pessary use and surgery significantly improved pelvic floor symptoms from baseline. However, concordance in degrees of improvement between these treatments was poor, with more favorable outcomes after surgery for prolapse symptoms.
Topics: Aged; Female; Humans; Middle Aged; Pelvic Floor; Pelvic Organ Prolapse; Pessaries; Prospective Studies
PubMed: 35244996
DOI: 10.4111/icu.20210395 -
International Urogynecology Journal Apr 2021Pessaries offer effective conservative management for symptoms of pelvic organ prolapse and are frequently used in the UK. Previous publications have highlighted a lack...
INTRODUCTION AND HYPOTHESIS
Pessaries offer effective conservative management for symptoms of pelvic organ prolapse and are frequently used in the UK. Previous publications have highlighted a lack of evidence-based pessary guidelines. There is also a dearth of evidence regarding who UK pessary practitioners are and the training received.
METHODS
A Freedom of Information request was sent to 167 healthcare organisations in the UK. Requested information included the number of pessaries inserted or changed, the grade and profession of pessary practitioners and training requirements at the organisation.
RESULTS
Responses were received from 128 organisations. One hundred and ten had provided information for practitioners managing pessaries. At 66% (72) of organisations, pessary care was provided by both doctors and nurses of varying grades. At 23% of organisations either solely doctors or solely nurses provided pessary care. At the remaining 9% there was a multidisciplinary approach to pessary care. At 3 hospitals, unregistered healthcare professionals provided pessary care. At the majority of organisations, respondents undertook supervised practise to gain skills in pessary management. Additional methods of training cited were learning through observation or achieving set competencies. Twenty-six percent received didactic training. At 21% of organisations there were no training requirements.
CONCLUSIONS
At most organisations, there was a multidisciplinary approach to pessary care. It is questionable whether unregistered healthcare professionals should be delegated responsibility for pessary care. A standardised approach to pessary practitioner training is advocated to ensure that women receive safe, evidence-based pessary care. The UK Clinical Guidance Group for the Use of Pessaries in Vaginal Prolapse is currently developing national evidence-based guidelines to support pessary practitioners in their practice, including training requirements.
Topics: Female; Humans; Pelvic Organ Prolapse; Pessaries; United Kingdom; Uterine Prolapse
PubMed: 32945903
DOI: 10.1007/s00192-020-04532-w -
The New England Journal of Medicine Aug 2016
Topics: Cervix Uteri; Female; Humans; Pessaries; Pregnancy; Premature Birth
PubMed: 27509120
DOI: 10.1056/NEJMc1605536 -
The New England Journal of Medicine Aug 2016
Topics: Cervix Uteri; Female; Humans; Pessaries; Pregnancy; Premature Birth
PubMed: 27509121
DOI: 10.1056/NEJMc1605536 -
Obstetrics and Gynecology Sep 2018To assess the effectiveness of cervical pessary in reducing the rate of preterm birth in women at high risk for preterm birth who did not deliver after an episode of... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
To assess the effectiveness of cervical pessary in reducing the rate of preterm birth in women at high risk for preterm birth who did not deliver after an episode of threatened preterm labor.
METHODS
In a multicenter open-label randomized controlled trial, a cervical pessary was compared with no intervention (control group) (one-to-one ratio). Women between 24 and 34 weeks of gestation at high risk for preterm birth based on a short cervical length (less than 15 mm) or an intermediate cervical length (between 15 and 30 mm) with a positive fetal fibronectin test who did not deliver after an episode of threatened preterm labor were eligible. The primary outcome was birth before 37 weeks of gestation. Secondary outcomes were a composite adverse neonatal outcome, preterm birth before 34 and 32 weeks of gestation, and side effects. A total sample size of 200 women carrying singletons was planned so as to have adequate statistical power to detect a reduction in the rate of preterm birth from 40% to 20%. Women with twin gestations were also enrolled but were considered only in secondary analyses. After a planned interim analysis, the trial was stopped for futility.
RESULTS
From November 2013 through September 2016, 130 women with a singleton pregnancy (65 pessary, 65 no treatment) were recruited. The groups had comparable baseline characteristics. In the cervical pessary group, 31 (48%) women delivered before 37 weeks of gestation compared with 25 (39%) in the no-treatment group (relative risk 1.2, 95% CI 0.83-1.8). Nine (15%) children in the cervical pessary group had the composite adverse perinatal outcome compared with eight (13%) in the control group (relative risk 1.2, 95% CI 0.49-2.9).
CONCLUSION
In women at high risk for preterm birth who did not deliver after an episode of threatened preterm labor, treatment with a cervical pessary is not effective.
CLINICAL TRIAL REGISTRATION
Netherlands Trial Register, NTR4210.
Topics: Adult; Female; Humans; Obstetric Labor, Premature; Pessaries; Pregnancy; Secondary Prevention; Young Adult
PubMed: 30095769
DOI: 10.1097/AOG.0000000000002798 -
Menopause (New York, N.Y.) Feb 2019
Topics: Estrogen Replacement Therapy; Estrogens; Female; Humans; Pelvic Organ Prolapse; Pessaries; Uterine Prolapse
PubMed: 30363013
DOI: 10.1097/GME.0000000000001256 -
BJOG : An International Journal of... May 2022
Topics: Humans; Pelvic Organ Prolapse; Pessaries; Prospective Studies; Surveys and Questionnaires
PubMed: 34845848
DOI: 10.1111/1471-0528.16997 -
Annual International Conference of the... Jul 2023This study proposed a novel design and personalized approach to developing an intra-vaginal device, also known as a pessary, for the treatment of Pelvic Organ Prolapse...
This study proposed a novel design and personalized approach to developing an intra-vaginal device, also known as a pessary, for the treatment of Pelvic Organ Prolapse (POP). Although POP is likely to have a more diverse dynamic than other health conditions in women, it is currently treated as a "one-shape-fits-all" problem in all cases. Pessaries are conservative devices inserted into the vagina to support its internal structure and predominantly come in a ring shape design. Failure rates as high as 50% within the first year of use have been attributed to the poor design of these pessaries; with symptoms such as irritation, bleeding, and lacerations felt by most users. To address this problem, a new base shape design was proposed and its deformation was examined using Finite Element Analysis (FEA). Based on the anatomical measurements of each patient, the base design can be adjusted accordingly. To demonstrate the effectiveness of the proposed design, a comparative study was conducted with the most commonly used support pessary, also known as the ring pessary. In order to model the large deformation of the pessaries, the hyperelastic constitutive law (Yeoh model) was fitted to the available stress-strain data of SIL 30 (a silicone urethane resin supplied by Carbon Inc.). The results showed that re-directing the reaction forces of the pessary towards the lateral walls, supported by the pelvic bones, could decrease the overall displacement of the pessaries, and provide effective symptomatic relief thereby, delaying or preventing surgical procedures.Clinical relevance- There is a clear clinical need to develop a more effective conservative therapy for managing POP. The personalized pessaries proposed in this paper can be an effective method for providing symptomatic relief and avoiding displacement, compared to the currently available devices on the market. Made-to-measure for each patient, the devices are anatomically suited and can be adjusted throughout a patient's treatment plan to allow for higher compliance and overall success rate.
Topics: Female; Humans; Pessaries; Pelvic Organ Prolapse; Vagina; Pelvis; Severity of Illness Index
PubMed: 38083613
DOI: 10.1109/EMBC40787.2023.10340082 -
The Cochrane Database of Systematic... Nov 2020Pelvic organ prolapse is a common problem in women. About 40% of women will experience prolapse in their lifetime, with the proportion expected to rise in line with an...
BACKGROUND
Pelvic organ prolapse is a common problem in women. About 40% of women will experience prolapse in their lifetime, with the proportion expected to rise in line with an ageing population. Women experience a variety of troublesome symptoms as a consequence of prolapse, including a feeling of 'something coming down' into the vagina, pain, urinary symptoms, bowel symptoms and sexual difficulties. Treatment for prolapse includes surgery, pelvic floor muscle training (PFMT) and vaginal pessaries. Vaginal pessaries are passive mechanical devices designed to support the vagina and hold the prolapsed organs back in the anatomically correct position. The most commonly used pessaries are made from polyvinyl-chloride, polythene, silicone or latex. Pessaries are frequently used by clinicians with high numbers of clinicians offering a pessary as first-line treatment for prolapse. This is an update of a Cochrane Review first published in 2003 and last published in 2013.
OBJECTIVES
To assess the effects of pessaries (mechanical devices) for managing pelvic organ prolapse in women; and summarise the principal findings of relevant economic evaluations of this intervention.
SEARCH METHODS
We searched the Cochrane Incontinence Specialised Register which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings (searched 28 January 2020). We searched the reference lists of relevant articles and contacted the authors of included studies.
SELECTION CRITERIA
We included randomised and quasi-randomised controlled trials which included a pessary for pelvic organ prolapse in at least one arm of the study.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed abstracts, extracted data, assessed risk of bias and carried out GRADE assessments with arbitration from a third review author if necessary.
MAIN RESULTS
We included four studies involving a total of 478 women with various stages of prolapse, all of which took place in high-income countries. In one trial, only six of the 113 recruited women consented to random assignment to an intervention and no data are available for those six women. We could not perform any meta-analysis because each of the trials addressed a different comparison. None of the trials reported data about perceived resolution of prolapse symptoms or about psychological outcome measures. All studies reported data about perceived improvement of prolapse symptoms. Generally, the trials were at high risk of performance bias, due to lack of blinding, and low risk of selection bias. We downgraded the certainty of evidence for imprecision resulting from the low numbers of women participating in the trials. Pessary versus no treatment: at 12 months' follow-up, we are uncertain about the effect of pessaries compared with no treatment on perceived improvement of prolapse symptoms (mean difference (MD) in questionnaire scores -0.03, 95% confidence interval (CI) -0.61 to 0.55; 27 women; 1 study; very low-certainty evidence), and cure or improvement of sexual problems (MD -0.29, 95% CI -1.67 to 1.09; 27 women; 1 study; very low-certainty evidence). In this comparison we did not find any evidence relating to prolapse-specific quality of life or to the number of women experiencing adverse events (abnormal vaginal bleeding or de novo voiding difficulty). Pessary versus pelvic floor muscle training (PFMT): at 12 months' follow-up, we are uncertain if there is a difference between pessaries and PFMT in terms of women's perceived improvement in prolapse symptoms (MD -9.60, 95% CI -22.53 to 3.33; 137 women; low-certainty evidence), prolapse-specific quality of life (MD -3.30, 95% CI -8.70 to 15.30; 1 study; 116 women; low-certainty evidence), or cure or improvement of sexual problems (MD -2.30, 95% -5.20 to 0.60; 1 study; 48 women; low-certainty evidence). Pessaries may result in a large increase in risk of adverse events compared with PFMT (RR 75.25, 95% CI 4.70 to 1205.45; 1 study; 97 women; low-certainty evidence). Adverse events included increased vaginal discharge, and/or increased urinary incontinence and/or erosion or irritation of the vaginal walls. Pessary plus PFMT versus PFMT alone: at 12 months' follow-up, pessary plus PFMT probably leads to more women perceiving improvement in their prolapse symptoms compared with PFMT alone (RR 2.15, 95% CI 1.58 to 2.94; 1 study; 260 women; moderate-certainty evidence). At 12 months' follow-up, pessary plus PFMT probably improves women's prolapse-specific quality of life compared with PFMT alone (median (interquartile range (IQR)) POPIQ score: pessary plus PFMT 0.3 (0 to 22.2); 132 women; PFMT only 8.9 (0 to 64.9); 128 women; P = 0.02; moderate-certainty evidence). Pessary plus PFMT may slightly increase the risk of abnormal vaginal bleeding compared with PFMT alone (RR 2.18, 95% CI 0.69 to 6.91; 1 study; 260 women; low-certainty evidence). The evidence is uncertain if pessary plus PFMT has any effect on the risk of de novo voiding difficulty compared with PFMT alone (RR 1.32, 95% CI 0.54 to 3.19; 1 study; 189 women; low-certainty evidence).
AUTHORS' CONCLUSIONS
We are uncertain if pessaries improve pelvic organ prolapse symptoms for women compared with no treatment or PFMT but pessaries in addition to PFMT probably improve women's pelvic organ prolapse symptoms and prolapse-specific quality of life. However, there may be an increased risk of adverse events with pessaries compared to PFMT. Future trials should recruit adequate numbers of women and measure clinically important outcomes such as prolapse specific quality of life and resolution of prolapse symptoms. The review found two relevant economic evaluations. Of these, one assessed the cost-effectiveness of pessary treatment, expectant management and surgical procedures, and the other compared pessary treatment to PFMT.
Topics: Bias; Female; Humans; Muscle Strength; Pelvic Floor; Pelvic Organ Prolapse; Pessaries; Randomized Controlled Trials as Topic; Rectal Prolapse; Urethral Diseases; Urinary Bladder Diseases; Uterine Prolapse
PubMed: 33207004
DOI: 10.1002/14651858.CD004010.pub4 -
Journal of the American Geriatrics... Sep 2021To present a flexible protocol of vaginal pessaries for older women with significant pelvic organ prolapse (POP).
OBJECTIVES
To present a flexible protocol of vaginal pessaries for older women with significant pelvic organ prolapse (POP).
DESIGN
A prospective cohort study of 140 consecutive older women (aged ≥65 years) with significant POP treated with individually fitted vaginal pessaries. After initial insertion, each patient was invited for a first evaluation after 1 month and subsequent follow-ups at increasing intervals of 1 month. During each examination, the pessary was removed and the vagina was inspected for infection, bleeding, or erosions. All patients were advised to use a vaginal estrogen cream twice a week.
SETTING
The study was conducted during 2020 in the urogynecology clinic of a tertiary medical center.
PARTICIPANTS
The study cohort included 140 consecutive older women with significant and symptomatic POP treated with vaginal pessaries.
MAIN OUTCOME
Primary outcomes included time intervals between follow-up visits, pessary-associated complications, need to change the pessary, need to remove the pessary temporarily, and whether the patients eventually underwent POP surgery.
RESULTS
The mean age of the patients at the time of pessary fitting was 76.7 ± 9.2 years (range 65-100 years). Mean interval between follow-up examinations was 3.3 ± 1.1 months (range 1-6 months). Most patients (83.6%) used a ring pessary with support, but only a small number of patients were able to maintain the pessary by themselves. Of the 140 patients, five (3.6%) patients only eventually underwent POP surgery, and in 11 (7.9%) patients, the vaginal pessary had to be removed for 2-4 weeks because of significant vaginal discharge or superficial erosions. Additionally, 12 (8.6%) patients developed stress urinary incontinence following pessary insertion.
CONCLUSIONS
Customized management with vaginal pessary for symptomatic POP in older women is effective and safe, and is a suitable therapeutic alternative for older women who are unable or unwilling to undergo reconstructive pelvic surgery.
Topics: Aged; Aged, 80 and over; Clinical Protocols; Equipment Design; Female; Humans; Pelvic Organ Prolapse; Pessaries; Prospective Studies; Vagina
PubMed: 33979457
DOI: 10.1111/jgs.17223