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Clinical Obstetrics and Gynecology Sep 2014Preterm birth remains a considerable public health concern and priority. Little headway has been made in the prevention of preterm birth despite considerable research in... (Review)
Review
Preterm birth remains a considerable public health concern and priority. Little headway has been made in the prevention of preterm birth despite considerable research in this area. New ideas and treatments are desperately needed. The pessary has emerged as a possible treatment for the prevention of preterm birth in both singleton and twin gestations. It appears to be low cost with minimal side effects. This review focuses on the available evidence for the use of cervical pessaries for the prevention of preterm birth, especially in a high-risk population with a shortened cervical length. Larger scale randomized-controlled trials are warranted before incorporation of the pessary into standard obstetrical practice.
Topics: Cervical Length Measurement; Cervix Uteri; Female; Humans; Pessaries; Pregnancy; Pregnancy, High-Risk; Pregnancy, Multiple; Premature Birth
PubMed: 24918776
DOI: 10.1097/GRF.0000000000000036 -
Journal de Gynecologie, Obstetrique Et... Dec 2016To determine the efficacy of the cervical pessary for the prevention of preterm delivery and to propose recommendations. (Review)
Review
OBJECTIVES
To determine the efficacy of the cervical pessary for the prevention of preterm delivery and to propose recommendations.
MATERIALS AND METHOD
We searched the MedLine and the Cochrane Library and checked the international guidelines: ACOG and SOGC.
RESULTS
The data concerning the efficacy of the cervical pessary for the prevention of preterm birth in a population of asymptomatic women with a singleton pregnancy with a short cervix≤25mm between 20 and 24 weeks 6 days of gestation and in a population of asymptomatic women with a twin pregnancy at high risk of preterm delivery defined by a short cervix are contradictory. More studies are necessary to recommend its use in these indications (Professional consensus). A cervical pessary placed before 22 weeks of gestation does not reduce the risk of preterm birth in the general population of asymptomatic women with a twin pregnancy (EL1). It is therefore not recommended to use the cervical pessary in order to prevent preterm delivery in the general population of asymptomatic women with a twin pregnancy (grade A).
CONCLUSION
More studies are necessary to recommend the use of the cervical pesssary in singleton and in twin pregnancies with a short cervix.
Topics: Cervix Uteri; Female; Humans; Pessaries; Pregnancy; Pregnancy, Twin; Premature Birth
PubMed: 27836378
DOI: 10.1016/j.jgyn.2016.09.010 -
Journal of Obstetrics and Gynaecology... Jul 2013This document has been archived because it contains outdated information. It should not be consulted for clinical use, but for historical research only. Please visit the... (Review)
Review
This document has been archived because it contains outdated information. It should not be consulted for clinical use, but for historical research only. Please visit the journal website for the most recent guidelines.
Topics: Canada; Female; Humans; Patient Satisfaction; Pelvic Organ Prolapse; Pessaries; Randomized Controlled Trials as Topic; Treatment Outcome; Urinary Incontinence; Vaginal Discharge
PubMed: 23876646
DOI: 10.1016/S1701-2163(15)30888-4 -
International Urogynecology Journal Feb 2022Vaginal support pessaries are intravaginal devices designed to relieve symptoms of pelvic organ prolapse, but they can cause serious medical complications if not managed... (Review)
Review
INTRODUCTION AND HYPOTHESIS
Vaginal support pessaries are intravaginal devices designed to relieve symptoms of pelvic organ prolapse, but they can cause serious medical complications if not managed well. Physiotherapists are well placed to manage pessaries, but there are no guidelines on the training required for competency in pessary management (PM).
METHODS
A scoping review of current literature on PM training was conducted to develop draft competency standards, which were reviewed by a multidisciplinary focus group. Using e-Delphi methodology, a multidisciplinary and multinational expert panel then refined the standards. Three rounds of e-Delphi online surveys were conducted, with individual participant feedback and one videoconference to discuss items that did not reach consensus. Consensus was set at 80% agreement and stability measured using kappa coefficient.
RESULTS
Pessary training competency standards, developed by 29 experts, covered three key domains including: (1) prerequisite knowledge and understanding; (2) entrustable professional activities; (3) pessary-specific standards under ten key roles. Consensus was reached on all 73 (100%) competency standards and stability demonstrated for 95.9% of standards. There was no attrition of expert panel participants through the e-Delphi rounds.
CONCLUSIONS
This e-Delphi study provides the first, robust recommendations on training standards for physiotherapists in PM. These competency standards will provide clinicians with a self-assessment tool, and educators and training institutions with a benchmark in training for PM, which should improve options and reduce risk for women with prolapse being managed with a pessary.
Topics: Consensus; Delphi Technique; Female; Humans; Pelvic Organ Prolapse; Pessaries; Physical Therapy Modalities
PubMed: 34089340
DOI: 10.1007/s00192-021-04843-6 -
International Urogynecology Journal Aug 2023Patients with vaginal pessaries can learn to care for their pessary by themselves or they can have provider-led care, which requires more frequent follow-up visits. We...
INTRODUCTION AND HYPOTHESIS
Patients with vaginal pessaries can learn to care for their pessary by themselves or they can have provider-led care, which requires more frequent follow-up visits. We aimed to understand motivations for and barriers to learning self-care of a pessary to inform strategies to promote pessary self-care.
METHODS
In this qualitative study, we recruited patients recently fitted with a pessary for stress incontinence or pelvic organ prolapse, and providers who perform pessary fittings. Semi-structured, one-on-one interviews were completed to data saturation. A constructivist approach to thematic analysis using the constant comparison method was used to analyze interviews. A coding frame was created following independent review of a subset of interviews by three members of the research team and this frame was used to code interviews and develop themes through interpretive engagement with the data.
RESULTS
Ten pessary users and four health care providers (physicians and nurses) participated. Three major themes were identified: motivators, benefits, and barriers. There were several motivators for learning self-care, including care provider advice, personal hygiene, and ease of care. Benefits of learning self-care included autonomy, convenience, facilitation of sexual relations, avoidance of complications, and decreased burden on the health care system. Barriers to self-care included physical, structural, mental, and emotional barriers; lack of knowledge; lack of time; and social taboo.
CONCLUSIONS
Promotion of pessary self-care should focus on patient education about benefits and ways of mitigating common barriers while focusing on normalizing patient engagement in pessary self-care.
Topics: Humans; Female; Pessaries; Self Care; Pelvic Organ Prolapse; Urinary Incontinence, Stress; Attitude
PubMed: 36795110
DOI: 10.1007/s00192-023-05472-x -
Journal of Obstetrics and Gynaecology... Feb 2021To review the use, care, and fitting of pessaries.
OBJECTIVE
To review the use, care, and fitting of pessaries.
TARGET POPULATION
Women requiring the use of vaginal pessaries for pelvic organ prolapse and/or stress urinary incontinence. Use may also be indicated for women with certain pregnancy-related clinical scenarios, including incarcerated uterus.
OPTIONS
Pessaries are an option for women presenting with prolapse and/or stress urinary incontinence. In addition, certain types of pessaries can be considered for patients with cervical insufficiency or incarcerated uterus.
OUTCOMES
Most women with prolapse or stress urinary incontinence can be successfully fitted with a pessary and experience excellent symptom relief, high satisfaction rates, and minimal complications.
BENEFITS, HARMS, AND COSTS
Women with pelvic organ prolapse and/or stress urinary incontinence may choose to use a pessary to manage their symptoms rather than surgery or while waiting for surgery. Major complications have been seen only when pessaries are neglected. Minor complications such as vaginal discharge, odour, and erosions can usually be successfully treated.
EVIDENCE
Medline was searched for relevant articles up to December 2018. This is an update of the SOGC technical update published in 2013, which was the first internationally published guidance on pessary use. Subsequently, an Australian guideline on the use of pessaries for the treatment of prolapse was published later in 2013.
VALIDATION METHODS
The authors rated the quality of evidence and strength of recommendations using the approach of the Canadian Task Force on Preventive Health Care (Appendix A).
INTENDED AUDIENCE
Gynaecologists, obstetricians, family physicians, physiotherapists, residents, and fellows.
SUMMARY STATEMENTS
RECOMMENDATION.
Topics: Canada; Female; Humans; Pelvic Organ Prolapse; Pessaries; Societies, Medical; Urinary Incontinence, Stress
PubMed: 33248302
DOI: 10.1016/j.jogc.2020.11.013 -
International Journal of Gynaecology... May 2024Findings from randomized trials (RCTs) on cervical pessary treatment to prevent spontaneous preterm birth are inconsistent. (Review)
Review
Cervical pessary to prevent preterm birth and poor neonatal outcome: An integrity meta-analysis of randomized controlled trials focusing on adherence to the European Medical Device Regulation.
BACKGROUND
Findings from randomized trials (RCTs) on cervical pessary treatment to prevent spontaneous preterm birth are inconsistent.
OBJECTIVES
Our hypothesis suggests that adhering to the European Medical Device Regulation (MDR) and following the instructions for use are essential prerequisites for successful therapy. Conversely, the non-adherence to these guidelines will probably contribute to its failure.
SEARCH STRATEGY AND SELECTION CRITERIA
Based on validated criteria from integrity assessments we performed a systematic review identifying 14 RCTs evaluating the effect of cervical pessaries.
DATA COLLECTION AND ANALYSIS
We analyzed the implications of 14 criteria each accounting for 0-2 points of a score reflecting the clinical evaluation plan (CEP) as proposed by the MDR to evaluate the risk-benefit ratio of medical devices.
MAIN RESULTS
Seven RCTs in each singleton and twin pregnancies (5193 "cases") were included, detecting a high heterogeneity within control groups (I = 85% and 87%, respectively, P < 0.01). The CEP score varied from 11 to 26 points for all studies. The most common reasons for low scores and potential data compromise were poor recruitment rates, no (completed) power analysis, and no pre-registration, but mainly non-adherence to technical, biological, and clinical equivalence to the instructions for use as required by the MDR. All trials with score values greater than 20 had applied audit procedures. Within this group we found significantly reduced rates of spontaneous preterm birth at less than 34 weeks within the pessary group in singleton (odds ratio 0.28; 95% confidence interval 0.12-0.65) and twin pregnancies (odds ratio 0.30; 95% confidence interval 0.13-0.67). Similarly, there was a significant reduction in the composite poor neonatal outcome in singleton (odds ratio 0.25; 95% confidence interval 0.10-0.61) and twin pregnancies (odds ratio 0.54; 95% confidence interval 0.35-0.82) after a pessary as compared with controls.
CONCLUSION
Non-audited RCTs and meta-analyses mixing studies of different clinical quality as pre-defined by a CEP and the MDR pose the risk for erroneous conclusions.
Topics: Pregnancy; Infant, Newborn; Female; Humans; Premature Birth; Pessaries; Medical Device Legislation; Randomized Controlled Trials as Topic; Cervix Uteri; Pregnancy, Twin
PubMed: 37830250
DOI: 10.1002/ijgo.15169 -
International Urogynecology Journal May 2019To (1) determine the proportion of hysterectomy cases with documentation of pessary counseling prior to prolapse surgery and (2) identify variables associated with women...
OBJECTIVES
To (1) determine the proportion of hysterectomy cases with documentation of pessary counseling prior to prolapse surgery and (2) identify variables associated with women offered a pessary.
STUDY DESIGN
The Michigan Surgical Quality Collaborative (MSQC) is a hysterectomy improvement initiative. Hysterectomies from 2013 to 2015 in which prolapse was the principal diagnosis were included. "Pessary offer" was defined as documentation showing the patient declined, could not tolerate, or failed a pessary trial. Bivariate analyses were used to compare demographics, medical history, surgical route, concomitant procedures (colpopexy or colporrhaphy), and intra- and postoperative complications between women with and without pessary offer. Hierarchical logistic regression was used to determine factors independently associated with pessary offer. Risk-adjusted pessary offer rates by hospital were calculated.
RESULTS
The adjusted rate of pessary offer was 25.2%, ranging from 3 to 76% per hospital. Bivariate comparisons showed differences between women with and without pessary offer in age, tobacco use, prior pelvic surgery, insurance status, surgical approach, secondary indication for surgery, concomitant prolapse procedure, teaching hospital status and hospital bed size. In logistic regression, odds of pessary offer increased with age > 55 years (OR 1.45, 95% CI 1.12-1.88, p = 0.006), Medicare insurance (OR 1.65, 95% CI 1.30-2.10, p < 0.0001), and a concomitant procedure (OR 1.5, 95% CI 1.16-1.93, p = 0.002). Postoperative urinary tract infections were more common in patients offered a pessary (6.4% vs. 2.5%, p < 0.0001), but other complications were similar.
CONCLUSIONS
Overall, only one-quarter of hysterectomies for prolapse in MSQC hospitals had documentation of pessary counseling-suggesting an opportunity to improve documentation, counseling regarding pessary use, or both.
Topics: Aged; Case-Control Studies; Conservative Treatment; Female; Humans; Hysterectomy; Middle Aged; Pelvic Organ Prolapse; Pessaries; Postoperative Complications; Preoperative Care; Quality Improvement; Retrospective Studies; Urinary Tract Infections
PubMed: 29934768
DOI: 10.1007/s00192-018-3696-1 -
JAMA Dec 2017
Topics: Cervix Uteri; Female; Humans; Infant, Newborn; Pessaries; Pregnancy; Premature Birth
PubMed: 29260206
DOI: 10.1001/jama.2017.18955 -
Urologic Nursing 2012In this final article in a series of three, components of pessary fitting, provision, and follow up are reviewed from a business perspective related to supplies, patient... (Review)
Review
In this final article in a series of three, components of pessary fitting, provision, and follow up are reviewed from a business perspective related to supplies, patient flow, billing, and coding.
Topics: Aged; Commerce; Education, Nursing, Continuing; Female; Humans; Nurse Practitioners; Office Management; Pessaries; Prosthesis Fitting; Specialties, Nursing
PubMed: 22860392
DOI: No ID Found