Pessary evaluation for genital prolapse treatment: From acceptance to successful fitting.

AIMS: To determine the percentage of women with symptomatic pelvic organ prolapse who opted for pessary and had a successful pessary fitting trial; to identify the most commonly used size of pessary for stage of prolapse; and to identify risk factors associated with unsuccessful fitting. METHODS: We conducted a prospective cohort study of women with symptoms of genital prolapse referred to a public hospital tertiary care clinic (2013-2019). We used ring and ring with support pessaries for fittings. We collected patient demographics, pelvic organ prolapse quantification, size of pessary used and evaluated factors associated with pessary fittings. We defined unsuccessful fit as failure to continue pessary use at 4 weeks post fitting trial. We used Mann-Whitney and χ2 tests to compare variables between groups of successfully and unsuccessfully fitted. Using logistic regression, we built a prediction model for unsuccessful fit. RESULTS: All 170 women with symptomatic prolapse referred to our clinic accepted to undergo a pessary fitting. More than 70% (n = 124/72.9%) were successfully at 4 weeks. We used an average of 1.7 pessaries (range: 1-6) per patient to identify the best-fitting pessary and #2, 5, 3, 7, and 4 were the sizes commonly used (78.2%). Women with body mass index ≥30 kg/m2 (odds ratio [OR]: 4.74; 95% confidence interval [CI], 1.98-11.32; P < .001), total vaginal length <7.5 cm (OR: 3.78; 95% CI, 1.98-11.32; P < .001), and sexually active women (OR: 2.26; 95% CI, 1.04-4.91; P = .035) were associated with increased unsuccessful fitting. CONCLUSION: The vaginal pessary proved to be an excellent choice, with high acceptance and successful fitting rates.

Uso de pesario para prolapso de órganos pélvicos durante el embarazo: serie de casos y revisión de la literatura / Pessary use in pelvic organ prolapse during pregnancy: case series and literature review

INTRODUCCIÓN: El prolapso de órganos pélvicos es infrecuente durante el embarazo y se asocia principalmente a mujeres multíparas. Dado que la población gestante no es la ideal para manejo quirúrgico, los pesarios son útiles para controlar los síntomas con pocos efectos adversos y contraindicaciones. Por su baja incidencia, la información reportada en la literatura se deriva de reportes de caso y las recomendaciones se extrapolan de pacientes no embarazadas. METODOLOGÍA: Revisión de la literatura y exposición de casos. Resultados: Se exponen cuatro casos de gestantes con prolapso de órganos pélvicos manejadas exitosamente con pesarios hasta el final de la gestación sin presentar complicaciones serias. CONCLUSIONES: Los pesarios son un método seguro y eficaz para el manejo de síntomas de prolapsos de órganos pélvicos durante el embarazo.

INTRODUCTION: Pelvic organ prolapse is rare during pregnancy and is associated to women with multiple vaginal child births. Pregnant women are not ideal candidates for surgical management of prolapse, making pessaries useful for symptom control with few adverse effects. Due to its low incidence, information reported in literature is derived from case reports and recommendations are extrapolated from non-pregnant patients. METHODOLOGY: Literature review and presentation of cases. RESULTS: Four cases of pregnant women with pelvic organ prolapse successfully managed with pessaries until the end of pregnancy without presenting serious complications are described. Conclusions: Pessaries are a safe and effective way to treat symptoms of pelvic organ prolapse during pregnancy.

A randomized controlled trial on the use of pessary plus progesterone to prevent preterm birth in women with short cervical length (P5 trial).

BACKGROUND: Preterm birth is the leading cause of mortality and disability in newborn and infants. Having a short cervix increases the risk of preterm birth, which can be accessed by a transvaginal ultrasound scan during the second trimester. In women with a short cervix, vaginal progesterone and pessary can both reduce this risk, which progesterone more established than cervical pessary. The aim of this study is to compare the use of vaginal progesterone alone versus the association of progesterone plus pessary to prevent preterm birth in women with a short cervix. METHODS: This is a pragmatic open-label randomized controlled trial that will take place in 17 health facilities in Brazil. Pregnant women will be screened for a short cervix with a transvaginal ultrasound between 18 0/7 until 22 6/7 weeks of gestational age. Women with a cervical length below or equal to 30 mm will be randomized to the combination of progesterone (200 mg) and pessary or progesterone (200 mg) alone until 36 + 0 weeks. The primary outcome will be a composite of neonatal adverse events, to be collected at 10 weeks after birth. The analysis will be by intention to treat. The sample size is 936 women, and a prespecified subgroup analysis is planned for cervical length (= < or > 25 mm). Categorical variables will be expressed as a percentage and continuous variables as mean with standard deviation. Time to delivery will be assessed with Kaplan-Meier analysis and Cox proportional hazard analysis. DISCUSSION: In clinical practice, the combination of progesterone and pessary is common however, few studies have studied this association. The combination of treatment might act in both the biochemical and mechanical routes related to the onset of preterm birth. TRIAL REGISTRATION: Brazilian Clinical Trial Registry (ReBec) RBR-3t8prz, UTN: U1111-1164-2636, 2014/11/18.

Manual clínico de cuidados de enfermagem a mulheres com prolapso de órgãos pélvicos / Clinical nursing care manual for women with pelvic organ prolapse

Resumo: Introdução: Diversas mulheres atendidas na rede pública apresentam prolapso de órgãos pélvicos. Estes, além de interferirem na função urinária, intestinal e sexual, impactam negativamente na qualidade de vida dessas mulheres. Os prolapsos de órgãos pélvicos podem ser corrigidos cirurgicamente ou pela inserção de pessários uroginecológicos no canal vaginal. Os pessários são dispositivos de silicone que podem ser inseridos e retirados pela própria mulher, com benefícios semelhantes ao procedimento cirúrgico. A capacitação para uso dos pessários pode ser uma prática do enfermeiro; o que contribuiria para a redução das filas cirúrgicas e resolução do problema para mulheres com alto risco operatório. Porém essa não é a realidade nacional. Diante dessa lacuna, se faz necessário fomentar a discussão entre esses profissionais. Objetivo: Construir um Manual Clínico de Cuidados de Enfermagem a mulheres com prolapso de órgãos pélvicos. Objetivos específicos: Quantificar o atendimento de mulheres com POP; Caracterizar o conhecimento dos enfermeiros sobre o tema; e Discutir o conteúdo do manual junto aos enfermeiros que atuam na atenção primária. Metodologia: Pesquisa metodológica com abordagem qualitativa, na atenção primária à saúde, num distrito de um Município no Paraná; que seguiu as seguintes etapas: quantificação do atendimento a muheres com prolapso de órgãos pélvicos, para identificação da demanda; caracterizar o nível de conhecimentos dos enfermeiros, por meio de questionário e realização de oficinas para discussão do manual com os profissionais, sensibilizando-os sobre a temática. Participaram desta pesquisa 42 enfermeiros que atuavam na assistência direta ou indireta da atenção primária à saúde. A coleta de dados ocorreu por meio de oficinas propostas e na análise dos dados foram seguidos os passos de John W. Creswell. Resultados: Identificou-se, por meio deste estudo, que de um número de 436 mulheres, 96,56% tinha algum tipo de incontinência urinária, sendo a de maior prevalência a incontinência urinária de esforço, representando 73,75% destes casos; 41,51% possuíam prolapso de órgãos pélvicos associado a incontinência urinária. O local de estudo ficou em segundo lugar em número de casos da cidade. As oficinas proporcionaram um melhor entendimento em relação à inserção dos profissionais no contexto dos cuidados de enfermagem à mulher com prolapso de órgãos pélvicos; nelas, os profissionais de enfermagem passaram por uma experiência nova que permitiu atentar para cada detalhe e conhecer melhor essa patologia, demonstrando a sensibilidade dos profissionais frente ao atendimento a estas mulheres. Os participantes demonstraram ter algum conhecimento referente aos prolapsos de órgãos pélvicos, porém possuíam conhecimento restrito sobre os pessários, ou quase nulo. Considerações finais: A construção de um manual clínico subsidiará a assistência e a tomada de decisão clínica, proporcionando um conhecimento científico e didático, aprimoramento da assistência a mulheres com prolapso de órgãos pélvicos, sensibilizando os enfermeiros para a discussão e planejamento da sistematização dos cuidados de enfermagem a pacientes acometidas pelo prolapso de órgãos pélvicos, num diálogo aberto, mostrando a importância de cuidar destas mulheres na atenção primária, aprimorando a assistência, e evitando a sobrecarga em outros níveis de atenção à saúde, de forma segura.

Abstract: Introduction: Many women attended in the health public system have pelvic organ prolapse (POP). This prevalent disease impact the life quality of these women, negatively, in addition to interfering with urinary, intestinal, and sexual functions. POP can be corrected surgically or by using the vaginal pessary (VP) device. Pessaries are silicone devices that can be inserted into the vaginal canal and removed by the own patient with benefits similar to the surgical procedure. Training for the use of pessaries can be a nurse's practice, which would contribute to reducing surgical queues and solving the problem for women with high surgical risk. However, this procedure is not the Brazilian national reality. In view of this gap, it is needed to encourage this theme discussion among health professionals. Objective: Prepare a Nursing Care Clinical Manual for women with POP. As specific objectives: (a) quantify attendance of women with POP; (b) characterize the nurses' knowledge on the theme; and (c) discuss the manual content with nurses working in primary care. Methodology: Methodological research with a qualitative approach in primary health care, in a county, in Paraná State, Brazil, following these steps: (a) quantifying attendance to women with POP to identify demand; and (b) characterizing nurses' knowledge level, using a questionnaire and workshops to discuss the manual, making professionals aware about the theme. Forty-two nurses participated in this research, who worked in the direct or indirect attendance of primary health care. Data were collected in workshops proposed, and the data analysis was carried out in accordance with John W. Creswell. Results: It was identified, by this study, that 96.56% from universe of 436 women had some type of urinary incontinence, being the stress urinary incontinence the highest prevalence, representing 73.75%; 41.51% had POP associated with urinary incontinence. This study site ranked second among the cases in this county. The workshops provided a better understanding and engagement of professionals in the context of nursing care for women with POP; the nursing professionals had a new experience with that women group, allowing them to pay attention to every detail and better understand this pathology, showing their sensitivity regarding the care of these women. The participants showed to have some knowledge regarding the POP, but they had limited knowledge about the pessaries, or almost none. Final considerations: The preparation of a clinical manual will subsidize attendance and clinical decision-making, providing scientific and didactic knowledge about the POP, in an open dialogue, sensitizing nurses to discuss and plan the systematization of nursing care to patients affected by this disease, showing the importance to care them in primary care, improving the attendance, and avoiding overload on other levels of health care in a safe way

Protocolo para tratamento de prolapso de órgãos pélvicos com pessário vaginal / Protocolo de tratamiento del prolapso de órganos pélvicos con pesario vaginal / Protocol for pelvic organ prolapse treatment with vaginal pessaries

Resumo Objetivo Desenvolver um protocolo clínico para o tratamento conservador do prolapso de órgãos pélvicos com pessário vaginal. Métodos Pesquisa de desenvolvimento ocorrida de julho de 2015 a janeiro de 2016 e realizada em etapas: refinamento dos tópicos/questões do protocolo; estabelecimento de recomendações para pesquisa e atualização; revisão por pares. A análise se deu por programa estatístico e pelo Índice de Validade de Conteúdo. Resultados O protocolo foi desenvolvido e avaliado por meio da técnica Delphi quanto aos critérios objetivos, conteúdo e apresentação e relevância por profissionais da área, sendo calculado o Índice de Validade de Conteúdo total de cada domínio e global. O Índice de Validade de Conteúdo total do domínio objetivos foi 1,00, do critério conteúdo e apresentação foi 0,98 e do domínio relevância, 0,96. Obteve-se o Índice de Validade de Conteúdo global de 0,98. Dessa forma, verificou-se concordância entre os participantes da técnica Delphi, com valor acima de 0,85, considerando o protocolo clínico válido. Conclusão Acredita-se que os profissionais de saúde, ao utilizar o protocolo clínico, terão maior embasamento na prática, oferecendo um cuidado de maior qualidade, pois é uma ferramenta válida e pautada cientificamente.

Resumen Objetivo Desarrollar un protocolo clínico para el tratamiento conservador del prolapso de órganos pélvicos con pesario vaginal. Métodos Investigación de desarrollo realizada entre julio de 2015 y enero de 2016, efectuada en etapas: refinación de tópicos/preguntas del protocolo; establecimiento de recomendaciones para investigación y actualización; revisión por pares. Análisis ejecutado mediante programa estadístico e Índice de Validez de Contenido. Resultados El protocolo fue desarrollado y evaluado utilizándose la técnica Delphi respecto a los criterios objetivos, contenido y presentación, y relevancia por profesionales del área, calculándose el Índice de Validez de Contenido total de cada dominio y el global. El Índice de Validez de Contenido total del dominio objetivos fue 1,00; el del criterio contenido y presentación, del 0,98; y el del dominio relevancia, 0,96. El Índice de Validez de Contenido global fue de 0,98. Así, se verificó concordancia de la técnica Delphi entre los participantes, con valor superior a 0,85; considerándose válido el protocolo clínico. Conclusión Al ser utilizado por los profesionales de salud, el protocolo clínico les brindará mayor fundamentación en la práctica, permitiéndoles ofrecer mejor calidad de atención, pues es una herramienta válida y elaborada científicamente.

Abstract Objective To develop a clinical protocol for the conservative treatment of pelvic organ prolapse with vaginal pessaries. Methods Developmental research conducted in the period from July 2015 to January 2016 and performed in the following steps: refinement of topics/protocol issues; establishing recommendations for research and updates; peer review. The analysis was by statistical program and the Content Validity Index (CVI). Results The protocol was developed and evaluated by professionals of the area through the Delphi technique regarding criteria of objectives, content and presentation, and relevance. The total CVI of each domain and the overall CVI were calculated. The total Content Validity Index for the objectives domain was 1.00, for content and presentation criterion was 0.98, and for the relevance domain was 0.96. The overall Content Validity Index obtained was 0.98. Thus, there was agreement among participants of the Delphi technique with value above 0.85, and the clinical protocol was considered valid. Conclusion When health professionals use the clinical protocol, they will have a better foundation in practice and offer a higher quality care, since this is a valid and scientifically based tool.

Quality of life and vaginal symptoms of postmenopausal women using pessary for pelvic organ prolapse: a prospective study

SUMMARY OBJECTIVE: The use of pessary is an option for the conservative treatment of pelvic organ prolapse (POP). However, here are few studies assess the quality of life (QoL) after inserting the pessary for POP. We have hypothesized that the use of pessary would modify QoL in women with POP. METHODS: A prospective, observational study was performed that included 19 women with advanced POP. Pessary was introduced, and the SF-36 (general quality of life) and ICIQ-VS (vaginal symptoms and quality of life subdomain) questionnaires were applied before the introduction and after six months. A single question about the satisfaction regarding the use of the device was presented (subjective impression). RESULTS: The mean age of the women included was 76 years. Most of them were non-caucasian (52.6%), with no prior pelvic surgery (57.5%), with urinary symptoms (78.9%). A third of the patients reported sexual activity. After treatment, 22.2% of them presented vaginal infection, and 27.7% increased vaginal discharge. Urinary symptoms remained unaltered. Women reported 100% satisfaction after using the pessary (77.7% partial improvement; 22.3% total improvement). SF-36 had significant improvement in three specific domains: general state of health (p=0.090), vitality (p=0.0497) and social aspects (p=0.007). ICIQ-VS presented a reduction in the vaginal symptoms (p < 0.0001) and an improvement in QoL (P < 0.0001). CONCLUSION: The use of pessary for six months improved the QoL and reduced vaginal symptoms for women with advanced POP.

RESUMO OBJETIVO: O pessário é uma opção para o tratamento conservador do prolapso genital. MÉTODOS: Um estudo prospectivo e observacional foi realizado com 19 mulheres com prolapso genital avançado. A avaliação da qualidade de vida e dos sintomas vaginais foi mensurada pelos questionários SF-36 e ICIQ-VS antes e seis meses depois da colocação do pessário. Uma pergunta simples sobre satisfação do uso do dispositivo foi também feita (impressão subjetiva). RESULTADOS: A idade média das mulheres foi de 76 anos. A maioria era parda/negra (52,6%), sem cirurgias pélvicas (57,5%), com sintomas urinários (78,9%). Um terço das pacientes relatou atividade sexual. Depois do tratamento, 22,2% apresentaram infecção vaginal e 27,7% fluxo vaginal aumentado. Não houve alteração da prevalência dos sintomas urinários. As mulheres relataram 100% de satisfação (77,7% melhora parcial e 22,3% melhora completa) depois do uso do pessário. Houve melhora em três domínios do SF-36: saúde em geral (p=0,090), vitalidade (p=0,0497) e aspectos sociais (p=0,007). O ICIQ-VS apresentou redução nos sintomas vaginais (p<0,0001) e melhora da qualidade de vida (p<0,0001). CONCLUSÕES: O uso do pessário por seis meses em mulheres com prolapso genital melhorou a qualidade de vida e reduziu os sintomas vaginais.

Female pelvic organ prolapse using pessaries: systematic review.

INTRODUCTION AND HYPOTHESIS: The purpose of this systematic review is to assess the impact of pessary use on the quality of life of women with pelvic organ prolapse, and to determine the satisfaction rate and rationale for discontinuation. METHODS: This review is recorded in the PROSPERO database under number CRD42015023384. The criteria for inclusion were observational study; cross section; cohort study; randomized controlled trial; study published in English, Portuguese, and Spanish; and study whose participants are women with female pelvic organ prolapse treated using a pessary. We did not include limitations on the year of publication. The criteria for exclusion included studies that did not include the topic, bibliographic or systematic reviews and articles that did not use validated questionnaires. The MeSH terms were "Pelvic Organ Prolapse AND Pessaries AND Quality of Life" OR "Pessary AND Quality of Life" OR "Pessaries". RESULTS: We found 89 articles. After the final analyses, seven articles were included. All articles associated pessary use with improved quality of life, and all used only validated questionnaires. Over half of the women continued using the pessary during the follow-up with acceptable levels of satisfaction. The main rationales for discontinuation were discomfort, pain in the area, and expulsion of the device. CONCLUSION: This systematic review demonstrates that the pessary can produce a positive effect on women's quality of life and can significantly improve sexual function and body perception.

Construção e validação de protocolo para utilização de pessário vaginal

O prolapso de órgãos pélvicos é considerado a desci da do conteúdo pélvico e/ou intraperitoneal pelo canal vaginal. Dentre os tipos de tratamentos conservadores, tem-se o pessário. Entende-se que o uso do dispositivo é uma opção viável, pois é um tratamento de primeira linha, de baixo custo e de baixo risco. A consulta a mulheres com esse agravo necessita ser sistematizada, e, dentre as ferrament as que auxiliam nessa sistematização, tem-se a utilização dos protocolos clínicos. Dessa forma, o objetivo geral do estudo foi desenvolver protocolo clínico para o tratamento conservador do prolapso de órgãos pélvicos com pessário vaginal. Tratou-se de uma pesquisa de desenvolvimen to a qual ocorreu de julho de 2015 a janeiro de 2016, dividindo-se em cinco etapas: 1) R efinamento dos tópicos/questões do protocolo; 2) Revisão sistemática; 3) Estabelecimen to de recomendações para pesquisa e atualização da diretriz/protocolo; 4) Revisão por p ares do protocolo; 5) Planejamento de disseminação da diretriz/protocolo, incluindo local ização e avaliação. O instrumento utilizado para a avaliação da qualidade do protocolo foi o Appraisal of Guidelines for Research and Evaluation . A análise se deu pelo programa SPSS versão 20.0 , pelo Índice de Validade de Conteúdo e por uma fórmula própria do instrumento d e avaliação que calcula a pontuação de qualidade do protocolo. Para refinar os tópicos/que stões do protocolo clínico, realizou-se brainstorming eletrônico com cinco profissionais da área de Urog inecologia, entrevista com quatro usuárias de pessário vaginal e imersão da pe squisadora no serviço...

The pelvic organ prolapse is regarded as the descen t of the pelvic contents and/or by intraperitoneal vaginal canal. Among the types of c onservative treatments, it has the pessary. It is understood that the use of the device is a vi able option as it is a first-line treatment, low cost and low risk. Consultation with women with thi s injury needs to be systematized, and, among the tools that help in this systematization, there is the use of clinical protocols. Thus, the overall objective of the study was to develop a clinical protocol for the conservative treatment of pelvic organ prolapse with vaginal pes sary. It was a development of research which took place from July 2015 to January 2016, di viding into five steps: 1) Refinement of topics/issues of the Protocol; 2) Systematic review ; 3) Establishment of recommendations for research and update the guideline/protocol; 4) Revi ew by the protocol peers; 5) Dissemination planning guideline/protocol, including location and evaluation. The instrument used for assessing the quality of the protocol was the Appra isal of Guidelines for Research and Evaluation. The analysis was done by SPSS version 2 0.0, the Content Validity Index and its own formula of assessment tool that calculates the protocol quality score. To refine topics/issues of the clinical protocol, was held el ectronic brainstorming with five professionals Urogynecology area, interview with fo ur users of vaginal pessary and immersion of the researcher in the service...

Complicaciones del uso del pesario con soporte y sin soporte en el prolapso genital completo / Complications from the use of pessary with support and without support in the complete genital prolapse

INTRODUCCIÓN: La prevalencia del prolapso genital se ha incrementado; a menudo cursa de forma asintomática, se suele presentar con síntomas de un "bulto" vaginal. Las opciones de tratamiento incluyen ejercicios del suelo pélvico, manejo expectante, el uso de dispositivos mecánicos y corrección quirúrgica. OBJETIVO: Evaluar las complicaciones inmediatas y tardías del uso del pesario sin soporte y con soporte, en el manejo conservador del prolapso genital completo. MATERIALES Y MÉTODOS: Estudio descriptivo, observacional, transversal y comparativo. Se revisaron 108 historias clínicas de las pacientes atendidas por prolapso genital completo y se evaluaron a las que se les manejó de forma conservadora con pesarios con soporte (Grupo A: 9) y sin soporte (Grupo B: 18). Los dos grupos se compararon tomando en cuenta el aumento de secreción vaginal, aparición de erosión y úlceras vaginales, impactación, fístulas, atipias citológicas, incarceración, hidronefrosis, infección vaginal y complicaciones intestinales. RESULTADOS: Se analizaron 27 pacientes en total, 9 manejadas con pesarios con soporte y 18 con pesarios sin soporte. Hubo diferencia significativa en cuanto al aumento de secreción vaginal con menor secreción en uso del pesarios sin soporte (p=0,045). Se encontró diferencia en la aparición de erosión y úlceras vaginales (p < 0,05). CONCLUSIONES: Hay diferencia significativa en cuanto al aumento de la secreción vaginal y la aparición de erosión y úlceras vaginales en el uso de pesarios sin soporte en comparación con el uso de pesarios con soporte

INTRODUCTION: The prevalence of genital prolapse has increased; often it is asymptomatic, usually presents with symptoms of a vaginal "bulge". Treatment options include pelvic floor exercises, expectant management, the use of mechanical devices and surgical correction. OBJECTIVES: Evaluate the immediate and late complications of the use of pessary without support and with support in the conservative management of the entire genital prolapse. MATERIALS AND METHODS: Descriptive, observational, transversal and comparative study. 108 medical records of patients treated by complete genital prolapse were reviewed and evaluated which were managed conservatively with pessaries supported (Group A: 9) and unsupported (Group B: 18). The two groups are compared taking into account the increased vaginal discharge, vaginal appearance of erosion and ulcers, impaction, fistulas, cytologic atypia, incarceration, hydronephrosis, vaginal infection and intestinal complications. RESULTS: 27 patients were analyzed in total, 9 handled pessaries supported and 18 unsupported pessaries. There was significant difference in terms of vaginal discharge increasment with less secretion in unsupported use of pessaries (p = 0.045). A difference was found in the occurrence of erosion and vaginal ulcers (p < 0.05 ). CONCLUSIONS: There is a significant difference in terms of vaginal discharge increasment and occurrence of erosion and ulcers vaginal pessaries using unsupported compared with using supported pessaries