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Идёт набор NCT03615872

Pessary Satisfaction Criteria for Urogenital Prolapse

— Наблюдательное Genital Prolapse Pessary Satisfaction

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: pessary use.
Кому может быть актуально
Состояния в реестре: Genital Prolapse, Pessary, Satisfaction. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Evaluation of Patient Satisfaction With Pessary in the Treatment of Genital Prolapse

Обзор

Genital prolapse is a common pathology with a prevalence ranging from 2.9 to 11.4% or 31.8% to 97.7%, depending on whether a questionnaire or clinical examination is used. The use of pessary in the treatment of prolapse remains discussed despite a satisfaction rate of 50 to 80% in the literature and a minimal complications rate. The main objective of this study is to assess the satisfaction of patients carrying a pessary in the first year after the laying.

Подробное описание

This is a prospective observational cohort conducted at the Universitary hospital of Caen over a total period of 5 years.

Patients with a symptomatic genital prolapse will all be offered the installation of a pessary. If they agree to participate in the study, they will be asked to respond to validated questionnaires: symptom questionnaires (PFDI-20, ICIQ-SF, USP), a sexuality questionnaire (PISQ-12), a quality of life questionnaire (PFIQ-7, BIS) and Satisfaction (PGI-I), several times: Before the installation of the pessary, at one month, at 6 months, then annually over 5 years

Вмешательства

  • Устройство pessary use
    evaluation of satisfaction of pessary use in case of symptomatic genital prolapse

Первичные конечные точки

  • Patient SATISFACTION assessed by the PGI-I score (Patient Global Impression of Improvement) in the first year after the installation of a pessary [Срок оценки: 1 year]
Вторичные конечные точки (12)
  • Patient SATISFACTION assessed by the PGI-I score (Patient Global Impression of Improvement) every year for five years after the installation of a pessary [Срок оценки: 1 to 5 years]
  • EFFICACY of pessary on genital symptoms assessed by the Pelvic Floor Distress Inventory (PFDI-20) questionnaire before and after the installation of the pessary. [Срок оценки: at 1 year, then every year for 5 years]
  • EFFICACY of pessary on urinary symptoms assessed by the International Consultation of Incontinence Questionnaire-Short Form (ICIQ-UI SF) and the Urinary Symptom Profile score (USP) before and after the installation of the pessary. [Срок оценки: at 1 year, then every year for 5 years]
  • Sexual impact of pessary assessed by the Pelvic organ prolapse urinary Incontinence Sexual Questionnaire (PISQ-12) [Срок оценки: at 1 year, then every year for 5 years]
  • QUALITY OF LIFE assessed by the Pelvic Floor Impact Questionnaire (PFIQ-7) before and after the installation of the pessary [Срок оценки: at 1 year, then every year for 5 years]
  • INVESTIGATE the impact of age on the removal or expulsion of pessary [Срок оценки: 1 year to 5 years]
  • INVESTIGATE the impact of menopausal status on the removal or expulsion of pessary [Срок оценки: 1 year to 5 years]
  • INVESTIGATE the impact of weight on the removal or expulsion of pessary [Срок оценки: 1 year to 5 years]
  • INVESTIGATE the impact of hysterectomy history on the removal or expulsion of pessary [Срок оценки: 1 year to 5 years]
  • INVESTIGATE the impact of prolapse surgery history on the removal or expulsion of pessary [Срок оценки: 1 year to 5 years]
  • INVESTIGATE the impact of the prolapse stage of on the removal or expulsion of pessary [Срок оценки: 1 year to 5 years]
  • Complications of pessary use reported by their rate [Срок оценки: 1 to 5 years]

Критерии участия

Критерии включения

  • The research protocol will be proposed to all patients with a symptomatic genital prolapse, over 18 years of age, who speak French and who agree to participate in this study
  • Prolapse defined according to the International Classification POP-Q-.

Критерии исключения

  • Minors under 18 years of age
  • Pregnant or lactating women
  • Women Not speaking French (the good understanding of French is necessary to answer questionnaires and for informed information)
  • Women unable to understand due to cognitive impairment or degenerative disease (dementia/ Alzheimer's disease)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • Pizzoferato — Caen

Публикации

  • Cundiff GW, Amundsen CL, Bent AE, Coates KW, Schaffer JI, Strohbehn K, Handa VL. The PESSRI study: symptom relief outcomes of a randomized crossover trial of the ring and Gellhorn pessaries. Am J Obstet Gynecol. 2007 Apr;196(4):405.e1-8. doi: 10.1016/j.ajog.2007.02.018. PMID 17403437
  • Clemons JL, Aguilar VC, Tillinghast TA, Jackson ND, Myers DL. Patient satisfaction and changes in prolapse and urinary symptoms in women who were fitted successfully with a pessary for pelvic organ prolapse. Am J Obstet Gynecol. 2004 Apr;190(4):1025-9. doi: 10.1016/j.ajog.2003.10.711. PMID 15118635
  • Patel M, Mellen C, O'Sullivan DM, LaSala CA. Impact of pessary use on prolapse symptoms, quality of life, and body image. Am J Obstet Gynecol. 2010 May;202(5):499.e1-4. doi: 10.1016/j.ajog.2010.01.019. Epub 2010 Feb 20. PMID 20171608
  • Lone F, Thakar R, Sultan AH, Karamalis G. A 5-year prospective study of vaginal pessary use for pelvic organ prolapse. Int J Gynaecol Obstet. 2011 Jul;114(1):56-9. doi: 10.1016/j.ijgo.2011.02.006. Epub 2011 May 14. PMID 21575953
  • Clemons JL, Aguilar VC, Sokol ER, Jackson ND, Myers DL. Patient characteristics that are associated with continued pessary use versus surgery after 1 year. Am J Obstet Gynecol. 2004 Jul;191(1):159-64. doi: 10.1016/j.ajog.2004.04.048. PMID 15295358
  • Panman CM, Wiegersma M, Kollen BJ, Burger H, Berger MY, Dekker JH. Predictors of unsuccessful pessary fitting in women with prolapse: a cross-sectional study in general practice. Int Urogynecol J. 2017 Feb;28(2):307-313. doi: 10.1007/s00192-016-3107-4. Epub 2016 Aug 15. PMID 27525693
  • Markle D, Skoczylas L, Goldsmith C, Noblett K. Patient characteristics associated with a successful pessary fitting. Female Pelvic Med Reconstr Surg. 2011 Sep;17(5):249-52. doi: 10.1097/SPV.0b013e31822f00ae. PMID 22453110
  • Mutone MF, Terry C, Hale DS, Benson JT. Factors which influence the short-term success of pessary management of pelvic organ prolapse. Am J Obstet Gynecol. 2005 Jul;193(1):89-94. doi: 10.1016/j.ajog.2004.12.012. PMID 16021064

Идентификаторы

NCT: NCT03615872 · 2018-A00004-51

Первоисточники (государственные реестры)

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