- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT06021769
Studio sull'esperienza del pessario
Valutazione longitudinale dell'esperienza del pessario
Pessaries are silicone devices inserted into the vagina for treatment of pelvic organ prolapse or stress urinary incontinence. They are adequate treatment options for patients who are poor surgical candidates, those who decline surgical intervention, or as a temporizing measure in those ultimately planning surgery. Most studies suggest that about 75% of patients are able to be successfully fit with a pessary, but about 50% discontinue pessary use within 12 months of initiation. The purpose of this study is to determine why pessaries are discontinued.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
Pessaries are silicone devices inserted into the vagina for treatment of pelvic organ prolapse or stress urinary incontinence. They are adequate treatment options for patients who are poor surgical candidates, those who decline surgical intervention, or as a temporizing measure in those ultimately planning surgery. Most studies suggest that about 75% of patients are able to be successfully fit with a pessary, but about 50% discontinue pessary use within 12 months of initiation.
Research concerning pessary discontinuation is currently focused on identifying factors that will predict outcomes of pessary use. It is generally agreed upon that pessaries are one of the favored option to conservatively treat pelvic organ prolapse or stress urinary incontinence, but there is not sufficient consensus on the rate of discontinuation, factors leading to discontinuation, and patient satisfaction.
Most studies recorded reasons for discontinuation and any adverse events. Patients' reasons for discontinuation of pessary use included frequent expulsion, difficulty removing pessary, new or worsening urinary incontinence, vaginal erosion, and pain/discomfort. Significant side effects or adverse events included vaginal discharge and erosion.
Several studies focused on anatomic and medical variables that were correlated to pessary discontinuation. A univariate analysis of factors contributing to discontinuation conducted by Yimphong et al.1 found that higher BMI and history of pelvic surgery were significant in predicting discontinuation. Similarly, Panman2 et al. conducted a multivariate analysis that found higher BMI was a significant factor. Panman et al. also found that both younger age and weaker pelvic floor muscles were predictors for discontinuation. The former finding is further supported by Umchanger et al., which cited that 33% of patients who discontinued pessary use within three months were generally less than 65 years. Umchanger et al. hypothesized that despite data suggesting that pessaries are as effective as surgery, younger patients may maintain the misconception that pessaries are not as effective.
Despite the data suggesting contributing factors such as BMI and age, none of the reviewed studies captured the qualitative reasoning behind patients' decisions. Only a few of the studies investigate patients' satisfaction with pessary use, quality of life, or opinion on their treatment.
Pessary use has been correlated to a wide variety of factors, such as a patient's medical history, anatomic characteristics, beliefs about pessary use, and personal satisfaction with treatment. Based on this review, a qualitative analysis of patient experience and priorities as they decide to continue or discontinue pessary use would be incredibly helpful for counseling and educating future patients when they are making treatment decisions about pessaries.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Luoghi di studio
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Virginia
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Charlottesville, Virginia, Stati Uniti, 22903
- University of Virginia
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Women in the area surrounding the University of Virginia who have stress urinary incontinences or pelvic organ prolapse.
Descrizione
Inclusion Criteria:
- English-speaking women aged 18 years or older
- Choosing to undergo a pessary fitting for symptomatic pelvic organ prolapse and/or stress urinary incontinence at the University of Virginia Pelvic Medicine and Reconstructive Surgery clinic
- Willingness and ability to comply with scheduled visits and study procedures.
- Successful pessary fitting
Exclusion Criteria:
- Pregnant women
- Prisoners
- Cognitively impaired
- Non-English speaking subjects
- Patients who cannot comply with pessary check visits
- Active vaginal infection
- Vaginal malignancy
- Genitourinary tract fistula
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: COHORT
- Prospettive temporali: PROSPECTIVE
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
Women being fitted with pessaries
Women being fitted with pessaries as standard of care will be eligible to participate. They will be asked to complete a recorded verbal interview and written questionnaires the day they have their pessaries fitted and at their follow-up clinic appointments at 4-6 weeks, 3 months, 6 months, and 12 months. Another recorded video interview will be completed at the 12 month appointment. |
No intervention |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Qualitative analysis
Lasso di tempo: up to 1 year after pessary fitting
|
Perform a patient-centered, qualitative analysis of pessary discontinuation |
up to 1 year after pessary fitting
|
|
Pelvic Floor symptom improvement as related to quality of life
Lasso di tempo: up to 1 year after pessary fitting
|
Assess changes in pelvic floor symptoms and quality of life before and after pessary use as measured by validated questionnaires |
up to 1 year after pessary fitting
|
|
Discontinuation of pessaries
Lasso di tempo: up to 1 year after pessary fitting
|
Rates of discontinuation at 1 year |
up to 1 year after pessary fitting
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|
Why do women discontinue using pessaries?
Lasso di tempo: up to 1 year after pessary fitting
|
Factors significantly associated with discontinuation |
up to 1 year after pessary fitting
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Monique Vaughan, MD, Assistant Professor
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
- Yimphong T, Temtanakitpaisan T, Buppasiri P, Chongsomchai C, Kanchaiyaphum S. Discontinuation rate and adverse events after 1 year of vaginal pessary use in women with pelvic organ prolapse. Int Urogynecol J. 2018 Aug;29(8):1123-1128. doi: 10.1007/s00192-017-3445-x. Epub 2017 Aug 16.
- Umachanger JK, Marcussen ML, Boggild H, Kjaergaard N, Glavind K. First-line treatment of pelvic organ prolapse and discontinuation of pessary treatment. Int Urogynecol J. 2020 Sep;31(9):1813-1819. doi: 10.1007/s00192-020-04338-w. Epub 2020 May 24.
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie urogenitali
- Malattie urogenitali maschili
- Condizioni patologiche, anatomiche
- Malattie urologiche
- Malattie urogenitali femminili
- Malattie urogenitali femminili e complicanze della gravidanza
- Disturbi della minzione
- Sintomi del tratto urinario inferiore
- Manifestazioni urologiche
- Incontinenza urinaria
- Prolasso
- Condizioni patologiche, segni e sintomi
- Segni e sintomi
- Incontinenza urinaria, Stress
- Prolasso degli organi pelvici
Altri numeri di identificazione dello studio
- HSR220160
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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