Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03615872

Pessary Satisfaction Criteria for Urogenital Prolapse

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Genital Prolapse Behavior Personal Satisfaction Pessary Satisfaction

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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-.

Exclusion criteria

  • 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)

Treatment and study plan

pessary use

Device

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

Primary outcomes

  1. Patient SATISFACTION assessed by the PGI-I score (Patient Global Impression of Improvement) in the first year after the installation of a pessary

    Time frame: 1 year

    The PGI-I score was developed and validated to quantify the effect of urinary incontinence or prolapse treatments

Secondary outcomes

  1. Patient SATISFACTION assessed by the PGI-I score (Patient Global Impression of Improvement) every year for five years after the installation of a pessary

    Time frame: 1 to 5 years

    The PGI-I score was developed and validated to quantify the effect of urinary incontinence or prolapse treatments

  2. EFFICACY of pessary on genital symptoms assessed by the Pelvic Floor Distress Inventory (PFDI-20) questionnaire before and after the installation of the pessary.

    Time frame: at 1 year, then every year for 5 years

    This score was developped to evaluate the genital, anorectal and urinary symptoms related to genital prolapse

  3. 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.

    Time frame: at 1 year, then every year for 5 years

    These scores are self-questionnaires specifically validated to evaluate urinary incontinence and urinary tract dysfunctions

  4. Sexual impact of pessary assessed by the Pelvic organ prolapse urinary Incontinence Sexual Questionnaire (PISQ-12)

    Time frame: at 1 year, then every year for 5 years

    Evaluation of the PISQ-12 score after the installation of a pessary. This score was developped specifically to evaluate sexual troubles in case of genital prolapse

  5. QUALITY OF LIFE assessed by the Pelvic Floor Impact Questionnaire (PFIQ-7) before and after the installation of the pessary

    Time frame: at 1 year, then every year for 5 years

    The PFIQ-7 was developped to evaluate the impact of the symptoms on the quality of life

  6. INVESTIGATE the impact of age on the removal or expulsion of pessary

    Time frame: 1 year to 5 years

    Impact of age (years) on treatment failure (removal or expulsion of pessary)

  7. INVESTIGATE the impact of menopausal status on the removal or expulsion of pessary

    Time frame: 1 year to 5 years

    Impact of menopausal status (yes/no) on treatment failure (removal or expulsion of pessary)

  8. INVESTIGATE the impact of weight on the removal or expulsion of pessary

    Time frame: 1 year to 5 years

    Impact of weight (Kg) on treatment failure (removal or expulsion of pessary)

  9. INVESTIGATE the impact of hysterectomy history on the removal or expulsion of pessary

    Time frame: 1 year to 5 years

    Impact of hysterectomy history (yes/no) on the removal or expulsion of pessary

  10. INVESTIGATE the impact of prolapse surgery history on the removal or expulsion of pessary

    Time frame: 1 year to 5 years

    Impact of prolapse surgery history (yes/no) on the removal or expulsion of pessary

  11. INVESTIGATE the impact of the prolapse stage of on the removal or expulsion of pessary

    Time frame: 1 year to 5 years

    Impact of the prolapse stage (assessed by the validated POP-Q classification) of on the removal or expulsion of pessary. The stage of prolapse is ranged from 1 to 4 in the POP-Q classification

  12. Complications of pessary use reported by their rate

    Time frame: 1 to 5 years

    Rate of complications related to the use of a pessary (frequencies)

Study contacts

Contact information is provided by the study sponsor or research team.

Anne Cecile PIZZOFERRATO, MD

CONTACT

[email protected]

+33231272723

Anne VILLOT, MD

CONTACT

[email protected]

+33231272336

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

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

Acronym: PeSaCUP

Important dates

Study start
2018
Primary completion
2018
Study completion
2025
First posted
Aug 6, 2018
Registry last updated
Sep 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.