Actively Recruiting

Age: 18Years +
FEMALE
ID03615872

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

Led by University Hospital, Caen · Updated on 2024-09-20

150

Participants Needed

1

Research Sites

362 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating patient satisfaction with the use of pessaries for treating symptomatic genital prolapse. This observational study is conducted at the University Hospital of Caen and aims to understand satisfaction within the first year after pessary placement, as well as over a five-year period. The study also investigates the impact of factors such as age, menopausal status, weight, hysterectomy history, prolapse surgery history, and prolapse stage on pessary removal or expulsion. Participants will be offered pessary installation and asked to complete a series of validated questionnaires assessing symptoms, sexual function, quality of life, and satisfaction. These questionnaires include the PFDI-20, ICIQ-SF, USP, PISQ-12, PFIQ-7, BIS, and the PGI-I for satisfaction. Assessments take place before pessary placement, then at one month, six months, and annually for up to five years. During the study, participants will complete symptom and quality of life questionnaires multiple times to track changes and satisfaction with the pessary over time. Researchers will monitor complications and explore how patient characteristics affect pessary use. The primary outcome is patient satisfaction measured by the PGI-I score at one year, with additional annual assessments up to five years, allowing for long-term observation of outcomes and device performance.

CONDITIONS

Brief Title

Pessary Satisfaction Criteria for Urogenital Prolapse

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with symptomatic genital prolapse
  • Age 18 years or older
  • Able to speak and understand French
  • Willing to participate in the study
  • Prolapse defined according to the International Classification POP-Q
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Pregnant or breastfeeding women
  • Women who do not speak French
  • Women with cognitive impairment or degenerative diseases such as dementia or Alzheimer's disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Implementation

Duration - 5 years

Participants receive a pessary for the treatment of symptomatic genital prolapse and complete questionnaires assessing symptoms, sexuality, quality of life, and satisfaction.

1 visit at baseline before pessary installation, followed by visits at 1 month, 6 months, and annually for up to 5 years

Trial Site Locations

Total: 1 location

1

Pizzoferato

Caen, France, 14000

Actively Recruiting

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Research Team

A

Anne Cecile PIZZOFERRATO, MD

A

Anne VILLOT, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

The PESSRI study: symptom relief outcomes of a randomized crossover trial of the ring and Gellhorn pessaries.

Geoffrey W Cundiff, Cindy L Amundsen, Alfred E Bent...

https://pubmed.ncbi.nlm.nih.gov/17403437

Patient satisfaction and changes in prolapse and urinary symptoms in women who were fitted successfully with a pessary for pelvic organ prolapse.

Jeffrey L Clemons, Vivian C Aguilar, Tara A Tillinghast...

https://pubmed.ncbi.nlm.nih.gov/15118635

Predictors of unsuccessful pessary fitting in women with prolapse: a cross-sectional study in general practice.

Chantal M C R Panman, Marian Wiegersma, Boudewijn J Kollen...

https://pubmed.ncbi.nlm.nih.gov/27525693