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Recruiting NCT04701047

Prospective Observational Prolapse Study

Observational Vaginal Prolapse

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: vaginal pessary, Vaginal prolapse surgery.
Who it may be relevant to
Registry conditions: Vaginal Prolapse. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Prospective Observational Study with Patient Reported Outcome Measures (PROM) for the Treatment of Vaginal Prolapse: Pessary Vs. Surgery

Overview

The rationale of the study is to investigate the results of a prolapse treatment in adult women with a vaginal prolapse. The investigators will investigate this by taking questionnaires in women undergoing a surgical prolapse repair and in women that are being treated by a vaginal pessary. The objective is to compare the results of the different methods with each other and to observe the evolution of the symptoms in patients undergoing surgery or pessary use. The investigators would also like to discover existing problems in pessary use and adverse effects.

Detailed description

The rationale of the study is to investigate the results of a prolapse treatment in adult women with a vaginal prolapse. The investigators will investigate this by taking questionnaires in women undergoing a surgical prolapse repair and in women that are being treated by a vaginal pessary. The objective is to compare the results of the different methods with each other and to observe the evolution of the symptoms in patients undergoing surgery or pessary use. The investigators would also like to discover existing problems in pessary use and adverse effects.

The questionnaires that will be used are the PFDI-20 (pelvic floor distress inventory), PFIQ-7 (pelvic floor impact questionnaire), PISQ-9 (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire) and a custom-made questionnaire to further investigate the behavior towards pessary use of our patients and the adverse effects they are dealing with. The questionnaires will be taken before the treatment has started, 6 weeks post treatment start, one-year post treatment start, two years post treatment start and 5 years post treatment start. A POP-Q (Pelvic Organ Prolapse Quantification) investigation will be performed to estimate the degree of vaginal prolapse before the start of the treatment. Since clinical follow up is not necessarily needed after one year for the women who undergo surgery, their questionnaires will be taken via telephone or e-mail. For women that are being treated with pessaries the investigators will also take our custom-made questionnaire at 4 and 8 months after starting the treatment.

The investigators would like to recruit 100 women for this study, older than 18 years old who have not undergone a previous treatment with a pessary or surgery for vaginal prolapse. Another exclusion criterium are women who still have a child wish and women who have contraindications for surgery. The investigators will also exclude women who don't speak Dutch or women who cannot give a written consent.

The investigators hypothesize that woman being treated with one year of pessary use are overall not having more symptoms than woman that underwent a surgery. The investigators hypothesize that woman being treated with five years of pessary use are overall having less symptoms than woman that underwent a surgery.

Interventions

  • Device vaginal pessary
    insertion and follow up of a vaginal pessary
  • Procedure Vaginal prolapse surgery
    surgery and follow up after vaginal prolapse surgery

Primary outcome measures

  • Change in Pelvic Floor Disability Index (PFDI-20) [Time frame: Baseline, 6 weeks, one year, two years, five years]
  • Change in pelvic floor impact questionnaire (PFIQ-7) [Time frame: Baseline, 6 weeks, one year, two years, five years]
  • Change in Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) [Time frame: Baseline, 6 weeks, one year, two years, five years]
Secondary outcome measures (6)
  • Subjective self-reported satisfaction scores for pessary use as measured via a custom-made Likert scale questionnaire [Time frame: 4 months after start of therapy]
  • Subjective self-reported satisfaction scores for pessary use as measured via a custom-made Likert scale questionnaire [Time frame: 8 months after start of therapy]
  • Self-reported behavior and patient preferences towards pessary use via a custom-made questionnaire [Time frame: 4 months after initiation of therapy]
  • Self-reported behavior and patient preferences towards pessary use via a custom-made questionnaire [Time frame: 8 months after initiation of therapy]
  • Subjective self-reported adverse effects of pessary use as measured via a custom-made questionnaire [Time frame: 4 months after initiation of therapy]
  • Subjective self-reported adverse effects of pessary use as measured via a custom-made questionnaire [Time frame: 8 months after initiation of therapy]

Eligibility criteria

Inclusion criteria

  • women with a symptomatic vaginal prolapse
  • older than 18 years

Exclusion criteria

  • under 18 years old
  • undergone a previous treatment with a pessary or surgery for vaginal prolapse
  • contra-indications for surgery or pessary use
  • active or passive child wish
  • not able to understand the Dutch language
  • not able to give a written consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Belgium · 1 center
  • Ghent University Hospital — Ghent

Identifiers

NCT: NCT04701047 · BC-08720-ADP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗