NCT04701047

Prospective Observational Prolapse Study

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Vaginal Prolapse

Interventions

Type	Name	Description
DEVICE	vaginal pessary	insertion and follow up of a vaginal pessary
PROCEDURE	Vaginal prolapse surgery	surgery and follow up after vaginal prolapse surgery

Timeline

• Start date: 2021-09-03
• Primary completion: 2028-01-01
• Completion: 2028-01-01
• First posted: 2021-01-08
• Last updated: 2025-01-15

Locations

1 site across 1 country: Belgium