Prospective Observational Prolapse Study

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

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.

Study Overview

• Status: Recruiting
• Conditions: Vaginal Prolapse
• Intervention / Treatment: Device: vaginal pessary; Procedure: Vaginal prolapse surgery

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Kessewa Abosi-Appeadu; Phone Number: +32 9 332 3774; Email: kessewa.abosiappeadu@ugent.be
• Study Contact Backup: Name: Steffi Van Wessel; Phone Number: +32 9 332 0289; Email: steffi.vanwessel@ugent.be

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Recruiting
    • Ghent University Hospital
    • Contact: Eline Meireson; Phone Number: 09/332 78 17; Email: eline.meireson@uzgent.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The research population will include women above the age of 18 years old who consult the department of urology or the department of gynaecology at the university hospital of Ghent with symptoms of vaginal prolapse. The patients will be recruited by their attending physician. There will be no exclusion on the degree of vaginal prolapse. All symptomatic prolapses will be included in this study. Exclusion criteria will be having undergone a previous treatment with a pessary or surgery for vaginal prolapse, contraindications for surgery or pessary use, active of passive child wish, not able to understand the Dutch language and not able to give a written consent.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
pessary; Vaginal prolapse being treated by pessary	Device: vaginal pessary; insertion and follow up of a vaginal pessary
surgery; Vaginal prolapse being treated by surgical repair	Procedure: Vaginal prolapse surgery; surgery and follow up after vaginal prolapse surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pelvic Floor Disability Index (PFDI-20)	Change in scores on the short-form version of the Pelvic Floor Distress Inventory (PFDI). It is a health-related quality of life questionnaire for women with pelvic floor conditions to fill out.	Baseline, 6 weeks, one year, two years, five years
Change in pelvic floor impact questionnaire (PFIQ-7)	Change in scores on the shortened version of the Pelvic Floor Impact Questionnaire (PFIQ). It is a health-related quality of life questionnaire for women with pelvic floor conditions to fill out.	Baseline, 6 weeks, one year, two years, five years
Change in Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)	Change in scores on the short form of the PISQ-31 that evaluates sexual function in women with urinary incontinence and/or pelvic organ prolapse	Baseline, 6 weeks, one year, two years, five years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective self-reported satisfaction scores for pessary use as measured via a custom-made Likert scale questionnaire	Study participants are asked how satisfied they are with their pessary use at 4 months after the initiation of pessary use. Participants can choose one of five graded answers on the Likert scale: 5 Very satisfied 4 satisfied 3 neutral 2 unsatisfied 1 very unsatisfied	4 months after start of therapy
Subjective self-reported satisfaction scores for pessary use as measured via a custom-made Likert scale questionnaire	Study participants are asked how satisfied they are with their pessary use at 8 months after the initiation of pessary use. Participants can choose one of five graded answers on the Likert scale: 5 Very satisfied 4 satisfied 3 neutral 2 unsatisfied 1 very unsatisfied	8 months after start of therapy
Self-reported behavior and patient preferences towards pessary use via a custom-made questionnaire	frequency of pessary use, subjective reasons why not to wear a pessary and alternative treatment considerations as assessed by open-ended and yes or no type questions	4 months after initiation of therapy
Self-reported behavior and patient preferences towards pessary use via a custom-made questionnaire	frequency of pessary use, subjective reasons why not to wear a pessary and alternative treatment considerations as assessed by open-ended and yes or no type questions	8 months after initiation of therapy
Subjective self-reported adverse effects of pessary use as measured via a custom-made questionnaire	Participants will be asked if they experienced side effects that they feel has been caused by pessary use via a custom-made questionnaire: The most commonly anticipated answers have been listed with the option of patients describing other potential adverse events (shown below): No side effects; It feels uncomfortable; It gives an itchy/burning sensation; More vaginal discharge; Other……….	4 months after initiation of therapy
Subjective self-reported adverse effects of pessary use as measured via a custom-made questionnaire	Participants will be asked if they experienced side effects that they feel has been caused by pessary use via a custom-made questionnaire: The most commonly anticipated answers have been listed with the option of patients describing other potential adverse events (shown below): No side effects; It feels uncomfortable; It gives an itchy/burning sensation; More vaginal discharge; Other……….	8 months after initiation of therapy

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of pessaries tried before current pessary	Number of pessaries that are being fitted before finding a suitable one via a custom made questionnaire.	4 months after initiation of therapy
Amount of pessaries tried before current pessary	Number of pessaries that are being fitted before finding a suitable one via a custom made questionnaire.	8 months after initiation of therapy
Duration of the pessary consultation	Duration of a pessary consultation in minutes.	4 months after initiation of therapy
Duration of the pessary consultation	Duration of a pessary consultation in minutes.	8 months after initiation of therapy

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Investigators: Principal Investigator: Tjalina Hamerlynck, UZ Gent; Principal Investigator: Steven Weyers, UZ Gent; Study Director: Van Wessel Steffi, UZ Gent; Study Chair: Abosi Appeadu Kessewa, UZ Gent; Study Chair: Decalf Veerle, UZ Gent

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2021
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: December 2, 2020
• First Submitted That Met QC Criteria: January 7, 2021
• First Posted (Actual): January 8, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 13, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathological Conditions, Anatomical; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Pelvic Organ Prolapse; Prolapse; Uterine Prolapse
• Other Study ID Numbers: BC-08720-ADP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No