Prospective Observational Prolapse Study

NCT04701047 | Recruiting

• 1 other identifier: BC-08720-ADP
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vaginal Prolapse

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Subjective self-reported satisfaction scores for pessary use as measured via a custom-made Likert scale questionnaire

  4 months after start of therapy

• Subjective self-reported satisfaction scores for pessary use as measured via a custom-made Likert scale questionnaire

  8 months after start of therapy

• Self-reported behavior and patient preferences towards pessary use via a custom-made questionnaire

  4 months after initiation of therapy

• Self-reported behavior and patient preferences towards pessary use via a custom-made questionnaire

  8 months after initiation of therapy

• Subjective self-reported adverse effects of pessary use as measured via a custom-made questionnaire

  4 months after initiation of therapy

Other Outcomes (4)

• Amount of pessaries tried before current pessary

  4 months after initiation of therapy

• Amount of pessaries tried before current pessary

  8 months after initiation of therapy

• Duration of the pessary consultation

  4 months after initiation of therapy

Study Arms (2)

pessary

Vaginal prolapse being treated by pessary

Device: vaginal pessary

surgery

Vaginal prolapse being treated by surgical repair

Procedure: Vaginal prolapse surgery

Interventions

vaginal pessary DEVICE

insertion and follow up of a vaginal pessary

pessary

Vaginal prolapse surgery PROCEDURE

surgery and follow up after vaginal prolapse surgery

surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Uterine Prolapse

Interventions

Pessaries

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pelvic Organ Prolapse; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies

Study Officials

• Tjalina Hamerlynck

  UZ Gent

  PRINCIPAL INVESTIGATOR

• Steven Weyers

  UZ Gent

  PRINCIPAL INVESTIGATOR

• Van Wessel Steffi

  UZ Gent

  STUDY DIRECTOR

• Abosi Appeadu Kessewa

  UZ Gent

  STUDY CHAIR

• Decalf Veerle

  UZ Gent

  STUDY CHAIR

Central Study Contacts

Kessewa Abosi-Appeadu

CONTACT

+32 9 332 3774; kessewa.abosiappeadu@ugent.be

Steffi Van Wessel

CONTACT

+32 9 332 0289; steffi.vanwessel@ugent.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: January 8, 2021
• Study Start: September 3, 2021
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: January 15, 2025

Record last verified: 2025-01

Locations

BE (1)