Observing treatment outcomes for vaginal prolapse in women
Prospective Observational Study with Patient Reported Outcome Measures (PROM) for the Treatment of Vaginal Prolapse: Pessary Vs. Surgery
This study tests how well different treatments for vaginal prolapse, like surgery and using a pessary, work for women and how they feel about them over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital, Ghent Academic / other |
| Locations | 1 site (Ghent) |
| Trial ID | NCT04701047 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of different treatments for vaginal prolapse in adult women, specifically comparing surgical repair and vaginal pessary use. Participants will complete a series of questionnaires before treatment and at various intervals post-treatment to assess symptom evolution and treatment outcomes. The study aims to identify any issues related to pessary use and document adverse effects associated with both treatment methods. The findings will help improve understanding of treatment efficacy and patient experiences.
Who should consider this trial
Good fit: Ideal candidates are adult women over 18 years old who are experiencing symptomatic vaginal prolapse.
Not a fit: Patients who have previously undergone treatment for vaginal prolapse or have contraindications for surgery or pessary use may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance treatment strategies for vaginal prolapse, leading to improved patient outcomes and satisfaction.
How similar studies have performed: Other studies have shown success in evaluating treatment outcomes for vaginal prolapse, making this approach both relevant and valuable.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ghent
- Ghent University Hospital — Ghent, Belgium (Recruiting)
Study contacts
- Principal investigator: Tjalina Hamerlynck — UZ Gent
- Study coordinator: Kessewa Abosi-Appeadu
- Email: kessewa.abosiappeadu@ugent.be
- Phone: +32 9 332 3774
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.