Observing treatment outcomes for vaginal prolapse in women
Official title: Prospective Observational Study with Patient Reported Outcome Measures (PROM) for the Treatment of Vaginal Prolapse: Pessary Vs. Surgery
Run by University Hospital, Ghent · NCT04701047 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 200 (estimated) |
| Sponsor | University Hospital, Ghent Academic / other |
| Locations | 1 site (Ghent) |
| Status | Recruiting |
| Started | September 3, 2021 |
| Main results expected | January 2028 |
| Study ends | January 2028 |
| Registry record updated | January 15, 2025 |
| Trial ID | NCT04701047 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adult women over 18 years old who are experiencing symptomatic vaginal prolapse.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown success in evaluating treatment outcomes for vaginal prolapse, making this approach both relevant and valuable.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Comparing two procedures for treating stress urinary incontinence during vaginal prolapse repair
This study is testing whether a new type of surgery or an injection is better for helping women with stress urinary incontinence during vaginal prolapse repair.
-
Treatment of vaginal atrophy using a low-intensity laser
This study is testing whether a low-intensity laser treatment can improve vaginal health in postmenopausal women who are dealing with vaginal atrophy.
-
Comparing the Manchester procedure versus vaginal hysterectomy for uterine prolapse
This study tests whether the Manchester procedure or vaginal hysterectomy works better for women with symptomatic uterine prolapse over a two-year follow-up.
-
Amniotic membrane grafting added to mesh surgery for pelvic prolapse and incontinence
This study tests whether adding a human amniotic membrane graft to polypropylene mesh surgeries helps patients with pelvic organ prolapse and stress urinary incontinence heal better and reduce complications.
-
Vaginal versus robotic-assisted abdominal mesh repair for apical prolapse
This study will test whether vaginal mesh repair works as well and is as safe as robotic-assisted abdominal mesh repair for women with stage II or higher apical pelvic organ prolapse.
-
Wrist activity tracking to guide early recovery after pelvic organ prolapse surgery
This study will try giving women having pelvic organ prolapse surgery either usual postoperative advice or a guided early-exercise plan while tracking activity with a wrist accelerometer to see which group reaches "mostly recovered" sooner.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.