Vaginal Native Tissues Repair for Pelvic Organ Prolapse
ConditionProlapse, Vaginal
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age50+
SponsorUniversity Hospital, Limoges
About this trial
The aim of the study is to assess at one year the effectiveness of the vaginal patch plastron in comparison of the anterior colporraphy through a combined definition of success: anatomic and functional.
Eligibility criteria
Qualifiers
Patient at 50 years of age or older
Symptomatic primary prolapse of the anterior vaginal wall defined by Aa and/or Ba points ≥0 according to the POP-Q system
A positive response to the question "Do you usually have a bulge or something falling out that you can see or feel in your vaginal area?" (question 3 of the PFDI-20)
Able to give informed consent
Disqualifiers
Patient with need for surgical treatment for myorraphy of levator ani muscles
Patient with previous surgical cystocele repair.
Patient with evolving gynaecologic cancer.
Pregnancy or wish for future pregnancy, lactating woman.
Trial design
Treatments tested in this trial
- Anterior colporraphy
- vaginal patch plastron
Treatment groups
214 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov