Transvaginal Human Acellular Dermal Matrix for Prolapse Treatment
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-100
SponsorHospital Mutua de Terrassa
About this trial
This is a randomised study in which we compare the effectiveness of three different procedures in mending symptomatic anterior and apical prolapse in patients who are candidates to receive surgery.
They will be randomly assigned in a ratio 1:1:1 to three different groups who will have assigned three different kinds of surgery. In the patients of the first group a classic vaginal hysterectomy with anterior colporrhaphy will be practised. Patients who belong to group two will undergo a vaginal hysterectomy followed by placement of an acellular dermal matrix from cadaveric donors (hADM) for anterior reinforcement and sacrospinous fixation with Anchorsure® device (Neomedic trade mark (TM) International, Spain). Finally, patients from group three will have vaginal hysterectomy followed by sacrospinous fixation with Anchorsure® alone .
Patients will be followed-up at 4 weeks, 6 months, 12 months and annually till 36 months to evaluate relapses and possible complications.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women with symptomatic POP with indication of vaginal surgery.
Women with hiatal ballooning or levator ani injury evaluated by 3D pelvic floor ultrasound.
Women ≥18 years old.
Women wishing to complete a 36-month follow-up.
Disqualifiers
Women with previous pelvic floor or prolapse surgery
Women with POP grade IV
Women with chronic pelvic pain.
Not being able to understand the nature of the study and/or the procedures to be followed.
Trial design
Design model
Parallel
Treatments tested in this trial
Vaginal hysterectomy plus matrix reinforcement and sacrospinous fixation with Anchorsure® device
Procedure/SurgeryVaginal hysterectomy plus matrix reinforcement and sacrospinous fixation with Anchorsure® device
Vaginal hysterectomy plus anterior colporrhaphy
Procedure/SurgeryVaginal hysterectomy plus anterior colporrhaphy
Vaginal hysterectomy plus sacrospinous fixation with Anchorsure® device
Procedure/SurgeryVaginal hysterectomy plus sacrospinous fixation with Anchorsure® device
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Vaginal hysterectomy plus anterior colporrhaphySham comparator 1 intervention
Group B: Vaginal hysterectomy plus sacrospinous fixation with Anchorsure® deviceSham comparator 1 intervention
Group C: Vaginal hysterectomy plus matrix reinforcement and sacrospinous fixation with Anchorsure® deviceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Recurrence of anatomical anterior vaginal wall prolapse
Defined as point Ba POP-Q stage ≥II by clinical examination
Time frame
36 monthsSecondary outcomes
1
Difference between groups in anatomical prolapse
Defined as point C POP-Q stage ≥II by clinical examination
Time frame
36 moths2
Differences between groups in symptomatic recurrence
Evaluated by Pelvic Floor Impact Questionnaire. Minimum value: 0. Maximum value: 300. The higher the value worse is the outcome
Time frame
36 months3
Differences between groups in quality of Life
Evaluated by European Quality of Life-5 Dimensions Questionnaire. Minimum value: 0. Maximum value: 1. The higher the value the worse is the outcome
Time frame
36 months4
Differences between groups in sexual functioning.
Evaluated by Pelvic organ Prolapse/Urinary Incontinence Sexual Questionnaire. Minimum value: 0. Maximum value: 100. The higher the value the worse is the outcome
Time frame
36 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hospital Mutua de Terrassa
Lead sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborator
Germans Trias i Pujol Hospital
Collaborator
Hospital Arnau de Vilanova
Collaborator
Source ClinicalTrials.gov