Transvaginal Human Acellular Dermal Matrix for Prolapse Treatment

Eligible patients will be women with symptomatic anterior and apical prolapse with hiatal ballooning or levator ani injury eligible for vaginal surgical treatment.

At the time of the indication for surgery, anatomical severity of the prolapse (according to the Pelvic Organ Prolapse Quantification System (POP-Q) scale) and the symptoms of prolapse and sexual function, as well as their impact on the quality of life of the patient, are evaluated using validated questionnaires "Pelvic Floor Impact Questionnaire (PFIQ)", "Pelvic organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)"and "European Quality of Life-5 Dimensions Questionnaire (EQ5D)". Anatomical severity of the prolapse will be also evaluated by ecography described as follows.

Three-dimensional 3D/4D transperineal ultrasound (TPS) will be performed using a GE Voluson® ultrasound system (GE Medical Systems) with a RAB 8-4-MHz transducer at an acquisition angle of 85°.

TPS will be performed with the probe covered with a powder-free glove and applied in the midsagittal plane to the introitus using moderate pressure. Volumes are acquired at rest, on maximum pelvic floor muscle contractility and during maximal Valsalva maneuver. Patients perform Valsalva for at least 5 s, and the best of three volumes is used for analysis. Using visual biofeedback, an attempt is made to correct for levator co-activation by requesting the women observe the narrowing and widening of the levator hiatus during the maneuvers.

3D volumes are measured offline using GE 4 Dimension View (GE Medical Systems). Using the best Valsalva maneuver, pelvic organ descent measurements are obtained relative to a horizontal line from the inferior margin of the pubic symphysis. Levator hiatal area is assessed in the plane of minimal hiatal dimensions.

Surgical indication will be determined by gynaecologists and the decision will be clearly dissociated from the decision of study inclusion. Therefore, the performance of the study should not modify the habits of surgical indication by the doctors.

The study will be a single-blinded study, as it is impossible to blind the health care workers involved for the surgical procedure to which the woman is randomized. The physician evaluating the patients during the follow-up will be blinded about the group the patients were randomized to.

Women will be randomly assigned after consenting for participation in the study, by means of an interactive response technology system in a 1:1:1 ratio to receive surgical treatment with vaginal hysterectomy followed by hADM anterior reinforcement and sacrospinous fixation with Anchorsure® device (NeomedicTM International, Spain), vaginal hysterectomy followed by sacrospinous fixation with Anchorsure® alone or classic vaginal hysterectomy with anterior colporrhaphy. A sacrospinous fixation-alone group was included to assess the impact of this technique in the principal surgery group. Patients will be followed-up at 4 weeks, 6 months, 12 months and annually till 36 months.

Anatomical results will be evaluated by a member of the team blinded to the surgery performed during follow-up visits after surgery and by 3D ultrasound of the pelvic floor. Functional results are evaluated using the validated questionnaires performed prior to surgery done by the patients during follow-up visits after surgery.

Inclusion criteria

• 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.
• Understand and accept the study procedures and sign the informed consent.

Exclusion criteria

• 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.
• Not signing the informed consent