RecruitingPhase 2NCT06404931

Transvaginal Human Acellular Dermal Matrix for Prolapse Treatment

Transvaginal Human Acellular Dermal Matrix and Sacrospinous Fixation for Anterior and Apical Prolapse Treatment in Patients With Hiatal Ballooning or Levator Ani Injury: a Randomized Pilot Trial


Sponsor

Hospital Mutua de Terrassa

Enrollment

90 participants

Start Date

Jul 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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

Sex: FEMALEMin Age: 18 YearsMax Age: 100 Years

Inclusion Criteria5

  • 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 Criteria5

  • 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

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Interventions

PROCEDUREVaginal hysterectomy plus matrix reinforcement and sacrospinous fixation with Anchorsure® device

Vaginal hysterectomy plus matrix reinforcement and sacrospinous fixation with Anchorsure® device

PROCEDUREVaginal hysterectomy plus anterior colporrhaphy

Vaginal hysterectomy plus anterior colporrhaphy

PROCEDUREVaginal hysterectomy plus sacrospinous fixation with Anchorsure® device

Vaginal hysterectomy plus sacrospinous fixation with Anchorsure® device


Locations(1)

Hospital Mutua de Terrassa

Terrassa, Spain

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NCT06404931


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