Transvaginal Human Acellular Dermal Matrix for Prolapse Treatment

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Vaginal hysterectomy plus anterior colporrhaphy: Vaginal hysterectomy plus anterior colporrhaphy

Vaginal hysterectomy plus sacrospinous fixation with Anchorsure® device: Vaginal hysterectomy plus sacrospinous fixation with Anchorsure® device

Study 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

Primary outcome measure(s)

• Recurrence of anatomical anterior vaginal wall prolapse — 36 months
  Defined as point Ba POP-Q stage ≥II by clinical examination

Trial sites (1)

More Hospital Mutua de Terrassa trials in Spain