The Influence of Using Vascularized Vaginal Flap on the Efficacy of Mesh-augmented Sacrospinous Hysteropexy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-80
SponsorSaint Petersburg State University, Russia

About this trial

This is a prospective randomized controlled trial designed to compare the effectiveness and safety of two methods of pelvic floor reconstruction in patients with pelvic organ prolapse (POP): sacrospinous hysteropexy (SSHP) with synthetic mesh, vascularized anterior vaginal wall flap, anterior colporrhaphy, and sacrospinous hysteropexy with synthetic mesh. , anterior colporrhaphy, as well as the impact of surgery on quality of life.

Eligibility criteria

Qualifiers

The subject is a woman with anterior and apical compartment pelvic organ prolapse

The age of a subject is 45-80 years

Leading point of prolapse is at the level of the hymen or distal to the hymen (Ba, C>=1 according to POP-Q classification)

The subject gave written consent to participate in the study

Disqualifiers

The subject has an active urinary tract infection or skin infection in the region of surgery or acute infectious disease

The subject had prior hysterectomy

The subject has previously diagnosed or currently active cancer

The subject has chronic pelvic pain

Trial design

Treatments tested in this trial

  • Sacrospinous hysteropexy with the synthetic mesh, vaginal flap and anterior colporrhaphy
  • Sacrospinous hysteropexy with the synthetic mesh and anterior colporrhaphy

Treatment groups

60 Participants
are divided into 2 treatment groups