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