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Recruiting NCT06494982

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

Trial Parameters

Condition Pelvic Organ Prolapse
Sponsor Saint Petersburg State University, Russia
Study Type INTERVENTIONAL
Phase N/A
Enrollment 60
Sex FEMALE
Min Age 45 Years
Max Age 80 Years
Start Date 2024-05-01
Completion 2024-10-01
Interventions
Sacrospinous hysteropexy with the synthetic mesh, vaginal flap and anterior colporrhaphySacrospinous hysteropexy with the synthetic mesh and anterior colporrhaphy

Brief Summary

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

Inclusion Criteria: * 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 * The subject is able to evaluate the risks of the treatment and make an independent decision on participation in the study * The subject is able to fill up validated questionnaires and come to the control visit after the surgery Exclusion Criteria: * 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 * The subject has cervical elongation * The subject has gynecological diseases (recurrent uterine bleeding, endometrial hyperplasia, the presence of atypic

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