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.
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 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
Parallel
Sacrospinous hysteropexy with the synthetic mesh, vaginal flap and anterior colporrhaphy
Procedure/SurgerySacrospinous hysteropexy with the synthetic mesh, vaginal flap and anterior colporrhaphy
Sacrospinous hysteropexy with the synthetic mesh and anterior colporrhaphy
Procedure/SurgerySacrospinous hysteropexy with the synthetic mesh and anterior colporrhaphy
Objective cure rate
The patient is considered cured if there is no prolapse beyond the hymen and the cervix is above -1 cm according to POP-Q (0-1 stage)
Satisfaction with the surgery
Measured through the Patient Global Impression of Improvement questionnaire (PGI-I), validated in Russia. The patient marks the number that best describes her post-operative condition, compared with how it was before surgery. The score ranges from 1 (very much better) to 7 (very much worse).
The impact of treatment on sexual function
Measured through the scoring of Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) validated in Russia. The scale evaluates sexual function in patients with urinary incontinence and/or POP. The responses are graded on a five-point Likert scale ranging from 0 (always) to 4 (never). Items 1 - 4 are reversely scored and a total of 48 is the maximum score. The higher scores indicate better sexual function.
The impact of treatment on the quality of life
Measured through the Pelvic Floor Disability Index (PFDI-20), validated in Russia. The item includes 20 questions. The score ranges from 0 to 300. The higher the score, the worse the outcome.
Observed complications
Presence of any adverse effects such as: bleeding requiring blood transfusion, haematoma, organ perforation, nerve injury, vaginal scarring and shortening, wound infection, urinary tract infection, pelvic pain, mesh extrusion in the vagina, mesh erosion into the urinary tract, dyspareunia de novo, de novo urgency, atonic bladder, de novo stress urinary incontinence.
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