The Influence of Using Vascularized Vaginal Flap on the Efficacy of Mesh-augmented Sacrospinous Hysteropexy
NCT Number: NCT06494982
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pelvic Organ Prolapse
Interventions: PROCEDURE: Sacrospinous hysteropexy with the synthetic mesh, vaginal flap and anterior colporrhaphy|PROCEDURE: Sacrospinous hysteropexy with the synthetic mesh and anterior colporrhaphy
Sponsor: Saint Petersburg State University, Russia
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-01
Completion Date: 2025-10-01
Locations: Saint-Petersburg State University Hospital, Saint Petersburg, 190103, Russian Federation

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.

Primary Outcome Measures: 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), 12 months (1 year)
Secondary Outcome Measures: 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)., Measured postoperatively at intervals of 6, 12 months postoperatively, up to 100 weeks|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., Measured postoperatively at intervals of 6, 12 months postoperatively, Measured postoperatively at intervals of 6, 12 months postoperatively, up to 100 weeks|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., Measured postoperatively at intervals of 6, 12 months postoperatively, Measured postoperatively at intervals of 6, 12 months postoperatively, up to 100 weeks|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., Measured postoperatively at intervals of 6, 12 months postoperatively, Measured postoperatively at intervals of 6, 12 months postoperatively, up to 100 weeks