Status:
ACTIVE_NOT_RECRUITING
The Influence of Simultaneous Posterior Colporrhaphy and Perineoplasty on the Efficiency and Safety of Mesh-augmented Sacrospinal Fixation (Apical Sling) in Advanced POP Repair.
Lead Sponsor:
Saint Petersburg State University, Russia
Conditions:
Pelvic Organ Prolapse
Eligibility:
FEMALE
45-80 years
Phase:
NA
Brief Summary
This is a prospective randomized controlled study, designed to assess the influence of posterior colporrhaphy and perineoplasty performed simultaneously with mesh-augmented sacrospinal fixation (apica...
Detailed Description
BACKGROUND Pelvic organ prolapse (POP) is revealed by the gynecological examination in 40-60 % of parous women. A pelvic floor defect is represented by cystocele almost in a half of cases. At the same...
Eligibility Criteria
Inclusion
- The age of a subject is 45 to 80 years.
- Leading point of prolapse is at the level of the hymen or distal to the hymen (Ba, C\>=0 according to POP-Q classification)
- Patient's ability to read and sign the informed consent form.
- Socialized patient who is able to fill in validated questionnaires and arrive for control postoperative examination in future.
- Patient's consent for participation in the study.
Exclusion
- The subject has presence of oncologic disease which was diagnosed earlier or is active now.
- The subject had prior surgery for POP, SUI or hysterectomy
- The subject has gynecological deseases (recurrent uterine bleeding, endometrial hyperplasia, the presence of atypical cells in cervical smears, adenomyosis, multiple uterine myoma)
- The subject has urinary incontinence
- The subject is planning pregnancy
- The subject has an active urinary tract infection or skin infection in the region of surgery or acute infectious desease
- The subject is unable to visit postoperative check-ups
- Refusal from participation.
- Bp \> C according to POP-Q system.
- gh \< 4 cm and \> 6 cm according to POP-Q system.
Key Trial Info
Start Date :
September 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 9 2025
Estimated Enrollment :
310 Patients enrolled
Trial Details
Trial ID
NCT05422209
Start Date
September 9 2022
End Date
May 9 2025
Last Update
July 3 2024
Active Locations (1)
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1
Saint-Petersburg State University Hospital
Saint Petersburg, Russia, 190103