Status:
RECRUITING
The Influence of Using Vascularized Vaginal Flap on the Efficacy of Mesh-augmented Sacrospinous Hysteropexy
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 trial designed to compare the effectiveness and safety of two methods of pelvic floor reconstruction in patients with pelvic organ prolapse (POP): sacrospin...
Detailed Description
BACKGROUND POP is an epidemiologically widespread condition, occurring in 40-60% of women who have given birth. With all the variety of anatomical defects of the pelvic floor, the most common variant ...
Eligibility Criteria
Inclusion
- 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
- 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 atypical cells in cervical smears, adenomyosis, multiple uterine myoma)
- The subject is planning pregnancy
- The subject is unable to visit postoperative check-ups
- Refusal from participation.
Key Trial Info
Start Date :
May 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06494982
Start Date
May 1 2024
End Date
October 1 2025
Last Update
July 10 2024
Active Locations (1)
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1
Saint-Petersburg State University Hospital
Saint Petersburg, Russia, 190103