Status:
UNKNOWN
Comparison of Vaginal and Laparoscopic Apical Fixation Techniques for Pelvic Organ Prolapse Treatment
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 compare efficacy and safety of two methods of apical fixation in patients with pelvic organ prolapse (POP) - sacrospinous hysteropexy (SS...
Detailed Description
BACKGROUND POP remains a widespread condition, that significantly affects patients' quality of life. The estimated incidence of POP in women varies from 10% in young age to 40% after menopause. Apical...
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\>=0 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 surgery for POP, stress urinary incontinence (SUI) or hysterectomy
- The subject has history of pelvic cancer
- The subject has chronic pelvic pain
- The subject has cervical elongation
- The subject has severe obesity (BMI \> 30)
- The subject has postoperative scars/suspected adhesions in the ares of surgical access to the abdomen
- The subject has gynecological diseases (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 is unable to visit postoperative check-ups
- Refusal from participation.
Key Trial Info
Start Date :
September 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 9 2025
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT05420831
Start Date
September 9 2022
End Date
May 9 2025
Last Update
December 27 2023
Active Locations (1)
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1
Saint-Petersburg State University Hospital
Saint Petersburg, Russia, 190103