NCT06494982 The Influence of Using Vascularized Vaginal Flap on the Efficacy of Mesh-augmented Sacrospinous Hysteropexy
| NCT ID | NCT06494982 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Saint Petersburg State University, Russia |
| Condition | Pelvic Organ Prolapse |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2024-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-05-01 with a primary completion date of 2024-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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): 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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Dmitry Shkarupa, MD, PhD
STUDY CHAIR
Saint Petersburg State University, Russia
Frequently Asked Questions
Who can join the NCT06494982 clinical trial?
This trial is open to female participants only, aged 45 Years or older, up to 80 Years, studying Pelvic Organ Prolapse. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06494982 currently recruiting?
Yes, NCT06494982 is actively recruiting participants. Contact the research team at denis.urolog@yandex.ru for enrollment information.
Where is the NCT06494982 trial being conducted?
This trial is being conducted at Saint Petersburg, Russia.
Who is sponsoring the NCT06494982 clinical trial?
NCT06494982 is sponsored by Saint Petersburg State University, Russia. The principal investigator is Dmitry Shkarupa, MD, PhD at Saint Petersburg State University, Russia. The trial plans to enroll 60 participants.