Actively Recruiting
The Influence of Using Vascularized Vaginal Flap on the Efficacy of Mesh-augmented Sacrospinous Hysteropexy
Led by Saint Petersburg State University, Russia · Updated on 2024-07-10
60
Participants Needed
1
Research Sites
74 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Influence of Using Vascularized Vaginal Flap on the Efficacy of Mesh-augmented Sacrospinous Hysteropexy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Woman with anterior and apical pelvic organ prolapse
- Age between 45 and 80 years
- Leading point of prolapse at or beyond the hymen level (Ba, C \u22651 according to POP-Q)
- Provided written consent to participate
- Able to understand treatment risks and decide independently
- Able to complete questionnaires and attend post-surgery follow-up visits
You will not qualify if you...
- Active urinary tract infection, skin infection near surgery area, or acute infectious disease
- Prior hysterectomy
- Diagnosed or active cancer
- Chronic pelvic pain
- Cervical elongation
- Gynecological diseases such as recurrent uterine bleeding, endometrial hyperplasia, atypical cervical cells, adenomyosis, or multiple uterine myoma
- Planning pregnancy
- Unable to attend postoperative check-ups
- Refusal to participate
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Saint-Petersburg State University Hospital
Saint Petersburg, Russia, 190103
Actively Recruiting
Research Team
D
Denis Suchkov, MD
CONTACT
R
Rustam Shakhaliev, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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