Comparing two surgical methods for pelvic organ prolapse repair
The Influence of Augmentation of the Anterior Vaginal Wall With a Vascularized Flap on the Effectiveness of Mesh-augmented Sacrospinous Hysteropexy and Anterior Subfascial Colporrhaphy During Reconstruction of the Pelvic Floor for POP
This study is testing two different surgical methods for fixing pelvic organ prolapse in women aged 45-80 to see which one works better and improves their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 45 Years to 80 Years |
| Sex | Female |
| Sponsor | Saint Petersburg State University, Russia Academic / other |
| Locations | 1 site (Saint Petersburg) |
| Trial ID | NCT06494982 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness and safety of two surgical techniques for pelvic organ prolapse (POP) repair: sacrospinous hysteropexy with synthetic mesh and a vascularized anterior vaginal wall flap versus sacrospinous hysteropexy with synthetic mesh alone. The study will involve women aged 45-80 with anterior and apical compartment POP, assessing the impact of these procedures on surgical outcomes and quality of life. Participants will be randomly assigned to one of the two intervention groups, and their progress will be monitored through validated questionnaires and follow-up visits post-surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 45-80 with anterior and apical compartment pelvic organ prolapse.
Not a fit: Patients with active infections, prior hysterectomy, or certain gynecological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and lower recurrence rates for women undergoing pelvic organ prolapse repair.
How similar studies have performed: Previous studies have shown varying success with similar surgical techniques, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Saint Petersburg
- Saint-Petersburg State University Hospital — Saint Petersburg, Russia (Recruiting)
Study contacts
- Study coordinator: Denis Suchkov, MD
- Email: denis.urolog@yandex.ru
- Phone: +79995218976
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.