Actively Recruiting

Phase Not Applicable
Age: 45Years - 80Years
FEMALE
NCT06494982

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

Age: 45Years - 80Years
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Saint-Petersburg State University Hospital

Saint Petersburg, Russia, 190103

Actively Recruiting

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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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