Recruiting NA Pelvic Organ Prolapse

Tests treatment safety and results for Pelvic Organ Prolapse

Official title The Influence of Using Vascularized Vaginal Flap on the Efficacy of Mesh-augmented Sacrospinous Hysteropexy

ClinicalTrials.gov ID: NCT06494982

What this study is testing

What it's testing
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.
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 45 to 80, women only

You may be able to join if

  • 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

You likely can't join if

  • 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...
See the full eligibility criteria
Who can join
  • 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
What rules you out
  • 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.

The study team makes the final eligibility decision.

Where it's taking place

  • Saint Petersburg, Russia

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling female, 45 years to 80 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Saint Petersburg, Russia. Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.