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

NCT06494982 | Recruiting

• 1 other identifier: Vaginal flap
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Organ Prolapse

Keywords

pelvic organ prolapse; vaginal repair; vaginal mesh; sacrospinous fixation; vaginal flap

Outcome Measures

Primary Outcomes (1)

• Objective cure rate

  The patient is considered cured if there is no prolapse beyond the hymen and the cervix is above -1 cm according to POP-Q (0-1 stage)

  12 months (1 year)

Secondary Outcomes (4)

• Satisfaction with the surgery

  Measured postoperatively at intervals of 6, 12 months postoperatively, up to 100 weeks

• The impact of treatment on sexual function

  Measured postoperatively at intervals of 6, 12 months postoperatively, Measured postoperatively at intervals of 6, 12 months postoperatively, up to 100 weeks

• The impact of treatment on the quality of life

  Measured postoperatively at intervals of 6, 12 months postoperatively, Measured postoperatively at intervals of 6, 12 months postoperatively, up to 100 weeks

• Observed complications

  Measured postoperatively at intervals of 6, 12 months postoperatively, Measured postoperatively at intervals of 6, 12 months postoperatively, up to 100 weeks

Study Arms (2)

Sacrospinous hysteropexy with the synthetic mesh, vaginal flap and anterior colporrhaphy

ACTIVE COMPARATOR

Procedure: Sacrospinous hysteropexy with the synthetic mesh, vaginal flap and anterior colporrhaphy

Sacrospinous hysteropexy with the synthetic mesh and anterior colporrhaphy

ACTIVE COMPARATOR

Procedure: Sacrospinous hysteropexy with the synthetic mesh and anterior colporrhaphy

Interventions

Sacrospinous hysteropexy with the synthetic mesh, vaginal flap and anterior colporrhaphy PROCEDURE

Sacrospinous hysteropexy with the synthetic mesh, vaginal flap and anterior colporrhaphy

Sacrospinous hysteropexy with the synthetic mesh, vaginal flap and anterior colporrhaphy

Sacrospinous hysteropexy with the synthetic mesh and anterior colporrhaphy PROCEDURE

Sacrospinous hysteropexy with the synthetic mesh and anterior colporrhaphy

Sacrospinous hysteropexy with the synthetic mesh and anterior colporrhaphy

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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
• The subject is able to fill up validated questionnaires and come to the control visit after the surgery

You may not qualify 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, adenomyosis, multiple uterine myoma)
• The subject is planning pregnancy
• The subject is unable to visit postoperative check-ups
• Refusal from participation.

Sponsors & Collaborators

• Saint Petersburg State University, Russia: lead

Study Sites (1)

Saint-Petersburg State University Hospital

Saint Petersburg, 190103, Russia

RECRUITING

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Dmitry Shkarupa, MD, PhD

  Saint Petersburg State University, Russia

  STUDY CHAIR

Central Study Contacts

Denis Suchkov, MD

CONTACT

+79995218976; denis.urolog@yandex.ru

Rustam Shakhaliev, MD

CONTACT

+79312368664; rustam.shahaliev@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD; Director, St. Petersburg State University Hospital

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: July 10, 2024
• Study Start: May 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2025
• Last Updated: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)