The Influence of Simultaneous Posterior Colporrhaphy and Perineoplasty on the Efficiency and Safety of Mesh-augmented Sacrospinal Fixation (Apical Sling) in Advanced POP Repair.

NCT05422209 | Active Not Recruiting

• 1 other identifier: SSF and perineoplasty
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective randomized controlled study, designed to assess the influence of posterior colporrhaphy and perineoplasty performed simultaneously with mesh-augmented sacrospinal fixation (apical sling) in advanced pelvic organ prolapse repair.

Conditions

Pelvic Organ Prolapse

Keywords

pelvic organ prolapse; vaginal repair; vaginal mesh; sacrospinous fixation; colporrhaphy; perineoplasty

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)

  24 months (2 years)

Secondary Outcomes (4)

• Satisfaction with the surgery

  Measured postoperatively at intervals of 6, 12 and 24 months postoperatively

• The impact of treatment on sexual function

  Measured postoperatively at intervals of 6, 12 and 24 months postoperatively

• The impact of treatment on the quality of life

  Measured postoperatively at intervals of 6, 12 and 24 months postoperatively

• Observed complications

  Measured postoperatively at intervals of 6, 12 and 24 months postoperatively

Study Arms (2)

Mesh-augmented sacrospinal fixation with posterior colporrhaphy and perineoplasty.

ACTIVE COMPARATOR

Procedure: Mesh-augmented sacrospinal fixation with posterior colporrhaphy and perineoplasty.

Mesh-augmented sacrospinal fixation with posterior colporrhaphy.

ACTIVE COMPARATOR

Procedure: Mesh-augmented sacrospinal fixation with posterior colporrhaphy.

Interventions

Mesh-augmented sacrospinal fixation with posterior colporrhaphy and perineoplasty. PROCEDURE

Vaginal mesh-augmented sacrospinal fixation with posterior colporrhaphy and perineoplasty.

Mesh-augmented sacrospinal fixation with posterior colporrhaphy and perineoplasty.

Mesh-augmented sacrospinal fixation with posterior colporrhaphy. PROCEDURE

Vaginal mesh-augmented sacrospinal fixation with posterior colporrhaphy.

Mesh-augmented sacrospinal fixation with posterior 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 age of a subject is 45 to 80 years.
• Leading point of prolapse is at the level of the hymen or distal to the hymen (Ba, C\>=0 according to POP-Q classification)
• Patient's ability to read and sign the informed consent form.
• Socialized patient who is able to fill in validated questionnaires and arrive for control postoperative examination in future.
• Patient's consent for participation in the study.

You may not qualify if:

• The subject has presence of oncologic disease which was diagnosed earlier or is active now.
• The subject had prior surgery for POP, SUI or hysterectomy
• The subject has gynecological deseases (recurrent uterine bleeding, endometrial hyperplasia, the presence of atypical cells in cervical smears, adenomyosis, multiple uterine myoma)
• The subject has urinary incontinence
• The subject is planning pregnancy
• The subject has an active urinary tract infection or skin infection in the region of surgery or acute infectious desease
• The subject is unable to visit postoperative check-ups
• Refusal from participation.
• Bp \> C according to POP-Q system.
• gh \< 4 cm and \> 6 cm according to POP-Q system.

Sponsors & Collaborators

• Saint Petersburg State University, Russia: lead

Study Sites (1)

Saint-Petersburg State University Hospital

Saint Petersburg, 190103, Russia

Location

Related Publications (1)

• Shakhaliev RA, Shulgin AS, Kubin ND, Kondratiev AS, Suchkov DA, Neklasova SV, Shkarupa DD. The influence of simultaneous posterior colporrhaphy and perineoplasty on the efficiency and safety of mesh-augmented sacrospinal fixation (apical sling) in advanced POP repair. Trials. 2024 Oct 2;25(1):647. doi: 10.1186/s13063-024-08448-4.

  PMID: 39358750 DERIVED

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

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: Ph.D., Deputy Director for medical care, Chief Urologist of Saint Petersburg State University Clinic of advanced medical technologies n.a. N.I.Pirogov.

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: June 16, 2022
• Study Start: September 9, 2022
• Primary Completion: March 9, 2024
• Study Completion: May 9, 2025
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)