Comparison of Vaginal and Laparoscopic Apical Fixation Techniques for Pelvic Organ Prolapse Treatment

NCT05420831 | Unknown

• 1 other identifier: Vaginal_or_laparoscopic
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective randomized controlled study, designed to compare efficacy and safety of two methods of apical fixation in patients with pelvic organ prolapse (POP) - sacrospinous hysteropexy (SSHP) with synthetic mesh and laparoscopic sacrohysteropexy (LSHP), and the impact of the surgery on quality of life.

Conditions

Pelvic Organ Prolapse

Keywords

sacrohysteropexy; pelvic organ prolapse; apical prolapse; vaginal repair; vaginal mesh; sacrospinous fixation

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)

Sacrospinous fixation of the vaginal apex with the synthetic mesh

ACTIVE COMPARATOR

Procedure: Vaginal

Laparoscopic sacrocolpopexy

ACTIVE COMPARATOR

Procedure: Laparoscopic

Interventions

Vaginal PROCEDURE

Sacrospinous hysteropexy using the synthetic mesh

Sacrospinous fixation of the vaginal apex with the synthetic mesh

Laparoscopic PROCEDURE

Laparoscopic Sacrohysteropexy

Laparoscopic sacrocolpopexy

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\>=0 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 surgery for POP, stress urinary incontinence (SUI) or hysterectomy
• The subject has history of pelvic cancer
• The subject has chronic pelvic pain
• The subject has cervical elongation
• The subject has severe obesity (BMI \> 30)
• The subject has postoperative scars/suspected adhesions in the ares of surgical access to the abdomen
• The subject has gynecological diseases (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 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

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

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 15, 2022
• Study Start: September 9, 2022
• Primary Completion: August 2, 2023
• Study Completion: May 9, 2025
• Last Updated: December 27, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)