NCT05420831

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

Comparison the Effectiveness and Safety of Vaginal and Laparoscopic Apical Fixation Techniques Using a Synthetic Mesh for Pelvic Organ Prolapse Treatment. A Randomized Controlled Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Saint Petersburg State University, Russia · Academic / Other
• Sex: Female
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

BACKGROUND POP remains a widespread condition, that significantly affects patients' quality of life. The estimated incidence of POP in women varies from 10% in young age to 40% after menopause. Apical defect is the least frequent of all types of POP and occurs in 5-15% of patients, however apical support is crucial to maintaining normal anatomy of the pelvic floor. Although the uterus itself is not the cause of POP, hysterectomy is the most common surgery for POP. However there is a growing interest in uterine-sparing surgical techniques because a lot of women express a desire to preserve uterus. There are various techniques for uterine-sparing apical repair, including abdominal (laparoscopic or robotic) and vaginal apical fixation. SSHP is the most studied method of apical fixation and was originally performed with sutures. The use of transvaginal mesh for SSHP is discussable in conjunction with numerous reports of complications and wariness towards synthetic materials use. Some authors though reported of comparable effectiveness and high safety of SSHP using mesh. Due to the lack of the reliable evidence, to date there are no consensus about optimal method of hysteropexy, as LSHP is not without its drawbacks and complications. PREOPERATIVE ASSESSMENT All patients who meet eligibility criteria will undergo a preoperative assessment: medical history, physical and vaginal examination, assessing pelvic organ prolapse according to Pelvic Organ Prolapse Quantification System (POP-Q). All patients will complete questionnaires validated in Russia: Pelvic Floor Disability Index (PFDI-20), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, short form (PISQ-SF), Patient Global Impression of Improvement (PGI-I). MATERIALS AND METHODS The investigators hypothesis is that SSHP is non-inferior to LSHP in terms of recurrence rate and complications. The sample size was calculated assuming an objective cure rate of 92% as described in literature. With a power of 80%, a level of 0,05 and the non-inferiority margin at 15%, the sample size is 92 patients. The investigators assume a drop-out rate of 10%, thus a total of 102 participants will be included in the study. All enrolled patients will be randomly assigned to SSHP or LSHP treatment groups in equal ratio the day before the surgery, using computer randomization. All data will be collected by medical staff not involved in treatment. Collected pre- and postoperative data will be anonymized using unique codes, that patients will receive immediately after randomization. All surgical interventions will be performed by 3 qualified surgeons. Postoperative follow-up will be performed 6, 12 and 24 months after surgery by 2 researchers, who will be blinded about the type of intervention.

Conditions

• Pelvic Organ Prolapse

Interventions

Type	Name	Description
PROCEDURE	Vaginal	Sacrospinous hysteropexy using the synthetic mesh
PROCEDURE	Laparoscopic	Laparoscopic Sacrohysteropexy

Timeline

• Start date: 2022-09-09
• Primary completion: 2023-08-02
• Completion: 2025-05-09
• First posted: 2022-06-15
• Last updated: 2023-12-27

Locations

1 site across 1 country: Russia