PDS Versus Prolene as Suture Material for Vaginal Sacrospinous Hysteropexy

Medical University of Vienna52 enrolled

Overview

Introduction: Pelvic organ prolapse is a common gynecological disease, which about 50% of women develop in the course of their lives. There are many different options for surgical care, e.g. the uterus-preserving sacrospinal fixation (= sacrospinal hysteropexy = SSHP). This technique has been increasingly used in recent years. However, there is still no data on whether the fixation sutures should be performed with absorbable or non-absorbable threads. Internationally, both types of threads are routinely used and both types of threads are described in publications. So far, there is no comparative data on the effectiveness and subjective results. The aim of this study is to compare subjective symptom improvement Materials \& Methods: This is a randomized, single-center superiority study. The sacrospinal fixation is performed according to a standardized method and two different types of threads (absorbable PDS sutures vs. non-absorbable Prolene sutures) are used for the fixation suture. Patients are randomized to either the absorbable PDS sutures group or the non-absorbable Prolene sutures group. The primary outcome of interest is the subjective symptom improvement 12 months after surgery (evaluated using the German version of the pelvic floor questionnaire). Secondary outcome variables are anatomical outcomes, condition-specific quality of life, and adverse events. 52 patients will be included in the study. The results of the study will be published in peer-reviewed journals and the results will be presented at scientific meetings.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Pelvic Organ Prolapse

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 100 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Anterior vaginal wall prolapse beyond the hymen (POP-Q-point Aa or Ba \>0) with central defect * Prolapse of the apical vaginal vault beyond the hymen (POP-Q point C \>0) with central defect * Symptoms of a vaginal bulge * A primary reconstructive operation using sacrospinous hysteropexy is planned Exclusion Criteria: * Recurrent prolapse * History of hysterectomy * A primary reconstructive operation with mesh or obliterative surgery is planned * An operation with hysterectomy is planned * Known pelvic malignancy * Known inflammatory disease * Current systemic treatment with glucocorticoids or immunosuppressants * The subject cannot or does not want to participate

Outcomes

Primary Outcomes

German pelvic floor questionnaire (subjective symptom improvement)

subjective symptom improvement 12 months after surgery evaluated using the German version of the pelvic floor questionnaire, which consist of 4 domains and a total of 42 questions