PDS Versus Prolene as Suture Material for Vaginal Sacrospinous Hysteropexy

Medical University of Vienna

Status: Enrolling

Conditions: Pelvic Organ Prolapse; Prolapse

Treatments: Procedure: sacrospinous hysteropexy

Study type: Interventional

Funder types: Other

Identifiers

NCT05964881

2079

Details and patient eligibility

About

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.

Enrollment: 52 estimated patients

Sex: Female

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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52 participants in 2 patient groups

PDS - resorbable suture

Active Comparator group

Description:

Operation through vaginal route, high posterior colpotomy is made towards the posterior cervix. Blunt preparation towards the right Spina ischiadica to visualise right sacrospinous ligament. PDS (0) sutures will be placed through the ligament (ca. 2 cm medial of the spina). This suture will then be placed through the posterior cervical wall, but not yet knotted. First, colpotomy will be closed via 2/0 vicryl, then pre-laid fixation sutures will be tied, whereby the portio will come to lie about 4-6 cm cranial of the level off the vulva towards the sacrospinous ligament.

Treatment:

Procedure: sacrospinous hysteropexy

Prolene - non-resorbable sutures

Experimental group

Description:

Operation through vaginal route, high posterior colpotomy is made towards the posterior cervix. Blunt preparation towards the right Spina ischiadica to visualise right sacrospinous ligament. Prolene (2-0) sutures will be placed through the ligament (ca. 2 cm medial of the spina). This suture will then be placed through the posterior cervical wall, but not yet knotted. First, colpotomy will be closed via 2/0 vicryl, then pre-laid fixation sutures will be tied, whereby the portio will come to lie about 4-6 cm cranial of the level off the vulva towards the sacrospinous ligament.

Treatment:

Procedure: sacrospinous hysteropexy