PDS Versus Prolene as Suture Material for Vaginal Sacrospinous Hysteropexy

NCT ID: NCT05964881

Last Updated: 2023-09-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-15
• Study Completion Date: 2025-12-31

Brief Summary

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.

Conditions

Pelvic Organ Prolapse; Prolapse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

PDS - resorbable suture

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.

Group Type: ACTIVE_COMPARATOR

sacrospinous hysteropexy

Intervention Type: PROCEDURE

sacrospinous hysteropexy

Prolene - non-resorbable sutures

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.

Group Type: EXPERIMENTAL

sacrospinous hysteropexy

Intervention Type: PROCEDURE

sacrospinous hysteropexy

Interventions

sacrospinous hysteropexy

sacrospinous hysteropexy

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Greta L Carlin, Dr.med.univ

Dr. med. univ.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Greta L Carlin, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

Medical University of Vienna

Vienna, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Greta L Carllin, MD

Role: CONTACT

greta.carlin@muv.ac.at

+43-1-40400-28220

Facility Contacts

Greta L Carlin, MD

Role: primary

greta.carlin@muv.ac.at

+43-1-40400-28220

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2079

Identifier Type: -

Identifier Source: org_study_id