PDS Versus Prolene as Suture Material for Vaginal Sacrospinous Hysteropexy

PDS (Polydiaxonene Suture) Versus Prolene (Polypropylene Suture) as Suture Material for Vaginal Sacrospinous Hysteropexy - a Randomised Controlled Study

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 Overview

• Status: Recruiting
• Conditions: Pelvic Organ Prolapse; Prolapse
• Intervention / Treatment: Procedure: sacrospinous hysteropexy

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Greta L Carllin, MD; Phone Number: +43-1-40400-28220; Email: greta.carlin@muv.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • Medical University of Vienna
    • Contact: Greta L Carlin, MD; Phone Number: +43-1-40400-28220; Email: greta.carlin@muv.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: sacrospinous hysteropexy; sacrospinous hysteropexy
Experimental: 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.	Procedure: sacrospinous hysteropexy; sacrospinous hysteropexy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 months post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
anatomical outcomes - POP-Q measurement	anatomical outcomes 12 months after surgery evaluated through POP-Q-system (standardised POP-Q scale ranging from 0-4; the higher the number the worse the prolapse)	12 months post surgery
anatomical outcomes - ultrasound imaging	anatomical outcomes 12 months after surgery evaluated through ultrasound (transvaginal ultrasound to measure size of uterus, length of cervix, perineal ultrasound for 3d imaging of perineal muscles)	12 months post surgery
German pelvic floor questionnaire (condition-specific quality of life)	condition-specific quality of life 12 months after surgery evaluated through validated german pelvic floor questionnaire (consisting of 4 domains and a total of 42 questions)	12 months post surgery
Clavien Dindo Scale for adverse events	assessment of adverse events during the first 12 months after surgery evaluated according to the Clavien Dindo scale from 1-5, with 5 consisting death)	12 months post surgery
Mini Nutritional Assessment	nutritional assessment 12 months after surgery (evaluated through Mini Nutritional Assessment (from 1-14 points: 12-14 points: normal nutrition, 8-11 points: at risk for malnutrition, 0-7 points: malnutrition)	12 months post surgery
Visual Analog Scale	pain assessment 12 months after surgery evaluated through Visual Analog Scale (VAS: pictograms of facial expression at different levels ranging from free of pain, to worst possible pain)	12 months post surgery
Numerical Rating Scale	pain assessment 12 months after surgery evaluated through Numeric Rating Scale (NRS: ranging from 0 (no pain) up to 10 (worst possible pain))	12 months post surgery
Patient Impression of Improvement Index	patient impression of improvment assessment 12 months after surgery evaluated through Patient Global Impression of Improvement Index (PGI-I: ranging from 1: very much better to 4: no change)	12 months post surgery

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Greta L Carlin, MD, Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: June 20, 2023
• First Submitted That Met QC Criteria: July 19, 2023
• First Posted (Actual): July 28, 2023

Study Record Updates

• Last Update Posted (Actual): September 5, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: 2079

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study Protocol and Statistical Analysis Plan will be public through upload on ClinicalTrials.gov Further information can be shared upon direct request from interested researchers
• IPD Sharing Time Frame: immediately
• IPD Sharing Access Criteria: Study Protocol and Statistical Analysis Plan will be accessible through ClinicalTrials.gov
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No