PDS Versus Prolene as Suture Material for Vaginal Sacrospinous Hysteropexy

NCT05964881 | Unknown

• 1 other identifier: 2079
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• anatomical outcomes - POP-Q measurement

  12 months post surgery

• anatomical outcomes - ultrasound imaging

  12 months post surgery

• German pelvic floor questionnaire (condition-specific quality of life)

  12 months post surgery

• Clavien Dindo Scale for adverse events

  12 months post surgery

• Mini Nutritional Assessment

  12 months post surgery

Study Arms (2)

PDS - resorbable suture

ACTIVE COMPARATOR

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

Prolene - non-resorbable sutures

EXPERIMENTAL

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

Interventions

sacrospinous hysteropexy PROCEDURE

sacrospinous hysteropexy

PDS - resorbable suture; Prolene - non-resorbable sutures

Eligibility Criteria

• Age: 18 Years - 100 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Pelvic Organ Prolapse; Prolapse

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Greta L Carlin, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Greta L Carllin, MD

CONTACT

+43-1-40400-28220; greta.carlin@muv.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med. univ.

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: July 28, 2023
• Study Start: May 15, 2023
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 5, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: immediately
• Access Criteria: Study Protocol and Statistical Analysis Plan will be accessible through ClinicalTrials.gov

Locations

AU (1)