PDS Versus Prolene as Suture Material for Vaginal Sacrospinous Hysteropexy

Not Applicable

Recruiting

• Conditions: Prolapse; Pelvic Organ Prolapse
• Interventions: Procedure: sacrospinous hysteropexy

• Registration Number: NCT05964881
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-15
• Study First Submitted: 2023-06-20
• Study First Submitted QC: 2023-07-19
• Study First Posted: 2023-07-28
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-30
• Last Update Posted: 2023-09-05
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 52

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prolene - non-resorbable sutures	sacrospinous hysteropexy	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.
PDS - resorbable suture	sacrospinous hysteropexy	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.

Primary Outcome Measures

Name	Time	Method
German pelvic floor questionnaire (subjective symptom improvement)	12 months post surgery	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

Secondary Outcome Measures

Name	Time	Method
anatomical outcomes - POP-Q measurement	12 months post surgery	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)
Mini Nutritional Assessment	12 months post surgery	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)
Visual Analog Scale	12 months post surgery	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)
anatomical outcomes - ultrasound imaging	12 months post surgery	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)
German pelvic floor questionnaire (condition-specific quality of life)	12 months post surgery	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)
Clavien Dindo Scale for adverse events	12 months post surgery	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)
Numerical Rating Scale	12 months post surgery	pain assessment 12 months after surgery evaluated through Numeric Rating Scale (NRS: ranging from 0 (no pain) up to 10 (worst possible pain))
Patient Impression of Improvement Index	12 months post surgery	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)

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria