PDS Versus Prolene as Suture Material for Vaginal Sacrospinous Hysteropexy

Study Overview
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Brief Summary
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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.

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

Conditions
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Prolapse, Pelvic Organ Prolapse

Intervention / Treatment
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* Procedure: sacrospinous hysteropexy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PDS - resorbable suture<br>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<br>* sacrospinous hysteropexy<br>|
| Experimental: Prolene - non-resorbable sutures<br>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<br>* sacrospinous hysteropexy<br>|

What is the study measuring?
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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 |