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PDS Versus Prolene as Suture Material for Vaginal Sacrospinous Hysteropexy

Primary Purpose

Pelvic Organ Prolapse, Prolapse

Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
sacrospinous hysteropexy
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Medical University of ViennaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

PDS - resorbable suture

Prolene - non-resorbable sutures

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
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)
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)
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)
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)
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)
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))
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)

Full Information

First Posted
June 20, 2023
Last Updated
August 30, 2023
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT05964881
Brief Title
PDS Versus Prolene as Suture Material for Vaginal Sacrospinous Hysteropexy
Official Title
PDS (Polydiaxonene Suture) Versus Prolene (Polypropylene Suture) as Suture Material for Vaginal Sacrospinous Hysteropexy - a Randomised Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2023 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse, Prolapse

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PDS - resorbable suture
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Prolene - non-resorbable sutures
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
sacrospinous hysteropexy
Intervention Description
sacrospinous hysteropexy
Primary Outcome Measure Information:
Title
German pelvic floor questionnaire (subjective symptom improvement)
Description
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
Time Frame
12 months post surgery
Secondary Outcome Measure Information:
Title
anatomical outcomes - POP-Q measurement
Description
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)
Time Frame
12 months post surgery
Title
anatomical outcomes - ultrasound imaging
Description
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)
Time Frame
12 months post surgery
Title
German pelvic floor questionnaire (condition-specific quality of life)
Description
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)
Time Frame
12 months post surgery
Title
Clavien Dindo Scale for adverse events
Description
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)
Time Frame
12 months post surgery
Title
Mini Nutritional Assessment
Description
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)
Time Frame
12 months post surgery
Title
Visual Analog Scale
Description
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)
Time Frame
12 months post surgery
Title
Numerical Rating Scale
Description
pain assessment 12 months after surgery evaluated through Numeric Rating Scale (NRS: ranging from 0 (no pain) up to 10 (worst possible pain))
Time Frame
12 months post surgery
Title
Patient Impression of Improvement Index
Description
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)
Time Frame
12 months post surgery

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Greta L Carllin, MD
Phone
+43-1-40400-28220
Email
greta.carlin@muv.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Greta L Carlin, MD
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Greta L Carlin, MD
Phone
+43-1-40400-28220
Email
greta.carlin@muv.ac.at

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

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PDS Versus Prolene as Suture Material for Vaginal Sacrospinous Hysteropexy

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