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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05964881
Other study ID # 2079
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 15, 2023
Est. completion date December 2025

Study information

Verified date August 2023
Source Medical University of Vienna
Contact Greta L Carllin, MD
Phone +43-1-40400-28220
Email greta.carlin@muv.ac.at
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 52
Est. completion date December 2025
Est. primary completion date June 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 100 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
sacrospinous hysteropexy
sacrospinous hysteropexy

Locations

Country Name City State
Austria Medical University of Vienna Vienna

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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