Pelvic Organ Prolapse, Prolapse
Conditions
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.
Interventions
PROCEDUREsacrospinous hysteropexy
sacrospinous hysteropexy
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
Countries
Austria
Contacts
Primary ContactGreta L Carllin, MD
Outcome results
None listed