Clinical trial NCT05964881: 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
Overall status: RECRUITING
Phase: NA
Conditions: Pelvic Organ Prolapse
Prolapse
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2023-07-28
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: German pelvic floor questionnaire (subjective symptom improvement)
timeFrame: 12 months post surgery
Secondary outcomes:
measure: anatomical outcomes - POP-Q measurement
timeFrame: 12 months post surgery
measure: anatomical outcomes - ultrasound imaging
timeFrame: 12 months post surgery
measure: German pelvic floor questionnaire (condition-specific quality of life)
timeFrame: 12 months post surgery
measure: Clavien Dindo Scale for adverse events
timeFrame: 12 months post surgery
measure: Mini Nutritional Assessment
timeFrame: 12 months post surgery
measure: Visual Analog Scale
timeFrame: 12 months post surgery
measure: Numerical Rating Scale
timeFrame: 12 months post surgery
measure: Patient Impression of Improvement Index
timeFrame: 12 months post surgery
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Greta L Carlin, MD
role: PRINCIPAL_INVESTIGATOR
References: