Pelvic Organ ProlapseNCT05964881
PDS Versus Prolene as Suture Material for Vaginal Sacrospinous Hysteropexy
A study testing sacrospinous hysteropexy in people with Pelvic Organ Prolapse and Prolapse, run by Medical University of Vienna at 1 site in Austria.
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). Read more about this study
- Who is it for?
- Ages 18 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Organ Prolapse, Prolapse
- What is being tested?
- sacrospinous hysteropexy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteAustria
- Study dates
- 15 May 2023to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Greta L Carlin, MD, +43-1-40400-28220, greta.carlin@muv.ac.at
About this study
Official title: PDS (Polydiaxonene Suture) Versus Prolene (Polypropylene Suture) as Suture Material for Vaginal Sacrospinous Hysteropexy - a Randomised Controlled Study
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.
- Conditions
- Pelvic Organ Prolapse, Prolapse
- Being tested
- sacrospinous hysteropexy
- Medical subject headings
- Pelvic Organ Prolapse, Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sacrospinous hysteropexyProcedure or surgery
sacrospinous hysteropexy
| Study group | Role | What they receive |
|---|---|---|
| PDS - resorbable suture | Active comparator | 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. Receives: Procedure: sacrospinous hysteropexy |
| Prolene - non-resorbable sutures | Experimental | 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. Receives: Procedure: sacrospinous hysteropexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months post surgery
Secondary outcomes (8)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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))
Measured: 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)
Measured: 12 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start15 May 2023
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Greta L Carlin, Dr.med.univ, Medical University of Vienna
- Investigators
- Greta L Carlin, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05964881
- Sponsor's protocol ID
- 2079
- Status last verified
- Aug 2023
- First submitted
- 20 Jun 2023
- Last updated
- 5 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PDS (Polydiaxonene Suture) Versus Prolene (Polypropylene Suture) as Suture Material for Vaginal Sacrospinous Hysteropexy - a Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT05964881
- Acronym / sponsor ID
- 2079
- Conditions
- Pelvic Organ Prolapse, Prolapse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 28 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PDS - resorbable suture | Active comparator | Procedure: sacrospinous hysteropexyOperation 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. |
| Prolene - non-resorbable sutures | Experimental | Procedure: sacrospinous hysteropexyOperation 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sacrospinous hysteropexysacrospinous hysteropexy | Procedure or surgery | PDS - resorbable suture, Prolene - non-resorbable sutures |
Primary outcome
German pelvic floor questionnaire (subjective symptom improvement)
Time frame: 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
8 secondary outcomes
anatomical outcomes - POP-Q measurement
Time frame: 12 months post surgery
anatomical outcomes - ultrasound imaging
Time frame: 12 months post surgery
German pelvic floor questionnaire (condition-specific quality of life)
Time frame: 12 months post surgery
Clavien Dindo Scale for adverse events
Time frame: 12 months post surgery
Mini Nutritional Assessment
Time frame: 12 months post surgery
Visual Analog Scale
Time frame: 12 months post surgery
Numerical Rating Scale
Time frame: 12 months post surgery
Patient Impression of Improvement Index
Time frame: 12 months post surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Greta L Carlin, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sacrospinous hysteropexy in people with Pelvic Organ Prolapse and Prolapse, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Greta L Carllin, MD (+43-1-40400-28220, greta.carlin@muv.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
German pelvic floor questionnaire (subjective symptom improvement) (time frame: 12 months post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2023.