Pelvic Organ ProlapseSAXONCT05042453
Long-term Evaluation of the Efficacy and Safety of Splentis for the Treatment of Primary Apical Pelvic Organ Prolapse
An observational study of Pelvic Organ Prolapse, run by Promedon at 7 sites in Germany.
Trial summary
This prospective, multi center cohort trial aims to evaluate the efficacy and safety of hysteropexy using Splentis via the vaginal route in primary uterine prolapse Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Splentis® POP Tissue Anchoring System
- Type of treatment
- Medical device
- How many people
- 140 participants
- Where
- 7 sitesGermany
- Study dates
- 19 Dec 2022to Jul 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Non-fertile women ≥ 18 years with uterine prolapse
Who may be able to join
- non-fertile women
- primary symptomatic uterine descent POP-Q≥2
- Scheduled apical POP repair with Splentis
- Willing and able to participate at study visits and to sign informed consent
Who cannot join
- Fertile women
- Recurrent apical prolapse
- Women with post hysterectomy vaginal vault prolapse
- Patients with active or latent infection of the vagina, cervix or uterus
- Patients with previous or current vaginal, cervical or uterine cancer
- Previous, current or planned pelvic radiation therapy
- Known allergy to polypropylene.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Germany7 sites, 7 recruiting
- Recruiting
DRK Hospital Chemnitz-Rabenstein
Chemnitz
Torsten Brosche, Dr. med.
- Recruiting
Helios Hospital Erfurt, Department of gynaecology
Erfurt
Gert Naumann, PD Dr.habil.
- Recruiting
University Hospital Freiburg
Freiburg im Breisgau
Markus Hübner, Prof. Dr. med.
- Recruiting
Clinic Kassel
Kassel
Christiane Schiffner, Dr. med.
- Recruiting
St. Elisabeth Hospital
Leipzig
Birgit Henne, Dr. med.
- Not yet recruiting
University Hospital
Mannheim
Benjamin Tuschy, Prof. Dr. med.
- Recruiting
Hospital Tettnang
Tettnang
Christian Fünfgeld, Dr.med.
About this study
Official title: Prospective, Multicenter, 60 Months, Single-arm Cohort Trial for Evaluation of the Efficacy and Safety of Transvaginal Sacrospinous Ligament Fixation With Splentis for the Treatment of Primary Apical Pelvic Organ Prolapse
This prospective, multi center cohort trial aims to evaluate the efficacy and safety of hysteropexy using Splentis via the vaginal route in primary uterine prolapse
Read the detailed description
Women who undergo hysteropexy with Splentis via the vaginal route for primary uterine prolapse will be evaluated regarding efficacy and safety in a long term follow-up of 60 months. The primary endpoint is composed of anatomical, subjective and re-treatment components, whereas several secondary endpoints focusing on functional outcome including overactive bladder symptoms, urinary incontinence, quality of life and sexual life will be considered. Furthermore, a detailed report about adverse events will be included.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Splentis® POP Tissue Anchoring System
- Keywords
- Apical Pelvic Organ Prolapse, Transvaginal repair, Mesh augmented repair, Sacrouterine ligament fixation
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Splentis® POP Tissue Anchoring SystemDevice
Anterior cervicopexy with bilateral sacrospinous ligament fixation using Splentis
| Study group | Role | What they receive |
|---|---|---|
| Hysteropexy using Splentis via vaginal route | Non-fertile women ≥ 18 years with uterine descent (POP-Q ≥ 2) which are study-independently scheduled for hysteropexy with Splentis Receives: Device: Splentis® POP Tissue Anchoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure of apical pelvic organ prolapse
Cure of apical pelvic organ prolapse is defined according the current recommendations by Barber et al. and ICS/IUGA recommendations. Therefore, a combined endpoint using anatomical, subjective and necessity retreatment criteria are utilized.
Primary endpoint is the number of patients achieving all criteria of the composite endpoint:
- leading edge of the apical vaginal wall at or above the hymen (C≤ 0)
- absence of a vaginal bulge symptom
- no need for retreatment of the apical prolapse by either pessary use or surgical intervention
Measured: 12 months
Secondary outcomes (10)
Health-related quality of life
Change of Quality of life and prolapse symptoms using the Prolapse-Quality of Life-Questionnaire in comparison between baseline and follow-up.
The questionnaire is divided in nine domains which are analyzed separately. The results will be transformed into a scale between 0 - 100 according the questionnaires description. The higher the score, the higher the impact of prolapse symptoms and the lower the quality of life.
Measured: Baseline, 6 weeks 12, 24, 36, 60 months
Quality of life
Change of quality of life using the EQ-5L-5D in comparison between baseline and follow-up.
It consists of a 5-item descriptive system as well as a visual analogue scale ranging from 0 to 100. It is conceptualized to assess deviation from health and hereby provide health related quality of life problems.
Measured: Baseline, 6 weeks and 12, 24, 36, 60 months
Urinary incontinence
Change of urinary incontinence using the International Consultation on Incontinence Questionnaire- Urinary Incontinence Short From in comparison between baseline and follow-up
The ICIQ-UI-SF includes four items with a sum score ranging between 0 and 21 points. The higher the score the higher the impact of symptoms.
Measured: Baseline, 6 weeks and 12, 24, 36, 60 months
Overactive Bladder
Change of urinary incontinence using the International Consultation on Incontinence Questionnaire- Overactive bladder in comparison between baseline and follow-up
The score of the ICIQ-OAB ranges from 0 to 16 points. The higher the sum score the higher the impact of symptoms.
Measured: Baseline, 6 weeks and 12, 24, 36, 60 months
Sexual life
Change of sexual life using the Pelvic Organ Prolapse Incontinence Sexual Questionnaire- IUGA revised in comparison between baseline and follow-up.
The result will be transformed into a scale between 0 - 100. The higher the score, the higher the impact of prolapse symptoms and the higher the impact on sexual life.
Measured: Baseline, 6 weeks and 12, 24, 36, 60 months
Pain according Visual analogue scale of pain
Change of pain using the visual analogue scale of pain in comparison between baseline and follow-up
The Wong-Baker Faces Pain Scale is a visual analogue scale to assess subject pain.The answers will be transformed in a scale from 0 to 10 whereas 0 implicate no pain and 10 worst pain.
Measured: Baseline, 24-48 hours postoperatively, 6 weeks and 12, 24, 36, 60 months
Patient global impression of improvement
Number of Patients with improvement of prolapse symptoms according the validated question Patient Global Impression of improvement
The PGI-I is a seven Likert scale from very much better to no change and very much worse.
Measured: 6 weeks and 12, 24, 36, 60 months
Cure according composite endpoint
Number of patients completing each component of the composite endpoint
Measured: 6 weeks and 24, 36, 60 months
Adverse Events
Number and severity of Adverse Events according guideline of AE reporting, Clavien Dindo and Terminology of IUGA/ICS
Measured: Intraoperatively, 24-48hours postoperatively, 6 weeks postoperatively and 12, 24, 36, 60 months, unscheduled visits
Exposure and extrusion free survival
Estimated exposure and extrusion free survival according Kaplan-Meier.
Measured: 6 weeks and 12, 24, 36, 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start19 Dec 2022
- Primary completionJul 2026 (estimated)
- Study completionJul 2030 (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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Promedon
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gert Naumann, MD, Principal investigator, Helios Clinic Erfurt, GermanyChristian Fünfgeld, MD, Principal investigator, Clinic Tettnang
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05042453
- Sponsor's protocol ID
- Sax_Pro
- Acronym
- SAXO
- Status last verified
- Nov 2024
- First submitted
- 12 Aug 2021
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, 60 Months, Single-arm Cohort Trial for Evaluation of the Efficacy and Safety of Transvaginal Sacrospinous Ligament Fixation With Splentis for the Treatment of Primary Apical Pelvic Organ Prolapse
- ClinicalTrials.gov ID
- NCT05042453
- Acronym / sponsor ID
- SAXO / Sax_Pro
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Apical Pelvic Organ Prolapse, Transvaginal repair, Mesh augmented repair, Sacrouterine ligament fixation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- PromedonIndustry (pharma, biotech, devices)
- Study start
- 19 Dec 2022 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 13 Sep 2021 (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.
This prospective, multi center cohort trial aims to evaluate the efficacy and safety of hysteropexy using Splentis via the vaginal route in primary uterine prolapse
Detailed description
Women who undergo hysteropexy with Splentis via the vaginal route for primary uterine prolapse will be evaluated regarding efficacy and safety in a long term follow-up of 60 months. The primary endpoint is composed of anatomical, subjective and re-treatment components, whereas several secondary endpoints focusing on functional outcome including overactive bladder symptoms, urinary incontinence, quality of life and sexual life will be considered. Furthermore, a detailed report about adverse events will be included.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hysteropexy using Splentis via vaginal route | – | Device: Splentis® POP Tissue Anchoring SystemNon-fertile women ≥ 18 years with uterine descent (POP-Q ≥ 2) which are study-independently scheduled for hysteropexy with Splentis |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non-fertile women ≥ 18 years with uterine prolapse
Key inclusion criteria (4 listed)
- non-fertile women
- primary symptomatic uterine descent POP-Q≥2
- Scheduled apical POP repair with Splentis
- Willing and able to participate at study visits and to sign informed consent
Key exclusion criteria (7 listed)
- Fertile women
- Recurrent apical prolapse
- Women with post hysterectomy vaginal vault prolapse
- Patients with active or latent infection of the vagina, cervix or uterus
- Patients with previous or current vaginal, cervical or uterine cancer
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 |
|---|---|---|
| Splentis® POP Tissue Anchoring SystemAnterior cervicopexy with bilateral sacrospinous ligament fixation using Splentis | Device | Hysteropexy using Splentis via vaginal route |
Primary outcome
Cure of apical pelvic organ prolapse
Time frame: 12 months
Cure of apical pelvic organ prolapse is defined according the current recommendations by Barber et al. and ICS/IUGA recommendations. Therefore, a combined endpoint using anatomical, subjective and necessity retreatment criteria are utilized. Primary endpoint is the number of patients achieving all criteria of the composite endpoint: 1. leading edge of the apical vaginal wall at or above the hymen (C≤ 0) 2. absence of a vaginal bulge symptom 3. no need for retreatment of the apical prolapse by either pessary use or surgical intervention
10 secondary outcomes
Health-related quality of life
Time frame: Baseline, 6 weeks 12, 24, 36, 60 months
Quality of life
Time frame: Baseline, 6 weeks and 12, 24, 36, 60 months
Urinary incontinence
Time frame: Baseline, 6 weeks and 12, 24, 36, 60 months
Overactive Bladder
Time frame: Baseline, 6 weeks and 12, 24, 36, 60 months
Sexual life
Time frame: Baseline, 6 weeks and 12, 24, 36, 60 months
Pain according Visual analogue scale of pain
Time frame: Baseline, 24-48 hours postoperatively, 6 weeks and 12, 24, 36, 60 months
Patient global impression of improvement
Time frame: 6 weeks and 12, 24, 36, 60 months
Cure according composite endpoint
Time frame: 6 weeks and 24, 36, 60 months
Adverse Events
Time frame: Intraoperatively, 24-48hours postoperatively, 6 weeks postoperatively and 12, 24, 36, 60 months, unscheduled visits
Exposure and extrusion free survival
Time frame: 6 weeks and 12, 24, 36, 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Pelvic Organ Prolapse
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Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
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i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
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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.
Gert Naumann, MD principal investigator
Helios Clinic Erfurt, Germany
Christian Fünfgeld, MD principal investigator
Clinic Tettnang
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Organ Prolapse, run by Promedon at 7 sites in Germany.
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 7 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: looking for participants now, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philipp Schelhorn (00498031900400, trials.de@promedon.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure of apical pelvic organ prolapse (time frame: 12 months). 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 22 Nov 2024.