Pelvic Organ ProlapseNCT05170074
Post-market Clinical Follow-up of the SRS Implant
An observational study of Pelvic Organ Prolapse, run by pfm medical gmbh at 6 sites in Germany.
Trial summary
National, multicentre observational study on surgical reconstruction of the anterior and apical compartment of the pelvic floor with an SRS implant Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- How many people
- 97 participants
- Where
- 6 sitesGermany
- Study dates
- 7 Apr 2022to 9 Sep 2026
- Phase
- Observational
- 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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with a symptomatic anterior vaginal wall prolapse with/without apex/uterine prolapse ≥ stage II (according to POP-Q system), transvaginal SRS implantation for pelvic organ prolapse surgery
Who may be able to join
- Women with a symptomatic anterior vaginal wall prolapse with/without apex/uterine prolapse ≥ stage II (according to POP-Q system). This applies to primary as well as recurrent intervention.
- Age ≥ 21 years.
- Patient is mentally able to understand the nature, aims, or possible consequences of the PMCF study.
- Patient information has been provided and written consent exists.
Who cannot join
- Contraindications according to the manufacturer's instructions for use.
- Patient with previous urogynaecological surgeries with alloplastic material.
- Patient with radiological treatment in the pelvic floor.
- Patient is institutionalised by court or official order (MPDG §27).
- Participation in another interventional study concerning pelvic floor reconstruction.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Universitätsklinikum Augsburg
Augsburg, 86156
Evangelisches Krankenhaus Hagen-Haspe
Hagen, 58135
Asklepios Klinik Altona
Hamburg, 22763
Städtisches Krankenhaus Kiel
Kiel, 24116
Marienhaus Klinikum Hetzelstift Neustadt/Weinstraße
Neustadt, 67434
Klinikum Oberlausitzer Bergland gGmbH
Zittau, 02763
About this study
Official title: National, Multicentre Observational Study on Surgical Reconstruction of the Anterior and Apical Compartment of the Pelvic Floor With a Single-incision, Fixation-free Self-Retaining Support Implant (SRS Implant)
National, multicentre observational study on surgical reconstruction of the anterior and apical compartment of the pelvic floor with an SRS implant
Read the detailed description
National, multicentre, prospective observational study on surgical reconstruction of the anterior and apical compartment in seven clinical centres in Germany to obtain post-market information on the SRS implant with a follow-up of 24 months. Patient reported satisfaction (measured by P QoL, Prolapse Quality of Life Questionnaire), anatomic outcome (measured by the POP-Q, Pelvic Organ Prolapse Quantification system) and the rate of complications (measured by adverse events during the study period) are focused.
- Conditions
- Pelvic Organ Prolapse
- Keywords
- SRS Implant, Quality of Life, Pelvic Organ Prolapse, Surgical Reconstruction
- 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.
| Study group | Role | What they receive |
|---|---|---|
| SRS implant | Surgical reconstruction of the anterior and apical compartment of the pelvic floor with an SRS implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient´s Quality of Life
Evaluation of changes in quality of life twelve months after implantation of the SRS implant compared to baseline. Quality of Life was assessed by the P-QOL (Prolapse Quality of Life Questionnaire). The P-QOL yields a domain score in the range from zero to 100, wheras a score of zero is the best.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2021
- Study start7 Apr 2022
- Primary completion24 Sep 2025
- Study completion9 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- pfm medical gmbh
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tina Cadenbach-Blome, Dr. med., Principal investigator, OBERSCHWABENKLINIK gGmbH Westallgäuklinikum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05170074
- Sponsor's protocol ID
- PMCF study SRS implant
- Status last verified
- Oct 2026
- First submitted
- 9 Dec 2021
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Levy G, Padoa A, Marcus N, Beck A, Fekete Z, Cervigni M. Anchorless implant for the treatment of advanced anterior and apical vaginal prolapse - Medium term follow up. Eur J Obstet Gynecol Reprod Biol. 2020 Mar;246:55-59. doi: 10.1016/j.ejogrb.2020.01.005. Epub 2020 Jan 9.
PubMed 31954369Levy G, Padoa A, Fekete Z, Bartfai G, Pajor L, Cervigni M. Self-retaining support implant: an anchorless system for the treatment of pelvic organ prolapse-2-year follow-up. Int Urogynecol J. 2018 May;29(5):709-714. doi: 10.1007/s00192-017-3415-3. Epub 2017 Jul 14.
PubMed 28710613
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National, Multicentre Observational Study on Surgical Reconstruction of the Anterior and Apical Compartment of the Pelvic Floor With a Single-incision, Fixation-free Self-Retaining Support Implant (SRS Implant)
- ClinicalTrials.gov ID
- NCT05170074
- Acronym / sponsor ID
- PMCF study SRS implant
- Conditions
- Pelvic Organ Prolapse
- Keywords
- SRS Implant, Quality of Life, Pelvic Organ Prolapse, Surgical Reconstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- pfm medical gmbhIndustry (pharma, biotech, devices)
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- 24 Sep 2025 (actual)
- Study completion
- 9 Sep 2026 (actual)
- First posted
- 27 Dec 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.
National, multicentre observational study on surgical reconstruction of the anterior and apical compartment of the pelvic floor with an SRS implant
Detailed description
National, multicentre, prospective observational study on surgical reconstruction of the anterior and apical compartment in seven clinical centres in Germany to obtain post-market information on the SRS implant with a follow-up of 24 months. Patient reported satisfaction (measured by P QoL, Prolapse Quality of Life Questionnaire), anatomic outcome (measured by the POP-Q, Pelvic Organ Prolapse Quantification system) and the rate of complications (measured by adverse events during the study period) are focused.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SRS implant | – | –Surgical reconstruction of the anterior and apical compartment of the pelvic floor with an SRS implant |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with a symptomatic anterior vaginal wall prolapse with/without apex/uterine prolapse ≥ stage II (according to POP-Q system), transvaginal SRS implantation for pelvic organ prolapse surgery
Key inclusion criteria (4 listed)
- Women with a symptomatic anterior vaginal wall prolapse with/without apex/uterine prolapse ≥ stage II (according to POP-Q system). This applies to primary as well as recurrent intervention.
- Age ≥ 21 years.
- Patient is mentally able to understand the nature, aims, or possible consequences of the PMCF study.
- Patient information has been provided and written consent exists.
Key exclusion criteria (5 listed)
- Contraindications according to the manufacturer's instructions for use.
- Patient with previous urogynaecological surgeries with alloplastic material.
- Patient with radiological treatment in the pelvic floor.
- Patient is institutionalised by court or official order (MPDG §27).
- Participation in another interventional study concerning pelvic floor reconstruction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient´s Quality of Life
Time frame: 12 months
Evaluation of changes in quality of life twelve months after implantation of the SRS implant compared to baseline. Quality of Life was assessed by the P-QOL (Prolapse Quality of Life Questionnaire). The P-QOL yields a domain score in the range from zero to 100, wheras a score of zero is the best.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Background: PubMed 31954369Levy G, Padoa A, Marcus N, Beck A, Fekete Z, Cervigni M. Anchorless implant for the treatment of advanced anterior and apical vaginal prolapse - Medium term follow up. Eur J Obstet Gynecol Reprod Biol. 2020 Mar;246:55-59. doi: 10.1016/j.ejogrb.2020.01.005. Epub 2020 Jan 9.
- Background: PubMed 28710613Levy G, Padoa A, Fekete Z, Bartfai G, Pajor L, Cervigni M. Self-retaining support implant: an anchorless system for the treatment of pelvic organ prolapse-2-year follow-up. Int Urogynecol J. 2018 May;29(5):709-714. doi: 10.1007/s00192-017-3415-3. Epub 2017 Jul 14.
- Homepage Manufacturer with information on the investigational productLink provided by the sponsor.
- Homepage Sponsor with information on the investigational productLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Tina Cadenbach-Blome, Dr. med. principal investigator
OBERSCHWABENKLINIK gGmbH Westallgäuklinikum
6 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 pfm medical gmbh at 6 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 5 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: finished, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient´s Quality of Life (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05170074, which also lists 2 linked publications.
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 23 Oct 2026.