Prospective application observation to evaluate recurrences and surgical or postoperative complications in the context of surgical practice for the treatment of female and male stress incontinence and female pelvic floor prolapse with DynaMesh® mesh implants

Prospective application observation to evaluate recurrences and surgical or postoperative complications in the context of surgical practice for the treatment of female and male stress incontinence and female pelvic floor prolapse with DynaMesh® mesh implants - Pro-Uro-Gyn-Register

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00033613

Enrollment

900

Registered

2024-02-20

Start date

2024-04-16

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

N81

Interventions

Group 1: Patients who will receive a corresponding DynaMesh® mesh implant due to surgical treatment of stress incontinence and/or pelvic floor prolapse with associated organ prolapse. The present stud

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients of legal age and legal capacity who will receive a corresponding DynaMesh® mesh implant due to surgical treatment of stress incontinence and/or pelvic floor prolapse with associated organ prolapse.

Exclusion criteria

Exclusion criteria: This is an observation of routine clinical practice, only patients who do not meet the inclusion criteria will be excluded.

Design outcomes

Primary

Measure	Time frame
The primary study objective results from the new MDR requirements, with increased standards for post-market surveillance in the sense of a proactive post-market follow-up. The MDR (EU 2017/745) [Medical Device Regulation] calls on manufacturers to establish proactive and systematic procedures that make it possible to collect information about the safety and performance in routine use of medical devices that have already been placed on the market. The goals is to derive potentially necessary preventative and corrective measures. The establishment of a uro-gynecological registry for systematically collecting data on safety and performance is the structural goal required by the MDR in the sense of a systematic PMCF	—

Measure

Time frame

The primary study objective results from the new MDR requirements, with increased standards for post-market surveillance in the sense of a proactive post-market follow-up. The MDR (EU 2017/745) [Medical Device Regulation] calls on manufacturers to establish proactive and systematic procedures that make it possible to collect information about the safety and performance in routine use of medical devices that have already been placed on the market. The goals is to derive potentially necessary preventative and corrective measures. The establishment of a uro-gynecological registry for systematically collecting data on safety and performance is the structural goal required by the MDR in the sense of a systematic PMCF

—

Secondary

Measure	Time frame
The secondary objective is collecting the clinical data in the registry to be able to assess the clinical and technical safety and performance of the relevant devices after reclassification by the MDR and to systematically monitor the devices further.	—

Countries

Germany

Contacts

Public ContactSebastian Ludwig

Universitätsklinikum Köln

sebastian.ludwig@uk-koeln.de+49 221 478-87550

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 9, 2026