N39.4
Conditions
Interventions
Group 1: Data will be collected from 200 female patients who underwent surgical treatment for stress incontinence using a DynaMesh®-SIS implant at the University Hospital Aachen between 2013 and 2018.
Sponsors
FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Women of legal age =18 years • Patients who have undergone surgical treatment of female stress urinary incontinence using a DynaMesh® sling mesh implant • Sufficient knowledge of the German language, both written and spoken. • Patients who have consented to data processing
Exclusion criteria
Exclusion criteria: As this is an observation of routine clinical practice, no patients meeting the inclusion criteria will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary purpose of this observational study is to assess the performance of the product. Performance parameters are: • Reoperation for recurrent or persistent incontinence • Correction of incontinence (based on the following possible parameters: stress test, urodynamics, 24h pad test, daily use of pads, ICIQ-SF 2004, subjective assessment) | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary study objective of the present study is to confirm the safety of the product. The Safety parameters are: • Intra-operative haemorrhage • Intra-operative lesion of neighbouring organs • Haematoma • Seroma • Wound healing disorder • Fistula formation • Infection of the wound/implant • Dislocation of the implant • Erosion/exposure • Voiding disorders • Urinary tract infection • De novo urge incontinence (UUI) • De novo dyspareunia • Post-operative pain ( 3 months) • Other complications | — |
Countries
Germany
Contacts
Public ContactLaila Najjari
Universitätsklinikum Aachen
Outcome results
None listed