Anterior Pelvic Prolapse Reconstruction With TiLOOP® PRO A Polypropylene Mesh

Launched by PFM MEDICAL GMBH · Feb 18, 2016

Keywords

ClinConnect Summary

This multicentre, non-randomized, observational clinical investigation will be performed to obtain usability and postmarket information on the TiLOOP® pelvic floor reconstruction meshes and in particular to obtain the improvement of patients' quality of life.

It is expected that the patient's quality of life is meliorated after implantation of a TiLOOP® PRO A mesh. To verify this, it will be shown that by means of a validated questionnaire the subjective quality of life after 12 months is significantly better than before implantation.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Existence of a cystocele. Women with a symptomatic genital descensus: at least stage II (ICS-classification according POP-Q system). This applies to primary as well as recurrent intervention.
• • 2. Patient is mentally able to understand the nature, aims, or possible consequences of the clinical investigation.
• • 3. Patient information has been handed out and written consent is at hand.
• • 4. Patient has attained full age (18 years or older).
• Exclusion Criteria:
• • 1. Unfinished family planning, pregnancy or breast-feeding mother.
• • 2. Known intolerance to the mesh-implants under investigation.
• • 3. Lack of written patients' informed consent.
• • 4. Lack of patient compliance regarding data collection, treatment or follow-up investigations in the scope of the protocol.
• • 5. Patients with acute (within the last 12 months) carcinoma in the pelvic area.
• • 6. Patients with history of radiotherapy in the pelvic area.
• • 7. Patients with implanted anterior pelvic floor mesh.
• • 8. Patient is institutionalized by court or official order (MPG §20.3).
• • 9. Participation in another interventional clinical investigation.