Active — Not RecruitingNot Applicable

Post-market Clinical Follow-up of the SRS Implant

Germany175 participantsStarted 2022-04-07

Plain-language summary

National, multicentre observational study on surgical reconstruction of the anterior and apical compartment of the pelvic floor with an SRS implant

Age range21 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

Patient´s Quality of Life

Timeframe: 12 months

NCT IDNCT05170074

Sponsorpfm medical gmbh

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-09