Long-term Evaluation of the Efficacy and Safety of Splentis for the Treatment of Primary Apical Pelvic Organ Prolapse

Recruiting now

Conditions studied: Pelvic Organ Prolapse

In brief

This prospective, multi center cohort trial aims to evaluate the efficacy and safety of hysteropexy using Splentis via the vaginal route in primary uterine prolapse

Key facts

Study ID

NCT05042453

Run by

Promedon

People needed

140

Starts

2022-12-19

Expected to finish

2030-07-01

Last updated by the study team

2024-11-22

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• non-fertile women
• primary symptomatic uterine descent POP-Q≥2
• Scheduled apical POP repair with Splentis
• Willing and able to participate at study visits and to sign informed consent

You may not qualify if…

• Fertile women
• Recurrent apical prolapse
• Women with post hysterectomy vaginal vault prolapse
• Patients with active or latent infection of the vagina, cervix or uterus
• Patients with previous or current vaginal, cervical or uterine cancer
• Previous, current or planned pelvic radiation therapy
• Known allergy to polypropylene.

Where it is running

• Clinic Kassel — Kassel, Germany (enrolling)
• Helios Hospital Erfurt, Department of gynaecology — Erfurt, Germany (enrolling)
• University Hospital Freiburg — Freiburg im Breisgau, Germany (enrolling)
• DRK Hospital Chemnitz-Rabenstein — Chemnitz, Germany (enrolling)
• St. Elisabeth Hospital — Leipzig, Germany (enrolling)
• Hospital Tettnang — Tettnang, Germany (enrolling)
• University Hospital — Mannheim, Germany

Full record on ClinicalTrials.gov

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