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

Recruitingn/aAges 18 Years - anyFemalePromedon
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In plain words

What the trial is, and whether it could suit you

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

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * non-fertile women * primary symptomatic uterine descent POP-Qโ‰ฅ2 * Scheduled apical POP repair with Splentis * Willing and able to participate at study visits and to sign informed consent Exclusion Criteria: * 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.
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What it tests

  • Splentisยฎ POP Tissue Anchoring System
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Where

7 sites
DRK Hospital Chemnitz-Rabenstein
Chemnitz, Germany
Helios Hospital Erfurt, Department of gynaecology
Erfurt, Germany
University Hospital Freiburg
Freiburg im Breisgau, Germany
Clinic Kassel
Kassel, Germany
St. Elisabeth Hospital
Leipzig, Germany
University Hospital
Mannheim, Germany
Hospital Tettnang
Tettnang, Germany
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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