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Clinical Trials in Germany / NCT05042453
Recruiting Observational

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

NCT05042453 · tracked via the Priya Life Science Germany tracker
Sponsor
Promedon
Phase
Observational
Started
2022-12-19
Last updated
2024-11-22

Condition(s) studied

Pelvic Organ Prolapse

Investigational drug(s) / intervention(s)

Splentis® POP Tissue Anchoring System

Splentis® POP Tissue Anchoring System: Anterior cervicopexy with bilateral sacrospinous ligament fixation using Splentis

Study summary

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

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 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.

Primary outcome measure(s)

  • Cure of apical pelvic organ prolapse — 12 months
    Cure of apical pelvic organ prolapse is defined according the current recommendations by Barber et al. and ICS/IUGA recommendations. Therefore, a combined endpoint using anatomical, subjective and necessity retreatment criteria are utilized. Primary endpoint is the number of patients achieving all criteria of the composite endpoint: 1. leading edge of the apical vaginal wall at or above the hymen (C≤ 0) 2. absence of a vaginal bulge symptom 3. no need for retreatment of the apical prolapse by either pessary use or surgical intervention

Trial sites (7)

FacilityCityRegionStatus
DRK Hospital Chemnitz-Rabenstein Chemnitz Germany Recruiting
Helios Hospital Erfurt, Department of gynaecology Erfurt Germany Recruiting
University Hospital Freiburg Freiburg im Breisgau Germany Recruiting
Clinic Kassel Kassel Germany Recruiting
St. Elisabeth Hospital Leipzig Germany Recruiting
University Hospital Mannheim Germany Not Yet Recruiting
Hospital Tettnang Tettnang Germany Recruiting

More Promedon trials in Germany

Prospective Long-term Evaluation of the Efficacy and Safety of Calistar S for Transvaginal Pelvic Organ Prolapse Repair Active, not recruiting

Other trials for the same condition

Ethicon Pelvic Mesh Post Market Clinical Follow-up Registry Recruiting
Prospective Long-term Evaluation of the Efficacy and Safety of Calistar S for Transvaginal Pelvic Organ Prolapse Repair Active, not recruiting
i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05042453 on ClinicalTrials.gov ↗ ← All trials in Germany