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

ConditionPelvic Organ Prolapse

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

Age18+

SponsorPromedon

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Fertile women

Recurrent apical prolapse

Women with post hysterectomy vaginal vault prolapse

Patients with active or latent infection of the vagina, cervix or uterus

Trial design

Treatments tested in this trial

Splentis® POP Tissue Anchoring System

Treatment groups

140 Participants

are divided into 1 treatment group

Sponsors and collaborators

Promedon

Lead sponsor

Source ClinicalTrials.gov