Long-term Evaluation of the Efficacy and Safety of Splentis for the Treatment of Primary Apical Pelvic Organ Prolapse
Recruiting
Observational Study
Pelvic Organ Prolapse
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Study type
- Observational
- Participants needed
- 140 (estimated)
- Sponsor
- Promedon · Industry
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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
Trial Locations
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Eligibility Criteria
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 hyster…
Contacts