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

Promedon

Status: Enrolling

Conditions: Pelvic Organ Prolapse

Treatments: Device: Splentis® POP Tissue Anchoring System

Study type: Observational

Funder types: Industry

Identifiers

NCT05042453

Sax_Pro

Details and patient eligibility

About

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

Full description

Women who undergo hysteropexy with Splentis via the vaginal route for primary uterine prolapse will be evaluated regarding efficacy and safety in a long term follow-up of 60 months. The primary endpoint is composed of anatomical, subjective and re-treatment components, whereas several secondary endpoints focusing on functional outcome including overactive bladder symptoms, urinary incontinence, quality of life and sexual life will be considered. Furthermore, a detailed report about adverse events will be included.

Enrollment: 140 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

140 participants in 1 patient group

Hysteropexy using Splentis via vaginal route

Description:

Non-fertile women ≥ 18 years with uterine descent (POP-Q ≥ 2) which are study-independently scheduled for hysteropexy with Splentis

Treatment:

Device: Splentis® POP Tissue Anchoring System