Prospective, Multicenter, 60 Months, Single-arm Cohort Trial for Evaluation of the Efficacy and Safety of Transvaginal Sacrospinous Ligament Fixation With Splentis for the Treatment of Primary Apical Pelvic Organ Prolapse
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Promedon
- Enrollment
- 140
- Locations
- 7
- Primary Endpoint
- Cure of apical pelvic organ prolapse
Study Overview
Brief 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
Detailed 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts 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.
Outcomes
Primary Outcomes
Cure of apical pelvic organ prolapse
Time Frame: 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
Secondary Outcomes
- Health-related quality of life(Baseline, 6 weeks 12, 24, 36, 60 months)
- Pain according Visual analogue scale of pain(Baseline, 24-48 hours postoperatively, 6 weeks and 12, 24, 36, 60 months)
- Adverse Events(Intraoperatively, 24-48hours postoperatively, 6 weeks postoperatively and 12, 24, 36, 60 months, unscheduled visits)
- Urinary incontinence(Baseline, 6 weeks and 12, 24, 36, 60 months)
- Quality of life(Baseline, 6 weeks and 12, 24, 36, 60 months)
- Overactive Bladder(Baseline, 6 weeks and 12, 24, 36, 60 months)
- Cure according composite endpoint(6 weeks and 24, 36, 60 months)
- Sexual life(Baseline, 6 weeks and 12, 24, 36, 60 months)
- Patient global impression of improvement(6 weeks and 12, 24, 36, 60 months)
- Exposure and extrusion free survival(6 weeks and 12, 24, 36, 60 months)