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Clinical Trials/NCT05042453
NCT05042453RecruitingNot Applicable

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

Promedon7 sites in 1 country140 target enrollmentStarted: December 19, 2022Last updated:
Conditions

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)

Investigators

Sponsor
Promedon
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (7)

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