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

Recruiting

• Conditions: Pelvic Organ Prolapse
• Interventions: Device: Splentis® POP Tissue Anchoring System

• Registration Number: NCT05042453
• Lead Sponsor: Promedon

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 Timeline

• Study First Submitted: 2021-08-12
• Study First Submitted QC: 2021-09-06
• Study First Posted: 2021-09-13
• Study Start: 2022-12-19
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-22
• Primary Completion: 2026-07
• Study Completion: 2030-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 140

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hysteropexy using Splentis via vaginal route	Splentis® POP Tissue Anchoring System	Non-fertile women ≥ 18 years with uterine descent (POP-Q ≥ 2) which are study-independently scheduled for hysteropexy with Splentis

Primary Outcome Measures

Name	Time	Method
Cure of apical pelvic organ prolapse	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 Outcome Measures

Name	Time	Method
Health-related quality of life	Baseline, 6 weeks 12, 24, 36, 60 months	Change of Quality of life and prolapse symptoms using the Prolapse-Quality of Life-Questionnaire in comparison between baseline and follow-up.; The questionnaire is divided in nine domains which are analyzed separately. The results will be transformed into a scale between 0 - 100 according the questionnaires description. The higher the score, the higher the impact of prolapse symptoms and the lower the quality of life.
Pain according Visual analogue scale of pain	Baseline, 24-48 hours postoperatively, 6 weeks and 12, 24, 36, 60 months	Change of pain using the visual analogue scale of pain in comparison between baseline and follow-up; The Wong-Baker Faces Pain Scale is a visual analogue scale to assess subject pain.The answers will be transformed in a scale from 0 to 10 whereas 0 implicate no pain and 10 worst pain.
Adverse Events	Intraoperatively, 24-48hours postoperatively, 6 weeks postoperatively and 12, 24, 36, 60 months, unscheduled visits	Number and severity of Adverse Events according guideline of AE reporting, Clavien Dindo and Terminology of IUGA/ICS
Urinary incontinence	Baseline, 6 weeks and 12, 24, 36, 60 months	Change of urinary incontinence using the International Consultation on Incontinence Questionnaire- Urinary Incontinence Short From in comparison between baseline and follow-up; The ICIQ-UI-SF includes four items with a sum score ranging between 0 and 21 points. The higher the score the higher the impact of symptoms.
Quality of life	Baseline, 6 weeks and 12, 24, 36, 60 months	Change of quality of life using the EQ-5L-5D in comparison between baseline and follow-up.; It consists of a 5-item descriptive system as well as a visual analogue scale ranging from 0 to 100. It is conceptualized to assess deviation from health and hereby provide health related quality of life problems.
Overactive Bladder	Baseline, 6 weeks and 12, 24, 36, 60 months	Change of urinary incontinence using the International Consultation on Incontinence Questionnaire- Overactive bladder in comparison between baseline and follow-up; The score of the ICIQ-OAB ranges from 0 to 16 points. The higher the sum score the higher the impact of symptoms.
Cure according composite endpoint	6 weeks and 24, 36, 60 months	Number of patients completing each component of the composite endpoint
Sexual life	Baseline, 6 weeks and 12, 24, 36, 60 months	Change of sexual life using the Pelvic Organ Prolapse Incontinence Sexual Questionnaire- IUGA revised in comparison between baseline and follow-up.; The result will be transformed into a scale between 0 - 100. The higher the score, the higher the impact of prolapse symptoms and the higher the impact on sexual life.
Patient global impression of improvement	6 weeks and 12, 24, 36, 60 months	Number of Patients with improvement of prolapse symptoms according the validated question Patient Global Impression of improvement; The PGI-I is a seven Likert scale from very much better to no change and very much worse.
Exposure and extrusion free survival	6 weeks and 12, 24, 36, 60 months	Estimated exposure and extrusion free survival according Kaplan-Meier.

Trial Locations

Locations (7)

DRK Hospital Chemnitz-Rabenstein; 🇩🇪 Chemnitz, Germany

University Hospital Freiburg; 🇩🇪 Freiburg, Germany

Clinic Kassel; 🇩🇪 Kassel, Germany

St. Elisabeth Hospital; 🇩🇪 Leipzig, Germany

University Hospital; 🇩🇪 Mannheim, Germany

Helios Hospital Erfurt, Department of gynaecology; 🇩🇪 Erfurt, Germany

Hospital Tettnang; 🇩🇪 Tettnang, Germany