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

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

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

Study Overview

• Status: Recruiting
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Device: Splentis® POP Tissue Anchoring System

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 Type: Observational
• Enrollment (Anticipated): 140

Contacts and Locations

• Study Contact: Name: Philipp Schelhorn; Phone Number: 00498031900400; Email: trials.de@promedon.com
• Study Contact Backup: Name: Lorena López, Ph.D, Bioeng; Phone Number: 005493514596072; Email: lorena.lopez@promedon.com

Study Locations

• Germany
  • Tettnang, Germany
    • Not yet recruiting
    • Hospital Tettnang
    • Contact: Christian Fünfgeld, Dr.med.
  • Thüringen
    • Erfurt, Thüringen, Germany
      • Recruiting
      • Helios Hospital Erfurt, Department of gynaecology
      • Contact: Gert Naumann, PD Dr.habil.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Non-fertile women ≥ 18 years with uterine prolapse

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hysteropexy using Splentis via vaginal route; Non-fertile women ≥ 18 years with uterine descent (POP-Q ≥ 2) which are study-independently scheduled for hysteropexy with Splentis	Device: Splentis® POP Tissue Anchoring System; Anterior cervicopexy with bilateral sacrospinous ligament fixation using Splentis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cure of apical pelvic organ prolapse	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: leading edge of the apical vaginal wall at or above the hymen (C≤ 0); absence of a vaginal bulge symptom; no need for retreatment of the apical prolapse by either pessary use or surgical intervention	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related quality of life	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.	Baseline, 6 weeks 12, 24, 36, 60 months
Quality of life	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.	Baseline, 6 weeks and 12, 24, 36, 60 months
Urinary incontinence	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.	Baseline, 6 weeks and 12, 24, 36, 60 months
Overactive Bladder	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.	Baseline, 6 weeks and 12, 24, 36, 60 months
Sexual life	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.	Baseline, 6 weeks and 12, 24, 36, 60 months
Pain according Visual analogue scale of pain	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.	Baseline, 24-48 hours postoperatively, 6 weeks and 12, 24, 36, 60 months
Patient global impression of improvement	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.	6 weeks and 12, 24, 36, 60 months
Cure according composite endpoint	Number of patients completing each component of the composite endpoint	6 weeks and 24, 36, 60 months
Adverse Events	Number and severity of Adverse Events according guideline of AE reporting, Clavien Dindo and Terminology of IUGA/ICS	Intraoperatively, 24-48hours postoperatively, 6 weeks postoperatively and 12, 24, 36, 60 months, unscheduled visits
Exposure and extrusion free survival	Estimated exposure and extrusion free survival according Kaplan-Meier.	6 weeks and 12, 24, 36, 60 months

Collaborators and Investigators

• Sponsor: Promedon
• Investigators: Principal Investigator: Gert Naumann, MD, Helios Clinic Erfurt, Germany; Principal Investigator: Christian Fünfgeld, MD, Clinic Tettnang

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2028

Study Registration Dates

• First Submitted: August 12, 2021
• First Submitted That Met QC Criteria: September 6, 2021
• First Posted (Actual): September 13, 2021

Study Record Updates

• Last Update Posted (Estimate): December 29, 2022
• Last Update Submitted That Met QC Criteria: December 27, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Transvaginal repair; Apical Pelvic Organ Prolapse; Mesh augmented repair; Sacrouterine ligament fixation
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: Sax_Pro

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No