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NCT Number: NCT05042453

Long-term Evaluation of the Efficacy and Safety of 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

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Key information

Conditions

Pelvic Organ Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

DRK Hospital Chemnitz-Rabenstein, Chemnitz, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Splentis® POP Tissue Anchoring System

Device

Anterior cervicopexy with bilateral sacrospinous ligament fixation using Splentis

Primary outcomes

  1. 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:

    • 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

Secondary outcomes

  1. Health-related quality of life

    Time frame: 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.

  2. Quality of life

    Time frame: 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.

  3. Urinary incontinence

    Time frame: 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.

  4. Overactive Bladder

    Time frame: 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.

  5. Sexual life

    Time frame: 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.

  6. Pain according Visual analogue scale of pain

    Time frame: 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.

  7. Patient global impression of improvement

    Time frame: 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.

  8. Cure according composite endpoint

    Time frame: 6 weeks and 24, 36, 60 months

    Number of patients completing each component of the composite endpoint

  9. Adverse Events

    Time frame: 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

  10. Exposure and extrusion free survival

    Time frame: 6 weeks and 12, 24, 36, 60 months

    Estimated exposure and extrusion free survival according Kaplan-Meier.

Study contacts

Contact information is provided by the study sponsor or research team.

Lorena López, Ph.D, Bioeng

CONTACT

[email protected]

005493514596072

Philipp Schelhorn

CONTACT

[email protected]

00498031900400

Sponsors and collaborators

Lead sponsor

Promedon

Industry

Registry information

Official study title

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

Acronym: SAXO

Important dates

Study start
2022
Primary completion
2026
Study completion
2030
First posted
Sep 13, 2021
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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