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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Device: Splentis® POP Tissue Anchoring System


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hysteropexy using Splentis via vaginal route<br>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<br>* Anterior cervicopexy with bilateral sacrospinous ligament fixation using Splentis<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Apical Pelvic Organ Prolapse, Transvaginal repair, Mesh augmented repair, Sacrouterine ligament fixation