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

Pelvic Organ Prolapse Clinical Trial

— SAXO  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05042453
• Other study ID #: Sax_Pro
• Status: Recruiting
• Start date: December 19, 2022
• Est. completion date: December 1, 2028

Study information

• Verified date: December 2022
• Source: Promedon
• Contact: Philipp Schelhorn
• Phone: 00498031900400
• Email: trials.de[@]promedon.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 1, 2028
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Device:
• Splentis® POP Tissue Anchoring System
Anterior cervicopexy with bilateral sacrospinous ligament fixation using Splentis

Locations

Country	Name	City	State
Germany	Helios Hospital Erfurt, Department of gynaecology	Erfurt	Thüringen
Germany	Hospital Tettnang	Tettnang

Sponsors (1)

Lead Sponsor	Collaborator
Promedon

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Cure according composite endpoint	Number of patients completing each component of the composite endpoint	6 weeks and 24, 36, 60 months
Secondary	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
Secondary	Exposure and extrusion free survival	Estimated exposure and extrusion free survival according Kaplan-Meier.	6 weeks and 12, 24, 36, 60 months