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
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
140
Anterior cervicopexy with bilateral sacrospinous ligament fixation using Splentis
DRK Hospital Chemnitz-Rabenstein
Chemnitz, Germany
RECRUITINGHelios Hospital Erfurt, Department of gynaecology
Erfurt, Germany
RECRUITINGUniversity Hospital Freiburg
Freiburg im Breisgau, Germany
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: 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
Time frame: 12 months
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 6 weeks and 12, 24, 36, 60 months
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Clinic Kassel
Kassel, Germany
RECRUITINGSt. Elisabeth Hospital
Leipzig, Germany
RECRUITINGUniversity Hospital
Mannheim, Germany
NOT_YET_RECRUITINGHospital Tettnang
Tettnang, Germany
RECRUITINGOveractive 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 weeks and 12, 24, 36, 60 months
Cure according composite endpoint
Number of patients completing each component of the composite endpoint
Time frame: 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
Time frame: 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.
Time frame: 6 weeks and 12, 24, 36, 60 months