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
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
Fertile women
Recurrent apical prolapse
Women with post hysterectomy vaginal vault prolapse
Patients with active or latent infection of the vagina, cervix or uterus
Non-fertile women ≥ 18 years with uterine prolapse
Cohort
Prospective
Splentis® POP Tissue Anchoring System
DeviceAnterior cervicopexy with bilateral sacrospinous ligament fixation using Splentis
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
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.
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.
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.
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.
