Long-term Evaluation of the Efficacy and Safety of Splentis for the Treatment of Primary Apical Pelvic Organ Prolapse
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Splentis® POP Tissue Anchoring System.
- Who it may be relevant to
- Registry conditions: Pelvic Organ Prolapse. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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
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.
Interventions
- Device Splentis® POP Tissue Anchoring System
Anterior cervicopexy with bilateral sacrospinous ligament fixation using Splentis
Primary outcome measures
- Cure of apical pelvic organ prolapse [Time frame: 12 months]
Secondary outcome measures (10)
- Health-related quality of life [Time frame: Baseline, 6 weeks 12, 24, 36, 60 months]
- Quality of life [Time frame: Baseline, 6 weeks and 12, 24, 36, 60 months]
- Urinary incontinence [Time frame: Baseline, 6 weeks and 12, 24, 36, 60 months]
- Overactive Bladder [Time frame: Baseline, 6 weeks and 12, 24, 36, 60 months]
- Sexual life [Time frame: Baseline, 6 weeks and 12, 24, 36, 60 months]
- Pain according Visual analogue scale of pain [Time frame: Baseline, 24-48 hours postoperatively, 6 weeks and 12, 24, 36, 60 months]
- Patient global impression of improvement [Time frame: 6 weeks and 12, 24, 36, 60 months]
- Cure according composite endpoint [Time frame: 6 weeks and 24, 36, 60 months]
- Adverse Events [Time frame: Intraoperatively, 24-48hours postoperatively, 6 weeks postoperatively and 12, 24, 36, 60 months, unscheduled visits]
- Exposure and extrusion free survival [Time frame: 6 weeks and 12, 24, 36, 60 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 7 centers
- DRK Hospital Chemnitz-Rabenstein — Chemnitz
- Helios Hospital Erfurt, Department of gynaecology — Erfurt
- University Hospital Freiburg — Freiburg im Breisgau
- Clinic Kassel — Kassel
- St. Elisabeth Hospital — Leipzig
- University Hospital — Mannheim
- Hospital Tettnang — Tettnang
Identifiers
NCT: NCT05042453 · Sax_Pro