Long-term evaluation of the efficacy and safety of the Calistar S pelvic floor repair system for the transvaginal The purpose of this investigation is the evaluation of the performance and safety of Calistar S in women with anterior POP with or…
ID
Bron
Verkorte titel
Aandoening
Female Pelvic Organ Prolapse
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Number of patients with surgical treatment success of anterior and apical pelvic organ prolapse after 24 months
Achtergrond van het onderzoek
This is a prospective, long-term, multicenter comparative matched cohort study to evaluate the efficacy and safety of the Calistar S pelvic Floor repair system in women undergoing transvaginal POP repair.
The surgical treatment of pelvic organ prolapse has significantly evolved over the last few decades due to increased understanding of the anatomy as well as the development of minimally invasive surgeries. For the treatment of POP different surgical approaches are available. One treatment option are vaginal implants, which are used in the anterior or posterior vaginal wall, to induce a foreign body response. Vaginal meshes also suspends the apex by a bilateral suspension of the vaginal vault or cervix to both sacrospinous ligaments. Within this study the efficacy and safety of one specific mesh is evaluated.
Doel van het onderzoek
Long-term evaluation of the efficacy and safety of the Calistar S pelvic floor repair system for the transvaginal The purpose of this investigation is the evaluation of the performance and safety of Calistar S in women with anterior POP with or without apical vaginal wall involvement in both, recurrent POP or primary complex POP as compared to control group of women treated with Restorelle mesh.
Onderzoeksopzet
Baseline
6-Week Follow-UP
6-Month Follow-UP
12-Month Follow-UP
24-Month Follow-UP
36-Month Follow-UP
Onderzoeksproduct en/of interventie
Calistar S for transvaginal pelvic organ prolapse repair
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Non-pregnant women > 18 years defined by postmenopausal status and / or iatrogenic causes which exclude women permanently from becoming pregnant (e.g. history of hysterectomy or sterilised women).
2. Anterior prolapse with or without apical vaginal wall involvement according POP-Q score ≥ 2
3. Subjects with recurrent prolapse as well as primary complex prolapse when other surgical procedures are expected to fail (i.e. high risk for recurrence) are eligible for the study.
4. Scheduled mesh-augmented anterior POP repair with Calistar S
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Pregnant women
2. Patients with active or latent infection of the vagina, cervix or uterus
3. Patients with previous or current vaginal, cervical or uterine cancer
4. Previous, current or planned pelvic radiation therapy
5. Known allergy to polypropylene
6. Ulcus of the vaginal wall
7. Subject is unable or unwilling to complete questionnaires (either self-administered, assisted or interviewed) and/or to follow scheduled visits and/or to sign informed consent
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9815 |
| Ander register | MEC-U : R20.013 |