title: A 3-month preclinical trial to assess the performance of a new TVT-like mesh (TVTx) in a sheep model.
abstract: The objective of this study was to evaluate in a sheep model the performance of a new polypropylene mesh (TVTx), which is intended as a less invasive treatment for female stress urinary incontinence. Eight female sheep were used in this study, each one being implanted with eight TVTx samples. At each time-point (weeks 1, 2, 4, and 12) seven TVTx were pulled out, while one TVTx was carefully dissected for histological investigations. One TVTx and one TVT, moreover, were inserted and immediately pulled out for obtaining the initial pullout forces in all sheep. The initial pullout values of TVT and TVTx were overlapping. The pullout forces of TVTx were >5 N (500 g) and increasing from weeks 1 to 12 (p<0.001). Histology revealed good tissue integration of TVTx in the tissue within 12 weeks after implantation. No abnormal histological findings were observed. This data could support the realization of a clinical trial with the TVTx mesh.
authors.affiliation: Department of Women's and Children's Health Obstetrics and Gynecology, Uppsala University, Uppsala, Sweden.
authors.forename: Masoumeh
authors.initials: M
authors.lastname: Rezapour
authors.forename: Giacomo
authors.initials: G
authors.lastname: Novara
authors.forename: Peter A
authors.initials: PA
authors.lastname: Meier
authors.forename: Joerg
authors.initials: J
authors.lastname: Holste
authors.forename: Susanne
authors.initials: S
authors.lastname: Landgrebe
authors.forename: Walter
authors.initials: W
authors.lastname: Artibani
mesh_terms: D000818:Animals; D001672:Biocompatible Materials / Q000009:adverse effects; D005260:Female; D008422:Materials Testing; D019060:Minimally Invasive Surgical Procedures / Q000009:adverse effects; D023421:Models, Animal; D011126:Polypropylenes; D011474:Prosthesis Design; D012756:Sheep; D053825:Suburethral Slings / Q000009:adverse effects; D013997:Time Factors; D014550:Urinary Incontinence, Stress / Q000601:surgery*
chemical_list: D001672:Biocompatible Materials; D011126:Polypropylenes