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In Vitro Bacterial Adhesion and Biofilm Formation on Fully Absorbable Poly-4-hydroxybutyrate and Nonabsorbable Polypropylene Pelvic Floor Implants.

ABSTRACT: Knitted polypropylene (PP) implants for the correction of pelvic organ prolapse have been associated with complications such as vaginal exposure, infection, and pain. Since certain complications may be linked to bacterial contamination and persistent inflammation, there is a rationale to develop a biocompatible implant that is less prone to bacterial adhesion and biofilm formation. Delayed absorbable materials could meet these requirements and poly-4-hydroxybutyrate (P4HB) might be such a new material for future pelvic floor implants. We studied in vitro bacterial adhesion and biofilm formation on P4HB in comparison to PP. We investigated the influence of both polymers using flat films and compared P4HB and PP implants with different knitting designs. P4HB flat films were demonstrated to be hydrophilic with significantly less Staphylococcus aureus and Escherichia coli cultured from P4HB films than from hydrophobic PP films after 24 h of incubation. On the implants, a higher number of E. coli were cultured after 1 h of incubation from the knitted P4HB implant with the highest density and smallest pore size, compared to other P4HB and PP implants. No differences were observed between the implants for E. coli at later time points or for S. aureus incubation. These results show that in flat films, the polymer influences biofilm formation, demonstrated by a reduced biofilm formation on P4HB compared with PP flat films. In addition, the knitting design may affect bacterial adhesion. Despite certain design and material characteristics that give the knitted P4HB implants a higher surface area, this did not result in more bacterial adhesion and biofilm formation overall. Collectively, these results warrant further (pre)clinical investigations of P4HB pelvic floor implants.

SUBMITTER: Verhorstert KWJ

PROVIDER: S-EPMC7716345 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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In Vitro Bacterial Adhesion and Biofilm Formation on Fully Absorbable Poly-4-hydroxybutyrate and Nonabsorbable Polypropylene Pelvic Floor Implants.

Verhorstert Kim W J KWJ Guler Zeliha Z de Boer Leonie L Riool Martijn M Roovers Jan-Paul W R JWR Zaat Sebastian A J SAJ

ACS applied materials & interfaces 20201119 48

Knitted polypropylene (PP) implants for the correction of pelvic organ prolapse have been associated with complications such as vaginal exposure, infection, and pain. Since certain complications may be linked to bacterial contamination and persistent inflammation, there is a rationale to develop a biocompatible implant that is less prone to bacterial adhesion and biofilm formation. Delayed absorbable materials could meet these requirements and poly-4-hydroxybutyrate (P4HB) might be such a new ma ...[more]

PMID: 33210919

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Project description:BACKGROUND:The objective of this study was to evaluate the mechanical and histological properties of a fully absorbable poly-4-hydroxybutyrate/absorbable barrier composite mesh (Phasix™ ST) compared to partially absorbable (Ventralight™ ST), fully absorbable (Phasix™), and biologically derived (Strattice™) meshes in a porcine model of ventral hernia repair. METHODS:Bilateral abdominal surgical defects were created in twenty-four Yucatan pigs, repaired with intraperitoneal (Phasix™ ST, Ventralight™ ST) or retromuscular (Phasix™, Strattice™) mesh, and evaluated at 12 and 24 weeks (n = 6 mesh/group/time point). RESULTS:Prior to implantation, Strattice™ demonstrated significantly higher (p < 0.001) strength (636.6 ± 192.1 N) compared to Ventralight™ ST (324.3 ± 37.1 N), Phasix™ ST (206.9 ± 11.3 N), and Phasix™ (200.6 ± 25.2 N). At 12 and 24 weeks, mesh/repair strength was significantly greater than NAW (p < 0.01 in all cases), and no significant changes in strength were observed for any meshes between 12 and 24 weeks (p > 0.05). Phasix™ mesh/repair strength was significantly greater than Strattice™ (p < 0.001) at 12 and 24 weeks, and Ventralight™ ST mesh/repair strength was significantly greater than Phasix™ ST mesh (p < 0.05) at 24 weeks. At 12 and 24 weeks, Phasix™ ST and Ventralight™ ST were associated with mild inflammation and minimal-mild fibrosis/neovascularization, with no significant differences between groups. At both time points, Phasix™ was associated with minimal-mild inflammation/fibrosis and mild neovascularization. Strattice™ was associated with minimal inflammation/fibrosis, with minimal neovascularization at 12 weeks, which increased to mild by 24 weeks. Strattice™ exhibited significantly less neovascularization than Phasix™ at 12 weeks and significantly greater inflammation at 24 weeks due to remodeling. CONCLUSIONS:Phasix™ ST demonstrated mechanical and histological properties comparable to partially absorbable (Ventralight™ ST) and fully resorbable (Phasix™) meshes at 12 and 24 weeks in this model. Data also suggest that fully absorbable meshes with longer-term resorption profiles may provide improved mechanical and histological properties compared to biologically derived scaffolds.

Project description:BACKGROUND:Pelvic floor myofascial pain, which is predominantly identified in the muscles of the levator ani and obturator internus, has been observed in women with chronic pelvic pain and other pelvic floor disorder symptoms, and is hypothesized to contribute to their symptoms. OBJECTIVES:To describe the prevalence of pelvic floor myofascial pain in patients presenting with pelvic floor disorder symptoms and to investigate whether severity of pelvic floor myofascial pain on examination correlates with degree of pelvic floor disorder symptom bother. STUDY DESIGN:All new patients seen at 1 tertiary referral center between 2014 and 2016 were included in this retrospectively assembled cross-sectional study. Pelvic floor myofascial pain was determined by transvaginal palpation of the bilateral obturator internus and levator ani muscles and scored as a discrete number on an 11-point verbal pain rating scale (range, 0-10) at each site. Scores were categorized as none (0), mild (1-3), moderate (4-6), and severe (7-10) for each site. Pelvic floor disorder symptom bother was assessed by the Pelvic Floor Distress Inventory short form scores. The correlation between these 2 measures was calculated using Spearman rank and partial rank correlation coefficients. RESULTS:A total of 912 new patients were evaluated. After exclusion of 79 with an acute urinary tract infection, 833 patients were included in the final analysis. Pelvic floor myofascial pain (pain rated >0 in any muscle group) was identified in 85.0% of patients: 50.4% rated as severe, 25.0% moderate, and 9.6% mild. In unadjusted analyses and those adjusted for postmenopausal status, severity of pelvic floor myofascial pain was significantly correlated with subjective prolapse symptoms such as pelvic pressure and heaviness but not with objective prolapse symptoms (seeing or feeling a vaginal bulge or having to push up on a bulge to start or complete urination) or leading edge. Severity of myofascial pain at several individual pelvic floor sites was also independently correlated with lower urinary tract symptoms, including pain in the lower abdomen (myofascial pain at all sites) and difficulty emptying the bladder (right obturator internus and left levator ani); and with defecatory dysfunction, including sensation of incomplete rectal emptying (pain at all sites combined and the right obturator internus), anal incontinence to flatus (pain at all sites combined), and pain with defecation (pain at all sites combined, and the right obturator internus and left levator ani). CONCLUSION:Pelvic floor myofascial pain was common in patients seeking evaluation for pelvic floor disorder symptoms. Location and severity of pelvic floor myofascial pain was significantly correlated with degree of symptom bother, even after controlling for postmenopausal status. Given the high prevalence of pelvic floor myofascial pain in these patients and correlation between pain severity and degree of symptom bother, a routine assessment for pelvic floor myofascial pain should be considered for all patients presenting for evaluation of pelvic floor symptoms.

Project description:BackgroundThere is a risk of pelvic floor dysfunction (PFD) from baby delivery. Many clinical guidelines recommend pelvic floor muscle training (PFMT) as the conservative treatment for PFD because pelvic floor muscles (PFMs) play a crucial role in development of PFD. However, there is disagreement about the method and intensity of PFM training and the relevant measurements. To pilot the study in PFM training, we designed a Pelvic Floor Workout (PEFLOW) for women to train their pelvic through entire body exercises, and we planned a trial to evaluate its effectiveness through comparing the outcomes from a group of postpartum women who perform PELFLOW at home under professional guidance online with the control group.Methods/designThe randomized controlled trial was projected to be conducted from November 2021 to March 2023. A total of 260 postpartum women would be recruited from the obstetrics departments of the study hospital and women would be eligible for participation randomized into experimental or control groups (EG/CG) if their PFM strength are scaled by less than Modified Oxford grading Scale (MOS) to be less than grade 3. Women in EG would perform a 12-week PEFLOW online under the supervision and guidance of a physiotherapist, while women in CG would have no interventions. Assessments would be conducted at enrollment, post intervention (for EG) or 18th to 24th week postpartum (for CG), and 1 year postpartum. Assessment would be performed in terms of pelvic floor symptoms, including MOS, cough stress test, urinary leakage symptoms, pelvic organ prolapse quantitation (POP-Q), and vaginal relaxation, clinic examinations including Pelvic floor electrophysiological test, Pelvic floor ultrasound and Spine X-ray, overall body test including trunk endurance test, handgrip test, body composition test, and questionnaires including International Physical Activity Questionnaire Score-Short Form(IPAQ-SF), Pelvic Floor Distress Inventory Questionnaire-20 (PFDI-20), Pelvic Floor Impact Questionnaire-7 (PFIQ-7), the 6-item Female Sexual Function Index (FSFI-6), and the Pittsburgh Sleep Quality Index (PSQI). Primary analysis will be performed to test our main hypothesis that PEFLOW is effective with respect to strengthen PFM strength.DiscussionThis trial will demonstrate that pelvic floor-care is accessible to most women and clinical practice on PFD may change relevantly should this study find that Online PEFLOW approach is effective to improve PFMs.Trial registrationClinicalTrials.gov, NCT05218239.

Dataset Information

In Vitro Bacterial Adhesion and Biofilm Formation on Fully Absorbable Poly-4-hydroxybutyrate and Nonabsorbable Polypropylene Pelvic Floor Implants.

Publications

In Vitro Bacterial Adhesion and Biofilm Formation on Fully Absorbable Poly-4-hydroxybutyrate and Nonabsorbable Polypropylene Pelvic Floor Implants.

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