Two-year effects and cost-effectiveness of pelvic floor muscle training in mild pelvic organ prolapse: a randomised controlled trial in primary care.

OBJECTIVE: To compare effects and cost-effectiveness of pelvic floor muscle training (PFMT) and watchful waiting in women with pelvic organ prolapse. DESIGN: Randomised controlled trial. SETTING: Dutch general practice. POPULATION: Women (≥55 years) with symptomatic mild prolapse, identified by screening. METHODS: Linear multilevel analysis. MAIN OUTCOME MEASURES: Primary outcome was change of pelvic floor symptoms (Pelvic-Floor-Distress-Inventory-20 [PFDI-20]) during 24 months. Secondary outcomes were condition-specific and general quality of life, costs, sexual functioning, prolapse stage, pelvic floor muscle function and women's perceived improvement of symptoms. RESULTS: PFMT (n = 145) resulted in a 12.2-point (95% CI 7.2-17.2, P < 0.001) greater improvement in PFDI-20 score during 24 months compared with watchful waiting (n = 142). Participants randomised to PFMT more often reported improved symptoms (43% versus 14% for watchful waiting). Direct medical costs per person were €330 for PFMT and €91 for watchful waiting but costs for absorbent pads were lower in the PFMT group (€40 versus €77). Other secondary outcomes did not differ between groups. Post-hoc subgroup analysis demonstrated that PFMT was more effective in women experiencing higher pelvic floor symptom distress at baseline. CONCLUSION: PFMT resulted in greater pelvic floor symptom improvement compared with watchful waiting. The difference was statistically significant, but below the presumed level of clinical relevance (15 points). PFMT more often led to women's perceived improvement of symptoms, lower absorbent pads costs, and was more effective in women experiencing higher pelvic floor symptom distress. Therefore, PFMT could be advised in women with bothersome symptoms of mild prolapse. TWEETABLE ABSTRACT: Pelvic floor muscle training can be effective in women with bothersome symptoms of mild prolapse.

Decreased plasma levels of activated factor VII in patients with deep vein thrombosis.

BACKGROUND: The initiating trigger in the development of deep vein thrombosis (DVT) remains unidentified. It has been suggested that tissue factor (TF)-bearing microparticles play a key role, which indicates a role for the TF pathway in the initiation of DVT. OBJECTIVE: To assess the role of the TF pathway in the initiation of venous thrombosis, we measured plasma levels of factor VII and VIIa in patients with acute DVT and in controls. METHODS: We included 148 patients diagnosed with acute DVT and 179 controls in this study. Antigen levels of FVII and FVIIa were measured by using assays recently developed in our laboratory. RESULTS: Median FVII levels in patients were 109.8% (interquartile range [IQR] 86.0-153.2) compared with 102.2% (IQR 76.1-141.7) in controls. Individuals with FVII levels in the upper quartile had a 1.6-fold increased risk for the presence of a DVT (odds ratio 1.6, 95% confidence interval 0.8-3.1). Median FVIIa levels in patients were 50.2 ng mL(-1) (IQR 25.2-86.1) compared with 96.6 ng mL(-1) (69.9-168.9) in controls. Individuals with FVIIa levels in the lowest quartile had a > 5-fold increased risk for the presence of a DVT (odds ratio 5.5, 95% confidence interval 2.8-10.6). Both risks did not change substantially after adjustment for potential confounders. CONCLUSION: Decreased plasma levels of FVIIa in patients with deep vein thrombosis may indicate ongoing consumption of FVIIa and suggest a contributory role for TF in venous thrombus formation.