OBJECTIVES: To compare the safety, effectiveness and patient satisfaction of an intraurethral valve-pump catheter (In-Flow) versus the current standard of care, clean intermittent catheterization (CIC), for females with hypocontractile or acontractile bladder. MATERIALS AND METHODS: The study was a multi-centre, prospective, single-arm crossover study. Eligible patients underwent a 1-week In-Flow tolerability trial. Successful patients then continued through an 8-week baseline phase using CIC, followed by a 16-week In-Flow treatment phase, and a final 4-week treatment withdrawal phase. Outcome measures included post-void residual (PVR), Wagner incontinence-specific quality of life (I-QOL), rate of urinary tract infection and adverse events. At study completion, open enrollment was offered. RESULTS: A total of 273 women with a mean age of 48.9 years using CIC entered the study in 18 centres under either the original (n=88) or revised protocols (n=185). The revised protocol included the addition of a 1-week tolerability trial. The reasons for the large early withdrawal of subjects (169/273) were mainly related to initial discomfort and leakage. A total of 77 patients completed the In-Flow treatment phase. PVR was comparable during baseline CIC phase and In-Flow treatment phase (20.3 ml vs. 16.1 ml), with significantly improved quality of life (QOL; mean improvement of I-QOL score +25.9; p<0.001). CONCLUSION: The In-Flow catheter appears to be a viable alternative to CIC. A subgroup of patients, mainly those unsatisfied with the currently available treatments, was more likely to tolerate In-Flow catheters, and they may achieve enhanced independence and QOL.
RCT Entities:
OBJECTIVES: To compare the safety, effectiveness and patient satisfaction of an intraurethral valve-pump catheter (In-Flow) versus the current standard of care, clean intermittent catheterization (CIC), for females with hypocontractile or acontractile bladder. MATERIALS AND METHODS: The study was a multi-centre, prospective, single-arm crossover study. Eligible patients underwent a 1-week In-Flow tolerability trial. Successful patients then continued through an 8-week baseline phase using CIC, followed by a 16-week In-Flow treatment phase, and a final 4-week treatment withdrawal phase. Outcome measures included post-void residual (PVR), Wagner incontinence-specific quality of life (I-QOL), rate of urinary tract infection and adverse events. At study completion, open enrollment was offered. RESULTS: A total of 273 women with a mean age of 48.9 years using CIC entered the study in 18 centres under either the original (n=88) or revised protocols (n=185). The revised protocol included the addition of a 1-week tolerability trial. The reasons for the large early withdrawal of subjects (169/273) were mainly related to initial discomfort and leakage. A total of 77 patients completed the In-Flow treatment phase. PVR was comparable during baseline CIC phase and In-Flow treatment phase (20.3 ml vs. 16.1 ml), with significantly improved quality of life (QOL; mean improvement of I-QOL score +25.9; p<0.001). CONCLUSION: The In-Flow catheter appears to be a viable alternative to CIC. A subgroup of patients, mainly those unsatisfied with the currently available treatments, was more likely to tolerate In-Flow catheters, and they may achieve enhanced independence and QOL.