Multi-centre study of intraurethral valve-pump catheter in women with a hypocontractile or acontractile bladder.
OBJECTIVE
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.


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).


CONCLUSIONS
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.
Chen
T Y-H
TY
Department of Urology, Sherbrooke University Hospital Centre, 3001 12th Avenue Nord, Fleurimont, PQ J1H 5N4, Canada. tony.chen@mail.mcgill.ca
Ponsot
Y
Y
Carmel
M
M
Bouffard
N
N
Kennelly
M J
MJ
Tu
L M
LM
D000328:Adult; D000368:Aged; D018592:Cross-Over Studies; D004867:Equipment Design; D004869:Equipment Safety; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D009656:North America / Q000453:epidemiology; D017060:Patient Satisfaction; D011446:Prospective Studies; D011788:Quality of Life; D016896:Treatment Outcome; D001745:Urinary Bladder Diseases / Q000503:physiopathology* / Q000628:therapy*; D014546:Urinary Catheterization / Q000009:adverse effects / Q000295:instrumentation; D014549:Urinary Incontinence / Q000503:physiopathology / Q000628:therapy; D014552:Urinary Tract Infections / Q000209:etiology; D014554:Urination; D028761:Withholding Treatment