Evaluation of the IncoStress device for urinary incontinence: a feasibility study and pilot randomised controlled trial.

ABSTRACT

INTRODUCTION AND HYPOTHESIS: The aim of this study was to assess the feasibility of recruitment to and outcomes from a pilot randomised study of the IncoStress device as an adjunct to conservative treatment for urinary incontinence. METHODS: Women with urinary incontinence were randomised on a 21 basis to usual care (control) or usual care plus use of the IncoStress device (intervention). Process outcomes (retention and compliance) were recorded plus symptom outcomes (IQOL and ICIQ-FLUTS questionnaires). A sample of participants took part in an interview to understand the frequency of use of the device and satisfaction. RESULTS: Eighty women (51 intervention, 29 control) were recruited. Follow-up responses were obtained from 34 intervention group (66.7%) and 17 (58.6%) control patients. Women used the device for a median 3 days a week (0-7), 18 out of 34 (53%) found it easy to use and 21 (61.8%) were satisfied with the device. Median IQOL score in the intervention group improved from a baseline of 42.4 (0-94) to 68.2 (5-98) at follow-up and in the control group from 45.5 (0-88) to 53.0 (0-94). Median ICIQ-FLUTS score in the intervention group improved from 14.5 (6-35) to 12.5 (4-26) and in the control group from 15.0 (5-35) to 14.0 (6-38). CONCLUSIONS: Recruitment and randomisation were feasible and robust. This study demonstrates that a large-scale RCT is feasible and the IncoStress has potential value.