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

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 2:1 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.