Comparison of FemSoft® urethral insert and vaginal tampons for stress urinary incontinence

INTERVENTION: Eligible participants will be assigned to a treatment group using computer generated randomisation in blocks, with allocation from a central office. Either device will be used, firstly for a training week to get used to the device and then for a further 6 weeks, during which voiding and incontinence diaries will be kept, after which the subject will be seen again at clinic and the following recorded: 1. Voiding and incontinence episodes diary will be returned 2. International Consultation on Incontinence Questionnaire ‐ Short Form (ICI‐Q SF) 3. Quality of life I‐QoL, SF36 4. Patient goals 5. Urine microbiology 6. Patient Global Impression of Improvement (PGI‐I) and Patient Global Impression of Severity (PGI‐S) 7. Urgency perception scale 8. Satisfaction with device ‐ Visual Analogue Scale (VAS) CONDITION: Female stress urinary incontinence ; Urological and Genital Diseases ; Stress incontinence PRIMARY OUTCOME: 1. Number of incontinence episodes per week (from voiding diary) whilst wearing a device; 2. The primary outcome will be compared between the two groups in two ways ‐ number of episodes (either with appropriate non‐parametric tests or generalised linear models, since incontinence episodes typically follow a Poisson distribution), and a separate comparison of subjects reporting no episodes that is those reporting continence whilst using the device (if there are sufficient of these) SECONDARY OUTCOME: 1. Incontinence severity and bother score measured by ICI‐Q SF questionnaire; 2. Patient global assessment of improvement (post treatment only) and severity by PGI‐I and PGI‐S; 3. Urgency perception scale (Cardoza et al, 2005); 4. Quality of life I‐QoL, SF36; 5. Patient goals ; 6. Urine microbiology (initially test strip ‐ if positive an mid stream specimen (MSU) will be taken for culture; 7. Secondary outcomes will be compared between groups using parametric or non‐parametric tests appropriate for the types of measures INCLUSION CRITERIA: 1. Female participants over 18 years of age 2. Not pregnant and if of child‐bearing age agrees to use reliable contraception throughout the trial 3. Able and willing to use tampons 4. Sufficient mobility / dexterity to use device and competent mentally 5. Able to give consent 6. Confirmed moderate to severe (at least one episode per day on average) SUI or mixed incontinence that is SUI predominant (cough test or urodynamic assessment) 7. Period of trial representative of normal activities (e.g. does not include a holiday)