Evaluation of a new technology for the treatment of bladder leakage in women

INTERVENTION: Participants are randomly allocated to either the control group or to the intervention group: Control group (standard best practice care): Participants continue routine standard treatment for their incontinence including any medication that has already been prescribed via their GP as normal. Routine treatment adheres to best practice standards as outlined in NICE Clinical Guidelines 171 (2013) where appropriate.Routine treatment may include pelvic floor exercises explained by the practitioner, weighted exercise cones, pelvic toner devices, vaginal insert devices (i.e. Contiform), pelvic floor physiotherapy, bladder re‐training (continence service) and/or medication (which could include anticholinergics or mirabegron. Participants who complete the study are offered vouchers for a 3‐month course of Pelviva. Intervention group (Pelviva group): Participants are supplied at their first visit with one 15‐day pack of single use disposable Pelviva devices to use for the initial month (at an average rate of one every other day) of a three month course of treatment. The next three months is the maintenance phase where participants continue using Pelviva at a dose of 6 devices per month (on average using one every five days) The Pelviva device has been designed to be soft and comfortable to wear, intuitive to use and capable of delivering effective stimulation to the pelvic floor muscles. The device is manufactured from reversibly compressible foam and is inserted like a tampon into the vagina and removed using a pull cord. Subsequent devices are posted to the patient’s home address in plain packaging. The stimulation programme is delivered using a duty cycle of 10 seconds stimulation followed by 10 seconds rest that runs for a period of 30 minutes. The Pelviva devices are pre‐programmed to automatically gradually ramp‐up the intensity of stimulation over a 24 second period to reach a therapeutic level and switch off automatically after 30 minutes. All devices are programm CONDITION: Female urinary incontinence ; Urological and Genital Diseases ; Female urinary incontinence PRIMARY OUTCOME: Quality of Life is measured using the International Consultation on Incontinence Questionnaire—Urinary Incontinence (ICIQ‐UI) at baseline, month one and a half, three, six, 12, 24 and 36. INCLUSION CRITERIA: 1. Women 2. Aged between 18 and 65 3. GP determined urinary incontinence SECONDARY OUTCOME: 1. Sexual function is measured using the International Urogynecological Association (IUGA) Pelvic Organ Prolapse/ Urinary Incontinence Sexual Questionnaire (PISQ‐IR) at baseline, mid point (one and a half months) and at the end of the trial (three months); 2. Patient Global Assessment of Severity at baseline, mid point (one and a half months) and at the end of the trial (three months); 3. Patient Global Assessment of Improvement at the end of the trial (three months); 4. Bladder leakage is measured using a 1 hour provocative pad weight test at baseline and at the end of the trial (three months); 5. Episodes of incontinence is measured using a regular diary record during the 3 month trial and then at 12 and 24 months; 6. Treatment usage and usability (pelvic floor exercises, vaginal cones, drug intervention) are measured using a regular diary record during the 3 month trial; 7. Health economics are measured using EQ‐5D and a diary of expenditure on incontinence products at baseline and month three, as well as month six, 12, 24 and 36