Female urinary incontinence Urological and Genital Diseases Female urinary incontinence
Conditions
Interventions
Participants are randomly allocated to either the control group or to the intervention group:
Control group (standard best practice care):
Participants continue routin
Sponsors
University of Manchester
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women 2. Aged between 18 and 65 3. GP determined urinary incontinence
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 01/09/2017: 1. Abnormal abdominal mass 2. Clinical history of urinary retention problems 3. Severe atrophic vaginitis, vaginal infection, vaginal lesion, severe urogenital prolapse at the level of the vaginal introitus or any other pathology of the vagina or labia 4. Pregnancy or given birth within the last three months 5. Implanted pacemaker 6. Recent pelvic surgery (within the last 12 months) 7. Recent haemorrhage, haematoma and/or tissue damage to the vagina 8. Undergoing any active therapy or review appointments for pelvic malignancy 9. Current urinary tract infection confirmed by urinary dip stick test on initial visit (can be included following a subsequent clear urinary dipstick test) 10. Manual dexterity insufficient to place the Pelviva device in the vagina 11. Presence of a severe neurological conditions such as Multiple Sclerosis, Motor Neuron Disease or Parkinson’s Disease 12. Anticholinergic and/or device treatment in the preceding 4 weeks 13. Multiple co-morbidities to the extent that the activities involved in the pad test (i.e. stair climbing) cannot be completed 14. Insufficient cognitive ability to provide informed consent and/or participate in the study 15. Unwillingness to participate in the study Previous exclusion criteria: 1. Abnormal abdominal mass 2. Problems with urinary retention 3. Severe atrophic vaginitis, vaginal infection, vaginal lesion, severe urogenital prolapse at the level of the vaginal introitus or any other pathology of the vagina or labia 4. Pregnancy or given birth within the last three months 5. Implanted pacemaker 6. Recent pelvic surgery (within the last 12 months) 7. Recent haemorrhage, haematoma and/or tissue damage to the vagina 8. Previous or current active treatment for pelvic malignancy 9. Current urinary tract infection confirmed by urinary dip stick test on initial visit 10. Manual dexterity insufficient to place the Pelviva device in the vagina 11. Presence of a severe neurological conditions such as Multiple Sclerosis, Motor Neuron Disease or Parkinson’s Disease 12. No anticholinergic and/or device treatment in the preceding 4 weeks 13. Multiple co-morbidities to the extent that the activities involved in the pad test (i.e. stair climbing) cannot be completed 14. Unwillingness to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, United Kingdom
Contacts
Public ContactJane Garnett
Outcome results
None listed