Female stress urinary incontinence Urological and Genital Diseases
Conditions
Interventions
Women will be provided with information about the study, and if the agree, they will be asked to sign a consent form confirming this and to complete a baseline questionnaire that asks about their qual
Sponsors
University of Aberdeen
Eligibility
Sex/Gender
Female
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Women aged 18 years or over with clinically diagnosed stress predominant UI and deemed by their clinician to be suitable for VCDs, and willing to self-manage VCDs. 2. Inclusion criteria for the health care professionals invited to take part in a focus group are: clinicians, physiotherapists and specialist nurses in the pilot sites who are involved in the care of women with stress predominant SUI.
Exclusion criteria
Exclusion criteria: 1. Vaginal prolapse more than POP-Q Stage 2a (POP-Q= Pelvic Organ Prolapse Quantification score) 2. Neurogenic bladder 3. Urgency predominant UI 4. Evidence of active pelvic or vaginal infection 5. Vaginal ulceration 6. Allergy to silicone or rubber 7. Known vaginal cancer 8. Current pregnancy or within 6 months postpartum 9. Completed full course of supervised Pelvic Floor Muscle Training and has been discharged by the physiotherapist within the last two years 10. Contraindications to vaginal devices: 10.1. Current vaginal infection or irritation 10.2. History of Toxic Shock Syndrome 10.3. Pelvic surgery in the last 6 months 10.4. Ongoing therapy for pelvic malignancy 10.5. Current urinary infection 10.6. Problems with manual dexterity which could cause insertion or removal issues 11. Women lacking capacity to consent 12. Inability to understand the PIL, consent and/or questionnaires in English
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of participant recruitment within the proposed time scale (I.e. achieve >/= 80% of the target recruitment within 6 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adherence to VCD use is measured using clinician-reported adherence logs and participant self-report diaries at baseline, 3 months, and 6 months 2. Adherence to PFMT is measured using participant self-reported attendance logs to individualised planned program appointments at baseline, 3 months, and 6 months 3. Retention rate is measured using study records of participant completion status at 6 months 4. Rates of missing data are measured using case report forms and electronic data capture system audit logs at baseline, 3 months, and 6 months 5. Patient-reported success rates of VCDs are measured using the Patient Global Impression of Improvement (PGI-I) scale at 3 months and 6 months 6. Adverse events related to VCDs are measured using adverse event reporting forms and participant interviews at baseline, 3 months, and 6 months 7. Use of self-funded VCDs is measured using participant self-report questionnaires at baseline, 3 months, and 6 months 8. Waiting times for physiotherapy are measured using clinic administrative records and participant self-report at baseline and 3 months 9. Recruitment projection reliability is measured using screening and enrolment logs compared to projected targets at monthly intervals throughout the recruitment period 10. Refinement of pre-defined progression criteria for a potential future RCT is measured using feasibility study outcomes and stakeholder feedback at study end (6 months) | — |
Countries
Scotland, United Kingdom
Contacts
Public ContactUzunma Onyeakazi
Outcome results
None listed