Other specified disorders of bladder Urological and Genital Diseases
Conditions
Interventions
The ACASO study will be conducted on a single site, the Newcastle upon Tyne Hospitals NHS Foundation Trust. It is a feasibility study involving NHS patients with overactive bladder symptoms, and it se
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults with a clinical diagnosis of idiopathic OAB syndrome - diagnosis is made by history taking and physical examination 2. Absence of other active urinary symptoms 3. Willingness to take part in the study protocol, ability to complete outcome measures and give informed consent 4. Acupuncture not contra-indicated i.e. no history of unstable heart conditions, unstable epilepsy or diabetes, bleeding disorders
Exclusion criteria
Exclusion criteria: 1. Evidence of other pathology that may be contributing to OAB symptoms i.e. urinary tract infection or a neurological condition. Treatment specific for these conditions should be offered to these individuals 2. Pregnancy - transient urinary symptoms can be present during pregnancy and often resolve spontaneously following delivery. There are some acupuncture points that are contraindicated in pregnant women 3. Unable to comprehend and retain the trial information i.e. poor understanding of English - the cost of employing interpreters to facilitate inclusion of patients who do not speak fluent English is beyond the financial scope of this feasibility study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Participants’ willingness to enter the trial, measured by the ratio between those who consented to participate and those who were eligible and approached 2. Participants acceptability of study design, measured by the completion rate of participants in each group and the degree of completeness of the three outcome measures selected (3DBD, ICIQ, and ICECAP A) 3. Participants' feedback on their experience of the study assessed using a questionnaire 4. Participant recruitment rate, measured by the number of patients randomised divided by the recruitment period. The recruitment period is defined as the date of the first patient first visit (FPFV) until the last patient first visit (LPFV). Anticipated recruitment rate is 2 per month giving a projected recruitment period of 15 months to recruit 30 participants 5. Study attrition rate, measured as the number of participants who failed to complete all aspects of the study Timepoint(s): End of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| At Baseline, at 8 weeks after starting treatment and at 14 weeks after starting treatment: 1. Three-day bladder diary - documenting frequency of voids, frequency of bladder leakage and episodes of nocturia 2. ICIQ-SF questionnaire to document bladder symptoms in the last 4 weeks 3. ICECAP-A - documenting the participants genral wellbeing over the past 4 weeks | — |
Countries
England, United Kingdom
Outcome results
None listed