Of the 4385 individuals eligible to be randomised into the trial, 3746 (85.4%) agreed to participate and were randomised. shows the flow of patients through the study.
Progress of participants through trail.
Baseline characteristics of intervention, control (with and without follow-up data) and non-participant groups were compared for demographic variables, urinary symptoms and impact. Trial groups were found to be comparable at baseline (), but the non-participant group tended to be older, and to report fewer urinary symptoms and less impact from symptoms.
Baseline demographics and clinical characteristics.
Urinary symptoms at 3 months. The percentage of individuals who improved (at least one symptom alleviated) at 3 months was 59% in the intervention group and 48% in the standard care group (difference of 11%, 95% CI = 7 to 16; P<0.001) (). At 3 months the proportion of people reporting no symptoms or ‘cured’ was 25% in the intervention group and 15% in the standard care group (difference of 10%, 95% CI = 6 to 13, P = 0.001) (). Individuals in the intervention group were less likely to report presence of urinary incontinence symptoms compared to the standard care group. Leakage was reported by 63% in the intervention group and 70% in the standard care group (difference of 7%, 95% CI = 3 to 11, P = 0.002). Similar reductions were also reported for frequency, urgency and nocturia ().
Number of individuals with each symptom and no symptoms at 3 and 6 months presented by randomisation group.
Quality of life, reported ‘problem’ and satisfaction at 3 months. Absolute change from baseline in the overall impact on quality of life scale was calculated as −3.57 (standard error [SE] = 0.13) for the intervention group and −2.65 (SE = 0.25) for the standard care group resulting in a absolute difference between the groups of −0.92 (95% CI = −1.48 to −0.37, P = 0.001). At 3 months, 74% in the intervention group reported no problem or a mild problem compared to 68% in the standard care group (difference of 6%, 95% CI = 2 to 10, P = 0.003) (). Fifty-two per cent in the intervention group reported satisfaction with their current urinary symptoms for the rest of their life compared to 45% in the standard care group (difference 7%, 95% CI = 3 to 12, P = 0.001). Individuals who had had contact with either service during the follow-up period were asked to complete a service satisfaction questionnaire (91% of the intervention group and 81% in the standard care group). Of individuals in the intervention group, 97% were satisfied with the service in general compared with 77% in the standard care group (difference of 19%, 95% CI = 15 to 23).
Number of individuals self reporting a mild problem or no problem and satisfaction with current urinary symptoms for rest of life at 3 and 6 months presented by randomisation group.
Outcomes at 6 months. The percentage of individuals who improved (with at least one symptom alleviated) at 6 months was 62% in the intervention arm compared with 52% in the standard care arm (difference 10%, 95% CI = 6 to 15, P = <0.001) (). At 6 months, the proportion of people reporting no symptoms or ‘cured’ was 28% in the intervention group and 19% in the standard care group (difference of 9%, 95% CI = 5 to 13, P = <0.001) (). Results at 6 months are similar to those reported at 3 months ( and ; and ). with persistence of benefit remaining significant for all symptoms except leakage. The difference in self-reported problems and satisfaction with urinary symptoms increased.
Number of symptoms alleviated at 3 months compared to baseline, presented by randomisation group.
Number of symptoms alleviated at 6 months compared to baseline, presented by randomisation group.
At 6 months there was little change in impact (−4.21 (SE = 0.14) for the intervention group and −3.44 (SE = 0.29) for the standard care group), resulting in an absolute difference between the groups of −0.76 (95% CI = −1.37 to −0.15; P = 0.014).
Components of standard care compared to continence nurse practitioner care. Of those individuals randomised to standard care, 502 (81%) saw a healthcare professional about their urinary symptoms (compared to 2272 [91%] in the intervention arm). Of these, 380 (76%) saw a GP, 29 (6%) saw a hospital doctor, 188 (37%) saw a nurse (97 [19%] saw a continence nurse; 54 [11%] saw a practice nurse; and 37 [7%] a district nurse), and 6 (1%) saw a physiotherapist (an individual may have seen more than one healthcare professional).
Within standard care 208 (41%) of those who saw a healthcare professional were asked to provide a urine sample for testing, 79 (16%) underwent a bladder scan, 99 (20%) were asked to complete a urinary diary and six (1%) a pad test. In the intervention arm over 90% of participants were asked to complete these investigations.
In the standard care arm, 372 (74%) were given treatment or advice (compared to 95% in the intervention arm). Pelvic floor advice was given to 171 (34%) individuals, 43 (9%) received bladder training, 79 (16%) received medication, 41 (8%) were referred to the hospital for specialist care, 117 (23%) were given advice on fluid intake and 43 (8%) were told to return if their symptoms worsened.
Subjects were included in the analysis if full costs and number of symptoms alleviated could be calculated at both the 3- and 6-month home interview. This meant that of the 1045 responders who completed resource data, 905 (87%) were included in the economic analysis: 171 in the standard care arm and 734 in the intervention arm.
Resources considered by the cost-effectiveness analysis were: GP visits; other healthcare professional contacts; medications; aids and appliances; investigations; and hospital transport. The average costs incurred were similar for the intervention and standard care groups at both 3 and 6 months for aids and appliances, the main differences between the groups were for health professional visits and investigations (details of these costs are given online in Supplementary Table 4). The results of the cost-effectiveness analysis are given in . Both cost and cost-effectiveness are higher at 6 months for improvement and symptoms alleviated. In the second 3-month period, costs generated by the continence nurse practitioner service were similar to the first 3-month period but the overall difference in the mean number of symptoms alleviated remained the same. This gives an incremental cost per additional symptom alleviated that was greater at 6 months (£488) than at 3 months (£242) ().
Results of cost-effectiveness study.