Patient and community nurse perspectives on recruitment to a randomized controlled trial of urinary catheter washout solutions

Aims To provide evidence around the acceptability of a proposed randomised controlled trial (RCT) of catheter washout solutions. Design: A sample of senior community nursing staff (n=7) were interviewed and four focus groups with a sample of community nurses were conducted. Eleven semi-structured face-to-face interviews were undertaken with patients using a long-term catheter. Methods: An in-depth qualitative study using a phenomenological approach was employed. This approach was suitable to explore the lived experiences of subjects and gain their viewpoints and experiences. Results: Nurse participants raised concerns regarding the removal of treatment or increased risk of infection in relation to which arm of the trial patients were randomised to. There was concern that patients could get used to the increased contact with nursing staff. Six patients who agreed to participate cited personal benefit, benefiting others, and a sense of indifference. Four patients were unsure about taking part and one declined

A randomised controlled trial of pelvic floor muscle training for stages I and II pelvic organ prolapse

Abstract Forty-seven women participated in a pilot study for a multi-centre randomized controlled trial of the effectiveness of pelvic floor muscle training (PFMT) for women with prolapse. Women with symptomatic stage I or II prolapse [measured by Pelvic Organ Prolapse Quantification (POP-Q)] were randomized to a 16-week physiotherapy intervention (PFMT and lifestyle advice; n=23) or a control group receiving a lifestyle advice sheet (n=24). Symptom severity and quality of life were measured via postal questionnaires. Blinded POP-Q was performed at baseline and follow-up. Intervention women had significantly greater improvement than controls in prolapse symptoms (mean score decrease 3.5 versus 0.1, p=0.021), were significantly more likely to have an improved prolapse stage (45% versus 0%, p=0.038) and were significantly more likely to say their prolapse was better (63% versus 24%, p=0.012). The data support the feasibility of a substantive trial of PFMT for prolapse. A multi-centre trial is underway.This study was funded by the Chief Scientist Office, Scottish Government (CZH/4/95)

Reflecting on the methodological challenges of recruiting to a United Kingdom-wide, multi-centre, randomised controlled trial in gynaecology outpatient settings

Peer reviewedPublisher PD

Abdominal massage for the relief of constipation in people with Parkinson’s: a qualitative study

Objectives. To explore the experiences of people with Parkinson’s (PwP) who suffer from constipation, the impact this has on their lives, and the effect of using lifestyle changes and abdominal massage as a form of constipation management. Method. Fourteen semistructured interviews were completed (8 males and 6 females; mean age 72.2 years) at the end of a care programme, which consisted of either lifestyle advice and abdominal massage (intervention group;) or lifestyle advice only (control group;). Data were analysed using constant-comparison techniques and Framework methods. Themes and key quotes were identified to depict major findings. Findings. Four key themes were identified: (i) the adverse impact of bowel problems on quality of life; (ii) positive experience of behaviour adjustments: experimentation; (iii) abdominal massage as a dynamic and relaxing tool: experiential learning (intervention group only); (iv) abdominal massage as a contingency plan: hesitation (control group only). Constipation was reported as having a significant impact on quality of life. Participants in both groups perceived lifestyle advice to relieve symptoms. Specific improvements were described in those who also received the abdominal massage. Conclusions. Both lifestyle advice and abdominal massage were perceived to be beneficial in relieving symptoms of constipation for PwP

Is urinary incontinence associated with sedentary behaviour in older women? Analysis of data from the National Health and Nutrition Examination Survey

BACKGROUND: Urinary incontinence (UI) is a common geriatric syndrome associated with physical and cognitive impairments. The association between type of UI and sedentary behaviour (SB) has not been explored. AIM: To determine association between moderate-severe UI, or any stress UI (SUI) or any urgency UI (UUI) and SB in community-dwelling older women. METHODS: Women aged 60 and over from the 2005-2006 cycle of the National Health and Nutrition Examination Survey (NHANES) with objectively measured (accelerometer) and self-reported SB and UI data were selected. Multivariate models exploring association between moderate-severe UI and SB, or SUI and SB, or UUI and SB were analysed using logistic regression adjusted for factors associated with UI. RESULTS: In the overall sample of 459 older women, 23.5% reported moderate-severe UI, 50.5% reported any SUI and 41.4% reported any UUI. In bivariate analysis objectively measured proportion of time in SB was associated with moderate-severe UI and UUI (p = 0.014 and p = 0.047) but not SUI. Average duration of SB bouts in those with moderate-severe UI or any SUI was no longer than older women reporting no continence issues, but it was significantly (19%) longer in older women with any UUI (mean difference 3.2 minutes; p = 0.001). Self-reported SB variables were not associated with any type of UI. Multivariate analysis showed an association between UUI and a longer average duration of SB bouts (OR = 1.05, 95% CI = 1.01-1.09, p = 0.006) but no association with moderate-severe UI or SUI. CONCLUSION: UUI was significantly associated with increased average duration of SB bouts in community-dwelling older women. The importance of objective measurement of SB is highlighted and suggests that decreasing time in prolonged sitting may be a target intervention to reduce UUI. Future studies are required to further explore the association between SB and incontinence

Assessment of the relative performance of the EQ-5D-3L, ICIQ UI SF and POP-SS using data from the OPAL trial

Conducting economic evaluations alongside randomised controlled trials (RCTs) is an efficient way to collect cost-effectiveness data. Generic preference-based measures, such as EQ-5D, are often used alongside clinical data measures in RCTs. However, in the case of female urinary incontinence (UI), evidence of the relative performance of EQ-5D with condition-specific measures such as the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF), measuring severity of UI, and Pelvic Organ Prolapse Symptom Score (POP-SS), measuring severity of prolapse symptoms, is limited. This study employed secondary analysis of outcome measures data collected during the Optimal Pelvic floor muscle training for Adherence Long-term (OPAL) RCT, which compared biofeedback-mediated pelvic floor muscle training to basic pelvic floor muscle training for women with UI. The relative performance of EQ-5D-3L and ICIQ-UI SF, and EQ-5D-3L and POP-SS was assessed for concurrent validity and known-groups validity. Data for 577 women (mean age 48) were available for EQ-5D-3L/ICIQ-UI SF, and 555 women (mean age 47) for EQ-5D-3L/POP-SS. Overall, EQ-5D-3L exhibited very weak association with the ICIQ-UI SF total score, or any subscale. EQ-5D-3L and POP-SS were found to be weakly correlated. EQ-5D-3L was able to distinguish between groups with known differences in severity of UI and also between types of UI. These findings provide useful information to guide researchers in selecting appropriate outcome measures for use in future clinical trials