For many women, incontinence is an embarrassing condition with an adverse effect on quality of life and social functioning for which many women delay seeking healthcare or do not seek it at all [1]. Despite a wide range treatments available, many women rely on the use of containment products to manage daily life. Whilst it may be assumed that use of pads is an effective means by which social continence is achieved, there is little evidence on the extent to which their use is associated with any impact on quality of life. This study aimed to assess the feasibility of conducting a formal trial on pad use and quality of life in women and to provide insight into women’s perception of urinary incontinence and pad usage.

This mixed methods study [2] consisted of a quasi-experimental quantitative assessment of quality of life followed by a qualitative phase of semi-structured interviews. Participants were recruited using print and digital media. Community dwelling women ≥ 18 years who had not previously used containment products for their urinary incontinence were included. Women with faecal incontinence or cognitive impairment were excluded. Using data on minimally important difference in improvement of quality of life from conservative treatment of stress incontinence using ICIQ-LUTSQoL (3.71) [3]  to calculate a sample size resulted in 23 women being required to detect a true difference with 80% power with an alpha of 0.05. Data were used to calculate an effect size with pads in order to inform a fully powered trial design. 
Each woman received a six-week supply of pads. Questionnaires were administered at baseline and six weeks later. Demographics data included age, parity, medical comorbidities, and medication use. Incontinence was assessed using the ICIQ-FLUTS long form and the Sandvik Severity Index. ICIQ-LUTSQoL, EQ-5D, and PADPROM were used to measure quality of life. Descriptive and comparative statistics were completed using SPSS v24.0. 
Convenience sampling of survey respondents was used to recruit participants for the interview. A semi-structured interview guide was constructed focusing on perceptions of utility, benefit, and disadvantages of containment products for incontinence as related to their quality of life. Interviews were digitally recorded and transcribed verbatim. The first interview was independently coded by two researchers to develop a coding framework. The remaining interviews were analyzed using a content analysis approach, adding new codes to the framework as they were identified. The codes were then collapsed into categories and finally themes. Reflexive notes were kept throughout analysis.

Of 95 women screened, 22 women of mean (SD) 62 (16.9) years of age were included in the study. Table 1 shows baseline and 6 week data from the study.  Results in all subdomains of the ICIQ-LUTSQoL short form except "worry about smell" (p=0.017) and " change clothes when wet" (p=0,025) showed no change following 6 weeks pad use.  Using the mean change in ICIQ-LUTSQoL total score (1.81), the study resulted in an effect size, d, of 0.23, giving a required sample size for a fully powered trail of 151 women (power 0.82, alpha 0.05).
15 survey respondents participated in interviews. Ages ranged from 24 to 84. Four themes were identified: Safety and Security, Perceptions of Incontinence and Wearing Pads, Navigating the Conversation, and The Right Design. Table 2 summarizes the qualitative findings. When wearing pads, these women described feeling safe and secure which reduced their incontinence-related anxiety and allowed them to take part in more activities. They associated the need to wear pads with ageing, either to reject or normalize the use of pads. Women were carefully selective with who, among friends and family, they would discuss incontinence and pad use. They also found that healthcare professionals had limited information or did not pursue the concern when brought up. These women expressed a desire to try out a number of different incontinence products as bulk and shape were important for concealability.

Quantitative change in QoL failed to reach MID for women in a treatment trial; this may have been expected, given the different framing of this study.  The calculated effect size on the primary outcome resulted in a potentially feasible sample size for further investigation, but the ability of formal scales to assess meaningful change must be questioned. There was disparity between qualitative and quantitative results with regards to severity of incontinence and the perceived effects on quality of life. For example, most women had moderate incontinence (Sandvik) but expressed a broader range of severity in interviews. Some participants described their incontinence as a minor issue for which  they would not use medication while others viewed their incontinence as a serious, uncontrollable problem.  These women described pads as a necessity. There was also a disparity between qualitative and quantitative results with regards to incontinence-related embarrassment. Interview data revealed detailed information, particularly how the pads helped to reduce embarrassment in public settings which was not identified by formal scales.

The use of mixed methods extended our understanding on issues such as design.  The interview data provided insight that bulk was an important aspect of design and shape as it affected the pad’s concealability and influenced the trial and error approach for finding what works for the individual. Understanding how incontinence affected social life was also extended through the use of mixed methods. Survey results indicated that this was not affected at all or only slightly but our qualitative analysis highlighted the concerns about being able to mask the leakage and indicated that using pads provided women with a feeling of security, particularly in public and social situations.

The use of pads for incontinence in women has a positive effect on their quality of life.  A formal effect size calculation results in useful knowledge for the planning of a formal, fully powered trial.

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