From the trial data analysis there was no evidence of statistical superiority of biofeedback-assisted PFMT compared to PFMT alone for the primary outcome (UI severity at 2 years), although for one secondary outcome (PFMT self-efficacy at two years) there was a difference that favoured biofeedback-assisted PFMT [23]. Case study analysis did compare cases in the biofeedback-assisted PFMT group with those in the PFMT alone group. There were more similarities in factors that influenced the Programme Theory, and its component parts, than there were differences between the groups. Therefore, the data presented below focus on the combined case study dataset, including participants from both trial groups, and draws upon specific evidence related to biofeedback-assisted PFMT or PFMT alone as and when it is relevant to understanding.
Recruited cases
Forty cases were recruited as planned (20 per trial group) (Table 2). Women were 20–76 years at baseline; 11 had SUI and 29 MUI. Six were treated in community clinics, 16 in University Hospitals and 18 in District General Hospitals. Most women (n = 36) were treated by physiotherapists and the remainder by nurses. Twenty-five women completed all four interviews. Due to a technical difficulty with the audio-recorder, full datasets were available for 24 (10 biofeedback-assisted PFMT, 14 PFMT alone). The total dataset contained 125 interviews. Interview recordings per case were 15-126 minutes long.
Logic model for the programme theory
The logic model for the Programme Theory is presented in Fig. 2 and explained below. Explanation of the components of the model follows.
Logic model of the Programme Theory of biofeedback-assisted PFMT and PFMT alone
The model demonstrates that there are inputs for women which start prior to treatment. These inputs are the motivating factors that take women to treatment (in this case trial randomisation). These motivating factors may underpin what is later expressed as their intentions to adhere, or behavioural adherence to prescribed treatment. Women received either biofeedback-assisted PFMT or PFMT alone, delivered by a therapist, and then showed individual variance in appointment attendance. The therapist was central to the development of a woman’s belief in her ability to undertake PFMT and its ability to reduce UI symptoms (i.e. to women gaining PFMT self-efficacy). Analysis identified that all four theorised self-efficacy sources (performance accomplishments, vicarious experience, verbal persuasion, physiological states) were present in the way women developed PFMT self-efficacy [20]. PFMT self-efficacy and adherence were intermediate outcomes on the pathway to the long-term UI outcomes. Contextual factors influenced how women developed self-efficacy or not, the pathway through which self-efficacy and adherence interacted, and adherence itself. The influence of any given contextual factor was not consistent across women, and the influence could alter over time. Based on factors that motivated women to attend treatment, the intervention they received from the therapist, the woman’s self-efficacy and the influencing contextual factors, women then adhered to a greater or lesser extent to PFMT. Some women demonstrated agency in that they adhered as much as they wished to, to achieve their personal goals. This may, or may not, have matched exactly the PFMT prescription by the therapist. Many women believed that PFMT adherence would improve UI outcomes. That is not to say that all women adhered or had improved outcomes, but that they articulated the link between adherence and outcome, and this was true whether they adhered or not. UI outcomes in turn influenced the extent to which the factors that led women to seek treatment were addressed. The case in Table 3 shows the inter-linking of these complex components.
Explanation of the components within the theory and how they interacted
Factors that motivate women to seek treatment for UI
While there was recognition within the OPAL intervention that women starting treatment had existing beliefs and understandings (therapists were asked to elicit and address misunderstandings about UI and its treatment), the original mechanism of action started with the allocated treatment to PFMT alone or biofeedback-assisted PFMT (Fig. 1). Data demonstrated that factors motivating treatment-seeking were important drivers in adherence to treatment (i.e. they were motivators that kept women doing PFMT or biofeedback-assisted PFMT over time); for example, if participating in physical activity was an important driver for a woman then it continued to influence her PFMT adherence over time.
The motivating factors related to: UI resolution / prevention of UI getting worse; UI resolution so women could live their lives the way they wanted to; emotional drivers; helping other aspects of health and well-being; and other outside influences.
The women wanted PFMT to resolve UI or prevent it getting worse, avoid or delay surgery, or to use fewer/smaller/less bulky pads. For example:
I was just fed up with [UI] getting worse … I don’t want to have to stop the exercising, … [I’m going to have to] get some help to try and see if there’s anything that could be done … I don’t want to have to wear pads all the time (Case 25 Interview A)
Women were motivated to do PFMT so that they could live the lives they wanted to lead, for example, so that they could exercise without leaking (Case 3), get up and get on (Case 24), and not leak when having sex (Case 39). Women were motivated by emotional drivers such as feeling less anxiety about UI, reducing the risk of being embarrassed and having confidence to do normal day-to-day activities. Women were hopeful that PFMT might resolve other issues such as back pain (Case 2).
I din’nae [don’t] really want tae [to] go out until I get everything sorted … or even better than what I am, ’cause I just worry about it and I wouldn’t be able tae [to] enjoy myself (Case 18, interview A)
Women worldwide contextualise UI as something to be tolerated [3] and women in our sample were no different. Sometimes it took someone else’s suggestion that help was needed to make women seek treatment.
the second time it happened [leaked when with family] my daughter-in-law … she said to me “you know, .. [you need to get this sorted?],” I said I’ve already been once a few years ago and the doctor at the time went “oh it’s just your age,” you know …. [my daughter in law said] “you need it sorted out, you don’t need to suffer like this,” you know and that’s when I went off to the doctor (Case 20 Interview A)
Each of these factors acted, over time, for individual women to motivate them to continue, but if the motivating factor no longer applied (e.g. they stopped going to an exercise class) then they would stop doing PFMT. This is explained in more detail in the sections below.
The development of PFMT self-efficacy
Key areas of treatment led to, or detracted from, women’s development of self-efficacy and/or their adherence. Analysis demonstrated that the therapist was a vehicle for change. Other factors were also influential such as the ease of PFMT, women’s sense of accountability and negative aspects of treatment.
The therapist as a vehicle for change
The core component of self-efficacy development was the therapist who delivered the treatment. The dataset contained voluminous data of women talking positively about the therapist who delivered PFMT. Table 4 provides illustration about the links between therapist-patient interaction about PFMT and Self-Efficacy Theory. The therapist supported, or detracted from, women developing PFMT self-efficacy. Women saw the therapist as a credible source of information. They described therapists in positive terms such as supportive, non-judgemental, motivational, and as someone who ensured women were ‘at their ease’. Women’s perspectives demonstrated that a therapist’s supportive behaviour enabled a decrease in women’s anxiety about treatment, that in turn may have supported women being in a more optimal physiological and affective state to learn. Women talked about the therapists helping them to find practical ways of fitting PFMT into their day-to-day lives e.g. supporting women to find the cues that would remind them to do PFMT.
[The therapist] is just tremendous, she’s very reassuring, she’s very kind, she’s a very clear communicator … very, very clear, she doesn’t wrap up things in hundreds of words so you get confused … she’s very clear about what you need to do. She’s very knowledgeable, she explains things so well, I’ve never met anyone who can explain things so well, …. that was the best thing about it all was seeing [therapist name], knowing that I was doing things right (Case 32 Interview B)
What women learned and “knowing” how to do a pelvic floor muscle contraction
Women learned about pelvic anatomy from the therapist and for some this was the most important part of treatment. Women also talked about the importance of learning about other aspects of UI management beyond PFMT, such as fluid management. However, by far the most important aspect of learning for women was how to do PFMT properly (performance accomplishment) and “knowing” that they were doing a pelvic floor muscle contraction properly, and that it was improving, based on therapist feedback (verbal persuasion). It was feedback from the vaginal examination (the physiological state of the contracting muscles) that, in the main, led women to “know” that they were undertaking PFMT in the way that was needed to get treatment effect. For women who had biofeedback-assisted PFMT, feedback from the biofeedback machine had a similar effect (as it too is designed to give feedback on physiological states).
you’ve got to try and light up, it’s a bit like the fairground thing where you whack the hammer and you’ve gotta [got to] try and get the light to the top (Case 39 Interview B)
Although women also talked about the embarrassment of vaginal examination, the benefits of “knowing” outweighed the embarrassment (Case 24). This knowing gave women the belief in their ability to undertake PFMT unsupervised at home (with or without biofeedback).
It was just having, it was almost like having a personal trainer, the nurse …I think that was the best thing for me; somebody that’s telling you, no, you’re doing the exercises right and I can feel an improvement too, I think having, ’cause you can’t see, it’s not like doing a bicep curl, you can see your biceps getting bigger and getting stronger, you can’t really measure it, so having somebody that’s saying naw [no], you’re doing fine (Case 34 Interview D)
Vicarious learning
Women also learned the importance of continuing PFMT in the long term from other people, either through reporting from the therapist or directly from others telling them how it had worked for them (vicarious learning experience).
I’ll tell you one thing that was really helpful, is I had a private conversation with a lady … who told me that she’s had this problem and she’d religiously followed the exercises and now, you know, several years on [UI] was absolutely no problem for her at all, and I, there’s something about having somebody totally independent of, you know, the medics and the, the, the and so on, that, I know it sounds silly but it, it sort of reinforces it in a different kind of way … (Case 14 Interview C)
The ease of PFMT
Women in both trial groups talked about PFMT without biofeedback being easy to do (Case 1). That it could be done anywhere at any time, that suited the woman’s life, facilitated adherence.
once you got to know how to do the … [PFMT] exercise, … it was easy (Case 36, Interview C)
Women also talked about accountability to the therapist, which was supported by attending clinic appointments and, for those with biofeedback, by the machine recording PFMT undertaken. Perhaps more powerfully, women felt accountable to themselves, to self-care in ways that promoted their health and well-being (Case 13).
Negative views on PFMT
There were considerably more positive reports of treatment than negatives. Negatives impacting women’s self-efficacy and adherence were: not being convinced that PFMT would work from the outset or when treatment effect took longer to occur than anticipated.
I was a bit sceptical that it [PFMT] would work completely, you know, it would completely cure my symptoms (Case 25 Interview C)
Not all women were randomised to their preferred treatment, and this influenced belief in, and adherence to, allocated treatment. The trial standardised the number of appointments women received to control for the duration of therapist contact, a possible confounder, but some women thought six appointments was too many while others had wanted more.
Through the above mechanisms within treatment, some women demonstrated PFMT self-efficacy and others did not. Women who articulated a belief in their abilities to undertake PFMT gained performance accomplishment for PFMT. The combination of knowing they had the correct exercise technique and having the underlying knowledge about their training programme seemed to create a dynamic of sustained belief in their ability to perform PFMT correctly that lasted long after formal instruction and the supervised treatment period was over. For example, Case 1 talked through all of her post-treatment interviews about her ability to re-start exercises and knowing that she had the skill to do so. Women embodied knowledge of their strengthened pelvic floor and they linked those changes in their pelvic floor, achieved by adhering to PFMT, to decreased UI symptoms.
knowing that the exercises help makes me do it more (Case 20 Interview B)
Even if women believed in their ability to do PFMT this did not necessarily mean that they adhered, some women chose to stop doing PFMT, but most of these women did say they knew what to do. This was evidenced by women restarting PFMT themselves after a break and saying they did not require further clinical appointments because they knew what to do.
I’ve maybe had my wee warning call there [experiencing return of UI when stopped doing PFMT], and I think that’ll just remind me that … I need tae [to] keep doing them every day (Case 34 Interview C)
However, those women who did not gain belief in either their PFMT ability or that PFMT would/had worked for them (i.e. they lacked performance accomplishment), tended to do less PFMT. For example, Case 32 felt that her UI was caused by an anatomical structural abnormality. These causal beliefs [36] were more influential and likely countered any opportunity to gain self-efficacy, which is based on the being able to achieve the desired outcome. For this woman, her strong belief that PFMT was not going to help, meant she did not adhere, thereby forgoing any possibility that PFMT would work.
In summary, treatment received by a therapist was linked to the development, or not, of self-efficacy. In turn self-efficacy, or not having self-efficacy for PFMT, was linked to adherence.
Adherence to PFMT over time
Some women described full adherence to prescribed regimens and others adhered partially, doing what they felt was enough exercise to achieve the effect they desired. This meant the degree of adherence to prescribed regimens over time varied. There were examples of consistent adherence to prescribed regimens over the two-year period. For example, Cases 36 (PFMT alone) and 23 (biofeedback-assisted PFMT) both adhered ‘religiously’ throughout the supervised phase and continued to undertake PFMT at levels above the prescribed maintenance dose throughout the two-year period. However, there were Cases where adherence was poor from the outset or for some Cases PFMT/biofeedback was variable during the supervised phase then ad hoc for the remaining period. Case 25 found it hard to get to appointments, and to do what the therapist asked her to do between appointments. Following treatment, she did PFMT very occasionally. Case 4 adhered throughout the supervised phase, slowly decreased the amount of PFMT she did and then after 12 months her partner had a stroke, and she did not do PFMT at all.
Women demonstrated agency in making decisions over time about how much PFMT to do to manage their UI symptoms such that they could cope and get on with their lives. Women created a balance between the time needed to do PFMT, the symptomatic outcome and the life they wanted to lead. For example, Case 28 followed the prescribed regimen to start with, thereafter she did as much PFMT as she felt was needed to keep her symptoms at bay.
Even when women articulated a link between adherence and outcome, it did not necessarily follow that they adhered. Contextual factors acted as barriers and the knowledge that PFMT would work to reduce symptoms if adherence was maintained was overridden.
if I was able to do this all the time and really sort o’ [of] concentrate on it and have it sort o’ [of] planned out during the day, [if I had] time to do the exercises, then I, yeah, I’m sure it would improve, ” (Case 15 Interview D)
In contrast, for other women, this adherence-outcome link was a key motivator to keep them doing PFMT.
I know that I’ve got to keep them going otherwise I’m going to slip back, but I know that I can actually fix this again by doing the exercises, so that’s useful (Case 5 Interview C)
When women did not perceive a link between adherence and outcome, then they also could not see the value of doing PFMT, in this situation adherence was ad hoc or non-existent (Case 25).
Contextual factors that influence self-efficacy, adherence and the link between them over time
Context was important in understanding PFMT within a woman’s life over time. Facilitators for self-efficacy and ongoing adherence were related to: the woman (personal drive, desire to live the life she wants to lead, ability to overcome obstacles); feelings about UI (it’s not only me); having a routine and prompts; and factors within the woman’s lived environment. Barriers could inhibit self-efficacy and/or adherence but they did not necessarily do so. Barriers included: loss of routine or prompts; comorbidity; factors that affect busyness and attention in day-to-day life; negative emotional attitudes to herself, to UI or to treatments; belief that PFMT would not be effective in resolving UI; loss of biofeedback unit at the end of the supervised treatment period and environmental factors.
Factors related to the woman
Women were empowered to achieve improvement in their lives. They saw PFMT as something about and for themselves and that they were the only person who could make the change happen.
I was so determined though, I mean the thing is you’ve got to want to, to help yourself (Case 20 Interview B)
The ability to overcome obstacles facilitated short and long-term PFMT adherence. For example, Case 20 maintained a strong sense of self-efficacy and adherence despite experiencing multi-morbidity (including cardiac surgery). For her, the positive outcome she had experienced in her life having resolved UI symptoms continued to fuel PFMT adherence in the longer term. In contrast, although UI could facilitate adherence, it was also a barrier; when women’s UI resolved, they lost that prompt, and for some, that meant PFMT adherence decreased.
my symptoms have reduced should I say, so I haven’t had as much of a, like a physical prompt to remind me to keep doing them (Case 28 Interview C)
Although multi-morbidity did not necessarily lead to non-adherence; co-existing health issues were sometimes a barrier to self-efficacy and/or adherence. Over the course of two years, women experienced long-term conditions like arthritis or asthma or short-term problems like flu, chest or urinary tract infection. For example, Case 23 had several medical diagnoses, one of which was fibromyalgia. The pain and direct muscle effects of the disease when it flared rendered her unable to do PFMT effectively as did a chest infection where she could not control her breathing. These effects were not consistent over time, rather they fluctuated in their impact on PFMT adherence.
Factors related to UI
Realising that UI was a common condition supported adherence. Negative emotional reactions were associated with the hidden nature of UI; women worked hard to keep UI concealed from society in general. Women were at times surprised and often relieved that UI was much more common than they thought pre-treatment. Realising that they were ‘not alone’ acted as a facilitator for undertaking PFMT by altering their mindset about being a person with UI who was taking control and dealing with their UI through PFMT.
I just learned that I wasn’t alone, that other people had this … (Case 6 Interview B)
Factors related to routines and prompts
Having a PFMT routine was helpful for adherence. Sometimes that routine gave women ‘hooks’ or ‘prompts’ which acted as exercise reminders. Many of these were usual day-to-day activities such as driving to work, brushing one’s teeth or putting the kettle on (Case 17). Others were learned from the trial treatment protocol, e.g. writing PFMT down in a diary. Conversely, loss of cues or routine could limit adherence. The benefits of prompts could be lost if women had a change in routine/or had not established a routine in the first place. Sometimes it was the specific activity associated with urine leakage that prompted adherence, and if this activity (such as running) was no longer undertaken then there was no prompt to adhere. Women could also report losing the motivation to do PFMT when they were content with alternative management (such as containment) that offered a solution and enabled living the lives they wanted to lead (Case 4). Again, these effects varied for individual women across the course of two years.
Factors related to the woman’s lived environment
PFMT was facilitated by women having flexibility at home to do PFMT/biofeedback as and when they wanted to. For some this was about having a private space and enough time whereas for others having someone else within their personal environment knowing they were being treated for UI permitted an openness that facilitated adherence. Where women got help from others within their environment, this facilitated adherence e.g. Case 23 waited until her partner came home from work to help her put the biofeedback probe in as she could not do this herself. There were factors in women’s lived environments that acted as barriers. For example, women’s jobs sometimes meant that they did not have easy access to toilets. For others, people in their home could be barriers e.g. a child coming into a room where a woman was trying to undertake PFMT/biofeedback.
The women lived busy lives often juggling work, families, and major life events. Busyness could act to prevent women gaining self-efficacy or adherence. There were multiple examples of this which included Case 1 where she was a partner, mother and she changed her job over the 24-month period. As a result, she stopped undertaking high impact exercise which was her motivator for attending (leakage when exercising) and so she stopped doing PFMT. Women spoke often about having a lack of time to fit PFMT into these busy lives. Many life events occurred for women which fed into their sense of a lack of time. These included changes in the health status of those around them such as unwell parents, partners, children, or stressful life events like moving house, getting divorced and bereavement. The influence of these contextual factors on PFMT adherence could be short lived or could have longer term impact.
I think life’s just got in the way, you know, things have happened, so, but it’s not, I’ve not treated it as priority myself, which I should do because I know if I don’t do it, I know if I don’t do this in years to come I will need an operation, so that should be enough gumption for me to you know do it (Case 2 Interview C)
Factors related to negative views about how a woman saw herself
Women spoke of themselves at times using negative, self-depreciating terms such as ‘lazy’, having ‘no willpower’, and ‘forgetful’ (Case 13). Women blamed themselves for non-adherence. Women also voiced negative reactions to PFMT and/or biofeedback. For example, one woman was embarrassed because her partner called the biofeedback machine a vibrator (Case 1). Many women were secretive about their UI, often not telling others (Case 39).
The trial treatment phase was 16 weeks. Although many women felt they had received enough treatment, others felt that their performance accomplishment and adherence were supported by clinic visits and the loss of these, and for those with biofeedback the loss of the biofeedback unit (which women only had during active treatment), could act as a barrier.
The evidence above demonstrates that there are many contextual factors that influence a woman’s ability to develop self-efficacy for PFMT, that influence how that self-efficacy interacts with adherence, and also whether and how a woman chooses to adhere to PFMT. The data showed that these factors vary in their influence between women, a contextual factor that may facilitate for one woman, may act as a barrier for another (comorbidity is a good example of this). The factors also vary over time for individual women with some factors having a more consistent influence over time and other factors waxing and waning over a two-year period (such as a health condition that flares and resolves).
UI symptoms and changes in factors that led to women seeking treatment
Consistent adherence to PFMT over time is needed to achieve and maintain improvements in UI symptoms [7, 8]. Women in the OPAL study discussed outcomes in two ways: they talked about 1) UI outcomes and 2) about improved continence as the vehicle for doing the other things that mattered to them (e.g. Case 27, Table 3). Many women were positive about their UI and other outcomes. Sometimes women’s outcomes were not linked to UI improvement, e.g. Case 4 was delighted she was prescribed pads to contain the UI and although she still leaked urine she could go about her day-to-day life the way she wanted to. For others the outcome was poor, e.g. Case 24 talked about an initial improvement in UI then deterioration, with symptoms at two years worse than when she started; this vexed her as when her symptoms were better she could get up and get on with the day and help other family members.
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