Informant Input

The primary theme across our informants was that, in practice, the highest priority outcomes for women seeking treatment for UI are highly variable. Some of these differences are likely due to variable preferences and values. As an example, consider the difference between two women who each had to use six large incontinence pads per day prior to treatment. One woman was highly satisfied that, after treatment, she only needed to use three heavy pads per day and experienced fewer episodes of nocturia (the need to urinate overnight). In contrast, the other woman was dissatisfied because she still had to use a single light pad after treatment. Other differences in treatment goals may be attributable to differences in patients’ ages, type and severity of UI, and comorbidities.

Informants described several outcome categories pertaining to different aspects of symptoms and the sequelae of and behaviors related to urgency and incontinence. These categories overlap to some extent, but can be summarized as follows:

• UI/physical symptoms. These primarily relate to a desired reduction in episodes and volume of incontinence, which may be expressed as the number and/or size of incontinence pads required or, simply, as avoidance of getting wet. One informant described this category as “comfort” (not being wet or bothered with pads). The ultimate goal is a cure of incontinence without the need to wear a pad. This also includes frequency of urgency symptoms (or need to use toilet).
• Psychological/emotional or self-concept. Women may be fearful of accidents, have embarrassment over wetness and odors, and have other emotional distress. Stated differently, women may have concerns, distress, or fear that people think they are dirty, smelly, or unhygienic. UI may also result in feelings of low self-esteem or that something is wrong with them. This can lead to anxiety and depression. Successful treatment can result in feelings of freedom or liberation, improved self-confidence, improved sense of self, and feeling more feminine.

  • A particular aspect that was deemed very important for some women is a sense of control of their lives.
• Interpersonal relationships. UI affects how women interact with family, friends, colleagues, strangers, and others. Not only are there psychological sequelae of UI, but there are also convenience and UI management issues. Examples of affected interpersonal relationships include inability to play with children or visit grandchildren without experiencing incontinence or having to urinate first; another complaint is the inability to travel without immediate/ready/prompt access to a bathroom resulting in restricted or limited activities with others.

  • An important aspect of impaired interpersonal relationships includes sexual activities which may be avoided or limited because of fear of incontinence, odors, and reduced self-esteem.
• Lifestyle restrictions. Many aspects of typical day to day events may be affected. Treatment goals may include return to normal activities, “reengaging in life”, or removal of travel restrictions and of employment impediments. Women may lose work time due to incontinence. One informant described patients who are relieved that they can decrease the number of requests for a “toilet pass”. One patient required a prescription for her employer to allow her to use the toilet every 2 hours.

  • A related aspect is the ability to stay healthy. This relates primarily to a lack or complete avoidance of exercise. Women with UI may not feel able to participate in sports or exercise, including going to the gym or a public pool. In part, this may be due to the frequent need to stop exercising to go to the toilet or the embarrassment caused by leakage during exercise.
• Inconvenience/coping. Issues relate to the need to change clothes, carry and dispose of incontinence pads, plan bathroom trips and locations, or the need to urinate frequently.
• Economic. The cost of incontinence pads or other devices.
• Sleep. UI, in particular urgency incontinence, may lead to nocturia, which can adversely affect women’s sleep, which can have important impacts on their health and wellbeing.

Literature Summary

Six articles that were particularly pertinent. Two studies conducted focus groups,^12,23 two were surveys,^13,24 and two were evaluations of drug studies.^25,26 Briefly, the six studies were as follows:

• Lee 2012 (PMID 22698418) conducted a survey of patients treated for overactive bladder (OAB), among whom was a subgroup of 103 women with UI. This survey focused on treatment goals.²⁴
• Sung 2011 (PMID 21400574) conducted focus groups in 35 women with UI. The primary purpose was to evaluate whether a PROMIS (Patient-Reported Outcomes Measurement Information System) questionnaire captured the concerns of women with UI.²³
• Cardozo 2012 (PMID 22576329) reported a single-arm study of fesoterodine in which a subgroup of 128 people had urgency UI, of whom about 90 percent were women.²⁵
• Heisen 2016 (PMID 26789823) conducted discrete choice experiments via a survey in 442 people with OAB to rank outcomes and potential adverse events related to oral pharmacotherapy (antimuscarinics and beta-3 adrenoceptor agonists).¹³ While 90 percent of those surveyed had UI, the study included both women and men (47%). However, no statistically significant differences were found between women and men. The discrete choice experiments involved asking participants to choose between two different scenarios. The scenarios randomly varied multiple outcomes, such that across a range of scenarios and across study participants, preferences could be inferred.
• Cartwright 2011 (PMID 21279328) analyzed data from a randomized controlled trial (RCT) of oxybutynin in 96 women with OAB, with or without incontinence.²⁶ Among these participants was a subgroup of 62 women with urgency incontinence.
• Coyne 2014 (PMID 20579138) conducted focus groups with 16 women with lower urinary tract symptoms. However, the number of women with UI was not reported. The goal was to develop a questionnaire related to urinary urgency.¹²

• Symptoms. The percentage of people who prioritized improving UI symptoms (such as incontinence, frequency, urgency) as a major treatment goal varied widely among studies, but among those studies that ranked outcomes, UI symptoms were always of the highest priorities. Cordozo 2012 found that 81 percent of study participants reported that the goal to “reduce my urine leakage” was very important.²⁵ Similarly, Lee 2012 reported that 80 percent of the goals discussed by women with UI were related to symptom relief. However, Cartwright 2011 found that 49 percent of women with OAB listed improved physical symptom goals and among the subset of women with urgency UI, only 45 percent cited eliminating urgency UI symptoms.²⁶

  • In two studies that ranked physical symptom goals in people with UI, each reported a different goal ranking or priority order:

    • Lee 2012 (103 women with incontinence): frequency (32%), incontinence (28%), and urgency (14%).²⁴
    • Heisen 2016 (442 women and men mostly with UI): incontinence, nocturia, urgency, frequency (percentages not reported).¹³
• Physical function. Sung 2011 performed focus group sessions that discussed physical, mental, and social health outcomes. They found that women were particularly concerned with both their level of physical functioning (i.e., their extent of participation in activities such as walking, shopping, and household chores), which they may be doing less than they would like because of UI, and their satisfaction with their activities (including comfort level and confidence with the activities).²³
• Social function. Sung 2011 also reported that women were concerned with interpersonal interactions, discussing occupational, social, and community roles. Similar to physical function, there were concerns with both level of social function and satisfaction with their interactions.²³ Cartwright 2011 reported that 12 percent of the goals elicited from women with OAB related to lifestyle restrictions.²⁶
• Coping behaviors. Lee 2012 and Cartwright 2011 reported that 13 and 19 percent, respectively, of the goals discussed by women with UI (or OAB) related to eliminating coping behaviors, such as being aware of toilet locations, fluid restriction, convenience voids, changing underwear, and wearing pads.^24,26
• Psychological symptoms. Cartwright 2011 reported that among women with OAB (with or without incontinence), 16 percent reported goals of decreasing anxiety, loss of control, stigma, depression, and sexual dysfunction and increasing self-esteem.
• Quality of life. Lee 2012 reported that 8 percent of patient goals related to improving health-related quality of life. Particular goals included improving sleep quality, continuing work, doing activities and travelling without worry of urinary frequency or incontinence.²⁴
• Adverse events. Heisen 2016 ranked patients’ concerns regarding potential adverse events from medication use in the following order: increased heart rate, increased blood pressure, constipation, and dry mouth.¹³
• Symptoms versus adverse events. Women considering treatment for UI are not only concerned about reduction of UI symptoms, but they also balance the benefits with the risks, severity, or types of adverse event that may occur. Coyne 2014 noted that when considering medications, women thought it was important to reduce symptoms without side effects.¹² Heisen 2016 (who also surveyed clinicians) found that patients put more emphasis on limiting the risk of side effects than on improving symptoms, in contrast with physicians who put more emphasis on increasing benefits.¹³
• Outcome ranking. Across all reported outcomes (UI improvement and adverse events) from medication therapy (antimuscarinic/beta-agonist), Heisen 2016 ranked outcomes as follows: (1) incontinence, (2) nocturia, (3) risk of increased heart rate, (4) urgency, (5) frequency, (6) risk of increased blood pressure, (7) risk of constipation, and (8) risk of dry mouth. Sung 2011 reported that women ranked physical function, social function, and daily life function (not defined) more important than mental/emotional health (including anxiety, depression, anger) or sexual function. However, items in all domains were rated highly relevant by at least some women (including sleep/wake, fatigue).¹³ Women with OAB, in Cartwright 2011, prioritized physical symptoms (49%), coping strategies (19%), psychological symptoms (16%) and lifestyle restrictions (12%).²⁶
• Outcome expectations. Without referring to specific outcomes, Coyne 2014 reported that few women (with lower urinary tract symptoms) expected restoration to “normal”, but instead had the goal of improvement to “near normal”. Half of the women said that resolution of just one of their symptoms would be a favorable outcome. More than 80 percent of the women described that a 50 percent reduction in symptoms would be indicative of a meaningful change, particularly if not accompanied by bothersome side effects.¹²

In summary, we conclude that while relief of UI (or physical) symptoms is often ranked as the most important outcome (or set of outcomes) by most women with UI, it is not the highest priority for all of them (20% to 50% in three studies), and other outcomes are highly important to many women. There is no clear ranking of the specific UI symptom outcomes, but the most important ones appear to be incontinence, urgency, and frequency. However, in at least one study,¹² many women would be satisfied with improvement in their symptoms or resolution of just one of their symptoms.

Other important categories of outcomes for a large percentage of women include (1) the ability to satisfactorily participate with both physical function (physical activities such as exercise) and social function (interacting with other people), (2) reduce the need for coping behaviors (e.g., wearing pads, toilet mapping), (3) improve psychological symptoms (e.g., anxiety, depression, self-esteem, loss of control), (4) improve quality of life (e.g., sleep, worry-free travel), and (5) lessen the degree of adverse events. Economic concerns related to out-of-pocket costs (e.g., of incontinence pads) and employment are likely also important concerns for many women.

Women with UI who are considering treatment may be more concerned than clinicians about the tradeoffs between reducing UI symptoms and the risks of adverse events. This finding was identified in a discrete choice experiment conducted among both patients and clinicians.¹³ None of our physician or nurse practitioner informants discussed the risk of adverse events.