Overactive bladder (OAB) is a common medical condition characterized by urinary urgency, often accompanied by urinary frequency, nocturia, and urge urinary incontinence.1 An estimated 43.1% of women 40 years of age or older in the United States experience OAB symptoms.2 Overactive bladder affects patients' quality of life, impairs social relationships, and can lead to significant morbidity if left untreated.3 The societal and fiscal burdens of the disease are immense and estimated to be greater than $24 billion in a study performed by Onukwuga et al.4–6 However, despite the range of therapies available, many women with OAB still live with debilitating symptoms affecting their quality of life.
First-line treatments for OAB include behavioral therapy, lifestyle modifications, and pelvic floor physical therapy.7 However, many women find that behavioral and physical therapy alone do not alleviate their symptoms. In the event of suboptimal response to first-line therapies, oral antimuscarinics and recently β3-adrenoceptor agonists may be initiated. The side effects of these medications include dry mouth, dry eyes, constipation, and heart palpitations. However, the response rate ranges from 40% to 60% and annual continuation is estimated at only 20%.1,8,9 Third-line interventions—onabotulinumtoxinA, sacral neuromodulation, and percutaneous tibial nerve stimulation—are effective and have a favorable side-effect profile when compared with oral medications.10 Despite these advantages, only a small number of eligible patients will graduate to third-line therapy.
Few studies explore the reasons patients do not seek treatment for their bladder symptoms. In part, this may be due to a multiyear delay in presentation for treatment or frustration with first- and second-line therapies.6,11,12 The low rate of third-line therapy utilization has not been adequately investigated. Other authors have speculated that early education may play a role in improving graduation to advanced therapy, but to date no study exists with patient-generated data supporting this claim.13
Qualitative research provides a unique advantage in answering these questions as it uses open-ended queries to elicit the inner dialogue that guides patients' complex medical decisions. Unlike existing studies, qualitative research is a more appropriate methodology in exploring the reasons that patients do not seek care with third-line therapies for OAB.14–18 Our objective was to explore the decision-making process in women who do not pursue third-line therapies using a qualitative approach.
Qualitative research is well-established as a sensitive, specific, and validated methodology used to examine patients' experiences.14–18 In this methodology, participants responses are elicited using open-ended interview techniques. Rather than formulating a hypothesis, this method of research identifies important points of interest as they emerge during the interview process. The complexity of patients' beliefs, values, health, bodies, and priorities are, thus, preserved. This study aimed to explore the decision-making process in women who did not pursue third-line therapies for OAB.
Women aged 18–80 years who had an International Classification of Diseases diagnosis of OAB and were evaluated in the Division of Female Pelvic Medicine and Reconstructive Surgery or Department of Urology at MetroHealth Medical Center between January 2017 and March 2018 were considered potential study candidates. Additionally, potential participants were required to have been counseled for third-line therapy, were refractory to two or more medications, or were lost to follow up after initiating a second medication. Previous recipients of third-line therapy and non–English-speaking patients were excluded. Non–English-speakers were excluded to aid in ease of conversation and because of financial restrictions. A summary of inclusion and exclusion criteria appears in Box 1 and a flow diagram of participant selection appears in Figure 1. Institutional review board approval at MetroHealth was obtained before study initiation (IRB18-00119).
Summary of Interview Guide Questions
- Describe OAB and some of its causes.
- Describe what it has been like to live with OAB.
- Have you talked to anyone besides your doctor about OAB? Who and why?
- How long did you wait to talk to your doctor about OAB? Why?
- Describe your first visit with your doctor. Did your understanding of OAB change after this visit? What were your goals for treatment? Were your questions answered?
- Describe your treatment experience. What were your expectations?
- What was most important for you in choosing a treatment? Why did you decide to change any treatments?
- Did your doctor talk to you about third-line therapies? Describe the conversation.
- Did you hear about third-line therapies from any other sources? Friends, family, the Internet, TV, etc. What did they say?
- Did your experience with any other treatments affect your decision to pursue third-line therapies? Why or how?
- Were money and time a big consideration for you? Why?
- Describe any fears you may have had about pursuing treatment.
- If you had been offered all of the therapeutic options at your first visit, which would you have chosen and why?
- After going through this experience, what would your advice be to friends/family if they needed treatment for OAB?
OAB, overactive bladder.
Before interviews began, participants were sent a letter stating the purpose of the study. Study participants were randomly selected for phone interview by simple randomization and also based on patient availability. Consent was obtained verbally as outlined in the approved institutional review board protocol at our institution. Basic demographic data that included age, parity, marital status, insurance, financial difficulties, and education level was collected. A beta-tested interview guide was used to direct the conversation. Interview topics included medical knowledge and beliefs, quality of life, and treatment experience. Examples of questions appearing in the interview guide are provided in Box 2. The interviews were then transcribed into text.
Inclusion and Exclusion Criteria
- Aged 18–80 years
- International Classification of Diseases diagnosis of OAB
- Office visit in the Division of Female Pelvic Medicine and Reconstructive Surgery or Department of Urology from January 2017 to March 2018
- Counseled about third-line therapy, failed two or more medications, or lost to follow-up after initiating a second medication
- Previous recipient of third-line therapy
OAB, overactive bladder.
The transcriptions were coded and analyzed thematically. Codes were identified, reviewed, and discussed between the first two authors. After reviewing the first few transcriptions, a coding framework was created to aid in coding subsequent interviews. The coding framework and codes were regularly discussed and modified in an iterative process for internal validation. Interviews continued until theoretical saturation was achieved. Theoretical saturation was defined a priori as the measure of internal and external validation, consistent with grounded theory.14–16 Theoretical saturation was measured by two independent methods: 1) interviews were conducted until no new themes emerged or previously identified themes emerged in subsequent individual interviews and 2) each researcher coded the de-identified transcripts independently. The first two authors concluded that theoretical saturation had been reached after 30 interviews based on the above criteria.
On chart review, 381 English-speaking women aged 18 to 80 years who had a diagnosis of OAB were evaluated in the office from January 2017 to March 2018. Sixty-six patients (17.3%) had already received third-line therapy and were excluded. Initially, 65 patients qualified for our study based on the additional inclusion criteria of being counseled about third-line therapy, being refractory to two or more medications, or being lost to follow up after initiating a second medication. Eight women were later disqualified because they received third-line therapy after study initiation, and one woman was excluded because she was scheduled for third-line therapy but then became pregnant. Fifty-six women were ultimately considered study candidates. The average interview length was approximately 30 minutes, and 30 interviews were performed in total before theoretical saturation was achieved.
Basic demographic information was collected during interviews and is available in Table 1. Major themes identified during data analysis are described in detail below, and a summary is available in Table 2. Supporting participant quotations are embedded within the text and additional quotations appear in Box 3.
Themes With Additional Supporting Quotations
Theme 1: Treatment Delay
- Natural process: “I think it's just years of childbearing and a lot of working and on my feet a lot.”
- Embarrassment: “But the thing is, I told him that I get embarrassed. I get like I'm disabled or something.”
- Resources: “He said that the Botox under the Metro plan they wouldn't pay for it;…what's the point of talking about it if he can't do the procedure?”
Theme 2: Education
- Conceptualization: “He was just explaining to me the other things that he could do. And I know that he stapled hers so I was gonna go for what she had, because I know what Botox is and I don't know if I want that in my bladder or even what it’s gonna do…But I understand staples.”
- Ignorance: “Is there anything else besides medicine?”
- Educational sources: “Botox…that's the same stuff, like I asked, they be sticking in their face trying to…He was like, “Yeah.” And I was like, “No.’”
Theme 3: Treatment Attitudes
- Past experiences: “It seems like whenever I come in there, I come for one thing and it ends up being something else. Something always goes wrong, always. Always.”
- Conservative: “I went to one doctor and they wanted to put needles in my back. And put me in the surgery room and attach an electrode. I said, ‘No way! You're not putting any needles in my back.’”
- Fatigue: “And in my mind, it's like, what kinda surgery could they do to stop me going to the bathroom this much?…What's gonna be the side effects from that?”
Theme 4: Office Factors
- Provider gender: “It's a man doctor. It's not too much comfortable to have a man doctor with you about that.”
- Time restrictions: “I had surgery so I couldn't reschedule.”
- Invasive testing: “It's embarrassing sitting there like that. I never had anything like that before…There was a bucket underneath the chair thing. And I peed all over the floor!”
In the treatment delay theme, participants described intrinsic factors that prevented them from obtaining care. Several factors contributed to delayed presentation to treatment. Nine participants described OAB as a natural progression of the aging process. Some were not aware that OAB was a problem that could be addressed by a specialist: “I thought it was just a part of aging.”
Fifteen participants also described embarrassment, shame, helplessness, or stigma. For 16 participants, living with OAB caused extreme social isolation and disruption in day-to-day tasks of living. “I don't even really like to go anywhere 'cause I don't wanna sit on nobody's furniture. I don't even sit on my own living room furniture, for that matter.” Participants were reticent to discuss their urinary problems with friends or even their physician. One woman stated, “Every woman don't do this. They don't talk to you. And [if] they talk about this, it's like a hidden secret. I had my pads delivered in a plain box ‘cause I don't want nobody knowing.”
Six participants described financial factors that affected their ability to obtain supplies and treatment. Two of these participants expressed interest in pursuing third-line therapy but were denied by their insurance companies. “Yeah, I doubt my insurance would pay for them,” said one woman. Participants expressed a sense of injustice with one patient stating, “Just ’cause I don't have money, doesn't mean I should be wet all the time.” Other factors included limited transportation, work obligations, family obligations, and medical comorbidities, many of which were affected by the participant's financial status.
In the education theme, participants described their understanding of OAB and the manner in which they acquired information about OAB and its treatments. Examples of common resources included physicians, friends and family, television, and the internet. Insufficient office education was the most common barrier identified during data analysis. Participants had misconceptions about the treatment options and cure rates of OAB. “Is there a cure?” asked one woman.
Seventeen participants expressed ignorance about the availability of third-line therapies. When asked whether she was educated about third-line options, one woman stated, “I don't remember any other options. If he did, it went in one ear and out the other. I can't imagine what they would be.” One participant described brief conversations with her provider and two participants described an inability to conceptualize third-line therapies. Two patients stated they would not pursue third-line therapy because they did not understand it. One participant requested the use of diagrams or figurines to aid in office educational sessions, and others described possible interest if they had more thorough conversation with their physician. Fourteen participants requested additional information about third-line therapies, and seven participants expressed an interest in learning about these options sooner. “I would have liked my doctors to mention something to me,” said one woman, “Maybe they coulda did something a long time ago.”
Five participants weighed the experiences and opinions of their acquaintances heavily. For example, one woman described a friend who suffered from fecal incontinence after receiving onabotulinumtoxinA. When asked whether her doctor spoke to her about advanced treatment she said, “No, no. He did not because I kind of, like, shut it down.” Another patient described a friend who had a stroke after receiving onabotulinumtoxinA injections in her neck. Several other patients had similar anecdotes which caused them to decline third-line options.
The media had an effect on the participant's initial reaction to hearing about third-line treatments, particularly onabotulinumtoxinA. Five participants who had heard of onabotulinumtoxinA as a cosmetic injectable were opposed to using it for any therapeutic application. “Botox? That's strictly for in the face!” said one woman. And another, “I've heard [of] Botox. I don't think I would want to try that…Because people use it for cosmetic stuff.”
In the treatment attitudes theme, the participant described how previous treatments or interventions negatively affected her decision to pursue more advanced therapies. This theme included subthemes such as experiences with previous treatments, desire for conservative therapy, treatment fatigue, and patient readiness to pursue more advanced options.
All 30 of the participants in this study had previously taken medications for OAB. Side effects from previous treatments ranged from constipation to vision changes. Side effects were distressing and disturbing, and nine participants stated that they would not pursue third-line therapy owing to concerns about the side-effect profile. A few women received more invasive treatments such as lidocaine distillation into the bladder. “Yeah, it's almost as if I caught all of the bad side effects. It ain't worth it. It ain't worth side effects,” one woman said. Patients found that their treatment experiences differed significantly from what they were expecting. Disappointment was a subtheme described by five participants: “It was like going through all of that for nothing. I was kind of let down.”
Many participants had surgeries for nonurologic indications. Fifteen participants expressed an aversion to procedures involving surgery, needles, or implantable devices. One patient stated, “I didn't want surgery. I didn't want stuff up in me. I didn't know what the side effects were.” Repeat procedures needed for a sustained therapeutic benefit were also viewed unfavorably. “I'd rather get something done and over with in one shot,” said one patient. “I'm just trying to get this done and over with as it is.” Pursuit of third-line options was perceived as an extreme leap rather than a natural progression to more advanced care. One patient stated, “It seems that lately everybody wants to experiment and stuff and I'm just not up for all that poking and prodding, sticking, and doing all this different stuff.”
Despite these negative experiences, eight participants did describe a point at which they would consider more invasive options and often expressed desperation. Compromise and open-mindedness were reported by multiple women. “I mean, the key word again is never say never,” said one patient. Another patient said, “I'm tired of hurting…I just want the pain to stop for a minute.”
Five participants described office factors that prevented them from making follow up appointments. Provider gender, wait times, and negative experiences with invasive testing all played a role in patients’ declining further care. “My time is important…It's ’cause he's always running late on appointments…By the time he's there, I've forgotten what I wanted to say to him,” said one patient. Another patient avoided care because of fear of repeating urodynamic testing. “’Cause one time I went and they filled me up and I'm not able to get that test done at all…Most of the time I waited to see about my bladder ‘cause I couldn't get that test done.”
Shame, embarrassment, and helplessness delayed patients' initial pursuit of treatment. Barriers to therapy were diverse and frequently rooted in misconceptions about the natural history of OAB and available treatment options. Themes specific to third-line therapy centered around poor education, the opinions of others, previous treatment experiences, and office factors.
Of the themes identified, insufficient counseling was the most common modifiable barrier to third-line therapy. Nonmedical influences (such as anecdotes from friends and the media) played a substantial role in the development of women's perceptions of advanced therapies. Many women were not counseled by their doctor about third-line therapy until they did not respond to conservative treatment modalities or were not counseled about these options at all. As a result, third-line therapies were perceived as invasive rather than an expected progression to more advanced therapy after conservative management failure.
The benefits of thorough patient counseling have been well-established in the literature. Patients are more satisfied and more compliant with interventions when educated thoroughly about their medical status and the potential benefits of starting therapies.19,20 The U.S. Department of Health and Human Services recommends health care providers offer patient-centered communication and increase education to improve health literacy and outcomes for patients in all socioeconomic groups.21
Traditionally, providers have used a step-wise approach to counseling. Treatment options are discussed beginning with more conservative therapies and then advancing to more invasive therapies once conservative options have failed. Our study suggests that this method of patient education may have a negative effect on patients’ desire to obtain advanced OAB therapies. Describing the complete breadth of treatment options from the beginning may mitigate expectations, normalize advanced options, and acclimate patients to the idea of more invasive therapies. Early education on the part of the physician may also temper the negative effect of sensationalized and anecdotal outside influences. Developing a treatment plan early on could engage patients in their care and reinforce realistic goals and expectations. This conversation should begin when the patient presents with symptoms—including those presenting to a generalist gynecologist or primary care physician. In cases of discomfort with counseling about advanced options, early referral to a urologist or urogynecologist should be considered. Box 4 reviews our recommendations for modifying in-office counseling based on our findings.
Lessons Learned: How to Improve In-Office Counseling at Each Visit
- Review the prevalence, natural history, and chronicity of OAB
- Discuss the efficacy and availability of all treatment options while reinforcing that symptoms may not entirely be resolved with treatment
- Review the patient's goals of therapy and create an individualized treatment plan at the initial visit. This should include the following:
Distribute a handout with information about OAB and available treatment options
Consider community outreach including pamphlets, educational sessions, and volunteering at health fairs to increase awareness about OAB
- Patient beliefs about OAB and available treatment options
- Goals for symptom improvement
- The possibility of invasive testing if unresponsive to initial treatments
- An acceptable timeline for advancing to the next treatment modality in the event of first- and second-line treatment failure
- A review of familial, personal, and work obligations as these may affect procedure scheduling, preoperative visits, or follow-up visits
- Insurance requirements for treatment with third-line options
- A review of the treatment plan with any modifications at each visit
OAB, overactive bladder.
There were several limitations of this study. These data are from a tertiary care center and women referred to an advanced practice with a urologist or urogynecologist. The results may therefore not be applicable to the general population of patients with OAB. Recall bias was another limitation as four participants stated that they had not been educated about third-line options despite contradictory documentation on chart review. Additionally, phone interviews may have resulted in patients screening calls creating a selection bias. Demographic information as appears in Table 1 is only available for study participants who participated in a phone interview. Demographic data therefore may not reflect the full pool of 56 potential study participants. To avoid bias associated with qualitative research methodology, three researchers independently coded the transcripts for internal validation. No discrepancies were identified.
In-office education is of paramount importance to women suffering from refractory OAB. Timing and frequency of counseling is of equal importance. Establishing a treatment plan that incorporates early education and a patient-centered timeline with treatment goals may improve patients’ understanding of their condition and help moderate expectations. Additionally, it may also serve to normalize the need for more advanced therapies especially as the majority of patients do not respond or tolerate conservative therapeutic options. Third-line therapy counseling should be incorporated into the initial office visit. This may improve patient compliance and graduation to advanced therapy in women who later go on to develop refractory symptoms.
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