Research in Gerontological Nursing

Empirical Research 

Mindfulness-Based Stress Reduction Versus a Health Enhancement Program in the Treatment of Urge Urinary Incontinence in Older Adult Women: A Randomized Controlled Feasibility Study

Katarina Friberg Felsted, PhD; Katherine P. Supiano, PhD, LCSW, FT

Abstract

Current treatment practices for older adult women with urge urinary incontinence (UUI) remain insufficient and ineffective. A randomized controlled feasibility trial was developed to evaluate three determinants of research feasibility and three determinants of intervention feasibility when comparing mindfulness-based stress reduction (MBSR) with a health enhancement program (HEP) in older adult women with UUI. Participants were recruited from the university health system, county senior centers, and community sites. Twenty-five postmenopausal women (mean age = 74 years) were randomized into MBSR treatment conditions or HEP comparison conditions for an 8-week intervention. Participants remained blinded to conditions. Research feasibility determinants were measured as recruitment, retention, and treatment delivery; intervention feasibility determinants were measured as acceptability, tolerability, and client receipt/enactment. Feasibility determinants established in the research literature as essential to intervention evaluation were recorded and evaluated throughout the current study. All six feasibility determinants confirmed positive results in the enrolled population. The use of MBSR and HEP as the active comparison to treat UUI in older adult women proved feasible in this trial. The results warrant the design of a larger-scale, multisite trial to study the efficacy of MBSR in treating UUI in older adult women.

Targets:

Older adult women with high incidence of UUI.

Intervention Description:

MBSR treatment conditions or HEP comparison conditions.

Mechanisms of Action:

Research and intervention feasibility determinants.

Outcomes:

The use of MBSR and HEP as the active comparison to treat UUI in older adult women proved feasible in this trial.

[ Research in Gerontological Nursing, 12(6), 285–297.]

Abstract

Current treatment practices for older adult women with urge urinary incontinence (UUI) remain insufficient and ineffective. A randomized controlled feasibility trial was developed to evaluate three determinants of research feasibility and three determinants of intervention feasibility when comparing mindfulness-based stress reduction (MBSR) with a health enhancement program (HEP) in older adult women with UUI. Participants were recruited from the university health system, county senior centers, and community sites. Twenty-five postmenopausal women (mean age = 74 years) were randomized into MBSR treatment conditions or HEP comparison conditions for an 8-week intervention. Participants remained blinded to conditions. Research feasibility determinants were measured as recruitment, retention, and treatment delivery; intervention feasibility determinants were measured as acceptability, tolerability, and client receipt/enactment. Feasibility determinants established in the research literature as essential to intervention evaluation were recorded and evaluated throughout the current study. All six feasibility determinants confirmed positive results in the enrolled population. The use of MBSR and HEP as the active comparison to treat UUI in older adult women proved feasible in this trial. The results warrant the design of a larger-scale, multisite trial to study the efficacy of MBSR in treating UUI in older adult women.

Targets:

Older adult women with high incidence of UUI.

Intervention Description:

MBSR treatment conditions or HEP comparison conditions.

Mechanisms of Action:

Research and intervention feasibility determinants.

Outcomes:

The use of MBSR and HEP as the active comparison to treat UUI in older adult women proved feasible in this trial.

[ Research in Gerontological Nursing, 12(6), 285–297.]

Urinary incontinence, defined as involuntary leakage of urine, is a syndrome of the lower urinary tract (Abrams et al., 2003; Holroyd-Leduc, Tannenbaum, Thorpe, & Straus, 2008; Nordqvist, 2015). Urinary incontinence is one of the foremost geriatric syndromes, yet it is underreported to health care providers (Ham, Sloane, Warshaw, Potter, & Flaherty, 2014; Mitteness, 1990) and is an undertreated syndrome in geriatric nursing facilities (Berlowitz, Brand, & Perkins, 1999; Lawhorne, Ouslander, Parmelee, Resnick, & Calabrese, 2008). Although urinary incontinence is assumed to be a normal part of aging, it is not (Doshi et al., 2010).

Urinary incontinence is classified by type: stress incontinence, urge incontinence, or mixed, which is a combination of stress and urge. Stress and urge incontinence are clinically differentiated by a series of simple questions about urgency and physical activity (Brown et al., 2006; Holroyd-Leduc et al., 2008; Rohr, Christensen, Ulstrup, & Kragstrup, 2004). Stress incontinence is characterized by leakage resulting from increased pressure on the bladder (e.g., upon exertion, sneezing/coughing, jumping) (Haylen et al., 2010). Stress incontinence is a structural disorder and occurs when the pelvic floor muscle, or the urethral sphincter muscle at the neck of the bladder, is weakened (A. Deneris, personal communication, September 9, 2017).

UUI is associated with a sudden need to urinate and insufficient time to void in the toilet (Dumoulin & Hay-Smith, 2010). Typical precipitating events of UUI are washing one's hands, sounds of running water, or familiar sights or actions signaling home—a garage door or unlocking the door to one's home. When patients present with mixed urinary incontinence, the predominant type is urinary incontinence urge predominant. According to Thuroff et al. (2011), the predominant type of UUI should be treated first.

Symptoms of UUI are reported by one half of older adults (Goode, Burgio, Richter, & Markland, 2010). However, only 25% of women with UUI seek care (Minassian, Yan, Lichtenfeld, Sun, & Stewart, 2012). Furthermore, older adult women are disproportionately affected by UUI. UUI is more difficult to treat than stress urinary incontinence (SUI), and its challenging effects are seen across various spectrums in a woman's life, such as health-related quality of life, emotional health, and sexual activity (Coyne et al., 2008; Nitti, 2001). This difficulty is alternately ascribed to detrusor muscle dysfunction or possible neural misregulation in the lower urinary tract (Banakhar, Al-Shaiji, & Hassouna, 2012). Although SUI is typically resolved with physical therapy or surgery, UUI proves more refractory to many common urinary incontinence treatments. However, UUI may respond to noninvasive mind–body interventions. Symptoms of UUI can be the decisive factor that keeps older women from living independently. More than one half of nursing facility admissions are related to incontinence (Coyne, Zhou, Thompson, & Versi, 2003). Thus, it may be important to focus UUI research in older adult women.

Recent studies in middle-aged women have shown that a mind–body connection may exist for persons with UUI, and that the practice of mindfulness may prove helpful in relieving UUI symptoms (Baker, Costa, Guarino, & Nygaard, 2014; Baker, Costa, & Nygaard, 2012; Griffiths & Tadic, 2008). These results have not been translated into research in predominantly affected populations of older adult women until now (Markland, Richter, Fwu, Eggers, & Kusek, 2011). Older adults and women continue to be underrepresented in research literature (Devlin, 2010; Mody et al., 2008; Provencher, Mortenson, Tanguay-Garneau, Bélanger, & Dagenais, 2014; Society for Women's Health Research, 2018).

Background

In an earlier study, an autonomic nervous system imbalance was detected in women with overactive bladder syndrome (OAB), of which UUI is included (Hubeaux, Deffieux, Ismael, Raibaut, & Amarenco, 2007). Women with OAB experienced significant increase in sympathetic tone as bladder filled, whereas women with SUI did not register such increase. Two subsequent studies reproduced this autonomic nervous system difference between participants with UUI and SUI (Hubeaux et al., 2011; Im, Kim, Kim, & Choi, 2010). Further research addressed the idea that contemplative practices could reduce the autonomic nervous system imbalance in women with UUI (Tenfelde & Janusek, 2014).

Various treatments have been applied to the older adult female population with UUI. Traditionally, behavioral and/or pharmacological therapies have been prescribed, recommended, or administered. However, with time, positive outcomes of these treatments fade even when combined, indicating a need for innovative, efficacious options in symptom management (Hartmann et al., 2009; Tenfelde & Janusek, 2014).

Mindfulness-Based Stress Reduction

Mindfulness-based stress reduction (MBSR) is a skill defined as “moment to moment awareness” (Grossman, Niemann, Schmidt, & Walach, 2004, p. 36), which is nonjudgmental and believed to promote well-being (Brown & Ryan, 2003). MBSR training was pioneered by Jon Kabat-Zinn in the late 1970s, and has shown long-lasting improvement of physical and mental health variables, such as coronary artery disease, depression, positive changes in attitudes and perceptions of participants with fibromyalgia and cancer, and reduced mood disturbances (i.e., anxiety disorder and increased self-esteem) (Grossman et al., 2004; Kabat-Zinn, 2003; Segal, Williams, & Teasdale, 2013). MBSR is taught as a series of eight 2-hour group sessions, with a full day retreat between Weeks 6 and 7 (Kabat-Zinn, 2005). Participants learn formal and informal ways to apply mindfulness to their daily lives. Mindfulness teaches participants to carefully attend to one thing at a time, and to notice thoughts and physical sensations without passing judgment (Kilpatrick et al., 2011). Participants learn to notice their environment and activities with a commitment to stay in the present moment. Mindfulness training improves attention-related behavioral responses (Jha, Krompinger, & Baime, 2007).

A recent systematic review of MBSR conducted by Fjorback, Arendt, Ørnbøl, Fink, and Walach (2011) showed impressive breadth of application across populations, such as medical students, women with fibromyalgia, community residents, recurrently depressed patients, and women with breast cancer. This systematic review also showed MBSR programs applied to various conditions, such as anxiety, emotional distress, multiple sclerosis, rheumatoid arthritis, and chronic obstructive pulmonary disease. MBSR showed demonstrable effects with the review concluding that MBSR is recommended for improved mental health, including lowering anxiety and depression, and also improved health-related quality of life (Fjorback et al., 2011).

Application of MBSR in Older Adults. MBSR has been used to treat multitudes of illnesses and conditions in older adults. The connection between the mind and body is applicable to many biophysical processes (Chiesa & Serretti, 2010; Franco, 2011; Jha et al., 2007). Research has been done on the precise components of mindfulness that produce positive outcomes in community-dwelling older adults (Gallegos et al., 2013). Gallegos et al. (2013) studied the effects of specific MBSR activities, such as yoga, sitting meditation, informal meditation, and body scanning on immune function, as measured by interleukin 6, insulin-like growth factor concentrations, and the Positive and Negative Affect Schedule (Watson, Clark, & Tellegen, 1988). Stronger immune function and positive affect were observed (Gallegos et al., 2013).

In older adult populations, MBSR has been successfully used to treat mood disturbances, loneliness, emotional distress, and improve executive function (Creswell et al., 2012; Lenze et al., 2014; Moynihan et al., 2013; Young & Baime, 2010). In a sample of older adults living in continuing care retirement communities, MBSR participants reported “significantly greater improvement in acceptance and psychological flexibility in role limitations due to physical health… [and] increased awareness, less judgment, and greater self-compassion” (Moss et al., 2015, p. 519). MBSR has been studied in minority and low-income older adult populations (Szanton, Wenzel, Connolly, & Piferi, 2011). Focus groups were conducted in a previous study with African American women older than 60 in low-income housing to understand “which parts of MBSR were most important… and whether they apply their training to daily challenges” (Szanton et al., 2011, p. 1). The researchers discovered that participants found MBSR useful when undergoing medical procedures as well as dealing with depression and managing anger (Szanton et al., 2011). Mindfulness has also been used to successfully treat chronic pain and other chronic conditions, including high blood pressure in older adult populations, as well as irritable bowel syndrome (IBS) in general populations (Gaylord et al., 2009; Morone, Greco, & Weiner, 2008; Palta et al., 2012).

Studies using mindfulness in persons with IBS may suggest that it is a chronic condition like UUI. Although mindfulness intervention has not been used in older adult populations, success of mindfulness interventions in participants with IBS is promising because of similar results found when imaging the brains of patients with IBS or UUI (Chang, 2005; Garland et al., 2012; Gaylord et al., 2009). Functional neuroimaging studies reveal different regional brain activation responses related to alterations in perception. Specifically, this exaggerated activation occurs in the emotional (anterior cingulate) cortex (Griffiths & Tadic, 2008). These differences occur in areas of the brain associated with attentional processes as well as response selection (Chang, 2005). Mindfulness enhances specific components of attention (Jha et al., 2007). Patients with IBS and UUI appear to catastrophize their experiences, and this heightened visceral sensitivity increases the likelihood of future episodes (Baker, 2012; Chang, 2005). Catastrophizing is a cognitive distortion in which the person not only predicts a negative outcome but also assumes that if the negative outcome occurred it would be a disaster (Boyes, 2013).

Coyne et al. (2009) reported heightened sensitivity of bladder urgency, mood disturbances accompanying these perceptions, and high levels of “psychiatric morbidity” (p. 4) in individuals with UUI. Mindfulness may cultivate a nonreactive (i.e., calm, less reactive) mindset, which lowers the visceral sensitivity, thus lowering evaluation and judgment of threats in the situation (Garland et al., 2012). Mindfulness may prove to be a fitting psychosocial intervention for UUI in older adult women. Baker et al. (2012) suggests MBSR may be “uniquely suited to treat the underlying psychological and physical symptoms associated with urge urinary incontinence” (p. 46). The current study is the first to compare the usefulness of MBSR versus a health enhancement program (HEP), an active comparison condition, in older adult women.

Objectives

The feasibility of using MBSR in comparison to HEP in treating older adult women with UUI was examined through a randomized controlled feasibility study (MacCoon et al., 2012). Feasibility determinants included research feasibility and intervention feasibility. Research feasibility refers to design feasibility and intervention feasibility refers to participant feasibility.

Research feasibility and intervention feasibility are expressed in the following aims:

  • Aim 1: Determine the research feasibility of a randomized controlled trial (RCT) comparing MBSR and HEP in older adult women presenting with UUI, measured by recruitment, retention, and treatment delivery.
  • Aim 2: Determine the intervention feasibility of an RCT comparing MBSR and HEP in older adult women presenting with UUI, measured by acceptability, tolerability, and client receipt/enactment.

Feasibility studies are designed to assess the “potential for successful implementation and validity” of larger, subsequent intervention studies (Tickle-Degnen, 2013, p. 171), which according to Thabane et al. (2010) are essential. An exploratory aim of preliminary efficacy was also addressed in the current study. Although the pilot nature and corresponding sample size did not allow for parametric statistical analysis, nonparametric statistics were calculated.

Method

Ethical Approval and Trial Design

Protocols, recruitment procedures, measures, and instruments were reviewed and approved by the University of Utah Institutional Review Board (IRB) and the Utah Department of Human Services Review Board, prior to recruitment. The authors used a RCT approach resulting in the highest rigor of scientific studies. Various authors and research groups have delineated necessary protocols and best practices for feasibility studies, and these were followed in the current study (Moore, Carter, Nietert, & Stewart, 2011; Nezu & Nezu, 2008; Thabane et al., 2010; Whitehead, Sully, & Campbell, 2014). Good clinical practices, which encompassed research staff training, informed consent procedures, IRB reporting, and monitoring/oversight of procedures of both interventionists and participants, were adhered to throughout the study (Leon, Davis, & Kraemer, 2011). In addition, the authors considered how best to assess safety, recruitment, ethics, and success, as recommended by the World Health Organization (2005) and the Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and International Conference on Harmonisation (1996).

Participants

Twenty-five postmenopausal women (mean age = 74 years) were recruited for the current study through university health sciences networks, county aging services networks, and community outreach. Inclusion criteria were: (a) being menopausal, with an emphasis on adult women older than 65; (b) experiencing moderate to severe levels of UUI symptoms for at least 3 months prior to screening, defined as a score of >3 on the Incontinence Severity Index (Sandvik, Espuna, & Hunskaar, 2006; Sandvik, Seim, Vanvik, & Hunskaar, 2000); (c) having predominant urges, not stress incontinence, as determined by Question 3 on the 3 Incontinence Questions (Brown et al., 2006); (d) being committed to attending 8 weekly sessions and a half day retreat between Weeks 6 and 7 of an educational intervention; (e) having no pharmacological therapy for UUI within 3 weeks of the beginning of the intervention, and having no plans to initiate such medications during the 8-week active treatment; (f) having had no previous intradetrusor Botox® injection or neurostimulation for UUI and no plans to receive it during the intervention; and (g) no or mild cognitive impairment, measured as a score of ≥25 on the Montreal Cognitive Assessment (MoCA); and (h) the ability to speak, read, and write English (Nasreddine et al., 2005).

Screening and Consent

Participant screenings occurred on the telephone with interested respondents. When potential participants called, the basic framework of the study, general time commitment, transportation options, and remunerations were explained. For the purposes of transparency and reproducibility, screening scripts were followed. When participants expressed interest, eligibility and exclusion criteria were reviewed one at a time. When a potential participant qualified for the current study, she was invited to come in for an enrollment interview.

The enrollment interview took place in the same location as intervention classes to facilitate participant comfort in the logistics of location and parking. A map and instructions for navigation and parking were sent via e-mail or mail. The principal investigator (K.F.F.) met participants at the parking garage and escorted them to the building where the enrollment interview and the course took place. This enhanced enrollment procedure allowed participants an advance orientation to the study site, increasing participant ease and facilitating retention (McHenry et al., 2015).

At the interview, potential participants who met eligibility criteria were provided with an informed consent document. The consent document, along with all study information, was written with ≥14-point font size, in serif font, in black type on matte, white paper, and double spaced, to accommodate this population (Kicklighter, 1991; National Institute on Aging, 2008). The language used in oral and written communication throughout the study process was as nontechnical as possible (U.S. Department of Health and Human Services, 1996). After giving participants ample time to read the document and ask questions, the principal investigator reviewed the consent document with participants paragraph by paragraph. Thus, participants were informed of confidentiality guidelines of participation and given a signed copy of the consent document to take home. Training for screening and consenting procedures was conducted by senior research team members (K.P.S. and others) who provided ongoing monitoring.

Interventions

Participants were randomized into one of two conditions: MBSR treatment condition, or HEP comparison condition. Participants in both groups attended 8 weekly sessions, approximately 2 hours each with one retreat day between Weeks 6 and 7. The MBSR condition was given the MBSR–protocol standardized intervention, focusing on mindfulness. The HEP condition was given the protocol standardized intervention, focusing on functional movement, nutrition, physical activity, and music therapy. Both group sessions also included daily homework practice. Participants were given modest compensation in the form of a gift card.

The interventionists in these two study conditions were certified and credentialed by the respective organizations corresponding to their training. The MBSR intervention was led by a certified MBSR instructor, credentialed through the Oasis Institute at the University of Massachusetts Medical School Center for Mindfulness in Medicine, Health Care, and Society. The HEP intervention was taught by a certified health education specialist. Certified health education specialists are credentialed through the accrediting body, the National Commission for Health Education Credentialing. Both interventionists were highly experienced in their respective treatments. Because of the sensitive nature of the UUI condition, female interventionists were hired for both treatments.

Feasibility Outcomes

To determine research feasibility, recruitment, retention, and treatment fidelity were measured and analyzed. Data analyses for recruitment and retention portions were performed through descriptive statistics and displayed in a Consolidated Standards of Reporting Trials (CONSORT) flowchart (Figure 1). Adequate treatment delivery was established a priori at 80% adherence of scheduled content to be delivered, as evidenced through interventionist verification and participant verification of treatment objectives.

CONSORT flow diagram of study.

Figure 1.

CONSORT flow diagram of study.

To determine intervention feasibility, acceptability, tolerability, and client receipt/enactment were analyzed. Acceptability was counted as positive and negative expression. Participant feedback was documented after each session, tolerability was measured as dropout count, and client receipt/enactment was measured as a count of attendance/homework completion. Each determinant was reported as a percentage.

Sample Size and Randomization

Thirteen participants were randomized into intervention conditions, whereas 12 participants were randomized into comparison conditions. As outlined in CONSORT, participants were assigned to their respective intervention condition through a process based on chance, which is random and cannot be predicted, to avoid selection bias or potentially biased outcomes (Chan et al., 2013; Schulz, Altman, & Moher, 2010). Participants were randomized into the MBSR or HEP condition according to the order of enrollment, and randomization was generated through the block method. The block method was used to ensure that enrollment was generated with a 1:1 ratio. Using blocking can increase predictability; CONSORT recommends blinding interventions and/or varying block sizes to retain unpredictability (Chan et al., 2013; Schulz et al., 2010). These measures of allocation concealment were applied, block sizes were varied, and randomized condition selections placed into an envelope, marked with an interview number. The researcher (K.F.F.) did not refer to the randomized result prior to the individual interviews. Participants were blinded to the condition, as they consented to an educational intervention and not specifically meditation or mindfulness. Adherence to CONSORT guidelines potentially diminishes dropout rates in the comparison condition (Chan et al., 2013; Schulz et al., 2010). Prior studies regarding methodology have provided support for such safeguards (Pildal et al., 2007; Wood et al., 2008).

Results

Each feasibility measure was calculated and reported as a percentage and baseline data and numbers were analyzed (Tables 13).

Characteristics of Overall Sample for Continuous Items (N = 25)

Table 1:

Characteristics of Overall Sample for Continuous Items (N = 25)

Characteristics of Overall Sample for Categorical Items (N = 25)

Table 2:

Characteristics of Overall Sample for Categorical Items (N = 25)

Fisher's Exact Test to Examine Differences in Baseline Characteristics Between MBSR (n = 13) and HEP Conditions (n = 12)

Table 3:

Fisher's Exact Test to Examine Differences in Baseline Characteristics Between MBSR (n = 13) and HEP Conditions (n = 12)

Research Feasibility Determinants

Recruitment. A total of 143 potential participants responded to recruitment materials. Sixteen (11%) gave no further contact. Therefore, 127 potential participants were screened over the telephone. Of these potential participants, 84 (66%) were not eligible and 14 (11%) were not interested. Twenty-nine (23%) were scheduled for enrollment and three of the 29 cancelled before their enrollment appointment and did not reschedule. Twenty-six attended their enrollment interview and one did not achieve the inclusion score on the MoCA (Nasreddine et al., 2005) and was declined enrollment by the researcher. The remaining 25 participants provided informed consent and were enrolled in the current study. The recruitment percentage was 17.48%, as defined by the PI, including those who only responded to an e-mail expressing no interest. No comparison feasibility data were shared from other MBSR studies; unfortunately, this is rarely reported in the complementary medicine literature. When accounting for eligibility in recruitment calculations, recruitment percentage was between 43.1% and 59.5%, and serves as an accurate range when examining feasibility. The presentation of a percentage range instead of a single percentage is because of an inability to know if the 16 participants who gave no further contact did so because they were ineligible or because they were not interested.

Retention. Of 25 participants enrolled into the two arms of the intervention, 19 completed the intervention, resulting in an overall retention rate of 73.1%. Prior MBSR studies with adults of all ages have reported retention rates of 70% to 80%, with those studies having older adult participants reporting retention rates at the lower end of that range (Creswell et al., 2012; Gallegos et al., 2013; White et al., 2010).

Thirteen participants were randomized into the intervention condition. One was unable to participate because of an unexpected move out of state. Another participant began the study with complications from cataract surgery and was hospitalized with pneumonia in the second week of class; she was ill for more than 1 month and did not return to the study. As such, 11 of the 13 participants enrolled and randomized into the intervention arm finished the study, resulting in a retention rate of 84.6%.

Twelve participants were randomized into the comparison condition. One dropped out before the study began, citing lack of transportation. Two dropped out due to volunteer and career demands (one left on a volunteer mission; one was given additional responsibility at work and could no longer attend the daytime intervention). One participant deemed the intervention unhelpful and stopped attending. Thus, eight of 12 participants in the comparison condition finished the intervention, resulting in a retention rate of 66.7%.

Treatment Delivery. Treatment delivery was measured from two perspectives, verified with both interventionists and participants to provide full triangulation of data. The PI met with each interventionist after each session to determine if the content of the intervention had been delivered. The MBSR interventionist verified content delivery at 100% across nine sessions. Two sessions were reported at 80%; however, the remaining material was presented in subsequent courses. This resulted in a per-class average of 95.6%. The HEP interventionist also confirmed 100% treatment delivery across all sessions. One session was reported at 75% and another at 90%, and again the remainder of the material was delivered in subsequent sessions, resulting in a per-class average of 96.1%.

Treatment delivery from the perspective of participants was measured through a checklist given to participants at the end of the intervention. Participants were asked to mark items that were taught throughout the course of the intervention. Each checklist contained 16 items, and participant responses averaged 93% (14.9 of 16) using an intent-to-treat analysis. This is well above the 80% rate considered to be the standard of treatment delivery (Nezu & Nezu, 2008).

A final feasibility measure of treatment delivery was to corroborate that each interventionist had a plan in place in case of absence. Each interventionist had one day that she was unable to teach, and after discussion with the PI, each chose to resolve it differently. The MBSR teacher needed to be absent in Week 8, and she arranged for a trained, certified substitute. The HEP interventionist needed to be absent in Week 7, and she rescheduled the date of the course to one day earlier, which was acceptable to all participants in the HEP comparison condition.

Intervention Feasibility Determinants

Acceptability. Acceptability in the current study was measured by randomly selecting two participants immediately after each class each week and asking them an open-ended question (e.g., “How did it go today?”). These questions resulted in a total of 32 unstructured responses. Each response was coded as positive or negative by the PI, and interrater reliability was achieved by having a second member of the research team independently code the responses. No discrepancies were noted between ratings, and they were accepted as correct. All 32 responses were positive, showing an acceptability rate of 100% for all participants, as well as participants per condition, which is a strong indicator that participants were fully accepting of an MBSR course as well as a HEP course to treat their UUI.

Tolerability. Tolerability was determined from the number of dropouts due to stated distress from or dislike of either intervention experience. In this case, a greater number of dropouts is associated with reduced tolerability. This is a separate measure from participants needing to withdraw because of a family emergency or a medical illness (Moore et al., 2011; Sturdy et al., 2003). All participants who withdrew were asked the following: “Help me understand what made this challenging.” Of the original 25 participants, 19 completed the study. Only one participant (in the HEP condition) dropped out because of her dislike of the intervention experience; she stated, “When it didn't seem to help I decided I wouldn't keep coming.” Given these data, tolerability for the current study was calculated at 96%: 100% for MBSR and 91.7% for HEP.

Client Receipt/Enactment. Client receipt/enactment was measured in two main categories at each session: attendance and homework completion. Results are reported for the 19 participants who completed the intervention. These were tallied by the interventionist and the PI, respectively. Attendance was recorded during all nine sessions of the course, Weeks 1 through 8 plus the retreat. Attendance averaged 96% for the MBSR condition and 97.2% for the HEP condition. Participants submitted each week's practice logs/homework to evidence client receipt/enactment. Homework was recorded for seven sessions of the course, as none was collected during Week 1 or the retreat. Homework submissions averaged 88.4% for the MBSR condition and 89.6% for the HEP condition.

Ancillary Analyses

In consideration of ancillary analyses, a preliminary efficacy analysis was also performed in this RCT using the Wilcoxon signed-ranks nonparametric test. Participants saw significant improvement in all four outcome measures: severity, bother, perceived stress, and perceived self-efficacy. Full preliminary efficacy results are forthcoming in a manuscript including the 6-month follow-up preliminary efficacy data. The full feasibility analysis was completed based on the study completion data. The 6-month follow-up data collected do not include any feasibility data or potential for further feasibility analysis. No harms or unintended effects in either group of participants were observed in the feasibility study.

Discussion

Research Determinants

The rationale for the selected research feasibility measures is drawn from the recommendations of notable researchers (Lancaster, Dodd, & Williamson, 2004; Leon et al., 2011; Nezu & Nezu, 2008; Thabane et al., 2010; Tickle-Degnen, 2013). These researchers recommended incorporating these measures in pilot studies to evaluate the capacity of the research team to properly and successfully conduct a larger study.

The consent rate of those who attended the enrollment interview was 100%, which is a strong indicator of feasibility. This demonstrated that the participants were well prepared for the enrollment interview. Providing clear recruitment fliers, presentations, and community interactions, combined with efficient screening for eligibility and exclusions, and thoroughly reviewing consent documents together with potential participants, may have contributed to high consent rates. Researchers offered each potential participant the opportunity to take consent documents home, study them further, and discuss with family. All potential participants consented at the enrollment interview.

Researchers were able to successfully recruit from many of the recruitment sites. The sites drawing the most participants were the county senior centers, followed by the University of Utah's Center on Aging participant registry.

Although participants remained blinded to condition throughout the study, lower retention rates in the comparison condition are not surprising. Although therapeutic, HEP remains an active control. It was created as a comparison condition to MBSR studies, matching MBSR in positive expectations, requiring an equivalent commitment from participants and providing a plausible alternative for success (Kok, Waugh, & Fredrickson, 2013).

Participants in both conditions showed mild to moderate surprise that their interventions were not “treatment as usual.” Unsolicited comments from at least one participant in each condition expressed that they wondered if they were in the control condition, as they were not learning or practicing typical treatments for urinary incontinence. Perplexity continued for the first several weeks of class, until the participants settled into their coursework. One participant commented during Week 3, “I thought I'd be doing Kegels. This is good.”

Treatment delivery addressed the adherence of the interventionists to content and protocols of their curricula. This adherence was measured from the perspectives of interventionists and participants.

Intervention Determinants

The rationale for the selected intervention feasibility measures was drawn from scientific literature regarding feasibility studies (Arain, Campbell, Cooper, & Lancaster, 2010; Bowen et al., 2009; Lancaster et al., 2004; Morin, 2013; Sturdy et al., 2003). Lancaster et al. (2004) recommended determining acceptability in a pilot study. Although this is not a full representation of every participant each week, collecting that amount of information from each participant would have resulted in participant burdens that researchers deemed too high during the current study design phase. In addition, researchers were concerned that this amount of feedback response would cause participant bias or confirmation bias, where participants may subconsciously alter their responses to elicit interviewer approval. Thus, two randomly selected participants were interviewed immediately after each class session. Random selection was operationalized by putting all participant names in an envelope and drawing two before each class session. Once all names had been drawn, names were re-entered into the envelope and the random draw continued. Acceptability data were collected by the research team, not the interventionists, to help avoid these biases.

It is postulated that the high acceptability percentage was influenced by hiring instructors with the highest levels of expertise and correct certifications. Comments on the MBSR instructor included:

I came and just thought the first time I did it, let it keep going going going going [sic]—it couldn't have been better—it was perfect. [Name]'s sure a great teacher—at least she sure connected with me.

Comments on the HEP instructor included:

[Name] is always well organized—she introduces every opportunity and guides you comfortably—she is always re-framing so we can all participate; I've never seen anyone not participate. She is so helpful and willing to interact personally.

Women in the current study often commented on the strong sense of community and pleasant group dynamics that developed in each intervention; this appeared to be meaningful and satisfying for them. This finding aligns with Lamb and Brady's (2005) findings that development of community is important to older adult learners. One woman stated after Week 5, “See [Name]? She and I have lived on the same street for 3 years and never said a word to each other, and now we're friends!”

Client receipt/enactment was observed in attendance and homework completion. Each week participants submitted practice logs and any other homework that had been assigned. Consistent with the adult learning environment, homework was not graded, but was marked as turned in/not turned in. All absences in both conditions during the current study were excused, as they were because of illness, travel, hardships, or religious obligations; no absences were unexplained by participants. In most instances, participants called before the date to let the interventionist know they would be absent and reasons for the absence, often submitting their homework the week they returned.

Regarding tolerability, participants were assured at the beginning of the intervention and throughout the course that homework participation was voluntary. The high rates of practice logs/homework submissions indicate an eagerness to participate fully in the intervention experience and this was equal across interventions.

Limitations and Generalizability

The current study recruited participants from one county within one state; therefore, results may not be generalizable. However, they serve as a guide for future trials. The methods followed the strongest scientific rigor and are generalizable for future trials. Participants gave qualitative responses; responses were coded for simplicity in evaluating qualitative acceptability. The authors believe the qualitative data will also contribute to implications and future research. Many unsolicited comments from participants were also noted throughout the current study, and these will be considered for qualitative analysis and subsequently submitted for publication.

Implications for Progression

The aims of the current study were to test research and intervention feasibility determinants in specific older adult female populations with moderate to severe UUI. Successful results will help researchers design a larger-scale hybrid implementation–effectiveness trial. Increases in older adult populations and costs of treating UUI make this research timely and are factors that spur future research. A multisite trial examining effectiveness of treatment can now be designed, as concerns regarding feasibility in this population are understood. Older adult women deserve better options for treating this condition. These findings point to the need for future research to determine whether MBSR can provide this needed treatment.

Conclusion

The results of the current study are encouraging for the development of future research studies. Recruitment, retention, treatment delivery, acceptability, tolerability, and client receipt/enactment were measured and evaluated as successful. This is a wide scope to examine, and all six feasibility determinants were successfully met.

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Characteristics of Overall Sample for Continuous Items (N = 25)

CharacteristicMeanSDRange
Age (years)73.528.4556 to 87
Body mass index (kg/m2)28.338.8818.37 to 61.08
Number of term pregnancies3.442.550 to 12
Age of onset of menopause (years)50.676.6440 to 65
Length of urge incontinence symptoms (years)7.979.813 to 50
Number of prescription medications3.362.011 to 8
Daily caffeine use (serving)1.331.440 to 4
Types of mental health conditions reported0.090.290 to 1

Characteristics of Overall Sample for Categorical Items (N = 25)

Characteristicn (%)
Marital status
  Married12 (48)
  Other13 (52)
Ethnicity
  Hispanic3 (12)
  Non-Hispanic22 (88)
Highest educational attainment
  High school/GED or lower3 (12)
  Some college6 (24)
  Trade/technical/vocational training1 (4)
  Associate degree2 (8)
  Bachelor's degree8 (32)
  Master's degree4 (16)
  Doctorate degree1 (4)
History of pregnancy
  Yes23 (92)
  No2 (8)
Life satisfaction
  Yes24 (96)
  No1 (4)
Life stressors
  Yes6 (24)
  No19 (76)
Current medical conditionsa
  High blood pressure9 (36)
  Diabetes4 (16)
  Cancer2 (8)
  Heart problems2 (8)
  Major depression1 (4)
  Anxiety disorder1 (4)
Current medication use
  Antidepressants or anxiolytics7 (28)
  Sleep medications3 (12)
  Pain medications3 (12)
  Beta-blockers2 (8)

Fisher's Exact Test to Examine Differences in Baseline Characteristics Between MBSR (n = 13) and HEP Conditions (n = 12)

Baseline Characteristicn (%)p Value
MBSRHEP
Marital status
  Married5 (38.5)7 (58.3)
  Other8 (61.5)5 (41.7)0.43
Race
  White11 (84.6)10 (84.6)
  Non-White2 (15.4)2 (16.7)1
Ethnicity
  Hispanic3 (23.1)0 (0)
  Non-Hispanic10 (76.9)12 (100)0.22
Highest educational level
  Less than bachelor's degree10 (76.9)2 (16.7)
  Bachelor's degree or higher3 (23.1)10 (83.3)0.01
History of pregnancy
  Yes12 (92.3)11 (91.7)
  No1 (7.7)1 (8.3)1
Life satisfaction
  Yes13 (100)11 (91.7)
  No0 (0)1 (8.3)0.48
Life stressors
  Yes2 (15.4)4 (33.3)
  No11 (84.6)8 (66.7)0.38
Authors

Dr. Felsted is Assistant Professor, and Dr. Supiano is Associate Professor, Gerontology Interdisciplinary Program, College of Nursing, University of Utah, Salt Lake City, Utah.

The authors have disclosed no potential conflicts of interest, financial or otherwise. This work was supported by the University of Utah College of Nursing Noorda-Hartford Fellowship, the University of Utah Office of the Associate Vice President for Health Equity and Inclusion, and the Sigma Theta Tau International Gamma Rho Chapter. The funding sources were not involved in the design of the current study; collection, analysis, and interpretation of data; writing of the report; or decision to submit the manuscript for publication.

The researchers acknowledge the guidance from the following faculty at the University of Utah: Drs. Michael Caserta, Angela Deneris, Jia-Wen Guo, and Paul Thielking.

Address correspondence to Katarina Friberg Felsted, Assistant Professor, PhD, College of Nursing, University of Utah, 10 South 2000 East, Salt Lake City, UT 84112; e-mail: katarina.felsted@nurs.utah.edu.

Received: December 31, 2018
Accepted: May 14, 2019
Posted Online: July 08, 2019

10.3928/19404921-20190702-02

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