Behavioral interventions are the first-line approach for addressing symptoms of overactive bladder (OAB).  Distraction for managing urinary urgency is a common component of behavioral interventions; recently, a focus on mindfulness has been proposed as an alternative to distraction.  The primary purpose of this pilot study was to examine the feasibility of implementing a novel mindfulness-informed group-based intervention for OAB, using a modified mindfulness-based stress reduction (MBSR) approach tailored to include behavioral interventions specific to OAB.  The secondary purpose was to examine the potential clinical utility of the program by evaluating the results of several outcome measures for indications of effectiveness of the intervention on improving OAB symptoms.

This was a single-arm pre-intervention post-intervention pilot study using a convenience sample.  No randomization or blinding occurred.  Participants were recruited by flyer placement at community venues, a local university, and a local hospital, and via email from area medical providers specializing in the treatment of women with OAB.  Inclusion criteria were women > 18 years of age with self-identified OAB symptoms, English language fluency, willingness to undergo screening, and a diagnosis of OAB based on their score on the Overactive Bladder Symptom Score (OAB-SS).  Exclusion criteria included current pregnancy, recent urinary tract infection (< 4 weeks), pelvic organ prolapse, any surgery for incontinence, initiation of OAB medication within the last month, previous nonpharmacologic treatment for urinary symptoms (behavioral interventions, physical therapy), past diagnosis of interstitial cystitis or painful bladder syndrome, or any neurological condition affecting bladder sensation.  The program was developed by two physical therapists with extensive training and clinical experience in physical therapy management of overactive bladder and one psychologist with specific training in MBSR, and was administered by one of the physical therapists and the psychologist.  Participants underwent six weekly group-based 2-hour sessions addressing mindfulness techniques related to bladder sensation and management of urinary urgency as well as healthy bladder habits, pelvic floor muscle exercise, and information on diet and fluid intake.   Program feasibility was assessed by measuring the number of potential participants screened, the number enrolled, retention rates, and personnel time spent preparing for and conducting of the sessions.  The desired sample size was ten, with plans to proceed with the program as long as at least three participants were available.  Potential clinical utility was measured with pre-intervention – post-intervention comparisons of individual scores on the OAB-SS, the University of South Australia Urinary Sensation Assessment (USA2), the 15-item Five-Facet Mindfulness Questionnaire (FFMQ-15), a one-day bladder diary, and a post-intervention 7-point global rating of change (GROC) scale.

Recruitment was limited to four weeks due to unforeseen schedule constraints.  Seven women expressed interest in study participation, five of whom completed the initial screening, fit the inclusion criteria and agreed to enroll in the study.  One attended the first session and then was unable to continue due to illness and scheduling issues (no USA2, FFMQ-15, or bladder diary data gathered); the other four completed all six sessions (retention rate 80%, 100% session participation rate by retained participants).  Total personnel hours (clinicians and assistants combined) for program set-up (including organizing the venue and contacting participants) and delivery were 15 hours/week for the six-week intervention (5 hours for the investigators and 10 hours for the assistants), and 30 hours were spent on recruitment procedures and screening potential participants.  While the desired n was not achieved, the minimum n to administer the program was met.  Additionally, the retention goal was met, and the time required to run the study was deemed feasible.
All four participants perceived a benefit from the program, based on improvements on some or all of the outcomes measured. (Table 1)  No adverse events were reported.  Of note, during the second half of the study all four participants requested referrals to mental health professionals.  Contact information for a local counseling center was provided but no data were available regarding how many participants followed up on the referrals.

The primary purpose of this study was to investigate program feasibility.  The original intent was for the program to be eight weeks long, but various delays necessitated shortening it to six weeks and reducing the recruitment period to four weeks.  Despite the shortened timeframe, the investigators were able to recruit enough participants to run the program and were able to cover all topics deemed relevant.  Regarding the feasibility outcomes, a longer timeline for recruitment would likely allow for larger recruitment numbers.  However, given that all topics were adequately covered in six weeks, we believe this to be an appropriate timeframe for this program.  Time estimated for clinicians to organize and deliver this program once recruitment was completed was 15 hours per week, making it a potentially effective way to treat OAB in the community.
The secondary purpose was to evaluate the potential clinical usefulness of the program.  While the small n negates generalizability of the results, the results support the potential clinical usefulness of the program.  The most impactful results were from the OAB-SS and the GROC (Table 1).  Three out of four participants met the minimum clinically important difference (MCID) of 3 points on the OAB-SS, indicating a clinically important improvement in their OAB symptoms.  Global Rating of Change results indicated all participants perceived a benefit from the program, rating themselves either “somewhat better” (n=2) or “moderately better” (n=2).  
This may be the first study to combine mindfulness-informed approaches with traditional behavioral interventions for OAB.  The key strength of this study is that it demonstrates feasibility of a novel group-based, mindfulness-informed intervention for OAB, including recruitment, retention, and program time burden.   Additionally, the program may be clinically useful in reducing the symptoms of OAB in women.  In combination, these results present an opportunity for researchers to further evaluate the program’s utility in larger, more diverse samples.  If positive results are found in future studies, clinicians may consider re-evaluating their approach to behavioral therapies for OAB to include a component of mindfulness.  Weaknesses include the small sample size which was not representative of the population of women with OAB, as well as no long-term follow-up.  Future studies should include a longer recruitment period to allow for a larger sample size, as well as a plan for long-term follow-up.

Findings from this study provide preliminary evidence in support of the feasibility and potential clinical utility of a group-based mindfulness-informed intervention for women with OAB.  Future studies should include a longer recruitment period and more extensive recruiting efforts in order to achieve a larger sample size, and should compare this intervention to other established interventions for OAB as well as the longer-term results of the intervention.