Andrew Sokol, MD
Georgetown University School of Medicine
Burgio KL, Locher JL, Goode PS, et al. Behavioral vs drug treatment for urge urinary incontinence in older women: a randomized controlled trial. JAMA. 1998;280:1995-2000.
Urgency incontinence is a common condition that has an impact on patients' daily activities and quality of life. Anticholinergic therapy is often prescribed; however, medication can be expensive, side effects can be bothersome, and rates of treatment discontinuation are consistently high. This study compares behavioral therapy with biofeedback to anticholinergic medications and placebo for the treatment of urgency and urge-predominant mixed urinary incontinence.
197 women ages 55-92 years with urgency or urge-predominant mixed urinary incontinence were randomized to 4 sessions (8 weeks) of biofeedback-assisted behavioral treatment, oxybutynin chloride (2.5 mg daily–5 mg 3 times daily), or a placebo control condition.
- Ambulatory women with urgency incontinence at least twice per week for at least 3 months were recruited
- Those initially screened underwent clinical evaluation to confirm eligibility, history and physical examination, 2-channel urodynamic testing, blood work, and mental status evaluation to screen for dementia
- Participants kept 2 week bladder diaries to document their voiding frequency, incontinence episodes, and volume of loss prior to randomization
- Subjects were stratified for type (urgency or mixed) and severity (mild, moderate or severe based on voiding diary) of incontinence prior to randomization to behavioral treatment, drug treatment, or placebo control condition
- All patients had 4 visits at 2 week intervals over an 8-week period
- The group receiving behavioral modification was taught how to perform Kegel exercises with the aid of biofeedback (45 squeezes per day) and instructed on urge deference techniques and home exercises
- Assignment to drug treatment or placebo was double-blinded, so all patients were managed as if they were taking oxybutynin. The group receiving active drug was started on 2.5 mg of oxybutynin chloride 3 times per day, with dosing flexibility up to 5 mg 3 times per day
- Subjects completed voiding diaries throughout treatment. At each clinic visit, diaries were reviewed and an adverse events checklist was completed
- A research assistant, blinded to treatment allocation, scored bladder diaries and managed the data
- After treatment, subjects completed 2 weeks of post-treatment voiding diaries and returned to the clinic for a final cystometrogram, adverse effects checklist, and patient satisfaction questionnaire
- The primary outcome was frequency of incontinent episodes as derived from bladder diaries
- The percentage reduction of urinary incontinence was calculated for each subject and was analyzed using a rank-based ANOVA procedure
- 468 were screened for inclusion and 197 women were randomized (behavioral N = 65, drug N = 67, control N = 65)
- During treatment, dry mouth and inability to void differed between groups (highest in the drug group, lowest in the behavioral modifications group)
- Attrition rates were highest in the control group (18.5%) and lowest in the behavioral group (6.2%)
- Despite similar rates in the pretreatment frequency of incontinence, the highest frequency of incontinence was in the control group and lowest in the behavioral group
- Mean improvement was 80.7% in the behavioral group, 68.5% in the drug treatment group, and 39.4% in the control group (P < 0.05)
- The proportion of patients who had at least 50% or 75% reduction in frequency of incontinence was greater with behavioral modification compared with drug or placebo treatment
- The behavioral group reported the highest improvement and satisfaction with the treatment process
- The behavioral group was most willing to continue the treatment indefinitely compared to the other groups and only 14% desired the addition of medication
This study was the first randomized clinical trial of biofeedback-assisted behavioral therapy for the treatment of urgency incontinence. While subsequent studies have shown that the addition of biofeedback or electrical stimulation to pelvic floor muscle physical therapy (PFMT) does not improve its effectiveness, strong evidence supports the effectiveness of PFMT for urgency and mixed urinary incontinence, and it is considered the first-line treatment for these bothersome conditions.