MOTIVE-ation!
Abstract & Commentary
By Allan J. Wilke, MD, Professor, Department of Introduction to Clinical Medicine, Ross University School of Medicine, Commonwealth of Dominica. Dr. Wilke reports no financial relationships relevant to this field of study.
This article originally appeared in the December 29, 2011, issue of Internal Medicine Alert. At that time, it was peer reviewed by Gerald Roberts, MD, Assistant Clincial Professor of Medicine, Albert Einstein College of Medicine, New York, NY. Dr Roberts reports no financial relationships relevant to this field of study.
Synopsis: Behavioral therapy works as well as drug treatment for male overactive bladder.
Source: Burgio KL, et al. Behavioral versus drug treatment for overactive bladder in men: The Male Overactive Bladder Treatment in Veterans (MOTIVE) Trial. J Am Geriatr Soc 2011;Nov 7. doi: 10.1111/j.1532-5415.2011.03724.x [Epub ahead of print].
Burgio and colleagues enrolled 203 male veterans (out of 360 assessed for eligibility), attending two VA Medical Centers in Alabama and Georgia, in this randomized, controlled equivalence trial of behavioral therapy (BEH) vs extended-release oxybutynin (OBN) for overactive bladder (OAB). All subjects underwent a clinical evaluation, which included urinalysis, urodynamic testing, post void residual volume (PVR) determination by ultrasound, and kept a voiding diary. They took the alpha-blocker tamsulosin 0.4 mg/d during a 4-week run-in period and continued it throughout the study. Inclusion criteria were self-reported urgency, frequent urination, and > 8 voids/day. Exclusion criteria were recent urological surgery, bed-bound, urine flow rate < 5 mL/s at baseline or < 10 mL/s after run-in, PVR > 250 mL at baseline or > 150 mL after run-in, continuous urine leakage, urinary tract infection, hematuria, fecal impaction, diabetes mellitus in poor control, unstable medical condition, dementia, narrow-angle glaucoma, gastric retention, hypersensitivity to the study drugs, new onset diuretic therapy, and sleep apnea.
The subjects in the behavioral arm were seen by nurse practitioners (NPs) for a comprehensive training program. The NPs taught them how to contract and relax their pelvic floor muscles. They were also instructed on the techniques of delayed voiding and urinary urge suppression. Nocturia was specifically addressed. The BEH group was told to restrict their fluid intake after 6 p.m. They were taught that if they awoke with the urge to void, they were to lie in bed and try to suppress the urgency by contracting their pelvic floor muscles.
Subjects in the drug-therapy arm were started on extended-release oxybutynin 10 mg daily. The dose was titrated upward or downward at follow-up visits, depending on patient tolerance of side effects and whether PVR was greater than 150 mL, which would trigger a dose reduction.
The trial lasted 10 weeks. The primary outcome was the average number of voids in a 24-hour period. Secondary outcome measures included patient global ratings, ratings of activity restriction, and measures of how disturbing the symptoms and side effects of the treatment were. The subjects were also asked whether they wanted to continue their present therapy or receive another form of treatment.
After the alpha-blocker run-in, 143 of the 203 men who were enrolled continued to have OAB symptoms, 73 randomized to BEH and 70 to OBN. Nineteen subjects dropped out, 9 from BEH and 10 from OBN. The average age of the participants was 64 years (range 42-88), 64% were white, 35% black, and 1% Hispanic. Subjects in BEH reduced their daily voids from an average of 11.3 at baseline to 9.1 at the end of the trial (normal < 8.) Similarly, subjects in the oxybutynin arm reduced their voids from 11.5 to 9.5. Both of these results were statistically significant. Before treatment, subjects in the behavioral arm averaged 2.2 episodes of nocturia per night vs 2.3 for subjects in OBN. Subjects in the behavioral arm had greater reduction in the number of nocturia episodes compared to the drug group (0.7 vs 0.32); this was statistically significant. When the investigators looked at mean urgency scores, OBN subjects had a statistically significant reduction compared to BEH. There was greater patient satisfaction among men in BEH, but this did not reach statistical significance. There were fewer men who complained of bothersome side effects in the behavioral group than the drug therapy group (12.6% vs 28.8%) and fewer wanted to change therapy (29.0% vs 50.0%). Both of these were statistically significant.
Commentary
As these investigators define it, OAB is urinary urgency, urge incontinence, frequency, and nocturia. Nocturia, which is often associated with urinary frequency, is defined as an urge to urinate that awakens the person during the night. OAB is usually thought of as a syndrome that afflicts females. However, 17% of males older than 60 years in the United States suffer from it.1
Although alpha-blockers commonly are associated with relaxation of the prostatic and bladder neck smooth muscles, they also relax the bladder dome smooth muscle, which accounts for their efficacy in OAB. Antimuscarinic drugs inhibit the muscarinic receptors that mediate normal bladder contractions.2 The oxybutynin-tamsulosin combination previously has been shown to be more effective than tamsulosin by itself,3 although, as was shown in the run-in period of this study, tamsulosin by itself was effective for 60 men (30% of those enrolled). Like other antimuscarinic drugs, oxybutynin can cause serious reactions, such as heat stroke and psychosis. However, there are many common reactions (dry mouth, dizziness, constipation, etc.) that are bothersome enough for patients to abandon therapy. Ironically, one of the most common reactions is urinary retention, which is why these investigators were using PVR for monitoring the subjects who were using drug therapy. Normal PVR is less than 100 mL.
Pelvic floor muscle strengthening (also known as Kegel exercises) works on the pubococcygeal muscle and other pelvic diaphragm muscles. Although primarily known as treatment for female stress incontinence, Kegel exercises also have been used in men for incontinence following prostate surgery4 and for premature ejaculation.5 To my knowledge, there are no adverse effects of performing Kegel exercises. The main problem in prescribing this therapy likely will be convincing the patient to allow a NP to place a finger into his anus, which is how the NP will teach him to recognize which muscles to contract.
This study raises some questions. It was of brief duration. How long-lasting will the results be? The main limitation of this study was that it was conducted on men who were already taking an alpha-blocker, tamsulosin. Would a different alpha-blocker (terazosin, doxazosin, etc.) work as well? Would the results of the study have been the same if the subjects had not been taking an alpha-blocker? The investigators used extended-release oxybutynin with the patients in the drug-therapy arm. Would much cheaper, short-acting oxybutynin have been as effective? What about other antimuscarinic drugs? Extended-release tolterodine in combination with tamsulosin has also been shown to be effective.6
The bottom line is this: Medication works for OAB, but behavioral therapy was as good as, if not better than, drug therapy for all outcome measures except urgency. The side effects of BEH are minimal, if not nonexistent. Antimuscarinic drugs have nontrivial side effects. Consider BEH and an alpha-blocker, unless urgency is the patient's overriding concern and he is willing to put up with the expense and side effects of oxybutynin.
References
1. Stothers L, et al. Urologic diseases in America project: Urinary incontinence in males demographics and economic burden. J Urol 2005;173:1302-1308.
2. Ruggieri MR Sr, et al. Combined use of alpha-adrenergic and muscarinic antagonists for the treatment of voiding dysfunction. J Urol 2005;174:1743-1748.
3. MacDiarmid SA, et al. Efficacy and safety of extended-release oxybutynin in combination with tamsulosin for treatment of lower urinary tract symptoms in men: Randomized, double-blind, placebo-controlled study. Mayo Clin Proc 2008;83:1002-1010.
4. Filocamo MT, et al. Effectiveness of early pelvic floor rehabilitation treatment for post-prostatectomy incontinence. Eur Urol 2005;48:734-738.
5. La Pera G, Nicastro A. A new treatment for premature ejaculation: The rehabilitation of the pelvic floor. J Sex Marital Ther 1996;22:22-26.
6. Kaplan SA, et al. Tolterodine and tamsulosin for treatment of men with lower urinary tract symptoms and overactive bladder: A randomized controlled trial. JAMA 2006;296:2319-2328.
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