Behavioral therapy to enable women with urge incontinence to discontinue drug treatment: a randomized trial.
BACKGROUND
Women with urge urinary incontinence are commonly treated with antimuscarinic medications, but many discontinue therapy.


OBJECTIVE
To determine whether combining antimuscarinic drug therapy with supervised behavioral training, compared with drug therapy alone, improves the ability of women with urge incontinence to achieve clinically important reductions in incontinence episodes and to sustain these improvements after discontinuing drug therapy.


METHODS
2-stage, multicenter, randomized clinical trial conducted from July 2004 to January 2006.


METHODS
9 university-affiliated outpatient clinics.


METHODS
307 women with urge-predominant incontinence.


METHODS
10 weeks of open-label, extended-release tolterodine alone (n = 153) or combined with behavioral training (n = 154), followed by discontinuation of therapy and follow-up at 8 months.


METHODS
The primary outcome, measured at 8 months, was no receipt of drugs or other therapy for urge incontinence and a 70% or greater reduction in frequency of incontinence episodes. Secondary outcomes were reduction in incontinence, self-reported satisfaction and improvement, and scores on validated questionnaires measuring symptom distress and bother and health-related quality of life. Study staff who performed outcome evaluations, but not participants and interventionists, were blinded to group assignment.


RESULTS
237 participants completed the trial. According to life-table estimates, the rate of successful discontinuation of therapy at 8 months was the same in the combination therapy and drug therapy alone groups (41% in both groups; difference, 0 percentage points [95% CI, -12 to 12 percentage points]). A higher proportion of participants who received combination therapy than drug therapy alone achieved a 70% or greater reduction in incontinence at 10 weeks (69% vs. 58%; difference, 11 percentage points [CI, -0.3 to 22.1 percentage points]). Combination therapy yielded better outcomes over time on the Urogenital Distress Inventory and the Overactive Bladder Questionnaire (both P <0.001) at both time points for patient satisfaction and perceived improvement but not health-related quality of life. Adverse events were uncommon (12 events in 6 participants [3 in each group]).


CONCLUSIONS
Behavioral therapy components (daily bladder diary and recommendations for fluid management) in the group receiving drug therapy alone may have attenuated between-group differences. Assigned treatment was completed by 68% of participants, whereas 8-month outcome status was assessed on 77%.


CONCLUSIONS
The addition of behavioral training to drug therapy may reduce incontinence frequency during active treatment but does not improve the ability to discontinue drug therapy and maintain improvement in urinary incontinence. Combination therapy has a beneficial effect on patient satisfaction, perceived improvement, and reduction of other bladder symptoms.
Burgio
Kathryn L
KL
University of Alabama at Birmingham and Department of Veterans Affairs, Birmingham, Alabama 35233, USA. kburgio@aging.uab.edu
Kraus
Stephen R
SR
Menefee
Shawn
S
Borello-France
Diane
D
Corton
Marlene
M
Johnson
Harry W
HW
Mallett
Veronica
V
Norton
Peggy
P
FitzGerald
Mary P
MP
Dandreo
Kimberly J
KJ
Richter
Holly E
HE
Rozanski
Thomas
T
Albo
Michael
M
Zyczynski
Halina M
HM
Lemack
Gary E
GE
Chai
Toby C
TC
Khandwala
Salil
S
Baker
Jan
J
Brubaker
Linda
L
Stoddard
Anne M
AM
Goode
Patricia S
PS
Nielsen-Omeis
Betsy
B
Nager
Charles W
CW
Kenton
Kimberly
K
Tennstedt
Sharon L
SL
Kusek
John W
JW
Chang
T Debuene
TD
Nyberg
Leroy M
LM
Steers
William
W
D000328:Adult; D000368:Aged; D001521:Behavior Therapy; D001559:Benzhydryl Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D003408:Cresols / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D010665:Phenylpropanolamine / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life; D000068737:Tolterodine Tartrate; D016896:Treatment Outcome; D014550:Urinary Incontinence, Stress / Q000628:therapy*
D001559:Benzhydryl Compounds; D003408:Cresols; D018727:Muscarinic Antagonists; D010665:Phenylpropanolamine; D000068737:Tolterodine Tartrate