title: Behavioral therapy to enable women with urge incontinence to discontinue drug treatment: a randomized trial.
abstract: 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.
authors.affiliation: University of Alabama at Birmingham and Department of Veterans Affairs, Birmingham, Alabama 35233, USA. kburgio@aging.uab.edu
authors.forename: Kathryn L
authors.initials: KL
authors.lastname: Burgio
authors.forename: Stephen R
authors.initials: SR
authors.lastname: Kraus
authors.forename: Shawn
authors.initials: S
authors.lastname: Menefee
authors.forename: Diane
authors.initials: D
authors.lastname: Borello-France
authors.forename: Marlene
authors.initials: M
authors.lastname: Corton
authors.forename: Harry W
authors.initials: HW
authors.lastname: Johnson
authors.forename: Veronica
authors.initials: V
authors.lastname: Mallett
authors.forename: Peggy
authors.initials: P
authors.lastname: Norton
authors.forename: Mary P
authors.initials: MP
authors.lastname: FitzGerald
authors.forename: Kimberly J
authors.initials: KJ
authors.lastname: Dandreo
authors.forename: Holly E
authors.initials: HE
authors.lastname: Richter
authors.forename: Thomas
authors.initials: T
authors.lastname: Rozanski
authors.forename: Michael
authors.initials: M
authors.lastname: Albo
authors.forename: Halina M
authors.initials: HM
authors.lastname: Zyczynski
authors.forename: Gary E
authors.initials: GE
authors.lastname: Lemack
authors.forename: Toby C
authors.initials: TC
authors.lastname: Chai
authors.forename: Salil
authors.initials: S
authors.lastname: Khandwala
authors.forename: Jan
authors.initials: J
authors.lastname: Baker
authors.forename: Linda
authors.initials: L
authors.lastname: Brubaker
authors.forename: Anne M
authors.initials: AM
authors.lastname: Stoddard
authors.forename: Patricia S
authors.initials: PS
authors.lastname: Goode
authors.forename: Betsy
authors.initials: B
authors.lastname: Nielsen-Omeis
authors.forename: Charles W
authors.initials: CW
authors.lastname: Nager
authors.forename: Kimberly
authors.initials: K
authors.lastname: Kenton
authors.forename: Sharon L
authors.initials: SL
authors.lastname: Tennstedt
authors.forename: John W
authors.initials: JW
authors.lastname: Kusek
authors.forename: T Debuene
authors.initials: TD
authors.lastname: Chang
authors.forename: Leroy M
authors.initials: LM
authors.lastname: Nyberg
authors.forename: William
authors.initials: W
authors.lastname: Steers
mesh_terms: 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*
chemical_list: D001559:Benzhydryl Compounds; D003408:Cresols; D018727:Muscarinic Antagonists; D010665:Phenylpropanolamine; D000068737:Tolterodine Tartrate