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Behavioral Therapy to Enable Women with Urge Incontinence to Discontinue Drug Treatment: A Randomized Trial

Kathryn L. Burgio, PhD; Stephen R. Kraus, MD; Shawn Menefee, MD; Diane Borello-France, PT, PhD; Marlene Corton, MD; Harry W. Johnson, MD; Veronica Mallett, MD; Peggy Norton, MD; Mary P. FitzGerald, MD; Kimberly J. Dandreo, MSc; Holly E. Richter, PhD, MD; Thomas Rozanski, MD; Michael Albo, MD; Halina M. Zyczynski, MD; Gary E. Lemack, MD; Toby C. Chai, MD; Salil Khandwala, MD; Jan Baker, APRN; Linda Brubaker, MD; Anne M. Stoddard, ScD; Patricia S. Goode, MD; Betsy Nielsen-Omeis, RN, BSN; Charles W. Nager, MD; Kimberly Kenton, MD; Sharon L. Tennstedt, PhD; John W. Kusek, PhD; T. Debuene Chang, MD; Leroy M. Nyberg, MD, PhD; William Steers, MD, Urinary Incontinence Treatment Network
[+] Article and Author Information

ClinicalTrials.gov registration number: NCT00090584.

For a list of the Urinary Incontinence Treatment Network investigators, see Appendix 1.


From the University of Alabama at Birmingham and Department of Veterans Affairs, Birmingham, Alabama; University of Texas Health Sciences Center, San Antonio, Texas; University of California, San Diego, San Diego, California; Duquesne University and Magee Women's Hospital, University of Pittsburgh, Pittsburgh, Pennsylvania; University of Texas Southwestern, Dallas, Texas; University of Maryland, Baltimore, Maryland; Oakwood Hospital, Dearborn, Michigan; University of Utah Health Sciences Center, Salt Lake City, Utah; Loyola University Medical Center, Maywood, Illinois; New England Research Institutes, Watertown, Massachusetts; National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland; and University of Virginia Health Systems, Charlottesville, Virginia.


Presented as a poster presentation at the annual meeting of the International Continence Society, 20–24 August 2007, Rotterdam, the Netherlands, and as an oral presentation at the American Urogynecologic Society Annual Scientific Meeting, 27–29 September 2007, Hollywood, Florida.

Acknowledgment: The authors thank Susan McDermott, MPH, RN, CS, New England Research Institutes, for her role in project coordination and interventionist training; Heather Litman, PhD, New England Research Institutes, for statistical analysis; and the study interventionists, listed in Appendix 1, for implementing the interventions.

Grant Support: By the National Institute of Diabetes and Digestive and Kidney Diseases (grants U01 DK58225, U01 DK58234, U01 DK58229, U01 DK58231, U01 DK60397, U01 DK60401, U01 DK60395, U01 DK60393, U01 DK60380, and U01 DK60379). Additional support, including provision of study drugs and funding, was contributed by Pfizer.

Potential Financial Conflicts of Interest:Consultancies: K.L. Burgio (Pfizer, Astellas Pharma, GlaxoSmithKline, Lilly, Ortho-McNeil, Novartis, Merck), S.R. Kraus (Pfizer, Lilly), P. Norton (Lilly, Pfizer, Novartis, Procter & Gamble), M.P. FitzGerald (GlaxoSmithKline, Astellas Pharma), G.E. Lemack (Pfizer, Astellas Pharma, Allergan, Novartis), T.C. Chai (Pfizer, Procter & Gamble), S. Khandwala (Ethicon, Astellas Pharma, Novartis), P.S. Goode (Ortho-McNeil), B. Nielsen-Omeis (Lilly-ICOS), W. Steers (Dynogen, Astellas Pharma, Sanofi, GlaxoSmithKline). Honoraria: S.R. Kraus (Novartis, Ortho-McNeil, Pfizer), V. Mallett (Astellas Pharma), M.P. FitzGerald (Medtronic), H.E. Richter (Pfizer), T. Rozanski (Pfizer), G.E. Lemack (Pfizer, Astellas Pharma, Allergan, Novartis), S. Khandwala (Ethicon), W. Steers (Watson, Astellas Pharma). Stock ownership or options (other than mutual funds): S. Menefee (Pfizer), A.M. Stoddard (Johnson & Johnson, Bristol-Meyers Squibb, Elan, Procter & Gamble), J.W. Kusek (Lilly, Pfizer), W. Steers (Johnson & Johnson). Grants received: K.L. Burgio (Pfizer, Alza), S.R. Kraus (Astellas Pharma, GlaxoSmithKline), S. Menefee (Solace Therapeutics, Renessa), M.P. FitzGerald (Pfizer, Astellas Pharma), H.E. Richter (Pfizer, Lilly, Bionovo), T.C. Chai (Pfizer), L. Brubaker (Pfizer, Allergan), P.S. Goode (Pfizer), K. Kenton (Pfizer), S.L. Tennstedt (Pfizer, Lilly-ICOS), W. Steers (Pfizer). Other: K.L. Burgio (Pfizer), H.M. Zyczynski (Johnson & Johnson, Novartis, Ethicon), L. Brubaker (Allergan, Pfizer, Q-Med), W. Steers (Astellas Pharma, Allergan).

Reproducible Research Statement:Study protocol: Published elsewhere (11). Statistical code and data set: The protocol, analytic data set, and the computer code used to generate the results are available from the Urinary Incontinence Treatment Network Data Coordinating Center, New England Research Institutes, Watertown, MA 02472. The study data set will also be available through the National Institute of Diabetes and Digestive and Kidney Diseases Data Repository at http://www3.niddk.nih.gov/research/resources in early 2009.

Corresponding Author: Kathryn L. Burgio, PhD, University of Alabama at Birmingham, Birmingham Veterans Affairs Medical Center, 11G, 700 South 19th Street, Birmingham, AL, 35233; e-mail, kburgio@aging.uab.edu.

Current Author Addresses: Drs. Burgio and Goode: University of Alabama at Birmingham, Birmingham Veterans Affairs Medical Center, 700 South 19th Street, Birmingham, AL 35233.

Dr. Kraus: University of Texas Health Science Center, Department of Urology, 7703 Floyd Curl Drive, San Antonio, TX 78229.

Dr. Menefee: Kaiser Permanente, 4647 Zion Avenue, San Diego, California 92120.

Dr. Borello-France: Duquesne University, 111 Health Sciences Building, Pittsburgh, PA 15282.

Drs. Corton and Lemack: University of Texas Southwestern Medical Center, 5323 Harry Hines Boulevard, Dallas, TX 75390-9032.

Drs. Johnson and Chai: University of Maryland, 22 South Greene Street, Baltimore, MD 21210.

Dr. Mallett: University of Tennessee, 853 Jefferson Avenue, Memphis, TN 38115.

Dr. Norton: University of Utah, 50 North Madison Drive, Salt Lake City, UT 84132.

Drs. FitzGerald, Brubaker, and Kenton: Loyola University Medical Center, 2160 South First Avenue, B103-Room 1004D, Maywood, IL 60153.

Ms. Dandreo and Drs. Stoddard and Tennstedt: New England Research Institutes, 9 Galen Street, Watertown, MA 02472.

Dr. Richter: University of Alabama at Birmingham, 618 20th Street, S NHB 219, Birmingham, AL 35233.

Dr. Rozanski: University of Texas Health Science Center, 7703 Floyd Curl Drive, MC7845, San Antonio, TX 78229.

Dr. Albo: University of California at San Diego Medical Center, 200 West Arbor Drive, San Diego, CA 92103.

Dr. Zyczynski: University of Pittsburgh, 300 Halket Street, Pittsburgh, PA 15213.

Dr. Khandwala: Oakwood Hospital and Medical Center, 18101 Oakwood Boulevard, Dearborn, MI 48124.

Ms. Baker: University of Utah, 30 North 1900 East, Salt Lake City, UT 84132.

Ms. Nielsen-Omeis: University of Texas Health Science Center, Department of Urology, 2833 Babcock Road #200, San Antonio, TX 78229.

Dr. Nager: University of California at San Diego, 9350 Campus Point Drive, La Jolla, CA 92037.

Drs. Kusek, Chang, and Nyberg: National Institutes of Health, 6707 Democracy Boulevard, Bethesda, MD 20892.

Dr. Steers: University of Virginia, Department of Urology, Box 800472, Charlottesville, VA 22908.

Author Contributions: Conception and design: K.L. Burgio, S.R. Kraus, D. Borello-France, H.W. Johnson, V. Mallett, P. Norton, M.P. FitzGerald, H.E. Richter, M. Albo, H.M. Zyczynski, G.E. Lemack, T.C. Chai, J. Baker, L. Brubaker, P.S. Goode, B. Nielsen-Omeis, C.W. Nager, K. Kenton, S.L. Tennstedt, J.W. Kusek, L.M. Nyberg, W. Steers.

Analysis and interpretation of the data: K.L. Burgio, S.R. Kraus, S. Menefee, D. Borello-France, V. Mallett, P. Norton, M.P. FitzGerald, T. Rozanski, H.M. Zyczynski, A.M. Stoddard, P.S. Goode, C.W. Nager, S.L. Tennstedt, J.W. Kusek, L.M. Nyberg.

Drafting of the article: K.L. Burgio, S.R. Kraus, S. Menefee, D. Borello-France, M. Corton, V. Mallett, P. Norton, M.P. FitzGerald, H.E. Richter, A.M. Stoddard, P.S. Goode, S.L. Tennstedt, W. Steers.

Critical revision of the article for important intellectual content: K.L. Burgio, S.R. Kraus, S. Menefee, D. Borello-France, M. Corton, H.W. Johnson, P. Norton, M.P. FitzGerald, K.J. Dandreo, H.E. Richter, T. Rozanski, M. Albo, H.M. Zyczynski, G.E. Lemack, T.C. Chai, J. Baker, L. Brubaker, A.M. Stoddard, P.S. Goode, B. Nielsen-Omeis, C.W. Nager, K. Kenton, S.L. Tennstedt, J.W. Kusek, W. Steers.

Final approval of the article: K.L. Burgio, S.R. Kraus, S. Menefee, D. Borello-France, M. Corton, H.W. Johnson, P. Norton, M.P. FitzGerald, K.J. Dandreo, H.E. Richter, T. Rozanski, M. Albo, H.M. Zyczynski, T.C. Chai, L. Brubaker, A.M. Stoddard, P.S. Goode, B. Nielsen-Omeis, C.W. Nager, K. Kenton, S.L. Tennstedt, J.W. Kusek, T.D. Chang, L.M. Nyberg, W. Steers.

Provision of study materials or patients: S.R. Kraus, S. Menefee, V. Mallett, P. Norton, M.P. FitzGerald, H.E. Richter, T. Rozanski, M. Albo, H.M. Zyczynski, T.C. Chai, J. Baker, L. Brubaker, P.S. Goode, B. Nielsen-Omeis, C.W. Nager, K. Kenton.

Statistical expertise: A.M. Stoddard.

Obtaining of funding: S.R. Kraus, P. Norton, H.E. Richter, M. Albo, T.C. Chai, L. Brubaker, S.L. Tennstedt, J.W. Kusek.

Collection and assembly of data: M. Albo, S. Khandwala.


Ann Intern Med. 2008;149(3):161-169. doi:10.7326/0003-4819-149-3-200808050-00005
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The BE-DRI (Behavior Enhances Drug Reduction of Incontinence) study was a 2-stage, randomized trial conducted by 9 clinical centers in the United States. (See Appendix 1 for a list of participating centers.) We randomly assigned patients to receive drug therapy alone or drug therapy combined with behavioral training. In stage 1, participants received 10 weeks of the assigned treatment. In stage 2, which immediately followed active treatment, we discontinued drug therapy in both groups. We measured outcomes at 6 months after discontinuation of therapy (month 8) as well as at the end of active therapy (week 10). We did not allow crossovers. Drug therapy was open-label, and we provided the drugs free of charge to all study participants. Study staff who performed outcome evaluations, but not participants and interventionists, were blinded to group assignment. Details of the study design (Appendix Figure) and methodology are described elsewhere (11). We recruited participants between July 2004 and January 2006 and completed the last follow-up in November 2006.

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Figures

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Figure 1.
Study flow diagram.

UI = urinary incontinence.

* Defined as attending 3 or 4 intervention visits and taking 80% of prescribed drug.

† 17 women (8 in the drug therapy alone group and 9 in the combination therapy group) returned to drug or other therapy before 8 months.

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Figure 2.
Adjusted mean total Urogenital Distress Inventory (UDI scores over time.

Higher scores indicate greater symptom distress. Scores ranged from 0 to 255 at baseline, 0 to 230 at the end of stage 1, and 0 to 211 at stage 2, of a possible 300. We calculated adjusted mean UDI score and corresponding 95% CIs by using mixed-effect modeling, controlling for study site and randomization stratum.

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