Cognitive behavioral therapy for overactive bladder in women: study protocol for a randomized controlled trial
Abstract Background Overactive bladder (OAB) symptoms affect daily life by decreasing health-related quality of life (HRQol). However, there remain no very effective treatment for OAB. Pharmacotherapy is one of the best treatments, but it is not always efficient and may incur adverse events. Althoug...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2020-08-01
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| Series: | BMC Urology |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s12894-020-00697-0 |
| _version_ | 1818883540299808768 |
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| author | Satoshi Funada Norio Watanabe Takayuki Goto Hiromitsu Negoro Shusuke Akamatsu Kentaro Ueno Ryuji Uozumi Kentaro Ichioka Takehiko Segawa Tatsuo Akechi Toshiaki A. Furukawa Osamu Ogawa |
| author_facet | Satoshi Funada Norio Watanabe Takayuki Goto Hiromitsu Negoro Shusuke Akamatsu Kentaro Ueno Ryuji Uozumi Kentaro Ichioka Takehiko Segawa Tatsuo Akechi Toshiaki A. Furukawa Osamu Ogawa |
| author_sort | Satoshi Funada |
| collection | DOAJ |
| description | Abstract Background Overactive bladder (OAB) symptoms affect daily life by decreasing health-related quality of life (HRQol). However, there remain no very effective treatment for OAB. Pharmacotherapy is one of the best treatments, but it is not always efficient and may incur adverse events. Although behavioral therapy is another effective treatment, there are very few structured treatment manuals on how to prescribe behavioral therapy to treat OAB for whom. Cognitive behavioral therapy (CBT) is a psychotherapy consisting of structured sessions to solve problems with the collaborative empiricism between therapists and patients. OAB symptoms are supposed to worsen with cognitive distortion, and CBT is expected to be effective in treating OAB by modifying such cognitive processes. In this trial, we will evaluate the efficacy of CBT for OAB. Methods A randomized, controlled, open-label, multicenter parallel-group superiority trial will be conducted. Participants with moderate to severe OAB symptoms with or without pharmacotherapy will be recruited and will be randomly allocated 1:1 to two different groups by minimization (age, baseline OAB severity, treatment status, types of intervention, and treating institutions). The intervention group will be prescribed an individual CBT program covering six techniques in 4 sessions (30 min each), with or without pharmacotherapy. The primary outcome is the change scores in an OAB-questionnaire (OAB-q) from baseline to the end of the trial (week 13). Secondary outcomes will include other patient reported outcome measures and the frequency volume chart. All analyses will be conducted on an intention-to-treat principle. Discussion This trial will determine the efficacy of CBT to treat OAB using a rigorous methodology. The effectiveness of CBT with a structured manual may not only lead to a new treatment option for patients suffering from OAB symptoms, but may also reduce the social burden by OAB. Trial registration UMIN-CTR Clinical Trial, CTR-UMIN000038513 . Registered on November 7, 2019. |
| first_indexed | 2024-12-19T15:35:16Z |
| format | Article |
| id | doaj.art-c476d5ceca904bf59201704a511b3aed |
| institution | Directory Open Access Journal |
| issn | 1471-2490 |
| language | English |
| last_indexed | 2024-12-19T15:35:16Z |
| publishDate | 2020-08-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Urology |
| spelling | doaj.art-c476d5ceca904bf59201704a511b3aed2022-12-21T20:15:38ZengBMCBMC Urology1471-24902020-08-0120111010.1186/s12894-020-00697-0Cognitive behavioral therapy for overactive bladder in women: study protocol for a randomized controlled trialSatoshi Funada0Norio Watanabe1Takayuki Goto2Hiromitsu Negoro3Shusuke Akamatsu4Kentaro Ueno5Ryuji Uozumi6Kentaro Ichioka7Takehiko Segawa8Tatsuo Akechi9Toshiaki A. Furukawa10Osamu Ogawa11Department of Urology, Kyoto University Graduate School of MedicineDepartment of Health Promotion and Human Behavior, Kyoto University School of Public HealthDepartment of Urology, Kyoto University Graduate School of MedicineDepartment of Urology, University of Tsukuba HospitalDepartment of Urology, Kyoto University Graduate School of MedicineDepartment of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of MedicineDepartment of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of MedicineIchioka Urological ClinicDepartment of Urology, Kyoto City HospitalDepartment of Psychiatry, Nagoya City University Graduate School of Medical SciencesDepartment of Health Promotion and Human Behavior, Kyoto University School of Public HealthDepartment of Urology, Kyoto University Graduate School of MedicineAbstract Background Overactive bladder (OAB) symptoms affect daily life by decreasing health-related quality of life (HRQol). However, there remain no very effective treatment for OAB. Pharmacotherapy is one of the best treatments, but it is not always efficient and may incur adverse events. Although behavioral therapy is another effective treatment, there are very few structured treatment manuals on how to prescribe behavioral therapy to treat OAB for whom. Cognitive behavioral therapy (CBT) is a psychotherapy consisting of structured sessions to solve problems with the collaborative empiricism between therapists and patients. OAB symptoms are supposed to worsen with cognitive distortion, and CBT is expected to be effective in treating OAB by modifying such cognitive processes. In this trial, we will evaluate the efficacy of CBT for OAB. Methods A randomized, controlled, open-label, multicenter parallel-group superiority trial will be conducted. Participants with moderate to severe OAB symptoms with or without pharmacotherapy will be recruited and will be randomly allocated 1:1 to two different groups by minimization (age, baseline OAB severity, treatment status, types of intervention, and treating institutions). The intervention group will be prescribed an individual CBT program covering six techniques in 4 sessions (30 min each), with or without pharmacotherapy. The primary outcome is the change scores in an OAB-questionnaire (OAB-q) from baseline to the end of the trial (week 13). Secondary outcomes will include other patient reported outcome measures and the frequency volume chart. All analyses will be conducted on an intention-to-treat principle. Discussion This trial will determine the efficacy of CBT to treat OAB using a rigorous methodology. The effectiveness of CBT with a structured manual may not only lead to a new treatment option for patients suffering from OAB symptoms, but may also reduce the social burden by OAB. Trial registration UMIN-CTR Clinical Trial, CTR-UMIN000038513 . Registered on November 7, 2019.http://link.springer.com/article/10.1186/s12894-020-00697-0Cognitive behavioral therapyOveractive bladderRandomized control trial |
| spellingShingle | Satoshi Funada Norio Watanabe Takayuki Goto Hiromitsu Negoro Shusuke Akamatsu Kentaro Ueno Ryuji Uozumi Kentaro Ichioka Takehiko Segawa Tatsuo Akechi Toshiaki A. Furukawa Osamu Ogawa Cognitive behavioral therapy for overactive bladder in women: study protocol for a randomized controlled trial BMC Urology Cognitive behavioral therapy Overactive bladder Randomized control trial |
| title | Cognitive behavioral therapy for overactive bladder in women: study protocol for a randomized controlled trial |
| title_full | Cognitive behavioral therapy for overactive bladder in women: study protocol for a randomized controlled trial |
| title_fullStr | Cognitive behavioral therapy for overactive bladder in women: study protocol for a randomized controlled trial |
| title_full_unstemmed | Cognitive behavioral therapy for overactive bladder in women: study protocol for a randomized controlled trial |
| title_short | Cognitive behavioral therapy for overactive bladder in women: study protocol for a randomized controlled trial |
| title_sort | cognitive behavioral therapy for overactive bladder in women study protocol for a randomized controlled trial |
| topic | Cognitive behavioral therapy Overactive bladder Randomized control trial |
| url | http://link.springer.com/article/10.1186/s12894-020-00697-0 |
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