Training and Counseling Program for Overactive Bladder Treatment
Primary Purpose
Overactive Bladder
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
a counseling and training program that consisted of a 45-minute presentation based on Pender's Health Promotion Model. Within the scope of the counseling and training program
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder focused on measuring Overactive bladder, healthy lifestyle behaviors, quality of life
Eligibility Criteria
Inclusion Criteria:
- Aged 18 years or older
- Being literate
- Diagnosed with OAB
- Beginning to receive pharmacological treatment for OAB
- Volunteering to participate in the study
Exclusion Criteria:
- Presence of a perceptual or psychiatric disorder which prevents communicating
- Presence of a neurological disorder
- Presence of neurological neuropathy caused by Diabetes Mellitus
- Second or higher stage pelvic organ prolapse
- Having an anti-incontinence surgery
- Being pregnant
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention group and control group
Arm Description
This research is planned with semi experimental design
Outcomes
Primary Outcome Measures
Change from baseline Overactive Bladder Questionnaire (OAB-V8) scores at 12 weeks
12 weeks a between implementation of pre-post test
Change from baseline King's Health Questionnaire (KHQ) scores at 12 weeks
12 weeks a between implementation of pre-post test.
Change from baseline Brief Symptom Inventory (BSI) scores at 12 weeks
12 weeks a between implementation of pre-post test
Change from baseline Healthy Life Style Behavior Scale II (HLSB II) scores at 12 weeks
12 weeks a between implementation of pre-post test
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03544554
Brief Title
Training and Counseling Program for Overactive Bladder Treatment
Official Title
The Effect of a Counseling and Training Program on the Treatment of Women With Overactive Bladder
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2015 (Actual)
Primary Completion Date
October 30, 2016 (Actual)
Study Completion Date
March 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Biruni University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study concluded that HLSB training reduced OAB symptoms among women, improved the quality of their lives, changed their HLSBs, and positively affected their mental states. Thus, a holistic approach to the treatment of women with OAB increased the success of the treatment.
Detailed Description
The population of this study included all women who received treatment in the Urogynecology Outpatient Clinic of the Gynecology and Obstetrics Department in İstanbul Faculty of Medicine at İstanbul University between January 2015 and October 2016. Permission was obtained for the study from the Ethics Committee of İstanbul University Cerrahpaşa Faculty of Medicine and İstanbul University İstanbul Faculty of Medicine. The study sample included 100 women diagnosed with OAB syndrome. Of them, 50 were selected for the intervention group and 50 were selected for the control group.
Detailed information was given to the women beginning pharmacological treatment who met the inclusion criteria, and their consent was obtained using an Informed Voluntary Consent Form. During the pharmacological treatment, anticholinergic drugs, which contained active ingredients such as tolterodine 4 mg/day, trospium cl 60 mg/day, fesoterodine 4-8 mg/day, and solifenacin 5 or 10 mg/day were prescribed. The women in each group were instructed to take the prescribed anticholinergic drugs regularly, informed about the side effects of these drugs, and advised on the situations when they should seek immediate treatment before their next scheduled appointment. The women with OAB were divided into groups using random allocation (by drawing lots). To set an equal distribution of patients into the intervention and control groups, the group of the first patient was determined by lot, and the next patient was allocated to the other group.
The control group was not provided with training. In addition to the pharmacological treatment, the intervention group was provided with a counseling and training program that consisted of a 45-minute presentation based on Pender's Health Promotion Model. Within the scope of the counseling and training program, the patients were given information about the female reproductive system, anatomy and physiology of the urinary system, OAB definition, OAB symptoms, and HLSBs (adequate fluid intake, diet, prevention methods for urinary tract infections, weight control, regular bowel movements, smoking cessation, treatment of chronic diseases, and regular medication). The patients were informed about the importance of concentration, learning about pelvic floor muscle contraction and exercises and performing them regularly, as well as designing bladder training programs and sticking to them to manage urgency and urinary incontinence. They were also given "A Manual for Training on Healthy Lifestyle Behaviors among Women with Overactive Bladder". Figure 1 shows the HLSB development based on Pender's Health Promotion Model in OAB treatment.
The intervention group was requested to follow a weekly-scheduled bladder training program, keep records on the Urinary Diary form for six weeks, and bring this form at the end of each week. The researcher called each patient 8-10 times: every week during the first six weeks and once a month afterwards to encourage implementation of the practices for three months starting from the first interview. During the phone calls, the patients were asked about their drug use, average daily fluid intake, and any concerns as well as state of performing pelvic floor muscle contraction and exercises, sticking to the scheduled bladder training hours, and weight loss. The data obtained through these calls were recorded on the Practice Registration Form. The control group, on the other hand, was called once a month and instructed to continue taking their drugs, which was also recorded on the form.
In the first interview and in the third month, the women in the intervention and control groups were administered the Introductory Information Form, Urinary Diary (4-day), 24-hour Standard Pad Test, Overactive Bladder Questionnaire (OAB V8), King's Health Questionnaire (KHQ), Healthy Lifestyle Behavior Scale II (HLSB II), and Brief Symptom Inventory (BSI). In addition, an Inspection Form was administered in the third month.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
Overactive bladder, healthy lifestyle behaviors, quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The study sample included 100women (50 for the intervention and 50 for the control group) diagnosed with OAB syndrome. The control group was not provided with training. In addition to the pharmacological treatment, the intervention group was provided with a counseling and training program that consisted of a 45minute presentation based on Pender's Health Promotion Model. They were also given "A Manual for Training on HealthyLifestyleBehaviors among women with OAB". The intervention group was requested to follow a weekly-scheduled bladder training program, keep records on the Urinary Diary form for six weeks. In the first interview and in the third month, the women in the intervention and control groups were administered the Introductory Information Form, Urinary Diary (4day), 24hour Standard Pad Test, OAB-V8, King'sHealthQuestionnaire, Healthy LifestyleBehaviorScaleII, and BriefSymptomInventory. In addition, an Inspection Form was administered in the third month.
Masking
None (Open Label)
Masking Description
Investigator
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group and control group
Arm Type
Experimental
Arm Description
This research is planned with semi experimental design
Intervention Type
Behavioral
Intervention Name(s)
a counseling and training program that consisted of a 45-minute presentation based on Pender's Health Promotion Model. Within the scope of the counseling and training program
Other Intervention Name(s)
The control group was not provided with training
Intervention Description
The intervention group was provided with a counseling and training program that consisted of a 45-minute presentation based on Pender's Health Promotion Model.
Primary Outcome Measure Information:
Title
Change from baseline Overactive Bladder Questionnaire (OAB-V8) scores at 12 weeks
Description
12 weeks a between implementation of pre-post test
Time Frame
Intervention and control group cases were assessed at baseline and week 12. The OAB-v8 is a patient-reported outcome questionnaire which have six point rating system (0-40 scores).
Title
Change from baseline King's Health Questionnaire (KHQ) scores at 12 weeks
Description
12 weeks a between implementation of pre-post test.
Time Frame
Intervention and control group cases were assessed at baseline and week 12. KHQ is a patient self-administered self-report . The responses in KHQ have four point rating system. The eight subscales scored between 0 (best) and 100 (worst).
Title
Change from baseline Brief Symptom Inventory (BSI) scores at 12 weeks
Description
12 weeks a between implementation of pre-post test
Time Frame
Intervention and control group cases were assessed at baseline and week 12. The Brief Symptom Inventory (BSI) is a brief form of the Symptom Checklist, The responses in BSI have five point rating system(0-212 scores).
Title
Change from baseline Healthy Life Style Behavior Scale II (HLSB II) scores at 12 weeks
Description
12 weeks a between implementation of pre-post test
Time Frame
Intervention and control group cases were assessed at baseline and week 12. HLSB II is used to measure the degree of engagement in a health-promoting lifestyle along 6 dimensions. The responses in HLPS II have four point rating system(52-208 scores).
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 18 years or older
Being literate
Diagnosed with OAB
Beginning to receive pharmacological treatment for OAB
Volunteering to participate in the study
Exclusion Criteria:
Presence of a perceptual or psychiatric disorder which prevents communicating
Presence of a neurological disorder
Presence of neurological neuropathy caused by Diabetes Mellitus
Second or higher stage pelvic organ prolapse
Having an anti-incontinence surgery
Being pregnant
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33870822
Citation
Cayir G, Kizilkaya Beji N. The effect of a counseling and training program on the treatment of women with overactive bladder. Psychol Health Med. 2022 Sep;27(8):1726-1738. doi: 10.1080/13548506.2021.1916962. Epub 2021 Apr 19.
Results Reference
derived
Learn more about this trial
Training and Counseling Program for Overactive Bladder Treatment
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