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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
Biruni University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    April 13, 2018
    Last Updated
    May 31, 2018
    Sponsor
    Biruni University
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    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

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    Training and Counseling Program for Overactive Bladder Treatment

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