Overactive BladderNCT03544554
Training and Counseling Program for Overactive Bladder Treatment
A study testing 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 in people with Overactive Bladder, run by Biruni University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- 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
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 1 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- Being literate
- Diagnosed with OAB
- Beginning to receive pharmacological treatment for OAB
- Volunteering to participate in the study
Who cannot join
- 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
About this study
Official title: The Effect of a Counseling and Training Program on the Treatment of Women With Overactive Bladder
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.
Read the 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.
- Conditions
- Overactive Bladder
- Being tested
- 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
- Keywords
- Overactive bladder, healthy lifestyle behaviors, quality of life
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 programBehavioural
Also called The control group was not provided with training
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group and control group | Experimental | This research is planned with semi experimental design Receives: Behavioral: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Overactive Bladder Questionnaire (OAB-V8) scores at 12 weeks
12 weeks a between implementation of pre-post test
Measured: 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).
Change from baseline King's Health Questionnaire (KHQ) scores at 12 weeks
12 weeks a between implementation of pre-post test.
Measured: 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).
Change from baseline Brief Symptom Inventory (BSI) scores at 12 weeks
12 weeks a between implementation of pre-post test
Measured: 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).
Change from baseline Healthy Life Style Behavior Scale II (HLSB II) scores at 12 weeks
12 weeks a between implementation of pre-post test
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start1 Jan 2015
- Primary completion30 Oct 2016
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulsen Cayir, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03544554
- Sponsor's protocol ID
- 0925-0586
- Status last verified
- May 2018
- First submitted
- 13 Apr 2018
- Last updated
- 4 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33870822
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Counseling and Training Program on the Treatment of Women With Overactive Bladder
- ClinicalTrials.gov ID
- NCT03544554
- Acronym / sponsor ID
- 0925-0586
- Conditions
- Overactive Bladder
- Keywords
- Overactive bladder, healthy lifestyle behaviors, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 30 Oct 2016 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 4 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group and control group | Experimental | Behavioral: 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 programThis research is planned with semi experimental design |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 years or older
- Being literate
- Diagnosed with OAB
- Beginning to receive pharmacological treatment for OAB
- Volunteering to participate in the study
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 programAlso: The control group was not provided with trainingThe intervention group was provided with a counseling and training program that consisted of a 45-minute presentation based on Pender's Health Promotion Model. | Behavioural | Intervention group and control group |
Primary outcome
Change from baseline Overactive Bladder Questionnaire (OAB-V8) scores at 12 weeks
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).
12 weeks a between implementation of pre-post test
Change from baseline King's Health Questionnaire (KHQ) scores at 12 weeks
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).
12 weeks a between implementation of pre-post test.
Change from baseline Brief Symptom Inventory (BSI) scores at 12 weeks
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).
12 weeks a between implementation of pre-post test
Change from baseline Healthy Life Style Behavior Scale II (HLSB II) scores at 12 weeks
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).
12 weeks a between implementation of pre-post test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2018.
- Derived from this study: PubMed 33870822Cayir 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing 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 in people with Overactive Bladder, run by Biruni University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Overactive Bladder Questionnaire (OAB-V8) scores at 12 weeks (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).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03544554, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2018.