Overactive BladderNCT03662893
Behavioural Therapy With Checklist for Overactive Bladder
A study testing behavioural therapy with written checklist form to complete, Antimuscarinic drugs used in overactive bladder and behavioural therapy with written guideline in people with Overactive Bladder, run by Ankara Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the efficiency of this newly-established checklist for overactive bladder (OAB) and whether determinate to adherence and persistence rate of combination of behavioural therapy and anticholinergic medications in patients with OAB. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- behavioural therapy with written checklist form to complete, Antimuscarinic drugs used in overactive bladder and behavioural therapy with written guideline
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2015to 15 Apr 2018
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with
- >8 micturitions,
- >1 nocturia,
- >6 urgency or
- >3 urgency urinary incontinence episodes per 24 h according to 3-day bladder diary.
Who cannot join
- active urinary tract infection,
- a maximum flow rate of 15 ml. per second or less at least 2 uroflow studies,
- residual volume of 100 cc or more,
- any medications for OAB, benign prostatic obstruction,
- polyuria (>3 l per 24 hour),
- endocrinological disease such as diabetes mellitus or diabetes insipidus which can cause polyuria,
Show all 10Show fewer
- neurological or psychological disease disease,
- prostate or bladder cancer, renal disease, hypertension, genitourinary or congenital abnormality,
- history of transobturator or transvaginal tape or pelvic organ prolapse surgery
- pelvic radiation or surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Training and Research Hospital
Ankara, 06340
About this study
Official title: Checklist to Increase Effectiveness of Behavioural Therapy for Overactive Bladder
The aim of this study is to investigate the efficiency of this newly-established checklist for overactive bladder (OAB) and whether determinate to adherence and persistence rate of combination of behavioural therapy and anticholinergic medications in patients with OAB.
Read the detailed description
Overactive bladder (OAB) can worsen quality of life but it is not life-threatening condition. Although OAB medications effectively decrease disturbing symptoms of OAB, there are a lot of adverse side effects such as dry mouth, cognitive changes, constipation, urinary retention, blurred vision and dyspepsia. Therefore, guidelines have firstly recommended behavioural therapy which are noninvasive and not linked with adverse side effects. These behavioural recommendations include an advice on fluid balance, bladder retraining, urgency suppression or normal voiding techniques, pelvic floor muscle training, caffeine reduction, dietary changes, weight loss and other life style changes to improve lower urinary tract symptoms of OAB.
Educational leaflets, verbal or audio-visual instructions and trainings for behavioural therapy have been recommended for patients with OAB, however, to date these beneficial instructions have not been documented as a written checklist. Therefore, they were collected and developed as a written checklist to instruct the patients. The aim of this study was to investigate the efficiency of this newly-established checklist for OAB and whether determinate to adherence and persistence rate of combination of behavioural therapy and anticholinergic medications in patients with OAB.
- Conditions
- Overactive Bladder
- Being tested
- behavioural therapy with written checklist form to complete, Antimuscarinic drugs used in overactive bladder, behavioural therapy with written guideline
- Keywords
- overactive bladder, behavioural therapy, adherence, drug persistence
- 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.
behavioural therapy with written checklist form to completeBehavioural
Behavioural therapy for overactive bladder such as advice on fluid balance, bladder retraining, urgency suppression or normal voiding techniques, pelvic floor muscle training, caffeine reduction, dietary changes, weight loss and other life style changes
Antimuscarinic drugs used in overactive bladderDrug
Antimuscarinic drugs (Tolterodine, solifenacin, propiverine, darifenacin,fesoterodine)
behavioural therapy with written guidelineBehavioural
behavioural therapy with written guideline,which are the same as those in the checklist
| Study group | Role | What they receive |
|---|---|---|
| Behavioural therapy with written guideline | Sham comparator | Patients were instructed to apply only written guideline forms of behavioural therapy which were the same as those in the checklist over six-month period. Receives: Behavioral: behavioural therapy with written guideline |
| Behavioural therapy with checklist | Active comparator | Patients were instructed to apply behavioural therapy with a written checklist for patients to fully complete over six-month period. Receives: Behavioral: behavioural therapy with written checklist form to complete |
| antimuscarinic drug plus verbal behavioural therapy | Active comparator | Patients received medical treatment (once or twice per day) plus behavioural therapy without checklist over six-month period. Receives: Drug: Antimuscarinic drugs used in overactive bladder; Behavioral: behavioural therapy with written guideline |
| antimuscarinics plus checklist | Active comparator | Patients received medical treatment (once or twice per day) with a written checklist to fully complete over six-month period. Receives: Behavioral: behavioural therapy with written checklist form to complete; Drug: Antimuscarinic drugs used in overactive bladder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary frequency
>8 micturitions per day
Measured: 6 months
Urgency
>6 urgency episodes per day
Measured: 6 months
Secondary outcomes (3)
Treatment Benefit Scale
Treatment Benefit Scale is consisted of four category including a score of 1 (greatly improved) or 2 (improved) is considered ''yes,'' and a score of 3 (not changed)or 4 (worsened) was considered ''no''
Measured: 6 months
Urgency urinary incontinence
>3 urgency urinary incontinence episodes per day
Measured: 6 months
Nocturia
>1 micturition at night
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start1 Jan 2015
- Primary completion31 Dec 2017
- Study completion15 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group I were instructed to apply only written guideline forms of behavioural therapy which were the same as those in the checklist, Group II were instructed to apply behavioural therapy with a written checklist for patients to fully complete and Group III received medical treatment plus behavioural therapy without checklist. Group IV received medical treatment with a written checklist to fully complete
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Turkey
- Responsible party
- Principal investigator, Muhammet Fatih Kilinc, Ankara Training and Research Hospital
- Investigators
- Koray Agras, Prof, Study chair, Ankara Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03662893
- Sponsor's protocol ID
- 5002
- Status last verified
- Sep 2018
- First submitted
- 6 Sep 2018
- Last updated
- 10 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dumoulin C, Hunter KF, Moore K, Bradley CS, Burgio KL, Hagen S, Imamura M, Thakar R, Williams K, Chambers T. Conservative management for female urinary incontinence and pelvic organ prolapse review 2013: Summary of the 5th International Consultation on Incontinence. Neurourol Urodyn. 2016 Jan;35(1):15-20. doi: 10.1002/nau.22677. Epub 2014 Nov 15.
PubMed 25400065Gezginci E, Iyigun E, Yilmaz S. Comparison of 3 Different Teaching Methods for a Behavioral Therapy Program for Female Overactive Bladder: A Randomized Controlled Trial. J Wound Ostomy Continence Nurs. 2018 Jan/Feb;45(1):68-74. doi: 10.1097/WON.0000000000000398.
PubMed 29300292
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Checklist to Increase Effectiveness of Behavioural Therapy for Overactive Bladder
- ClinicalTrials.gov ID
- NCT03662893
- Acronym / sponsor ID
- 5002
- Conditions
- Overactive Bladder
- Keywords
- overactive bladder, behavioural therapy, adherence, drug persistence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ankara Training and Research HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health, Turkey
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 15 Apr 2018 (actual)
- First posted
- 10 Sep 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 aim of this study is to investigate the efficiency of this newly-established checklist for overactive bladder (OAB) and whether determinate to adherence and persistence rate of combination of behavioural therapy and anticholinergic medications in patients with OAB.
Detailed description
Overactive bladder (OAB) can worsen quality of life but it is not life-threatening condition. Although OAB medications effectively decrease disturbing symptoms of OAB, there are a lot of adverse side effects such as dry mouth, cognitive changes, constipation, urinary retention, blurred vision and dyspepsia. Therefore, guidelines have firstly recommended behavioural therapy which are noninvasive and not linked with adverse side effects. These behavioural recommendations include an advice on fluid balance, bladder retraining, urgency suppression or normal voiding techniques, pelvic floor muscle training, caffeine reduction, dietary changes, weight loss and other life style changes to improve lower urinary tract symptoms of OAB.
Educational leaflets, verbal or audio-visual instructions and trainings for behavioural therapy have been recommended for patients with OAB, however, to date these beneficial instructions have not been documented as a written checklist. Therefore, they were collected and developed as a written checklist to instruct the patients. The aim of this study was to investigate the efficiency of this newly-established checklist for OAB and whether determinate to adherence and persistence rate of combination of behavioural therapy and anticholinergic medications in patients with OAB.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Group I were instructed to apply only written guideline forms of behavioural therapy which were the same as those in the checklist, Group II were instructed to apply behavioural therapy with a written checklist for patients to fully complete and Group III received medical treatment plus behavioural therapy without checklist. Group IV received medical treatment with a written checklist to fully complete
| Arm | Type | Receives |
|---|---|---|
| Behavioural therapy with written guideline | Sham comparator | Behavioral: behavioural therapy with written guidelinePatients were instructed to apply only written guideline forms of behavioural therapy which were the same as those in the checklist over six-month period. |
| Behavioural therapy with checklist | Active comparator | Behavioral: behavioural therapy with written checklist form to completePatients were instructed to apply behavioural therapy with a written checklist for patients to fully complete over six-month period. |
| antimuscarinic drug plus verbal behavioural therapy | Active comparator | Drug: Antimuscarinic drugs used in overactive bladder, Behavioral: behavioural therapy with written guidelinePatients received medical treatment (once or twice per day) plus behavioural therapy without checklist over six-month period. |
| antimuscarinics plus checklist | Active comparator | Behavioral: behavioural therapy with written checklist form to complete, Drug: Antimuscarinic drugs used in overactive bladderPatients received medical treatment (once or twice per day) with a written checklist to fully complete over six-month period. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with
- >8 micturitions,
- >1 nocturia,
- >6 urgency or
- >3 urgency urinary incontinence episodes per 24 h according to 3-day bladder diary.
Key exclusion criteria (10 listed)
- active urinary tract infection,
- a maximum flow rate of 15 ml. per second or less at least 2 uroflow studies,
- residual volume of 100 cc or more,
- any medications for OAB, benign prostatic obstruction,
- polyuria (>3 l per 24 hour),
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 |
|---|---|---|
| behavioural therapy with written checklist form to completeBehavioural therapy for overactive bladder such as advice on fluid balance, bladder retraining, urgency suppression or normal voiding techniques, pelvic floor muscle training, caffeine reduction, dietary changes, weight loss and other life style changes | Behavioural | Behavioural therapy with checklist, antimuscarinics plus checklist |
| Antimuscarinic drugs used in overactive bladderAntimuscarinic drugs (Tolterodine, solifenacin, propiverine, darifenacin,fesoterodine) | Drug | antimuscarinic drug plus verbal behavioural therapy, antimuscarinics plus checklist |
| behavioural therapy with written guidelinebehavioural therapy with written guideline,which are the same as those in the checklist | Behavioural | Behavioural therapy with written guideline, antimuscarinic drug plus verbal behavioural therapy |
Primary outcome
Urinary frequency
Time frame: 6 months
>8 micturitions per day
Urgency
Time frame: 6 months
>6 urgency episodes per day
3 secondary outcomes
Treatment Benefit Scale
Time frame: 6 months
Urgency urinary incontinence
Time frame: 6 months
Nocturia
Time frame: 6 months
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 10 Sep 2018.
- Results publication: PubMed 25400065Dumoulin C, Hunter KF, Moore K, Bradley CS, Burgio KL, Hagen S, Imamura M, Thakar R, Williams K, Chambers T. Conservative management for female urinary incontinence and pelvic organ prolapse review 2013: Summary of the 5th International Consultation on Incontinence. Neurourol Urodyn. 2016 Jan;35(1):15-20. doi: 10.1002/nau.22677. Epub 2014 Nov 15.
- Results publication: PubMed 29300292Gezginci E, Iyigun E, Yilmaz S. Comparison of 3 Different Teaching Methods for a Behavioral Therapy Program for Female Overactive Bladder: A Randomized Controlled Trial. J Wound Ostomy Continence Nurs. 2018 Jan/Feb;45(1):68-74. doi: 10.1097/WON.0000000000000398.
- Individual participant dataSharing planned: Undecided
Related trials for Overactive Bladder
Active, not recruiting
APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Overactive Bladder (OAB), Urinary Urgency
Not yet recruitingPhase 4
Behavioral and/or Mirabegron to Treat Urinary Symptoms in Parkinson Disease
Overactive Bladder, Parkinson Disease
Recruiting
Ambulatory Long Length URodynamics Evaluation
Urology, Urinary Bladder, Overactive
RecruitingObservational study
Tensi+ European Post-Market Clinical Follow-Up
Overactive Bladder
Not yet recruiting
Transcranial Direct Current Stimulation for Neurogenic Overactive Bladder Symptoms Among People With Stroke
Stroke, Neurogenic Overactive Bladder
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.
Koray Agras, Prof study chair
Ankara Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing behavioural therapy with written checklist form to complete, Antimuscarinic drugs used in overactive bladder and behavioural therapy with written guideline in people with Overactive Bladder, run by Ankara Training and Research Hospital at 1 site in Turkey (Türkiye).
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 10 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 10 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Urinary frequency (time frame: 6 months). The study lists 2 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 NCT03662893, which also lists 2 linked publications.
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 10 Sep 2018; AzTrials last refreshed its copy on 2 Nov 2026.