Overactive BladderNCT04068025
Information, Motivation, Behavioral Skills Model on Urinary Incontinence and Quality of Life in Men
A study testing Assigned Interventions in people with Overactive Bladder and Quality of Life, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
Multiple studies have shown that education based on the IMB model is effective at bringing about health-related behavior change. The IMB model was found to be effective in developing healthy behaviors aimed at maintaining heart health, providing behavior to prevent smoking addiction, diabetes management, correct… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Overactive Bladder, Quality of Life
- What is being tested?
- Assigned Interventions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2018to 1 Feb 2019
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patient
- Over 18 years old
- Overactive Bladder
- Urge urinary incontinence
- Voluntarily agreed to participate in the research
Who cannot join
- Benign prostatic hyperplasia
- Prostate cancer
- Congenital urinary anomalies
- Neurological or spinal cord injury,
- Diabetes mellitus
- Hypertension
- A mental disability
- Receive medical treatment for incontinence
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Yildirim Beyazit University
Ankara, 06010
About this study
Official title: The Effect of Information, Motivation, Behavioral Skills Model on Urinary Incontinence and Quality of Life in Men With Overactive Bladder: A Randomized Controlled Trial
Multiple studies have shown that education based on the IMB model is effective at bringing about health-related behavior change. The IMB model was found to be effective in developing healthy behaviors aimed at maintaining heart health, providing behavior to prevent smoking addiction, diabetes management, correct nutrition in iron deficiency anemia, and using condoms to prevent HIV. There are no studies in the literature regarding the adaptation of the IMB model to behavioral therapy in patients with OAB or urinary incontinence. To address this, there we aimed to investigate the effect of the IMB model on urinary incontinence and quality of life in men with OAB.
Read the detailed description
This study aimed to investigate the effect of the Information, Motivation, Behavioral Skills Model (IMB) on urinary incontinence and quality of life in men with overactive bladder.
This is a single-center, parallel-group, open-label, randomized controlled clinical trial.
This study was conducted between February 2018 and February 2019, with a total of 60 male patients admitted to the urology clinic of a training and research hospital. Patients over the age of 18, male, and with overactive bladder were included in the study.
Participants were randomized into two equal groups: the intervention group (n=30) and control group (n=30). Structured bladder training with the IMB model was applied to the intervention group. This model was not applied to the control group. The primary outcome was the mean score change over the severity of incontinence measured by the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF). The other outcomes were measured by the Urogenital Distress Inventory (UDI-6), Incontinence Impact Questionnaire-7 (IIQ-7), and Urinary Incontinence Information Rating scores. All outcome measures were evaluated before and 6 months after the training. Bladder training with IMB model was found to be effective at ameliorating urinary incontinence and improving quality of life in patients with an overactive bladder.
- Conditions
- Overactive Bladder, Quality of Life
- Being tested
- Assigned Interventions
- Keywords
- incontinence, male, overactive bladder, 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.
Assigned InterventionsOther
Information: In the information step of the bladder training program given through the IMB model, training was given about pelvic floor muscle exercises, bladder program formation, and lifestyle change. The training was conducted face-to-face by the nurse researcher for about 15-20 min, and the training booklet was given to the patients.
Motivation: The patients in the intervention group were interviewed by the nurse researcher by phone or face-to-face in the 1st, 3rd, and 6th months after the training. The patients were motivated by providing information and counseling on the necessary issues. This process was carried out using motivational interviewing principles. Patients were given positive behavioral feedback and encouraged to control urinary incontinence.
Behavioral Skills: Behavioral skills related to urinary incontinence were evaluated 6 months after the training,together with their effects on urinary incontinence symptom score and quality of life.
| Study group | Role | What they receive |
|---|---|---|
| No Intervention: Control group | No intervention | Patients in the control group were given usual care by a health professional who was not involved in the study and who worked in the Department of Urology. After the end of the study, the patients in the control group were also given structured bladder training similar to the patients in the intervention group. |
| the IMB model | Active comparator | Structured bladder training was applied to the patients in the intervention group via the IMB model. Receives: Other: Assigned Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
A Change on Incontinence Severity Measured by The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
The primary outcome measure was the mean score change from baseline incontinence severity at 6 months measured by the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF). The ICIQ-SF consists of a total of six items, including the birth date, gender and urinary incontinence characteristics. The score range of this scale is 0-21. High scores indicate increased urinary incontinence severity.
Measured: 20 minutes before and 6 months after the training
Secondary outcomes (2)
The Urogenital Distress Inventory (UDI-6)
UDI-6 is short forms of the scales developed by Uebersax et al. with six and seven questions, respectively. The Turkish validity study of these forms was made by Cam et al., who reported a Cronbach's alpha coefficient for UDI-6 as 0.74. In this study, the Cronbach's alpha coefficient for UDI-6 was 0.786 before training and 0.746 after the training implementations. Each item was scored between zero and 3, and the total score was calculated in the range of zero to 100. Higher scores obtained from these scales indicate that bladder function is worse.
Measured: 20 minutes before and 6 months after the training
The Incontinence Impact Questionnaire-7 (IIQ-7)
IIQ-7 is short forms of the scales developed by Uebersax et al. with six and seven questions, respectively. The Turkish validity study of these forms was made by Cam et al., who reported a Cronbach's alpha coefficient for IIQ-7 as 0.87. In this study, the Cronbach's alpha coefficient for IIQ-7 was 0.933 before training and 0.902 after the training implementations. Each item was scored between zero and 3, and the total score was calculated in the range of zero to 100. Higher scores obtained from these scales indicate that bladder function is worse.
Measured: 20 minutes before and 6 months after the training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Feb 2018
- Primary completion1 Aug 2018
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hilal Tüzer, RN, PhD, Study director, Ankara Yildirim Beyazıt UniversityElif Gezginci, RN, PhD, Principal investigator, Saglik Bilimleri UniversitesiTuba Yılmazer, RN, PhD, Principal investigator, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04068025
- Sponsor's protocol ID
- 16.01.2018 18/10
- Status last verified
- Aug 2019
- First submitted
- 22 Jun 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-committee of the International Continence Society. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78. doi: 10.1002/nau.10052. No abstract available.
PubMed 11857671Stewart WF, Van Rooyen JB, Cundiff GW, Abrams P, Herzog AR, Corey R, Hunt TL, Wein AJ. Prevalence and burden of overactive bladder in the United States. World J Urol. 2003 May;20(6):327-36. doi: 10.1007/s00345-002-0301-4. Epub 2002 Nov 15.
PubMed 12811491Irwin DE, Milsom I, Hunskaar S, Reilly K, Kopp Z, Herschorn S, Coyne K, Kelleher C, Hampel C, Artibani W, Abrams P. Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol. 2006 Dec;50(6):1306-14; discussion 1314-5. doi: 10.1016/j.eururo.2006.09.019. Epub 2006 Oct 2.
PubMed 17049716Irwin DE, Abrams P, Milsom I, Kopp Z, Reilly K; EPIC Study Group. Understanding the elements of overactive bladder: questions raised by the EPIC study. BJU Int. 2008 Jun;101(11):1381-7. doi: 10.1111/j.1464-410X.2008.07573.x. Epub 2008 Mar 10.
PubMed 18336602Eapen RS, Radomski SB. Gender differences in overactive bladder. Can J Urol. 2016 Feb;23(Suppl 1):2-9.
PubMed 26924589Jeon E, Park HA. Development of the IMB Model and an Evidence-Based Diabetes Self-management Mobile Application. Healthc Inform Res. 2018 Apr;24(2):125-138. doi: 10.4258/hir.2018.24.2.125. Epub 2018 Apr 30.
PubMed 29770246Zarani F, Besharat MA, Sarami G, Sadeghian S. An information-motivation-behavioral skills (IMB) model-based intervention for CABG patients. Int J Behav Med. 2012 Dec;19(4):543-9. doi: 10.1007/s12529-011-9193-2.
PubMed 21948041Kiene SM, Fisher WA, Shuper PA, Cornman DH, Christie S, Macdonald S, Pillay S, Mahlase G, Fisher JD. Understanding HIV transmission risk behavior among HIV-infected South Africans receiving antiretroviral therapy: an information--motivation--behavioral skills model analysis. Health Psychol. 2013 Aug;32(8):860-8. doi: 10.1037/a0030554. Epub 2013 Mar 11.
PubMed 23477576Konkle-Parker DJ, Amico KR, McKinney VE. Effects of an intervention addressing information, motivation, and behavioral skills on HIV care adherence in a southern clinic cohort. AIDS Care. 2014;26(6):674-83. doi: 10.1080/09540121.2013.845283. Epub 2013 Oct 14.
PubMed 24116922Uebersax JS, Wyman JF, Shumaker SA, McClish DK, Fantl JA. Short forms to assess life quality and symptom distress for urinary incontinence in women: the Incontinence Impact Questionnaire and the Urogenital Distress Inventory. Continence Program for Women Research Group. Neurourol Urodyn. 1995;14(2):131-9. doi: 10.1002/nau.1930140206.
PubMed 7780440Cam C, Sakalli M, Ay P, Cam M, Karateke A. Validation of the short forms of the incontinence impact questionnaire (IIQ-7) and the urogenital distress inventory (UDI-6) in a Turkish population. Neurourol Urodyn. 2007;26(1):129-33. doi: 10.1002/nau.20292.
PubMed 17083117Aydin Sayilan A, Ozbas A. The Effect of Pelvic Floor Muscle Training On Incontinence Problems After Radical Prostatectomy. Am J Mens Health. 2018 Jul;12(4):1007-1015. doi: 10.1177/1557988318757242. Epub 2018 Mar 14.
PubMed 29540090Shell DF, Newman IM, Perry CM, Folsom AR. Changing intentions to use smokeless tobacco: an application of the IMB model. Am J Health Behav. 2011 Sep;35(5):568-80. doi: 10.5993/ajhb.35.5.6.
PubMed 22040618Walsh JL, Senn TE, Scott-Sheldon LA, Vanable PA, Carey MP. Predicting condom use using the Information-Motivation-Behavioral Skills (IMB) model: a multivariate latent growth curve analysis. Ann Behav Med. 2011 Oct;42(2):235-44. doi: 10.1007/s12160-011-9284-y.
PubMed 21638196Osborn CY, Egede LE. Validation of an Information-Motivation-Behavioral Skills model of diabetes self-care (IMB-DSC). Patient Educ Couns. 2010 Apr;79(1):49-54. doi: 10.1016/j.pec.2009.07.016. Epub 2009 Aug 21.
PubMed 19699601
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Information, Motivation, Behavioral Skills Model on Urinary Incontinence and Quality of Life in Men With Overactive Bladder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04068025
- Acronym / sponsor ID
- 16.01.2018 18/10
- Conditions
- Overactive Bladder, Quality of Life
- Keywords
- incontinence, male, overactive bladder, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 28 Aug 2019 (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.
Multiple studies have shown that education based on the IMB model is effective at bringing about health-related behavior change. The IMB model was found to be effective in developing healthy behaviors aimed at maintaining heart health, providing behavior to prevent smoking addiction, diabetes management, correct nutrition in iron deficiency anemia, and using condoms to prevent HIV. There are no studies in the literature regarding the adaptation of the IMB model to behavioral therapy in patients with OAB or urinary incontinence. To address this, there we aimed to investigate the effect of the IMB model on urinary incontinence and quality of life in men with OAB.
Detailed description
This study aimed to investigate the effect of the Information, Motivation, Behavioral Skills Model (IMB) on urinary incontinence and quality of life in men with overactive bladder.
This is a single-center, parallel-group, open-label, randomized controlled clinical trial.
This study was conducted between February 2018 and February 2019, with a total of 60 male patients admitted to the urology clinic of a training and research hospital. Patients over the age of 18, male, and with overactive bladder were included in the study.
Participants were randomized into two equal groups: the intervention group (n=30) and control group (n=30). Structured bladder training with the IMB model was applied to the intervention group. This model was not applied to the control group. The primary outcome was the mean score change over the severity of incontinence measured by the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF). The other outcomes were measured by the Urogenital Distress Inventory (UDI-6), Incontinence Impact Questionnaire-7 (IIQ-7), and Urinary Incontinence Information Rating scores. All outcome measures were evaluated before and 6 months after the training. Bladder training with IMB model was found to be effective at ameliorating urinary incontinence and improving quality of life in patients with an overactive bladder.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Intervention: Control group | No intervention | –Patients in the control group were given usual care by a health professional who was not involved in the study and who worked in the Department of Urology. After the end of the study, the patients in the control group were also given structured bladder training similar to the patients in the intervention group. |
| the IMB model | Active comparator | Other: Assigned InterventionsStructured bladder training was applied to the patients in the intervention group via the IMB model. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male patient
- Over 18 years old
- Overactive Bladder
- Urge urinary incontinence
- Voluntarily agreed to participate in the research
Key exclusion criteria (8 listed)
- Benign prostatic hyperplasia
- Prostate cancer
- Congenital urinary anomalies
- Neurological or spinal cord injury,
- Diabetes mellitus
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 |
|---|---|---|
| Assigned InterventionsInformation: In the information step of the bladder training program given through the IMB model, training was given about pelvic floor muscle exercises, bladder program formation, and lifestyle change. The training was conducted face-to-face by the nurse researcher for about 15-20 min, and the training booklet was given to the patients. Motivation: The patients in the intervention group were interviewed by the nurse researcher by phone or face-to-face in the 1st, 3rd, and 6th months after the training. The patients were motivated by providing information and counseling on the necessary issues. This process was carried out using motivational interviewing principles. Patients were given positive behavioral feedback and encouraged to control urinary incontinence. Behavioral Skills: Behavioral skills related to urinary incontinence were evaluated 6 months after the training,together with their effects on urinary incontinence symptom score and quality of life. | Other | the IMB model |
Primary outcome
A Change on Incontinence Severity Measured by The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
Time frame: 20 minutes before and 6 months after the training
The primary outcome measure was the mean score change from baseline incontinence severity at 6 months measured by the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF). The ICIQ-SF consists of a total of six items, including the birth date, gender and urinary incontinence characteristics. The score range of this scale is 0-21. High scores indicate increased urinary incontinence severity.
2 secondary outcomes
The Urogenital Distress Inventory (UDI-6)
Time frame: 20 minutes before and 6 months after the training
The Incontinence Impact Questionnaire-7 (IIQ-7)
Time frame: 20 minutes before and 6 months after the training
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 28 Aug 2019.
- Background: PubMed 11857671Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-committee of the International Continence Society. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78. doi: 10.1002/nau.10052. No abstract available.
- Background: PubMed 12811491Stewart WF, Van Rooyen JB, Cundiff GW, Abrams P, Herzog AR, Corey R, Hunt TL, Wein AJ. Prevalence and burden of overactive bladder in the United States. World J Urol. 2003 May;20(6):327-36. doi: 10.1007/s00345-002-0301-4. Epub 2002 Nov 15.
- Background: PubMed 17049716Irwin DE, Milsom I, Hunskaar S, Reilly K, Kopp Z, Herschorn S, Coyne K, Kelleher C, Hampel C, Artibani W, Abrams P. Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol. 2006 Dec;50(6):1306-14; discussion 1314-5. doi: 10.1016/j.eururo.2006.09.019. Epub 2006 Oct 2.
- Background: PubMed 18336602Irwin DE, Abrams P, Milsom I, Kopp Z, Reilly K; EPIC Study Group. Understanding the elements of overactive bladder: questions raised by the EPIC study. BJU Int. 2008 Jun;101(11):1381-7. doi: 10.1111/j.1464-410X.2008.07573.x. Epub 2008 Mar 10.
- Background: PubMed 26924589Eapen RS, Radomski SB. Gender differences in overactive bladder. Can J Urol. 2016 Feb;23(Suppl 1):2-9.
- Background: PubMed 29770246Jeon E, Park HA. Development of the IMB Model and an Evidence-Based Diabetes Self-management Mobile Application. Healthc Inform Res. 2018 Apr;24(2):125-138. doi: 10.4258/hir.2018.24.2.125. Epub 2018 Apr 30.
- Background: PubMed 21948041Zarani F, Besharat MA, Sarami G, Sadeghian S. An information-motivation-behavioral skills (IMB) model-based intervention for CABG patients. Int J Behav Med. 2012 Dec;19(4):543-9. doi: 10.1007/s12529-011-9193-2.
- Background: PubMed 23477576Kiene SM, Fisher WA, Shuper PA, Cornman DH, Christie S, Macdonald S, Pillay S, Mahlase G, Fisher JD. Understanding HIV transmission risk behavior among HIV-infected South Africans receiving antiretroviral therapy: an information--motivation--behavioral skills model analysis. Health Psychol. 2013 Aug;32(8):860-8. doi: 10.1037/a0030554. Epub 2013 Mar 11.
- Background: PubMed 24116922Konkle-Parker DJ, Amico KR, McKinney VE. Effects of an intervention addressing information, motivation, and behavioral skills on HIV care adherence in a southern clinic cohort. AIDS Care. 2014;26(6):674-83. doi: 10.1080/09540121.2013.845283. Epub 2013 Oct 14.
- Background: PubMed 7780440Uebersax JS, Wyman JF, Shumaker SA, McClish DK, Fantl JA. Short forms to assess life quality and symptom distress for urinary incontinence in women: the Incontinence Impact Questionnaire and the Urogenital Distress Inventory. Continence Program for Women Research Group. Neurourol Urodyn. 1995;14(2):131-9. doi: 10.1002/nau.1930140206.
- Background: PubMed 17083117Cam C, Sakalli M, Ay P, Cam M, Karateke A. Validation of the short forms of the incontinence impact questionnaire (IIQ-7) and the urogenital distress inventory (UDI-6) in a Turkish population. Neurourol Urodyn. 2007;26(1):129-33. doi: 10.1002/nau.20292.
- Background: PubMed 29540090Aydin Sayilan A, Ozbas A. The Effect of Pelvic Floor Muscle Training On Incontinence Problems After Radical Prostatectomy. Am J Mens Health. 2018 Jul;12(4):1007-1015. doi: 10.1177/1557988318757242. Epub 2018 Mar 14.
- 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.
Hilal Tüzer, RN, PhD study director
Ankara Yildirim Beyazıt University
Elif Gezginci, RN, PhD principal investigator
Saglik Bilimleri Universitesi
Tuba Yılmazer, RN, PhD principal investigator
Ankara Yildirim Beyazıt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assigned Interventions in people with Overactive Bladder and Quality of Life, run by Ankara Yildirim Beyazıt University 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 8 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 28 Aug 2019. 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. 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?
A Change on Incontinence Severity Measured by The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) (time frame: 20 minutes before and 6 months after the training). 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 NCT04068025, which also lists 23 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 28 Aug 2019; AzTrials last refreshed its copy on 7 Nov 2026.