Urinary Bladder, OveractiveNCT02505607
Overactive Bladder Education
A study testing Overactive Bladder Care Plan counseling in people with Urinary Bladder, Overactive and Urinary Incontinence, Urge, run by Hartford Hospital at 3 sites in United States.
Trial summary
Overactive bladder (OAB) is a common, chronic condition, characterized by urinary "urgency, with or without urge incontinence, usually with frequency and nocturia." Treatment adherence is a major barrier to management of OAB and drug continuation is poor. Read more about this study
- Who is it for?
- Ages 18 to 89 years, women only
- Conditions the study is for
- Urinary Bladder, Overactive, Urinary Incontinence, Urge
- What is being tested?
- Overactive Bladder Care Plan counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2015to Dec 2015
- 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 89 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of overactive bladder
- able and willing to participate and consent
- age >17 years, <90 years
- female sex
Who cannot join
- male sex
- patients who do not have a diagnosis of overactive bladder
- age <18 years, >89 years
- unable or unwilling to participate
- patients who are already being treated for overactive bladder
- patients who are planning surgical intervention for pelvic organ prolapse prior to treatment of overactive bladder
- patients who are planning surgical intervention for stress urinary incontinence prior to treatment of overactive bladder
- pregnancy
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Hartford Hospital, Urogynecology Division
Glastonbury, Connecticut
Hartford Hospital, Urogynecology Division
Hartford, Connecticut, 06106
Hartford Hospital, Urogynecology Division
West Hartford, Connecticut
About this study
Overactive bladder (OAB) is a common, chronic condition, characterized by urinary "urgency, with or without urge incontinence, usually with frequency and nocturia." Treatment adherence is a major barrier to management of OAB and drug continuation is poor. Many factors may play a role in non-adherence to medication management of OAB including drug cost, side effects, and a lack of understanding of the disease and treatment process.Studies show that recall of disease information and treatment is often suboptimal. Literature shows that providing written materials is an efficacious way to aid in recall. Based on known poor adherence to OAB medication treatment and the clear role patient education methods have on patient information recall, the investigators believe that improvement of participant education through use of a OAB care plan will improve participant understanding and treatment adherence.
Through this randomized trial, the investigators plan to evaluate whether implementation of a OAB Care Plan improves understanding of disease and treatment options, treatment success, and satisfaction.
Read more
This is a prospective, randomized, controlled study of OAB counseling in new patients presenting to the Urogynecology offices of Hartford Hospital. All new patients with a diagnosis of OAB will be offered participation. All consenting participants will be randomized 1:1 to one of two groups: 1) Standard Care group or 2) Care Plan group. In the Standard Care group, participants will be counseled as the physician routinely counsels patients about OAB, in the Care Plan group, participants will be counseled a printed "Overactive Bladder Plan of Care" information sheet. At the end of the visit, the participant will complete a Baseline Survey. The Baseline Survey includes basic demographic information, a physician satisfaction survey, and a OAB knowledge survey. The participant will return for follow up as directed by the physician.
At the follow up visit, participants in both groups will complete a Followup Survey. The Followup Survey will be completed before the participant sees the physician. The Followup Survey assesses OAB knowledge.
Eight months after the baseline visit, each participant's chart will be reviewed for final data collection. If a participant progresses to a treatment method where she is satisfied and would like to remain, this will be documented.
- Being tested
- Overactive Bladder Care Plan counseling
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Overactive Bladder Care Plan counselingOther
Use of a printed "Overactive Bladder Plan of Care" information sheet.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care Group | No intervention | In this group, subjects will receive standard counseling regarding Overactive Bladder. |
| Care Plan Group | Experimental | In this group, subjects will receive counseling regarding Overactive Bladder using a printed "Overactive Bladder Plan of Care" information sheet. Receives: Other: Overactive Bladder Care Plan counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Understanding of Overactive Bladder questionnaire
Measured: Change from baseline knowledge at follow up visit (on average 8 weeks)
Secondary outcomes (2)
Subject satisfaction questionnaire
Measured: Baseline visit (time 0)
Treatment success chart review
Measured: 8 months after baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: feasibility issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Urinary Bladder, OveractiveStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hartford Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katie Propst, Hartford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02505607
- Sponsor's protocol ID
- HHC-2015-0109
- Status last verified
- Dec 2015
- First submitted
- 20 Jul 2015
- Last updated
- 31 Dec 2015
- Results posted
- No
- Data monitoring committee
- 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 in lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Urology. 2003 Jan;61(1):37-49. doi: 10.1016/s0090-4295(02)02243-4. No abstract available.
PubMed 12559262D'Souza AO, Smith MJ, Miller LA, Doyle J, Ariely R. Persistence, adherence, and switch rates among extended-release and immediate-release overactive bladder medications in a regional managed care plan. J Manag Care Pharm. 2008 Apr;14(3):291-301. doi: 10.18553/jmcp.2008.14.3.291.
PubMed 18439051Yeaw J, Benner JS, Walt JG, Sian S, Smith DB. Comparing adherence and persistence across 6 chronic medication classes. J Manag Care Pharm. 2009 Nov-Dec;15(9):728-40. doi: 10.18553/jmcp.2009.15.9.728.
PubMed 19954264Pickney CS, Arnason JA. Correlation between patient recall of bone densitometry results and subsequent treatment adherence. Osteoporos Int. 2005 Sep;16(9):1156-60. doi: 10.1007/s00198-004-1818-8. Epub 2005 Mar 3.
PubMed 15744452Watson PW, McKinstry B. A systematic review of interventions to improve recall of medical advice in healthcare consultations. J R Soc Med. 2009 Jun;102(6):235-43. doi: 10.1258/jrsm.2009.090013.
PubMed 19531618
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overactive Bladder Education
- ClinicalTrials.gov ID
- NCT02505607
- Acronym / sponsor ID
- HHC-2015-0109
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: feasibility issues
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Hartford HospitalUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 22 Jul 2015 (estimated)
- 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.
Overactive bladder (OAB) is a common, chronic condition, characterized by urinary "urgency, with or without urge incontinence, usually with frequency and nocturia." Treatment adherence is a major barrier to management of OAB and drug continuation is poor. Many factors may play a role in non-adherence to medication management of OAB including drug cost, side effects, and a lack of understanding of the disease and treatment process.Studies show that recall of disease information and treatment is often suboptimal. Literature shows that providing written materials is an efficacious way to aid in recall. Based on known poor adherence to OAB medication treatment and the clear role patient education methods have on patient information recall, the investigators believe that improvement of participant education through use of a OAB care plan will improve participant understanding and treatment adherence.
Through this randomized trial, the investigators plan to evaluate whether implementation of a OAB Care Plan improves understanding of disease and treatment options, treatment success, and satisfaction.
This is a prospective, randomized, controlled study of OAB counseling in new patients presenting to the Urogynecology offices of Hartford Hospital. All new patients with a diagnosis of OAB will be offered participation. All consenting participants will be randomized 1:1 to one of two groups: 1) Standard Care group or 2) Care Plan group. In the Standard Care group, participants will be counseled as the physician routinely counsels patients about OAB, in the Care Plan group, participants will be counseled a printed "Overactive Bladder Plan of Care" information sheet. At the end of the visit, the participant will complete a Baseline Survey. The Baseline Survey includes basic demographic information, a physician satisfaction survey, and a OAB knowledge survey. The participant will return for follow up as directed by the physician.
At the follow up visit, participants in both groups will complete a Followup Survey. The Followup Survey will be completed before the participant sees the physician. The Followup Survey assesses OAB knowledge.
Eight months after the baseline visit, each participant's chart will be reviewed for final data collection. If a participant progresses to a treatment method where she is satisfied and would like to remain, this will be documented.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care Group | No intervention | –In this group, subjects will receive standard counseling regarding Overactive Bladder. |
| Care Plan Group | Experimental | Other: Overactive Bladder Care Plan counselingIn this group, subjects will receive counseling regarding Overactive Bladder using a printed "Overactive Bladder Plan of Care" information sheet. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of overactive bladder
- able and willing to participate and consent
- age >17 years, <90 years
- female sex
Key exclusion criteria (8 listed)
- male sex
- patients who do not have a diagnosis of overactive bladder
- age <18 years, >89 years
- unable or unwilling to participate
- patients who are already being treated for overactive bladder
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 |
|---|---|---|
| Overactive Bladder Care Plan counselingUse of a printed "Overactive Bladder Plan of Care" information sheet. | Other | Care Plan Group |
Primary outcome
Understanding of Overactive Bladder questionnaire
Time frame: Change from baseline knowledge at follow up visit (on average 8 weeks)
2 secondary outcomes
Subject satisfaction questionnaire
Time frame: Baseline visit (time 0)
Treatment success chart review
Time frame: 8 months after baseline visit
Results and safety
The study was stopped early (reason given: feasibility issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2015.
- Background: PubMed 12559262Abrams 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 in lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Urology. 2003 Jan;61(1):37-49. doi: 10.1016/s0090-4295(02)02243-4. No abstract available.
- Background: PubMed 18439051D'Souza AO, Smith MJ, Miller LA, Doyle J, Ariely R. Persistence, adherence, and switch rates among extended-release and immediate-release overactive bladder medications in a regional managed care plan. J Manag Care Pharm. 2008 Apr;14(3):291-301. doi: 10.18553/jmcp.2008.14.3.291.
- Background: PubMed 19954264Yeaw J, Benner JS, Walt JG, Sian S, Smith DB. Comparing adherence and persistence across 6 chronic medication classes. J Manag Care Pharm. 2009 Nov-Dec;15(9):728-40. doi: 10.18553/jmcp.2009.15.9.728.
- Background: PubMed 15744452Pickney CS, Arnason JA. Correlation between patient recall of bone densitometry results and subsequent treatment adherence. Osteoporos Int. 2005 Sep;16(9):1156-60. doi: 10.1007/s00198-004-1818-8. Epub 2005 Mar 3.
- Background: PubMed 19531618Watson PW, McKinstry B. A systematic review of interventions to improve recall of medical advice in healthcare consultations. J R Soc Med. 2009 Jun;102(6):235-43. doi: 10.1258/jrsm.2009.090013.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Overactive Bladder Care Plan counseling in people with Urinary Bladder, Overactive and Urinary Incontinence, Urge, run by Hartford Hospital at 3 sites in United States.
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 4 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: stopped early, as of the sponsor's last update on 31 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 was stopped early (reason given: feasibility issues). Results are not available in the source record.
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?
Understanding of Overactive Bladder questionnaire (time frame: Change from baseline knowledge at follow up visit (on average 8 weeks)). 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 NCT02505607, which also lists 5 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 31 Dec 2015; AzTrials last refreshed its copy on 28 Oct 2026.