Overactive BladderOAB TelemedNCT05117918
Overactive Bladder Telemedicine Non-inferiority Trial
A study testing SUFU Clinical Care Pathway for Overactive Bladder and Telemedicine in people with Overactive Bladder, run by University of California, Los Angeles at 1 site in United States.
Trial summary
In this study, the investigators aim to validate the telemedicine paradigm as a feasible alternative to traditional in-person clinic visits for the management of overactive bladder (OAB). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- SUFU Clinical Care Pathway for Overactive Bladder and Telemedicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 177 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 31 Aug 2023
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Idiopathic overactive bladder diagnosis, both OAB wet and OAB dry
Who cannot join
- Active Urinary Tract Infection (UTI)
- Stage 3 or 4 prolapse
- Underlying neurologic condition contributing to OAB
- Use of catheter
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Study Evaluating the Feasibility of Telemedicine Use in the Overactive Bladder Clinical Care Pathway: a Non-inferiority Study Assessing Patient Satisfaction and Progression to Third Line Overactive Bladder Therapies
In this study, the investigators aim to validate the telemedicine paradigm as a feasible alternative to traditional in-person clinic visits for the management of overactive bladder (OAB).
Read the detailed description
This is a single-center, prospective randomized controlled trial. The study population will consist of two primary cohorts stratified based on the method of follow-up, either traditional in-person clinic visit or telemedicine appointment. The primary outcome will be satisfaction with OAB treatment. Secondary endpoints include rate of progression to third line therapies, changes in OAB symptom scores, safety, and cost. This non-inferiority trial is designed to provide an alternative option for care delivery that may result in improved patient satisfaction and compliance, and decreased cost, time, and travel burden for patients.
- Conditions
- Overactive Bladder
- Being tested
- SUFU Clinical Care Pathway for Overactive Bladder, Telemedicine
- 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.
SUFU Clinical Care Pathway for Overactive BladderOther
Treatment of OAB via the SUFU clinical care pathway
TelemedicineOther
Delivery of care via telemedicine
| Study group | Role | What they receive |
|---|---|---|
| Traditional In-Person Clinic Visit Arm | Placebo comparator | Patients will receive overactive bladder (OAB) treatment as described in the Society for Urodynamics and Female Pelvic Medicine and Urogenital Reconstruction (SUFU) OAB clinical care pathway. These patients will have all visits in-person Receives: Other: SUFU Clinical Care Pathway for Overactive Bladder |
| Telemedicine Arm | Experimental | Patients will receive OAB treatment as described in the SUFU OAB clinical care pathway but all visits will be performed via telemedicine Receives: Other: SUFU Clinical Care Pathway for Overactive Bladder; Other: Telemedicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction
Treatment Satisfaction Visual Analogue Scale (TS-VAS), scale scored from 0 - 100 with 100 indicating highest satisfaction
Measured: 1 year
Secondary outcomes (5)
PGII
Patient Global impression of improvement (PGII), minimum of 0, maximum of 6 with 0 indicating the patient is most improved
Measured: 1 year
Incidence of Treatment-emergent adverse events (safety and tolerability)
Adverse events related to treatment requiring emergency room visits, urgent care visits, hospital admissions
Measured: 1 year
Accumulated cost of visit to patient (Cost)
Cost of parking, travel, and other visit-associated expenses to patient
Measured: 1 year
Accumulated time of visit for patient (Time)
Time of travel to visit, time of visit, wait time of visit
Measured: 1 year
Overactive Bladder Symptoms
Overactive Bladder Questionnaire Short-Form (OAB-q SF), scale from 6-36 with 36 indicating the most severe OAB symptoms
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start1 Jul 2021
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victor W. Nitti, MD, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05117918
- Sponsor's protocol ID
- 21-000458
- Acronym
- OAB Telemed
- Status last verified
- Dec 2023
- First submitted
- 18 Aug 2021
- Last updated
- 12 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study Evaluating the Feasibility of Telemedicine Use in the Overactive Bladder Clinical Care Pathway: a Non-inferiority Study Assessing Patient Satisfaction and Progression to Third Line Overactive Bladder Therapies
- ClinicalTrials.gov ID
- NCT05117918
- Acronym / sponsor ID
- OAB Telemed / 21-000458
- Conditions
- Overactive Bladder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 11 Nov 2021 (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.
In this study, the investigators aim to validate the telemedicine paradigm as a feasible alternative to traditional in-person clinic visits for the management of overactive bladder (OAB).
Detailed description
This is a single-center, prospective randomized controlled trial. The study population will consist of two primary cohorts stratified based on the method of follow-up, either traditional in-person clinic visit or telemedicine appointment. The primary outcome will be satisfaction with OAB treatment. Secondary endpoints include rate of progression to third line therapies, changes in OAB symptom scores, safety, and cost. This non-inferiority trial is designed to provide an alternative option for care delivery that may result in improved patient satisfaction and compliance, and decreased cost, time, and travel burden for patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional In-Person Clinic Visit Arm | Placebo comparator | Other: SUFU Clinical Care Pathway for Overactive BladderPatients will receive overactive bladder (OAB) treatment as described in the Society for Urodynamics and Female Pelvic Medicine and Urogenital Reconstruction (SUFU) OAB clinical care pathway. These patients will have all visits in-person |
| Telemedicine Arm | Experimental | Other: SUFU Clinical Care Pathway for Overactive Bladder, Other: TelemedicinePatients will receive OAB treatment as described in the SUFU OAB clinical care pathway but all visits will be performed via telemedicine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Idiopathic overactive bladder diagnosis, both OAB wet and OAB dry
Key exclusion criteria (4 listed)
- Active Urinary Tract Infection (UTI)
- Stage 3 or 4 prolapse
- Underlying neurologic condition contributing to OAB
- Use of catheter
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 |
|---|---|---|
| SUFU Clinical Care Pathway for Overactive BladderTreatment of OAB via the SUFU clinical care pathway | Other | Telemedicine Arm, Traditional In-Person Clinic Visit Arm |
| TelemedicineDelivery of care via telemedicine | Other | Telemedicine Arm |
Primary outcome
Patient Satisfaction
Time frame: 1 year
Treatment Satisfaction Visual Analogue Scale (TS-VAS), scale scored from 0 - 100 with 100 indicating highest satisfaction
5 secondary outcomes
PGII
Time frame: 1 year
Incidence of Treatment-emergent adverse events (safety and tolerability)
Time frame: 1 year
Accumulated cost of visit to patient (Cost)
Time frame: 1 year
Accumulated time of visit for patient (Time)
Time frame: 1 year
Overactive Bladder Symptoms
Time frame: 1 year
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 12 Dec 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SUFU Clinical Care Pathway for Overactive Bladder and Telemedicine in people with Overactive Bladder, run by University of California, Los Angeles at 1 site 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 1 inclusion and 4 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 12 Dec 2023. 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 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. 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?
Patient Satisfaction (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Dec 2023.