Overactive Bladder SyndromeNCT06438861
Role of Combination Therapy in Women With Refractory Overactive Bladder
A study testing Vibegron 75mg in people with Overactive Bladder Syndrome, run by University of Alabama at Birmingham.
Trial summary
Defined by the International Continence Society (ICS) as urinary "urgency, with or without urge incontinence, usually with frequency and nocturia", overactive bladder (OAB) presents as challenging syndrome to treat. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overactive Bladder Syndrome
- What is being tested?
- Vibegron 75mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 31 Dec 2025
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women undergoing intradetrusor botulinum injections for refractory OAB
- Age 18 years old or greater
- Fluency and literacy in English
- Capacity to provide consent
Who cannot join
- Allergy to Vibegron
- Currently pregnant or planning to become pregnant
- Breastfeeding
- Current digoxin use
About this study
Official title: Exploring the Additive Effect of Vibegron to Intradetrusor OnabotulinumtoxinA in Women With Refractory Overactive Bladder
Defined by the International Continence Society (ICS) as urinary "urgency, with or without urge incontinence, usually with frequency and nocturia", overactive bladder (OAB) presents as challenging syndrome to treat. OAB is a very prevalent condition, affecting between 11.8% to 16% of the population with equal impact on women and men and growing prevalence with age. OAB is associated with a significant financial burden to both patients and the health care system with a estimated cost of US $82.6 billion in 2020. Traditionally, a stepwise approach has been taken in managing OAB; starting first with lifestyle modifications, followed by anticholinergic or beta-3-agonist medications as the second line, and lastly, intradetrusor onabotulinumtoxinA injections, percutaneous tibial nerve stimulation (PTNS), and sacral neuromodulation (SNM) as third line options. Given the limitations of this stepwise approach in patients with refractory OAB, combination therapy offers patients an increasing number of treatment options but the literature surrounding the efficacy of combination therapy is somewhat limited. A 2019 systematic review revealed there were only 32 studies in the current OAB literature that explored the role of combination therapy, and the majority of these studies examined the effect of lifestyle modifications with another intervention strategy, highlighting an untapped area of research5.
To date, there has only been a single pilot study conducted in Taiwan examining the effect of intradetrusor onabotulinumtoxinA injections with the addition of mirabegron for patients with refractory OAB. This study by Wang et al. explored the therapeutic impact of adding either an anticholinergic, solifenacin, or a beta-3 agonist, mirabegron, to intradetrusor onabotulinumtoxinA injections as compared to each other as well as patients receiving onabotulinumtoxinA alone. Ninety patients were enrolled with 30 patients allocated to the solifenacin arm, 31 to the mirabegron arm, and 29 to the control group. While the baseline data among the three arms was comparable, the percentage of OAB wet in the mirabegron plus onabotulinumtoxinA group was significantly less at 3-, 6-, 9-, and 12-month intervals than the solifenacin plus onabotulinumtoxinA and the onabotulinumtoxinA alone groups. While this pilot study reveals the potential additive benefit of a beta-3 agonist to intradetrusor onabotulinumtoxinA, no further studies have been performed to date and there are no studies regarding the additive benefit of vibegron, which has a more tolerable side effect profile and is not as limited by as many contraindications as mirabegron. If vibegron can potentiate the effect of intradetrusor onabotulinumtoxinA, this presents a new treatment strategy for OAB and could offer patients an additional line of therapy before having to pursue more invasive and costly management option of sacral neuro modulation.
Read the detailed description
The study will be a prospective double-blinded randomized control trial to examine the effect of administering vibegron versus placebo in conjunction with intradetrusor onabotulinumtoxinA injections for the management of refractory OAB. Patients who present to the University of Alabama at Birmingham urogynecology practice with refractory OAB undergoing the standard 100U intradetrusor onabotulinumtoxinA will be offered enrollment to either the onabotulinumtoxinA plus vibegron or the onabotulinumtoxinA plus placebo groups. Prior to onabotulinumtoxinA injections, patients' baseline demographics will be documented and their genitourinary symptoms will be assessed using the previously validated Urinary Distress Inventory Short Form (UDI-6), the Incontinence Impact Questionnaire Short Form (IIQ-7), the Overactive Bladder Questionnaire (The OAB-q), and a 3 day voiding diary. Patients will be blinded to which cohort they are randomized to. Each patient will undergo intradetrusor onabotulinumtoxinA injections of 100U either in the office or in the operating room depending on patient and provider preference. Patients will begin taking vibegron or a placebo pill daily starting the day of their procedure. At 12 weeks, patients will complete a 3 day voiding diary as well as the UDI-6, IIQ-7, and OAB-q questionnaires. Patient charts will be queried for timing of repeat onabotulinumtoxinA injection as another secondary outcome.
Primary outcome: Change in mean urinary urgency incontinence episodes at 12 weeks based on 3 day voiding diary
Secondary outcomes: Mean change in UDI-6 responses at 12 weeks, mean change in IIQ-7 responses at 12 weeks, mean change in OAB-q responses at 12 weeks, duration to repeat onabotulinumtoxinA injection
Sample Size Calculation:
It is anticipated that women randomized to the 100U intradetrusor onabotulinumtoxinA plus vibegron arm will experience a greater improvement in UUI episodes compared to the 100U intradetrusor onabotulinumtoxinA plus placebo cohort. A recent study comparing the PTNS plus mirabegron to PTNS plus placebo performed a sample size calculation using existing data 7,8. In that calculation, a 2-sided alpha=0.05, the estimate for that difference in improvement had been estimated to be 2.5 UUI episodes over a 3-day bladder diary pre-vs. post-treatment with a standard deviation of 3 and a power of 0.80 and given the assumed attrition rate of 10%, the total N per arm was estimated to be 27 subjects for the study. Given the similarities between this study and our proposed study, the sample size calculation was felt be applicable to this study.
- Conditions
- Overactive Bladder Syndrome
- Being tested
- Vibegron 75mg, Placebo
- Keywords
- Refractory Overactive Bladder Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibegron 75mgDrug
Each patient will undergo intradetrusor onabotulinumtoxinA injections of 100U either in the office or in the operating room depending on patient and provider preference. Patients will begin taking vibegron 75mg daily or a placebo pill daily starting the day of their procedure and continue for 3 months.
PlaceboDrug
Each patient will undergo intradetrusor onabotulinumtoxinA injections of 100U either in the office or in the operating room depending on patient and provider preference. Patients will begin taking vibegron 75mg daily or a placebo pill daily starting the day of their procedure and continue for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| 100U intradetrusor onabotulinumtoxinA plus vibegron | Active comparator | Each patient will undergo intradetrusor onabotulinumtoxinA injections of 100U either in the office or in the operating room depending on patient and provider preference. Patients randomized to this arm will begin taking vibegron 75mg daily, which is the standard dose, starting the day of their procedure and continue for 3 months. Receives: Drug: Vibegron 75mg |
| 100U intradetrusor onabotulinumtoxinA plus placebo | Placebo comparator | Each patient will undergo intradetrusor onabotulinumtoxinA injections of 100U either in the office or in the operating room depending on patient and provider preference. Patients randomized to this arm will begin taking a placebo pill daily starting the day of their procedure and continue for 3 months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in urinary urgency incontinence (UUI) episodes on 3 day voiding diary at 12 weeks after starting treatment as compared to baseline
Patients will be asked to complete a 3 day voiding diary at baseline and at 12 weeks following intradetrusor onabotulinumtoxinA injections and oral medication. The mean change in UUI episodes will be compared between the onabotulinumtoxinA injection plus vibegron verus onabotulinumtoxinA injection plus placebo groups.
Measured: Pre-intervention baseline to 12 weeks following initiation of intervention
Secondary outcomes (4)
Change in Symptom Distress as Measured by the Urogenital Distress Index (UDI-6) Questionnaire Pre-Intervention versus 12 weeks Post-Intervention
The UDI-6 is the short form validated patient questionnaire that was developed from the urogenital distress inventory (UDI). It consists of six questions that focus on lower urinary tract dysfunction including obstructive, irritative, and stress symptoms. The responses are scored as follows: (0) not at all, (1) slightly, (2) moderately, (3) greatly. The mean score is multiplied by 33 1/3 to convert to a 0 to 100 scale with higher scores indicative of more symptoms distress. Subjects will complete the UDI-6 survey at baseline and at 12 weeks post-intervention. The mean change in UDI-6 responses will be compared.
Measured: Pre-intervention baseline to 12 weeks following initiation of intervention
Change in UUI (Urge Urinary Incontinence)/OAB (Overactive Bladder) Quality of Life as Measured by the Incontinence Impact Questionnaire Short Form (IIQ-7) Questionnaire Pre-Intervention versus 12 weeks Post-Intervention
The IIQ-7 is the short form validated patient questionnaire that was developed from the incontinence impact questionnaire (IIQ). It consists of seven questions that focus on the impact of UUI on physical activity, travel, relationships, and emotional health. The responses are scored as follows: (0) not at all, (1) slightly, (2) moderately, (3) greatly. The mean score is multiplied by 33 1/3 to convert to a 0 to 100 scale with higher scores indicative of more symptoms distress. Subjects will complete the IIQ-7 survey at baseline and at 12 weeks post-intervention. The mean change in IIQ-7 responses will be compared.
Measured: Pre-intervention baseline to 12 weeks following initiation of intervention
hange in UUI (Urge Urinary Incontinence)/OAB (Overactive Bladder) Quality of Life as Measured by the Overactive Bladder Questionnaire-Short Form (OAB-q SF) Questionnaire Pre-Intervention versus 12 weeks Post-Intervention
The OAB-q SF is the short form validated patient questionnaire that was developed from the Overactive Bladder Questionnaire (OAB-q). It consists of six questions that focus on the impact of bladder symptoms over the past 4 weeks. The responses are scored as follows: (1) not at all, (2) a little bit, (3) somewhat, (4) quite a bit, (5) a great deal, (6) a very great deal. The mean score is converted to a 0 to 100 scale with higher scores indicative of more symptoms distress. Subjects will complete the OAB-q SF survey at baseline and at 12 weeks post-intervention. The mean change in OAB-q SF responses will be compared.
Measured: Pre-intervention baseline to 12 weeks following initiation of intervention
Duration to repeat onabotulinumtoxinA injection
Patient require repeat intradetrusor onabotulinumtoxinA injection to treat refractory OAB. A chart review will be performed to determine time interval between initial onabotulinumtoxinA injection and subsequent injection to see if there is a difference with the addition of vibegron as compared to placebo.
Measured: Initiation of intervention until repeat injection, anticipate average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start1 Jan 2025
- Primary completion1 Dec 2025
- Study completion31 Dec 2025
Why it stopped: Not funded by industry
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Overactive Bladder SyndromeStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katelyn Donaldson, MD, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06438861
- Sponsor's protocol ID
- IRB-300012698
- Other IDs
- Pending
- Status last verified
- Feb 2026
- First submitted
- 15 May 2024
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 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 12559262Coyne KS, Wein A, Nicholson S, Kvasz M, Chen CI, Milsom I. Economic burden of urgency urinary incontinence in the United States: a systematic review. J Manag Care Pharm. 2014 Feb;20(2):130-40. doi: 10.18553/jmcp.2014.20.2.130.
PubMed 24456314Irwin 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 17049716Stewart 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 12811491Kasman A, Stave C, Elliott CS. Combination therapy in overactive bladder-untapped research opportunities: A systematic review of the literature. Neurourol Urodyn. 2019 Nov;38(8):2083-2092. doi: 10.1002/nau.24158. Epub 2019 Sep 4.
PubMed 31483070Wang CC, Lee CL, Hwang YT, Kuo HC. Adding mirabegron after intravesical onabotulinumtoxinA injection improves therapeutic effects in patients with refractory overactive bladder. Low Urin Tract Symptoms. 2021 Oct;13(4):440-447. doi: 10.1111/luts.12384. Epub 2021 May 6.
PubMed 33960119Sancaktar M, Ceyhan ST, Akyol I, Muhcu M, Alanbay I, Mutlu Ercan C, Atay V. The outcome of adding peripheral neuromodulation (Stoller afferent neuro-stimulation) to anti-muscarinic therapy in women with severe overactive bladder. Gynecol Endocrinol. 2010 Oct;26(10):729-32. doi: 10.3109/09513591003649815.
PubMed 20210697Stanley RF, Meyer I, Blanchard CT, Richter HE. Posterior Tibial Nerve Stimulation With versus Without Mirabegron: A Randomized Controlled Trial. Int Urogynecol J. 2024 Aug;35(8):1709-1717. doi: 10.1007/s00192-024-05835-y. Epub 2024 Aug 5.
PubMed 39101958
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Additive Effect of Vibegron to Intradetrusor OnabotulinumtoxinA in Women With Refractory Overactive Bladder
- ClinicalTrials.gov ID
- NCT06438861
- Acronym / sponsor ID
- IRB-300012698
- Conditions
- Overactive Bladder Syndrome
- Keywords
- Refractory Overactive Bladder Syndrome
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not funded by industry
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 3 Jun 2024 (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.
Defined by the International Continence Society (ICS) as urinary "urgency, with or without urge incontinence, usually with frequency and nocturia", overactive bladder (OAB) presents as challenging syndrome to treat. OAB is a very prevalent condition, affecting between 11.8% to 16% of the population with equal impact on women and men and growing prevalence with age. OAB is associated with a significant financial burden to both patients and the health care system with a estimated cost of US $82.6 billion in 2020. Traditionally, a stepwise approach has been taken in managing OAB; starting first with lifestyle modifications, followed by anticholinergic or beta-3-agonist medications as the second line, and lastly, intradetrusor onabotulinumtoxinA injections, percutaneous tibial nerve stimulation (PTNS), and sacral neuromodulation (SNM) as third line options. Given the limitations of this stepwise approach in patients with refractory OAB, combination therapy offers patients an increasing number of treatment options but the literature surrounding the efficacy of combination therapy is somewhat limited. A 2019 systematic review revealed there were only 32 studies in the current OAB literature that explored the role of combination therapy, and the majority of these studies examined the effect of lifestyle modifications with another intervention strategy, highlighting an untapped area of research5.
To date, there has only been a single pilot study conducted in Taiwan examining the effect of intradetrusor onabotulinumtoxinA injections with the addition of mirabegron for patients with refractory OAB. This study by Wang et al. explored the therapeutic impact of adding either an anticholinergic, solifenacin, or a beta-3 agonist, mirabegron, to intradetrusor onabotulinumtoxinA injections as compared to each other as well as patients receiving onabotulinumtoxinA alone. Ninety patients were enrolled with 30 patients allocated to the solifenacin arm, 31 to the mirabegron arm, and 29 to the control group. While the baseline data among the three arms was comparable, the percentage of OAB wet in the mirabegron plus onabotulinumtoxinA group was significantly less at 3-, 6-, 9-, and 12-month intervals than the solifenacin plus onabotulinumtoxinA and the onabotulinumtoxinA alone groups. While this pilot study reveals the potential additive benefit of a beta-3 agonist to intradetrusor onabotulinumtoxinA, no further studies have been performed to date and there are no studies regarding the additive benefit of vibegron, which has a more tolerable side effect profile and is not as limited by as many contraindications as mirabegron. If vibegron can potentiate the effect of intradetrusor onabotulinumtoxinA, this presents a new treatment strategy for OAB and could offer patients an additional line of therapy before having to pursue more invasive and costly management option of sacral neuro modulation.
Detailed description
The study will be a prospective double-blinded randomized control trial to examine the effect of administering vibegron versus placebo in conjunction with intradetrusor onabotulinumtoxinA injections for the management of refractory OAB. Patients who present to the University of Alabama at Birmingham urogynecology practice with refractory OAB undergoing the standard 100U intradetrusor onabotulinumtoxinA will be offered enrollment to either the onabotulinumtoxinA plus vibegron or the onabotulinumtoxinA plus placebo groups. Prior to onabotulinumtoxinA injections, patients' baseline demographics will be documented and their genitourinary symptoms will be assessed using the previously validated Urinary Distress Inventory Short Form (UDI-6), the Incontinence Impact Questionnaire Short Form (IIQ-7), the Overactive Bladder Questionnaire (The OAB-q), and a 3 day voiding diary. Patients will be blinded to which cohort they are randomized to. Each patient will undergo intradetrusor onabotulinumtoxinA injections of 100U either in the office or in the operating room depending on patient and provider preference. Patients will begin taking vibegron or a placebo pill daily starting the day of their procedure. At 12 weeks, patients will complete a 3 day voiding diary as well as the UDI-6, IIQ-7, and OAB-q questionnaires. Patient charts will be queried for timing of repeat onabotulinumtoxinA injection as another secondary outcome.
Primary outcome: Change in mean urinary urgency incontinence episodes at 12 weeks based on 3 day voiding diary
Secondary outcomes: Mean change in UDI-6 responses at 12 weeks, mean change in IIQ-7 responses at 12 weeks, mean change in OAB-q responses at 12 weeks, duration to repeat onabotulinumtoxinA injection
Sample Size Calculation:
It is anticipated that women randomized to the 100U intradetrusor onabotulinumtoxinA plus vibegron arm will experience a greater improvement in UUI episodes compared to the 100U intradetrusor onabotulinumtoxinA plus placebo cohort. A recent study comparing the PTNS plus mirabegron to PTNS plus placebo performed a sample size calculation using existing data 7,8. In that calculation, a 2-sided alpha=0.05, the estimate for that difference in improvement had been estimated to be 2.5 UUI episodes over a 3-day bladder diary pre-vs. post-treatment with a standard deviation of 3 and a power of 0.80 and given the assumed attrition rate of 10%, the total N per arm was estimated to be 27 subjects for the study. Given the similarities between this study and our proposed study, the sample size calculation was felt be applicable to this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 100U intradetrusor onabotulinumtoxinA plus vibegron | Active comparator | Drug: Vibegron 75mgEach patient will undergo intradetrusor onabotulinumtoxinA injections of 100U either in the office or in the operating room depending on patient and provider preference. Patients randomized to this arm will begin taking vibegron 75mg daily, which is the standard dose, starting the day of their procedure and continue for 3 months. |
| 100U intradetrusor onabotulinumtoxinA plus placebo | Placebo comparator | Drug: PlaceboEach patient will undergo intradetrusor onabotulinumtoxinA injections of 100U either in the office or in the operating room depending on patient and provider preference. Patients randomized to this arm will begin taking a placebo pill daily starting the day of their procedure and continue for 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women undergoing intradetrusor botulinum injections for refractory OAB
- Age 18 years old or greater
- Fluency and literacy in English
- Capacity to provide consent
Key exclusion criteria (4 listed)
- Allergy to Vibegron
- Currently pregnant or planning to become pregnant
- Breastfeeding
- Current digoxin use
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 |
|---|---|---|
| Vibegron 75mgEach patient will undergo intradetrusor onabotulinumtoxinA injections of 100U either in the office or in the operating room depending on patient and provider preference. Patients will begin taking vibegron 75mg daily or a placebo pill daily starting the day of their procedure and continue for 3 months. | Drug | 100U intradetrusor onabotulinumtoxinA plus vibegron |
| PlaceboEach patient will undergo intradetrusor onabotulinumtoxinA injections of 100U either in the office or in the operating room depending on patient and provider preference. Patients will begin taking vibegron 75mg daily or a placebo pill daily starting the day of their procedure and continue for 3 months. | Drug | 100U intradetrusor onabotulinumtoxinA plus placebo |
Primary outcome
Change in urinary urgency incontinence (UUI) episodes on 3 day voiding diary at 12 weeks after starting treatment as compared to baseline
Time frame: Pre-intervention baseline to 12 weeks following initiation of intervention
Patients will be asked to complete a 3 day voiding diary at baseline and at 12 weeks following intradetrusor onabotulinumtoxinA injections and oral medication. The mean change in UUI episodes will be compared between the onabotulinumtoxinA injection plus vibegron verus onabotulinumtoxinA injection plus placebo groups.
4 secondary outcomes
Change in Symptom Distress as Measured by the Urogenital Distress Index (UDI-6) Questionnaire Pre-Intervention versus 12 weeks Post-Intervention
Time frame: Pre-intervention baseline to 12 weeks following initiation of intervention
Change in UUI (Urge Urinary Incontinence)/OAB (Overactive Bladder) Quality of Life as Measured by the Incontinence Impact Questionnaire Short Form (IIQ-7) Questionnaire Pre-Intervention versus 12 weeks Post-Intervention
Time frame: Pre-intervention baseline to 12 weeks following initiation of intervention
hange in UUI (Urge Urinary Incontinence)/OAB (Overactive Bladder) Quality of Life as Measured by the Overactive Bladder Questionnaire-Short Form (OAB-q SF) Questionnaire Pre-Intervention versus 12 weeks Post-Intervention
Time frame: Pre-intervention baseline to 12 weeks following initiation of intervention
Duration to repeat onabotulinumtoxinA injection
Time frame: Initiation of intervention until repeat injection, anticipate average of 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- 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 24456314Coyne KS, Wein A, Nicholson S, Kvasz M, Chen CI, Milsom I. Economic burden of urgency urinary incontinence in the United States: a systematic review. J Manag Care Pharm. 2014 Feb;20(2):130-40. doi: 10.18553/jmcp.2014.20.2.130.
- 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 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 31483070Kasman A, Stave C, Elliott CS. Combination therapy in overactive bladder-untapped research opportunities: A systematic review of the literature. Neurourol Urodyn. 2019 Nov;38(8):2083-2092. doi: 10.1002/nau.24158. Epub 2019 Sep 4.
- Background: PubMed 33960119Wang CC, Lee CL, Hwang YT, Kuo HC. Adding mirabegron after intravesical onabotulinumtoxinA injection improves therapeutic effects in patients with refractory overactive bladder. Low Urin Tract Symptoms. 2021 Oct;13(4):440-447. doi: 10.1111/luts.12384. Epub 2021 May 6.
- Background: PubMed 20210697Sancaktar M, Ceyhan ST, Akyol I, Muhcu M, Alanbay I, Mutlu Ercan C, Atay V. The outcome of adding peripheral neuromodulation (Stoller afferent neuro-stimulation) to anti-muscarinic therapy in women with severe overactive bladder. Gynecol Endocrinol. 2010 Oct;26(10):729-32. doi: 10.3109/09513591003649815.
- Background: PubMed 39101958Stanley RF, Meyer I, Blanchard CT, Richter HE. Posterior Tibial Nerve Stimulation With versus Without Mirabegron: A Randomized Controlled Trial. Int Urogynecol J. 2024 Aug;35(8):1709-1717. doi: 10.1007/s00192-024-05835-y. Epub 2024 Aug 5.
- 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 Vibegron 75mg in people with Overactive Bladder Syndrome, run by University of Alabama at Birmingham.
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 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: withdrawn, as of the sponsor's last update on 12 Feb 2026. 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. 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 was withdrawn before enrolling participants, so there are no results.
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 in urinary urgency incontinence (UUI) episodes on 3 day voiding diary at 12 weeks after starting treatment as compared to baseline (time frame: Pre-intervention baseline to 12 weeks following initiation of intervention). 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 NCT06438861, which also lists 8 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 12 Feb 2026.