Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06438861
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-05-15
Brief Title:
Role of Combination Therapy in Women With Refractory Overactive Bladder
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Exploring the Additive Effect of Vibegron to Intradetrusor OnabotulinumtoxinA in Women With Refractory Overactive Bladder
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 OAB is a very prevalent condition affecting between 118 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 826 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
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 78 In that calculation a 2-sided alpha005 the estimate for that difference in improvement had been estimated to be 25 UUI episodes over a 3-day bladder diary pre-vs post-treatment with a standard deviation of 3 and a power of 080 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
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 78 In that calculation a 2-sided alpha005 the estimate for that difference in improvement had been estimated to be 25 UUI episodes over a 3-day bladder diary pre-vs post-treatment with a standard deviation of 3 and a power of 080 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Pending | OTHER_GRANT | Pending | None |