Overactive Bladder SyndromePhase 4NCT05221021
Vaginal Estradiol vs Oral Beta-3 Agonist for Overactive Bladder Syndrome
A Phase 4 study testing Vaginal estrogen and Mirabegron 50 MG [Myrbetriq] in people with Overactive Bladder Syndrome, run by Walter Reed National Military Medical Center at 1 site in United States.
Trial summary
A single site, double-blinded, randomized controlled trial for postmenopausal women with urinary frequency, urgency, nocturia with or without urgency urinary incontinence symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overactive Bladder Syndrome
- What is being tested?
- Vaginal estrogen and Mirabegron 50 MG [Myrbetriq]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2022to 30 Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Raw score of 14 or more on OAB-q SF (adjusted score of 20)
- Postmenopausal defined by not having a period for 12 months or bilateral oophorectomy a least 12 months status post procedure, or women with prior hysterectomy and preserved ovaries over age 55 years old or having a documented follicle stimulating hormone level greater than 40mIU/mL.
- Ability to speak and read English
Who cannot join
- Contraindications to Vaginal Estrogen or Mirabegron
- Post void residual >200mL or >1/3 patient's total bladder volume
- Currently on or previously taking anticholinergic or beta- 3 agonists within the past 1 month
- Symptomatic pelvic organ prolapse greater than Stage 2, contraindication to vaginal estrogen therapy
- Undiagnosed postmenopausal vaginal bleeding within the past 12 months
- Current diagnosis of Multiple sclerosis, Parkinson's Disease, prior spinal cord injury, Spina Bifida, prior pelvic irradiation, Interstitial Cystitis, recurrent urinary tract infection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
Deborah Kessler, RN, MSN, 301-213-0143, deborah.d.kessler.civ@mail.mil
About this study
Official title: Vaginal Estradiol vs Oral Beta-3 Agonist for Treatment of Overactive Bladder Syndrome: A Single-Therapy, Double-Blind, Randomized Controlled Trial
A single site, double-blinded, randomized controlled trial for postmenopausal women with urinary frequency, urgency, nocturia with or without urgency urinary incontinence symptoms. Patient's will be randomized between 0.01% vaginal estradiol cream with placebo oral pill or daily 50 milligrams oral Mirabegron with a placebo vaginal cream for 12 weeks.
Read the detailed description
Background/significance: Overactive Bladder Syndrome (OAB) is defined as urinary urgency, with or without urgency incontinence, and usually accompanied by frequency and nocturia. OAB remains an increasingly more prevalent disease, affecting over 45% of postmenopausal women over the age 65 within the United States. Epidemiological research continues to consistently highlight OAB's impact on patience's mental health, sleep quality, physical activity, occupational productivity and overall quality of life. OAB's economic burden cannot be overstated as well as a US cost-of-illness study reported a total cost of $66 billion in 2007 and estimated cost of over $82 billion in 2021.
Mainstay first-line forms of management for OAB include behavioral modifications such as bladder training (timed voiding, urge suppression techniques), pelvic floor physical therapy, fluid management and bladder irritant restrictions. Second-line forms of management consistent of pharmacotherapy including oral anticholinergics or beta-3 adrenoreceptor agonists. Multiple studies have shown that vaginal estrogen improves symptoms of urinary urgency and frequency in postmenopausal women. Limited data currently exist comparing beta-3 antagonists to vaginal estrogen use for overactive bladder syndrome as well as the combination of both.
Purpose: This study aims to compare the efficacy of vaginal estradiol with that of oral mirabegron in the treatment of overactive bladder in postmenopausal women and characterize outcomes in women undergoing combined therapy.
Study design: This is a single site, double-blinded, randomized controlled trial for 152 postmenopausal women with urinary frequency, urgency, nocturia with or without urgency urinary incontinence symptoms. Patient's will be randomized between 0.01% vaginal estradiol cream 1/2 gram once nightly for two weeks then three times per week or 50 milligrams oral Mirabegron once a night.
Procedures: Postmenopausal women with bothersome OAB symptoms will be eligible for the study. OAB symptoms will be based on the OAB-q (SF) symptom bother questionnaire with an initial score greater than 20. Other inclusion criteria include ability to speak English. Exclusion criteria include: Post void residual >200mL or >1/3 patient's total bladder volume, currently on or previously taking anticholinergic or beta- 3 antagonists within the past 1 month, untreated, symptomatic pelvic organ prolapse greater than Stage 2, contraindication to vaginal estrogen therapy, contraindication to Mirabegron, undiagnosed postmenopausal vaginal bleeding within the past 12 months, current diagnosis of a condition which explains their overactive bladder or incontinence symptoms.
Participants who elect to enroll will have a post-void residual determined, a demographic sheet, the OAB-q (SF) health-related quality of life (HRQL) questionnaire, a 24-hour voiding diary and Patient Global Impression of Severity (PGI-S). Participants will be randomized via random allocation rule fixed blocking in a 1:1 ratio to either vaginal estrogen or oral Mirabegron. After 12 weeks of single therapy, the patients will be contacted for follow up to complete all previous questionnaires, a 24-hour voiding diary as well as the PGI-I questionnaire. After the initial 12-weeks, single therapy follow up appointment, participants will be offered dual treatment (both vaginal estrogen and Mirabegron same doses/frequencies.) If the patient agrees she will receive dual treatment for 12 weeks and follow up with the same questionnaires.
- Conditions
- Overactive Bladder Syndrome
- Being tested
- Vaginal estrogen, Mirabegron 50 MG [Myrbetriq]
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal estrogenDrug
Also called Estrace, Estradiol, Micronized Estrogen
0.01% estradiol cream 1/2 gram applied vaginally once nightly for two weeks then three times per week with once daily placebo oral pill
Mirabegron 50 MG [Myrbetriq]Drug
Also called Myrbetriq
50mg oral Mirabegron once daily
| Study group | Role | What they receive |
|---|---|---|
| Vaginal Estradiol with placebo oral pill | Active comparator | Patient will receive 0.01% estradiol cream 1/2 gram applied vaginally once nightly for two weeks then three times per week with once daily placebo oral pill Receives: Drug: Vaginal estrogen |
| Oral Mirabegron with placebo vaginal cream | Active comparator | Patient will receive 50 milligrams oral Mirabegron once daily and placebo vaginal cream (Medisca's VersaPro Cream Base) once nightly for two weeks then three times per week Receives: Drug: Mirabegron 50 MG [Myrbetriq] |
What is being measured
The primary outcome is the main question the study is designed to answer.
OAB-q short form (SF) symptom bother scores
Primary Aim: Compare changes in the six-item OAB-q short form (SF) symptom bother scores from baseline to 12 weeks post treatment in postmenopausal women who receive either vaginal estradiol or Mirabegron. We will also compare 12-weeks post treatment OAB-q SF symptom bother scores after single therapy trials with patients who desire combined therapy for another 12 weeks.
The OAB-q SF symptom bother questionnaire is based on six individual questions a 6-point scale ranging from 1 or "not at all" to 6 or "a very great deal." Per the guidance of the scoring manual, the raw scores are converted into scores ranging from 0 to 100 (0 being the minimum score and 100 being the maximum score.) The higher the score signifies that the patient has worse bothersome overactive bladder symptoms. The conversion to a 100 point scale is based on the equation as follows: ((Raw score - 6) / 36) x 100.
Measured: 12 weeks
Secondary outcomes (5)
health-related quality of life (HRQL) of the OAB-q SF scores
Compare health-related quality of life (HRQL) of the OAB-q SF from baseline to 12 weeks post treatment. We will also compare 12-weeks post treatment HRQL scores after single therapy trials with patients who desire combined therapy for another 12 weeks.
The health-related quality of life (HRQL) portion of the OAB-q SF is based on 13 individual questions a 6-point scale ranging from 1 or "none of the time" to 6 or "all of the time" with the lowest score being 13 to the highest score being 78. The higher the score signifies that the patient has worse overactive bladder symptoms that affect their quality of life.
Measured: 12 weeks
Patient Global Impression of Severity (PGI-S) scores
Compare Patient Global Impression Severity (PGI-S) scores at baseline versus 12 weeks post treatment. We will also compare 12-weeks post treatment Patient Global Impression of Severity (PGI-S) scores after single therapy trials with patients who desire combined therapy for another 12 weeks.
The Patient Global Impression Severity (PGI-S) is a single question which describes the severity of their urinary tract condition. It is a single question on a scale ranging from 1 "not present" to 7 "extremely severe." The higher the score signifies that the patient has worse severity of their symptoms.
Measured: 12 weeks
Patient Global Impression of Improvement (PGI-I) scores
Evaluate Patient Global Impression of Improvement (PGI-I) scores at 12 weeks post treatment. We will also compare 12-weeks post treatment Patient Global Symptom Improvement (PGI-I) scores after single therapy trials with patients who desire combined therapy for another 12 weeks.
The Patient Global Impression of Improvement (PGI-I) is a single question which describes how their urinary tract condition is compared to how it was before treatment. It is a single question on a scale ranging from 1 "very much improved" to 7 "very much worse." The higher the score signifies that the patient has worse symptoms compared to prior treatment, the lower the score signifies that the patient has improved symptoms compared how it was before treatment. A score of 4 signifies not change in their described symptoms compared with how it was before treatment.
Measured: 12 weeks
Number of voids
Compare number of times the patient voids via 24-hour bladder diary at baseline and 12 weeks post treatment. We will also compare 12-weeks post treatment number of voids after single therapy trials with patients who desire combined therapy for another 12 weeks. This is an objective measurement of how many times the patient voids over a 24 hour time frame post treatment. Though unlikely the lowest quantity would be 0 throughout the day. The more the patient documents voiding throughout the day the signifies worse the patient's described overactive bladder symptoms.
Measured: 12 weeks
Number of urge incontinence episodes
Compare number of urge incontinence episodes via 24-hour bladder diary at baseline and 12 weeks post treatment. We will also compare 12-weeks post treatment number of urge incontinence episodes after single therapy trials with patients who desire combined therapy for another 12 weeks. This is an objective measurement of how many times the patient has urge incontinence episodes over a 24 hour time frame post treatment. Though unlikely the lowest quantity would be 0 throughout the day. The more the patient documents voiding throughout the day the signifies worse the patient's described overactive bladder symptoms.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start1 Oct 2022
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Overactive Bladder SyndromeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single site, double blinded, randomized controlled trial of Mirabegron vs Vaginal Estradiol for overactive bladder syndrome
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Walter Reed National Military Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Christopher W. Heuer, DO, Walter Reed National Military Medical Center
- Investigators
- Christopher W Heuer, DO, Principal investigator, Urogynecology Fellow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05221021
- Sponsor's protocol ID
- 21-14282
- Status last verified
- Aug 2024
- First submitted
- 22 Dec 2021
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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 12559262Sexton CC, Coyne KS, Thompson C, Bavendam T, Chen CI, Markland A. Prevalence and effect on health-related quality of life of overactive bladder in older americans: results from the epidemiology of lower urinary tract symptoms study. J Am Geriatr Soc. 2011 Aug;59(8):1465-70. doi: 10.1111/j.1532-5415.2011.03492.x. Epub 2011 Jun 30.
PubMed 21718275Reynolds WS, Fowke J, Dmochowski R. The Burden of Overactive Bladder on US Public Health. Curr Bladder Dysfunct Rep. 2016 Mar;11(1):8-13. doi: 10.1007/s11884-016-0344-9. Epub 2016 Jan 23.
PubMed 27057265Coyne 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 24456314Milsom I, Coyne KS, Nicholson S, Kvasz M, Chen CI, Wein AJ. Global prevalence and economic burden of urgency urinary incontinence: a systematic review. Eur Urol. 2014 Jan;65(1):79-95. doi: 10.1016/j.eururo.2013.08.031. Epub 2013 Aug 27.
PubMed 24007713Benner JS, Nichol MB, Rovner ES, Jumadilova Z, Alvir J, Hussein M, Fanning K, Trocio JN, Brubaker L. Patient-reported reasons for discontinuing overactive bladder medication. BJU Int. 2010 May;105(9):1276-82. doi: 10.1111/j.1464-410X.2009.09036.x. Epub 2009 Nov 12.
PubMed 19912188Gray SL, Anderson ML, Dublin S, Hanlon JT, Hubbard R, Walker R, Yu O, Crane PK, Larson EB. Cumulative use of strong anticholinergics and incident dementia: a prospective cohort study. JAMA Intern Med. 2015 Mar;175(3):401-7. doi: 10.1001/jamainternmed.2014.7663.
PubMed 25621434Chancellor MB, Migliaccio-Walle K, Bramley TJ, Chaudhari SL, Corbell C, Globe D. Long-term patterns of use and treatment failure with anticholinergic agents for overactive bladder. Clin Ther. 2013 Nov;35(11):1744-51. doi: 10.1016/j.clinthera.2013.08.017. Epub 2013 Oct 3.
PubMed 24091072Chua KJ, Patel HV, Tabakin A, Srivastava A, Doppalapudi SK, Hyams E, Tunuguntla HSGR. Yearly Trends of Overactive Bladder Medication Usage. Urol Pract. 2021 Sep;8(5):546-554. doi: 10.1097/UPJ.0000000000000243. Epub 2021 Jun 24.
PubMed 37145398Maman K, Aballea S, Nazir J, Desroziers K, Neine ME, Siddiqui E, Odeyemi I, Hakimi Z. Comparative efficacy and safety of medical treatments for the management of overactive bladder: a systematic literature review and mixed treatment comparison. Eur Urol. 2014 Apr;65(4):755-65. doi: 10.1016/j.eururo.2013.11.010. Epub 2013 Nov 18.
PubMed 24275310Welk B, McArthur E. Increased risk of dementia among patients with overactive bladder treated with an anticholinergic medication compared to a beta-3 agonist: a population-based cohort study. BJU Int. 2020 Jul;126(1):183-190. doi: 10.1111/bju.15040. Epub 2020 Mar 19.
PubMed 32167223Wu T, Duan X, Cao CX, Peng CD, Bu SY, Wang KJ. The role of mirabegron in overactive bladder: a systematic review and meta-analysis. Urol Int. 2014;93(3):326-37. doi: 10.1159/000361079. Epub 2014 Aug 7.
PubMed 25115445Ketai LH, Komesu YM, Dodd AB, Rogers RG, Ling JM, Mayer AR. Urgency urinary incontinence and the interoceptive network: a functional magnetic resonance imaging study. Am J Obstet Gynecol. 2016 Oct;215(4):449.e1-449.e17. doi: 10.1016/j.ajog.2016.04.056. Epub 2016 May 9.
PubMed 27173081Yoshida M, Miyamae K, Iwashita H, Otani M, Inadome A. Management of detrusor dysfunction in the elderly: changes in acetylcholine and adenosine triphosphate release during aging. Urology. 2004 Mar;63(3 Suppl 1):17-23. doi: 10.1016/j.urology.2003.11.003.
PubMed 15013648Pratt TS, Suskind AM. Management of Overactive Bladder in Older Women. Curr Urol Rep. 2018 Sep 10;19(11):92. doi: 10.1007/s11934-018-0845-5.
PubMed 30203368
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Estradiol vs Oral Beta-3 Agonist for Treatment of Overactive Bladder Syndrome: A Single-Therapy, Double-Blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05221021
- Acronym / sponsor ID
- 21-14282
- Conditions
- Overactive Bladder Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Walter Reed National Military Medical CenterUS federal agency
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 2 Feb 2022 (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.
A single site, double-blinded, randomized controlled trial for postmenopausal women with urinary frequency, urgency, nocturia with or without urgency urinary incontinence symptoms. Patient's will be randomized between 0.01% vaginal estradiol cream with placebo oral pill or daily 50 milligrams oral Mirabegron with a placebo vaginal cream for 12 weeks.
Detailed description
Background/significance: Overactive Bladder Syndrome (OAB) is defined as urinary urgency, with or without urgency incontinence, and usually accompanied by frequency and nocturia. OAB remains an increasingly more prevalent disease, affecting over 45% of postmenopausal women over the age 65 within the United States. Epidemiological research continues to consistently highlight OAB's impact on patience's mental health, sleep quality, physical activity, occupational productivity and overall quality of life. OAB's economic burden cannot be overstated as well as a US cost-of-illness study reported a total cost of $66 billion in 2007 and estimated cost of over $82 billion in 2021.
Mainstay first-line forms of management for OAB include behavioral modifications such as bladder training (timed voiding, urge suppression techniques), pelvic floor physical therapy, fluid management and bladder irritant restrictions. Second-line forms of management consistent of pharmacotherapy including oral anticholinergics or beta-3 adrenoreceptor agonists. Multiple studies have shown that vaginal estrogen improves symptoms of urinary urgency and frequency in postmenopausal women. Limited data currently exist comparing beta-3 antagonists to vaginal estrogen use for overactive bladder syndrome as well as the combination of both.
Purpose: This study aims to compare the efficacy of vaginal estradiol with that of oral mirabegron in the treatment of overactive bladder in postmenopausal women and characterize outcomes in women undergoing combined therapy.
Study design: This is a single site, double-blinded, randomized controlled trial for 152 postmenopausal women with urinary frequency, urgency, nocturia with or without urgency urinary incontinence symptoms. Patient's will be randomized between 0.01% vaginal estradiol cream 1/2 gram once nightly for two weeks then three times per week or 50 milligrams oral Mirabegron once a night.
Procedures: Postmenopausal women with bothersome OAB symptoms will be eligible for the study. OAB symptoms will be based on the OAB-q (SF) symptom bother questionnaire with an initial score greater than 20. Other inclusion criteria include ability to speak English. Exclusion criteria include: Post void residual >200mL or >1/3 patient's total bladder volume, currently on or previously taking anticholinergic or beta- 3 antagonists within the past 1 month, untreated, symptomatic pelvic organ prolapse greater than Stage 2, contraindication to vaginal estrogen therapy, contraindication to Mirabegron, undiagnosed postmenopausal vaginal bleeding within the past 12 months, current diagnosis of a condition which explains their overactive bladder or incontinence symptoms.
Participants who elect to enroll will have a post-void residual determined, a demographic sheet, the OAB-q (SF) health-related quality of life (HRQL) questionnaire, a 24-hour voiding diary and Patient Global Impression of Severity (PGI-S). Participants will be randomized via random allocation rule fixed blocking in a 1:1 ratio to either vaginal estrogen or oral Mirabegron. After 12 weeks of single therapy, the patients will be contacted for follow up to complete all previous questionnaires, a 24-hour voiding diary as well as the PGI-I questionnaire. After the initial 12-weeks, single therapy follow up appointment, participants will be offered dual treatment (both vaginal estrogen and Mirabegron same doses/frequencies.) If the patient agrees she will receive dual treatment for 12 weeks and follow up with the same questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single site, double blinded, randomized controlled trial of Mirabegron vs Vaginal Estradiol for overactive bladder syndrome
| Arm | Type | Receives |
|---|---|---|
| Vaginal Estradiol with placebo oral pill | Active comparator | Drug: Vaginal estrogenPatient will receive 0.01% estradiol cream 1/2 gram applied vaginally once nightly for two weeks then three times per week with once daily placebo oral pill |
| Oral Mirabegron with placebo vaginal cream | Active comparator | Drug: Mirabegron 50 MG [Myrbetriq]Patient will receive 50 milligrams oral Mirabegron once daily and placebo vaginal cream (Medisca's VersaPro Cream Base) once nightly for two weeks then three times per week |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Raw score of 14 or more on OAB-q SF (adjusted score of 20)
- Postmenopausal defined by not having a period for 12 months or bilateral oophorectomy a least 12 months status post procedure, or women with prior hysterectomy and preserved ovaries over age 55 years old or having a documented follicle stimulating hormone level greater than 40mIU/mL.
- Ability to speak and read English
Key exclusion criteria (6 listed)
- Contraindications to Vaginal Estrogen or Mirabegron
- Post void residual >200mL or >1/3 patient's total bladder volume
- Currently on or previously taking anticholinergic or beta- 3 agonists within the past 1 month
- Symptomatic pelvic organ prolapse greater than Stage 2, contraindication to vaginal estrogen therapy
- Undiagnosed postmenopausal vaginal bleeding within the past 12 months
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 |
|---|---|---|
| Vaginal estrogenAlso: Estrace, Estradiol, Micronized Estrogen0.01% estradiol cream 1/2 gram applied vaginally once nightly for two weeks then three times per week with once daily placebo oral pill | Drug | Vaginal Estradiol with placebo oral pill |
| Mirabegron 50 MG [Myrbetriq]Also: Myrbetriq50mg oral Mirabegron once daily | Drug | Oral Mirabegron with placebo vaginal cream |
Primary outcome
OAB-q short form (SF) symptom bother scores
Time frame: 12 weeks
Primary Aim: Compare changes in the six-item OAB-q short form (SF) symptom bother scores from baseline to 12 weeks post treatment in postmenopausal women who receive either vaginal estradiol or Mirabegron. We will also compare 12-weeks post treatment OAB-q SF symptom bother scores after single therapy trials with patients who desire combined therapy for another 12 weeks. The OAB-q SF symptom bother questionnaire is based on six individual questions a 6-point scale ranging from 1 or "not at all" to 6 or "a very great deal." Per the guidance of the scoring manual, the raw scores are converted into scores ranging from 0 to 100 (0 being the minimum score and 100 being the maximum score.) The higher the score signifies that the patient has worse bothersome overactive bladder symptoms. The conversion to a 100 point scale is based on the equation as follows: ((Raw score - 6) / 36) x 100.
5 secondary outcomes
health-related quality of life (HRQL) of the OAB-q SF scores
Time frame: 12 weeks
Patient Global Impression of Severity (PGI-S) scores
Time frame: 12 weeks
Patient Global Impression of Improvement (PGI-I) scores
Time frame: 12 weeks
Number of voids
Time frame: 12 weeks
Number of urge incontinence episodes
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- 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 21718275Sexton CC, Coyne KS, Thompson C, Bavendam T, Chen CI, Markland A. Prevalence and effect on health-related quality of life of overactive bladder in older americans: results from the epidemiology of lower urinary tract symptoms study. J Am Geriatr Soc. 2011 Aug;59(8):1465-70. doi: 10.1111/j.1532-5415.2011.03492.x. Epub 2011 Jun 30.
- Background: PubMed 27057265Reynolds WS, Fowke J, Dmochowski R. The Burden of Overactive Bladder on US Public Health. Curr Bladder Dysfunct Rep. 2016 Mar;11(1):8-13. doi: 10.1007/s11884-016-0344-9. Epub 2016 Jan 23.
- 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 24007713Milsom I, Coyne KS, Nicholson S, Kvasz M, Chen CI, Wein AJ. Global prevalence and economic burden of urgency urinary incontinence: a systematic review. Eur Urol. 2014 Jan;65(1):79-95. doi: 10.1016/j.eururo.2013.08.031. Epub 2013 Aug 27.
- Background: PubMed 19912188Benner JS, Nichol MB, Rovner ES, Jumadilova Z, Alvir J, Hussein M, Fanning K, Trocio JN, Brubaker L. Patient-reported reasons for discontinuing overactive bladder medication. BJU Int. 2010 May;105(9):1276-82. doi: 10.1111/j.1464-410X.2009.09036.x. Epub 2009 Nov 12.
- Background: PubMed 25621434Gray SL, Anderson ML, Dublin S, Hanlon JT, Hubbard R, Walker R, Yu O, Crane PK, Larson EB. Cumulative use of strong anticholinergics and incident dementia: a prospective cohort study. JAMA Intern Med. 2015 Mar;175(3):401-7. doi: 10.1001/jamainternmed.2014.7663.
- Background: PubMed 24091072Chancellor MB, Migliaccio-Walle K, Bramley TJ, Chaudhari SL, Corbell C, Globe D. Long-term patterns of use and treatment failure with anticholinergic agents for overactive bladder. Clin Ther. 2013 Nov;35(11):1744-51. doi: 10.1016/j.clinthera.2013.08.017. Epub 2013 Oct 3.
- Background: PubMed 37145398Chua KJ, Patel HV, Tabakin A, Srivastava A, Doppalapudi SK, Hyams E, Tunuguntla HSGR. Yearly Trends of Overactive Bladder Medication Usage. Urol Pract. 2021 Sep;8(5):546-554. doi: 10.1097/UPJ.0000000000000243. Epub 2021 Jun 24.
- Background: PubMed 24275310Maman K, Aballea S, Nazir J, Desroziers K, Neine ME, Siddiqui E, Odeyemi I, Hakimi Z. Comparative efficacy and safety of medical treatments for the management of overactive bladder: a systematic literature review and mixed treatment comparison. Eur Urol. 2014 Apr;65(4):755-65. doi: 10.1016/j.eururo.2013.11.010. Epub 2013 Nov 18.
- Background: PubMed 32167223Welk B, McArthur E. Increased risk of dementia among patients with overactive bladder treated with an anticholinergic medication compared to a beta-3 agonist: a population-based cohort study. BJU Int. 2020 Jul;126(1):183-190. doi: 10.1111/bju.15040. Epub 2020 Mar 19.
- Background: PubMed 25115445Wu T, Duan X, Cao CX, Peng CD, Bu SY, Wang KJ. The role of mirabegron in overactive bladder: a systematic review and meta-analysis. Urol Int. 2014;93(3):326-37. doi: 10.1159/000361079. Epub 2014 Aug 7.
- Individual participant dataSharing planned: No
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Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
Tensi+ for Treating Overactive Bladder
Overactive Bladder (OAB)
Not yet recruitingObservational study
Efficacy and Safety of Peroneal Electric Transcutaneous Neuromodulation in the Real-world Clinical Practice
Overactive Bladder Syndrome
Recruiting
Improving Overactive Bladder Treatment Access and Adherence
Overactive Bladder Syndrome, Urinary Incontinence
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.
Christopher W Heuer, DO principal investigator
Urogynecology Fellow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vaginal estrogen and Mirabegron 50 MG [Myrbetriq] in people with Overactive Bladder Syndrome, run by Walter Reed National Military Medical Center 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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 19 Aug 2024. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher W Heuer, DO (2626231053, christopher.w.heuer@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OAB-q short form (SF) symptom bother scores (time frame: 12 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 NCT05221021, which also lists 29 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 19 Aug 2024.