Overactive BladderPhase 4NCT04020510
Standard Injections Versus Reduced Injections for Intravesical onabotulinumtoxinA Treatment of Overactive Bladder
A Phase 4 study testing onaBoNT-A in people with Overactive Bladder, run by Walter Reed National Military Medical Center at 1 site in United States.
Trial summary
OnabotulinumtoxinA is an effective treatment for both idiopathic and neurogenic overactive bladder and was FDA approved for this indication in 2013. The standard technique for injecting onabotulinumtoxinA into the detrusor is mixing 100 units of onabotulinumtoxinA into 10mL of injectable normal saline and injecting 20… 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?
- onaBoNT-A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 31 Dec 2021
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males or Females ≥ 18 years of age
- Predominant complaint of urinary urgency, urinary frequency or urge incontinence
- Failed at least one medication (inadequate or poorly tolerated response) or behavior modification technique (timed voiding, pelvic floor physical therapy, etc.), or decline such interventions
- Willingness to perform self-catheterization in the event of symptomatic urinary retention
- Ability to follow study instructions and likely to complete all required follow-up
Who cannot join
- Concurrent use of oral medications for treatment of OAB (anticholinergics or beta 3 agonists).
- Post void residual volume > 200 ml
- Symptomatic prolapse > POP-Q (Pelvic Organ Prolapse Quantification) stage 2 or greater that is untreated
- Evidence of active UTI (bladder infection)
- Any previous use of intradetrusor botulinum toxin (onabotulinumtoxinA or abobotulinumtoxinA) within the preceding 6 months
- Use of >/= 400 units bontulinum toxin in the preceding 3months in other areas of the body
Show all 13Show fewer
- Procedure performed in the main operating room (not outpatient setting)
- Concurrent diagnosis of interstitial cystitis/painful bladder syndrome
- Females who are pregnant or planning a pregnancy during the study or who think that they may be pregnant at the start of the study, or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study.
- Any medical condition that may put the subject at increased risk with exposure to botulinum-A toxin, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis/motor neuron disease, neuropathy, renal stones, or any other disorder that might interfere with neuromuscular function
- Known allergy or sensitivity to any of the components of onabotulinumtoxinA
- Concurrent participation in another investigational drug or device study that could impact the results
- Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study
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
Angela M DiCarlo-Meacham, MD, 636-288-2955, angeladmmd@gmail.com
Christine Vaccaro, DO, 301-400-2469, christine.m.vaccaro.mil@mail.mil
About this study
Official title: Standard Injections Versus Reduced Injections for Intravesical onabotulinumtoxinA for Treatment of Idiopathic and Neurogenic Overactive Bladder: a Randomized Trial
OnabotulinumtoxinA is an effective treatment for both idiopathic and neurogenic overactive bladder and was FDA approved for this indication in 2013. The standard technique for injecting onabotulinumtoxinA into the detrusor is mixing 100 units of onabotulinumtoxinA into 10mL of injectable normal saline and injecting 20 sites with 0.5mL in the posterior wall of hte bladder for idiopathic overactive bladder and mixing 200 units into 30mL and injecting 30 sites with 1mL for neurogenic overactive bladder. The purpose of this study is to compare the efficacy of a technique using a reduced number of injections with the same dosage of onabotulinumtoxinA to the standard technique. The hypothesis is that the reduced technique will not be inferior in terms of efficacy as the standard technique and that there will be a lower incidence of urinary tract infections and urinary retention requiring catheterization post-procedure.
Read the detailed description
Overactive bladder has a large economic burden within the United States and internationally. Patients are often non-compliant with first and second line treatments for overactive bladder or find that they do not significantly improve symptoms. Intradetrusor onabotulinumtoxinA injection has been showed in many studies to significantly improve overactive bladder symptoms and quality of life in patients and was approved by the FDA for the treatment of overactive bladder in 2013.
Intradetrusor onabotulinumtoxinA injections are often performed in the office setting under local anesthesia. The standard technique for injecting onabotulinumtoxinA into the detrusor is mixing 100 units of onabotulinumtoxinA into 10mL of injectable normal saline and injecting 20 sites with 0.5mL in the posterior wall of hte bladder for idiopathic overactive bladder and mixing 200 units into 30mL and injecting 30 sites with 1mL for neurogenic overactive bladder. Despite instillation of local anesthetic into the bladder prior to the procedure, many patients still find the procedure uncomfortable and may elect not to have treatment or to undergo treatment under sedation.
Some literature exists that suggests that a fewer number of injections with the same dosage of onabotulinumtoxinA still provides significant improvement in symptoms for patients with the potential for fewer adverse events, specifically urinary tract infection and urinary retention requiring catheterization.
The purpose of this study is to directly compare the standard techniqe for intradetrusor onabotulinumtoxinA injections to a reduced injection technique to compare efficacy and rates of adverse events between the two groups. The hypothesis is that the reduced injection technique will be non-inferior to the standard technique.
Participants in the study will be randomized to either the standard technique or the reduced technique at the time of their procedures, provided they meet the inclusion and exclusion criteria and provide written consent to participate. Efficacy will be measured using a series of validated patient questionnaires. Scores will be obtained at a baseline and then at two other time points post-procedure (4-12 weeks and 6-9 months). Rates of adverse outcomes, specifically urinary tract infection and urinary retention requiring catheterization, will also be obtained following the procedure.
Other than the randomization of patients into study and control groups and having patients complete a series of questionnaires, the care of patients undergoing intradetrusor onabotulinumtoxinA injections will follow the standard of care. All patients will be screened for urinary tract infection prior to the procedure and if they screen positive will have their procedures delayed until after they are treated. All patients will receive pre-procedure antibiotics according to the American Urological Association guidelines. All patients will be screened for urinary retention and for symptoms of urinary tract infection at their initial post-procedure follow-up at 4-12 weeks and treated accordingly if they develop either.
- Conditions
- Overactive Bladder
- Being tested
- onaBoNT-A
- 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.
onaBoNT-ADrug
Also called Botox
Intradetrusor onabotulinumtoxinA in either the standard number of injections or a reduced number of injections
| Study group | Role | What they receive |
|---|---|---|
| Standard Injections | Active comparator | For idiopathic overactive bladder, 100 units of onabotulinumtoxinA mixed in 10mL of injectable saline injected in 20 sites with 0.5mL per injection along the posterior wall of the bladder above the trigone. For neurogenic overactive bladder, 200 units of onabotulinumtoxinA mixed in 30mL of injectable saline injected in 30 sites with 1mL per injection along the posterior wall of the bladder above the trigone. Receives: Drug: onaBoNT-A |
| Reduced Injections | Experimental | For idiopathic overactive bladder, 100 units of onabotulinumtoxinA mixed in 10mL of injectable saline injected in 5 sites with 2mL per injection in an "X" configuration on posterior wall of the bladder above the trigone. For neurogenic overactive bladder, 200 units of onabotulinumtoxinA mixed in 10mL of injectable saline injected in 5 sites with 2mL per injection in an "X" configuration on posterior wall of the bladder above the trigone. Receives: Drug: onaBoNT-A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in overactive bladder symptom severity and health related quality of life scores on the overactive bladder questionnaire short form
The overactive bladder questionnaire short form is a validated questionnaire assessing both symptoms and quality of life related to overactive bladder. The survey has two subscales, a health related quality of life scale and a symptom severity scale. Each subscale is scored separately with a range of 0 to 100. For health related quality of life a score of 0 indicates worst quality of life and 100 indicating best quality of life. For symptom severity, the scores also range from 0 to 100 but with higher scores indicating greater symptom severity and lower scores less symptom severity.
Measured: 4-12 weeks post-procedure
Mean change from baseline in overactive bladder symptom severity and health related quality of life scores on the overactive bladder questionnaire short form
The overactive bladder questionnaire short form is a validated questionnaire assessing both symptoms and quality of life related to overactive bladder. The survey has two subscales, a health related quality of life scale and a symptom severity scale. Each subscale is scored separately with a range of 0 to 100. For health related quality of life a score of 0 indicates worst quality of life and 100 indicating best quality of life. For symptom severity, the scores also range from 0 to 100 but with higher scores indicating greater symptom severity and lower scores less symptom severity.
Measured: 6-9 months post-procedure
Mean change from baseline in overactive bladder symptoms on the International Consultation on Incontinence Questionnaire short form
The International Consultation on Incontinence Questionnaire short form is a validated questionnaire assessing symptoms of overactive bladder and effect on quality of life. The scores range from 0 to 21 with higher scores indicating worse symptom severity and effect on quality of life.
Measured: 4-12 weeks post-procedure
Mean change from baseline in overactive bladder symptoms on the International Consultation on Incontinence Questionnaire short form
The International Consultation on Incontinence Questionnaire short form is a validated questionnaire assessing symptoms of overactive bladder and effect on quality of life. Scores range from 0 to 21 with higher scores indicating greater symptom severity.
Measured: 6-9 months post-procedure
Mean change from baseline in overactive bladder symptoms assessed with the Patient Global Impression of Severity and Improvement scores
The Patient Global Impression of Severity and Patient Global Impression of Improvement scores are validated single question surveys that assess patients' impression of the severity of their illness prior to treatment intervention and the degree of improvement following treatment intervention. The Patient Global Impression of Severity is a 4 point Likert scale ranging from 1 to 4 with 1 being normal and 4 being severe symptoms (mild and moderate completing the range of scores). The Patient Global Impression of Improvement is a 7 point Likert scale with 1 being very much better and 7 being very much worse (much better, a little better, no change, a little worse, and much worse completing the range of scores).
Measured: baseline, 4-12 weeks post-procedure and 6-9 months post-procedure
Mean change from baseline in overactive bladder symptoms assessed with the Patient Global Impression of Severity and Improvement scores
The Patient Global Impression of Severity and Patient Global Impression of Improvement scores are validated single question surveys that assess patients' impression of the severity of their illness prior to treatment intervention and the degree of improvement following treatment intervention. The Patient Global Impression of Severity is a 4 point Likert scale ranging from 1 to 4 with 1 being normal and 4 being severe symptoms (mild and moderate completing the range of scores). The Patient Global Impression of Improvement is a 7 point Likert scale with 1 being very much better and 7 being very much worse (much better, a little better, no change, a little worse, and much worse completing the range of scores).
Measured: 4-12 weeks post-procedure
Mean change from baseline in overactive bladder symptoms and incontinence episodes using patient reported pad counts and episodes of nocturia
Number of pads used for urge incontinence and nocturia episodes are frequent metrics used for assessing efficacy of overactive bladder treatments
Measured: 6-9 months post-procedure
Secondary outcomes (3)
Incidence of urinary tract infection
Urinary tract infection is a common complication from intradetrusor onabotulinumtoxinA treatment
Measured: 1 day to 12 weeks post-procedure
Incidence of urinary retention requiring intermittent catheterization
Urinary retention is a common complication following intradetrusor onabotulinumtoxinA treatment
Measured: 2-6 weeks post-procedure
Mean change in pain from baseline following intradetrusor onabotulinumtoxinA injection using visual analog scale
Visual Analog Scales are validated tools for assessing pain. The scale is scored from 0 to 10 with 0 being no pain and 10 being worst possible pain.
Measured: immediately post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start1 Jul 2019
- Primary completion1 Jul 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies 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
- Masking
- None (open label)
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Walter Reed National Military Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Angela DiCarlo-Meacham, Walter Reed National Military Medical Center
- Investigators
- Angela DiCarlo-Meacham, MD, Principal investigator, Walter Reed National Military Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04020510
- Sponsor's protocol ID
- 2019-0232
- Status last verified
- Apr 2020
- First submitted
- 11 Jul 2019
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Avallone MA, Sack BS, El-Arabi A, Guralnick ML, O'Connor RC. Less is more-A pilot study evaluating one to three intradetrusor sites for injection of OnabotulinumtoxinA for neurogenic and idiopathic detrusor overactivity. Neurourol Urodyn. 2017 Apr;36(4):1104-1107. doi: 10.1002/nau.23052. Epub 2016 Jun 10.
PubMed 27283922Lopez Ramos H, Torres Castellanos L, Ponce Esparza I, Jaramillo A, Rodriguez A, Moreno Bencardino C. Management of Overactive Bladder With OnabotulinumtoxinA: Systematic Review and Meta-analysis. Urology. 2017 Feb;100:53-58. doi: 10.1016/j.urology.2016.10.026. Epub 2016 Oct 24.
PubMed 27789302Sirls LT, Tennstedt S, Brubaker L, Kim HY, Nygaard I, Rahn DD, Shepherd J, Richter HE. The minimum important difference for the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form in women with stress urinary incontinence. Neurourol Urodyn. 2015 Feb;34(2):183-7. doi: 10.1002/nau.22533. Epub 2013 Nov 23.
PubMed 24273137Yalcin I, Bump RC. Validation of two global impression questionnaires for incontinence. Am J Obstet Gynecol. 2003 Jul;189(1):98-101. doi: 10.1067/mob.2003.379.
PubMed 12861145Visco AG, Brubaker L, Richter HE, Nygaard I, Paraiso MF, Menefee SA, Schaffer J, Lowder J, Khandwala S, Sirls L, Spino C, Nolen TL, Wallace D, Meikle SF; Pelvic Floor Disorders Network. Anticholinergic therapy vs. onabotulinumtoxina for urgency urinary incontinence. N Engl J Med. 2012 Nov 8;367(19):1803-13. doi: 10.1056/NEJMoa1208872. Epub 2012 Oct 4.
PubMed 23036134Coyne KS, Matza LS, Thompson CL, Kopp ZS, Khullar V. Determining the importance of change in the overactive bladder questionnaire. J Urol. 2006 Aug;176(2):627-32; discussion 632. doi: 10.1016/j.juro.2006.03.088.
PubMed 16813906Ramirez-Castaneda J, Jankovic J, Comella C, Dashtipour K, Fernandez HH, Mari Z. Diffusion, spread, and migration of botulinum toxin. Mov Disord. 2013 Nov;28(13):1775-83. doi: 10.1002/mds.25582. Epub 2013 Jul 18.
PubMed 23868503Coelho A, Cruz F, Cruz CD, Avelino A. Spread of onabotulinumtoxinA after bladder injection. Experimental study using the distribution of cleaved SNAP-25 as the marker of the toxin action. Eur Urol. 2012 Jun;61(6):1178-84. doi: 10.1016/j.eururo.2012.01.046. Epub 2012 Feb 1.
PubMed 22306320Karsenty G, Denys P, Amarenco G, De Seze M, Game X, Haab F, Kerdraon J, Perrouin-Verbe B, Ruffion A, Saussine C, Soler JM, Schurch B, Chartier-Kastler E. Botulinum toxin A (Botox) intradetrusor injections in adults with neurogenic detrusor overactivity/neurogenic overactive bladder: a systematic literature review. Eur Urol. 2008 Feb;53(2):275-87. doi: 10.1016/j.eururo.2007.10.013. Epub 2007 Oct 16.
PubMed 17988791Liao CH, Chen SF, Kuo HC. Different number of intravesical onabotulinumtoxinA injections for patients with refractory detrusor overactivity do not affect treatment outcome: A prospective randomized comparative study. Neurourol Urodyn. 2016 Aug;35(6):717-23. doi: 10.1002/nau.22780. Epub 2015 Apr 24.
PubMed 25914349Stewart 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 12811491Tijnagel MJ, Scheepe JR, Blok BF. Real life persistence rate with antimuscarinic treatment in patients with idiopathic or neurogenic overactive bladder: a prospective cohort study with solifenacin. BMC Urol. 2017 Apr 13;17(1):30. doi: 10.1186/s12894-017-0216-4.
PubMed 28403849Coyne KS, Thompson CL, Lai JS, Sexton CC. An overactive bladder symptom and health-related quality of life short-form: validation of the OAB-q SF. Neurourol Urodyn. 2015 Mar;34(3):255-63. doi: 10.1002/nau.22559. Epub 2014 Jan 13.
PubMed 25783168Crowner BE, Torres-Russotto D, Carter AR, Racette BA. Systemic weakness after therapeutic injections of botulinum toxin a: a case series and review of the literature. Clin Neuropharmacol. 2010 Sep-Oct;33(5):243-7. doi: 10.1097/WNF.0b013e3181f5329e.
PubMed 20852412
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard Injections Versus Reduced Injections for Intravesical onabotulinumtoxinA for Treatment of Idiopathic and Neurogenic Overactive Bladder: a Randomized Trial
- ClinicalTrials.gov ID
- NCT04020510
- Acronym / sponsor ID
- 2019-0232
- Conditions
- Overactive Bladder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Walter Reed National Military Medical CenterUS federal agency
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 16 Jul 2019 (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.
OnabotulinumtoxinA is an effective treatment for both idiopathic and neurogenic overactive bladder and was FDA approved for this indication in 2013. The standard technique for injecting onabotulinumtoxinA into the detrusor is mixing 100 units of onabotulinumtoxinA into 10mL of injectable normal saline and injecting 20 sites with 0.5mL in the posterior wall of hte bladder for idiopathic overactive bladder and mixing 200 units into 30mL and injecting 30 sites with 1mL for neurogenic overactive bladder. The purpose of this study is to compare the efficacy of a technique using a reduced number of injections with the same dosage of onabotulinumtoxinA to the standard technique. The hypothesis is that the reduced technique will not be inferior in terms of efficacy as the standard technique and that there will be a lower incidence of urinary tract infections and urinary retention requiring catheterization post-procedure.
Detailed description
Overactive bladder has a large economic burden within the United States and internationally. Patients are often non-compliant with first and second line treatments for overactive bladder or find that they do not significantly improve symptoms. Intradetrusor onabotulinumtoxinA injection has been showed in many studies to significantly improve overactive bladder symptoms and quality of life in patients and was approved by the FDA for the treatment of overactive bladder in 2013.
Intradetrusor onabotulinumtoxinA injections are often performed in the office setting under local anesthesia. The standard technique for injecting onabotulinumtoxinA into the detrusor is mixing 100 units of onabotulinumtoxinA into 10mL of injectable normal saline and injecting 20 sites with 0.5mL in the posterior wall of hte bladder for idiopathic overactive bladder and mixing 200 units into 30mL and injecting 30 sites with 1mL for neurogenic overactive bladder. Despite instillation of local anesthetic into the bladder prior to the procedure, many patients still find the procedure uncomfortable and may elect not to have treatment or to undergo treatment under sedation.
Some literature exists that suggests that a fewer number of injections with the same dosage of onabotulinumtoxinA still provides significant improvement in symptoms for patients with the potential for fewer adverse events, specifically urinary tract infection and urinary retention requiring catheterization.
The purpose of this study is to directly compare the standard techniqe for intradetrusor onabotulinumtoxinA injections to a reduced injection technique to compare efficacy and rates of adverse events between the two groups. The hypothesis is that the reduced injection technique will be non-inferior to the standard technique.
Participants in the study will be randomized to either the standard technique or the reduced technique at the time of their procedures, provided they meet the inclusion and exclusion criteria and provide written consent to participate. Efficacy will be measured using a series of validated patient questionnaires. Scores will be obtained at a baseline and then at two other time points post-procedure (4-12 weeks and 6-9 months). Rates of adverse outcomes, specifically urinary tract infection and urinary retention requiring catheterization, will also be obtained following the procedure.
Other than the randomization of patients into study and control groups and having patients complete a series of questionnaires, the care of patients undergoing intradetrusor onabotulinumtoxinA injections will follow the standard of care. All patients will be screened for urinary tract infection prior to the procedure and if they screen positive will have their procedures delayed until after they are treated. All patients will receive pre-procedure antibiotics according to the American Urological Association guidelines. All patients will be screened for urinary retention and for symptoms of urinary tract infection at their initial post-procedure follow-up at 4-12 weeks and treated accordingly if they develop either.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Injections | Active comparator | Drug: onaBoNT-AFor idiopathic overactive bladder, 100 units of onabotulinumtoxinA mixed in 10mL of injectable saline injected in 20 sites with 0.5mL per injection along the posterior wall of the bladder above the trigone. For neurogenic overactive bladder, 200 units of onabotulinumtoxinA mixed in 30mL of injectable saline injected in 30 sites with 1mL per injection along the posterior wall of the bladder above the trigone. |
| Reduced Injections | Experimental | Drug: onaBoNT-AFor idiopathic overactive bladder, 100 units of onabotulinumtoxinA mixed in 10mL of injectable saline injected in 5 sites with 2mL per injection in an "X" configuration on posterior wall of the bladder above the trigone. For neurogenic overactive bladder, 200 units of onabotulinumtoxinA mixed in 10mL of injectable saline injected in 5 sites with 2mL per injection in an "X" configuration on posterior wall of the bladder above the trigone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males or Females ≥ 18 years of age
- Predominant complaint of urinary urgency, urinary frequency or urge incontinence
- Failed at least one medication (inadequate or poorly tolerated response) or behavior modification technique (timed voiding, pelvic floor physical therapy, etc.), or decline such interventions
- Willingness to perform self-catheterization in the event of symptomatic urinary retention
- Ability to follow study instructions and likely to complete all required follow-up
Key exclusion criteria (13 listed)
- Concurrent use of oral medications for treatment of OAB (anticholinergics or beta 3 agonists).
- Post void residual volume > 200 ml
- Symptomatic prolapse > POP-Q (Pelvic Organ Prolapse Quantification) stage 2 or greater that is untreated
- Evidence of active UTI (bladder infection)
- Any previous use of intradetrusor botulinum toxin (onabotulinumtoxinA or abobotulinumtoxinA) within the preceding 6 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 |
|---|---|---|
| onaBoNT-AAlso: BotoxIntradetrusor onabotulinumtoxinA in either the standard number of injections or a reduced number of injections | Drug | Reduced Injections, Standard Injections |
Primary outcome
Mean change from baseline in overactive bladder symptom severity and health related quality of life scores on the overactive bladder questionnaire short form
Time frame: 4-12 weeks post-procedure
The overactive bladder questionnaire short form is a validated questionnaire assessing both symptoms and quality of life related to overactive bladder. The survey has two subscales, a health related quality of life scale and a symptom severity scale. Each subscale is scored separately with a range of 0 to 100. For health related quality of life a score of 0 indicates worst quality of life and 100 indicating best quality of life. For symptom severity, the scores also range from 0 to 100 but with higher scores indicating greater symptom severity and lower scores less symptom severity.
Mean change from baseline in overactive bladder symptom severity and health related quality of life scores on the overactive bladder questionnaire short form
Time frame: 6-9 months post-procedure
The overactive bladder questionnaire short form is a validated questionnaire assessing both symptoms and quality of life related to overactive bladder. The survey has two subscales, a health related quality of life scale and a symptom severity scale. Each subscale is scored separately with a range of 0 to 100. For health related quality of life a score of 0 indicates worst quality of life and 100 indicating best quality of life. For symptom severity, the scores also range from 0 to 100 but with higher scores indicating greater symptom severity and lower scores less symptom severity.
Mean change from baseline in overactive bladder symptoms on the International Consultation on Incontinence Questionnaire short form
Time frame: 4-12 weeks post-procedure
The International Consultation on Incontinence Questionnaire short form is a validated questionnaire assessing symptoms of overactive bladder and effect on quality of life. The scores range from 0 to 21 with higher scores indicating worse symptom severity and effect on quality of life.
Mean change from baseline in overactive bladder symptoms on the International Consultation on Incontinence Questionnaire short form
Time frame: 6-9 months post-procedure
The International Consultation on Incontinence Questionnaire short form is a validated questionnaire assessing symptoms of overactive bladder and effect on quality of life. Scores range from 0 to 21 with higher scores indicating greater symptom severity.
Mean change from baseline in overactive bladder symptoms assessed with the Patient Global Impression of Severity and Improvement scores
Time frame: baseline, 4-12 weeks post-procedure and 6-9 months post-procedure
The Patient Global Impression of Severity and Patient Global Impression of Improvement scores are validated single question surveys that assess patients' impression of the severity of their illness prior to treatment intervention and the degree of improvement following treatment intervention. The Patient Global Impression of Severity is a 4 point Likert scale ranging from 1 to 4 with 1 being normal and 4 being severe symptoms (mild and moderate completing the range of scores). The Patient Global Impression of Improvement is a 7 point Likert scale with 1 being very much better and 7 being very much worse (much better, a little better, no change, a little worse, and much worse completing the range of scores).
Mean change from baseline in overactive bladder symptoms assessed with the Patient Global Impression of Severity and Improvement scores
Time frame: 4-12 weeks post-procedure
The Patient Global Impression of Severity and Patient Global Impression of Improvement scores are validated single question surveys that assess patients' impression of the severity of their illness prior to treatment intervention and the degree of improvement following treatment intervention. The Patient Global Impression of Severity is a 4 point Likert scale ranging from 1 to 4 with 1 being normal and 4 being severe symptoms (mild and moderate completing the range of scores). The Patient Global Impression of Improvement is a 7 point Likert scale with 1 being very much better and 7 being very much worse (much better, a little better, no change, a little worse, and much worse completing the range of scores).
Mean change from baseline in overactive bladder symptoms and incontinence episodes using patient reported pad counts and episodes of nocturia
Time frame: 6-9 months post-procedure
Number of pads used for urge incontinence and nocturia episodes are frequent metrics used for assessing efficacy of overactive bladder treatments
3 secondary outcomes
Incidence of urinary tract infection
Time frame: 1 day to 12 weeks post-procedure
Incidence of urinary retention requiring intermittent catheterization
Time frame: 2-6 weeks post-procedure
Mean change in pain from baseline following intradetrusor onabotulinumtoxinA injection using visual analog scale
Time frame: immediately post-procedure
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 28 Apr 2020.
- Background: PubMed 27283922Avallone MA, Sack BS, El-Arabi A, Guralnick ML, O'Connor RC. Less is more-A pilot study evaluating one to three intradetrusor sites for injection of OnabotulinumtoxinA for neurogenic and idiopathic detrusor overactivity. Neurourol Urodyn. 2017 Apr;36(4):1104-1107. doi: 10.1002/nau.23052. Epub 2016 Jun 10.
- Background: PubMed 27789302Lopez Ramos H, Torres Castellanos L, Ponce Esparza I, Jaramillo A, Rodriguez A, Moreno Bencardino C. Management of Overactive Bladder With OnabotulinumtoxinA: Systematic Review and Meta-analysis. Urology. 2017 Feb;100:53-58. doi: 10.1016/j.urology.2016.10.026. Epub 2016 Oct 24.
- Background: PubMed 24273137Sirls LT, Tennstedt S, Brubaker L, Kim HY, Nygaard I, Rahn DD, Shepherd J, Richter HE. The minimum important difference for the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form in women with stress urinary incontinence. Neurourol Urodyn. 2015 Feb;34(2):183-7. doi: 10.1002/nau.22533. Epub 2013 Nov 23.
- Background: PubMed 12861145Yalcin I, Bump RC. Validation of two global impression questionnaires for incontinence. Am J Obstet Gynecol. 2003 Jul;189(1):98-101. doi: 10.1067/mob.2003.379.
- Background: PubMed 23036134Visco AG, Brubaker L, Richter HE, Nygaard I, Paraiso MF, Menefee SA, Schaffer J, Lowder J, Khandwala S, Sirls L, Spino C, Nolen TL, Wallace D, Meikle SF; Pelvic Floor Disorders Network. Anticholinergic therapy vs. onabotulinumtoxina for urgency urinary incontinence. N Engl J Med. 2012 Nov 8;367(19):1803-13. doi: 10.1056/NEJMoa1208872. Epub 2012 Oct 4.
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- Background: PubMed 22306320Coelho A, Cruz F, Cruz CD, Avelino A. Spread of onabotulinumtoxinA after bladder injection. Experimental study using the distribution of cleaved SNAP-25 as the marker of the toxin action. Eur Urol. 2012 Jun;61(6):1178-84. doi: 10.1016/j.eururo.2012.01.046. Epub 2012 Feb 1.
- Background: PubMed 17988791Karsenty G, Denys P, Amarenco G, De Seze M, Game X, Haab F, Kerdraon J, Perrouin-Verbe B, Ruffion A, Saussine C, Soler JM, Schurch B, Chartier-Kastler E. Botulinum toxin A (Botox) intradetrusor injections in adults with neurogenic detrusor overactivity/neurogenic overactive bladder: a systematic literature review. Eur Urol. 2008 Feb;53(2):275-87. doi: 10.1016/j.eururo.2007.10.013. Epub 2007 Oct 16.
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- Background: PubMed 28403849Tijnagel MJ, Scheepe JR, Blok BF. Real life persistence rate with antimuscarinic treatment in patients with idiopathic or neurogenic overactive bladder: a prospective cohort study with solifenacin. BMC Urol. 2017 Apr 13;17(1):30. doi: 10.1186/s12894-017-0216-4.
- 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.
Angela DiCarlo-Meacham, MD principal investigator
Walter Reed National Military Medical Center
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 onaBoNT-A in people with Overactive Bladder, 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 5 inclusion and 13 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 28 Apr 2020. 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 Angela DiCarlo-Meacham, MD (636-288-2955, angeladmmd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from baseline in overactive bladder symptom severity and health related quality of life scores on the overactive bladder questionnaire short form (time frame: 4-12 weeks post-procedure). The study lists 7 primary outcomes in all. 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 NCT04020510, which also lists 14 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 28 Apr 2020.