Overactive BladderNCT06483217
Optimal Injection Interval for Intra-Detrusor Botulinum Toxin
A study testing Patient-directed follow up in people with Overactive Bladder and Urinary Urgency, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
Trial summary
The goal of this clinical trial is to see if patients deciding their own follow up times can increase the effectiveness of botulinum toxin (BTX or "Botox") injection for overactive bladder (OAB). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overactive Bladder, Urinary Urgency, Urinary Incontinence
- What is being tested?
- Patient-directed follow up
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2024to Oct 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
- diagnosis of overactive bladder, detrusor overactivity, urinary urgency, urinary frequency, nocturnal polyuria, or urge urinary incontinence
- pursuing treatment with intravesical botulinum toxin injections
Who cannot join
- non-OAB diagnosis such as pelvic pain or interstitial cystitis
Trial locations and contacts
1 site in 1 country.
United States1 site
Louisiana State University Health Science Center
New Orleans, Louisiana, 70112
Zachary Selzler, MD, 504-568-2383, zselzl@lsuhsc.edu
Zachary Selzler, MD
About this study
Official title: Optimal Injection Interval for Intra-Detrusor Botulinum Toxin: A Randomized Controlled Trial Utilizing a Patient-Centered Approach
The goal of this clinical trial is to see if patients deciding their own follow up times can increase the effectiveness of botulinum toxin (BTX or "Botox") injection for overactive bladder (OAB). The main questions it aims to answer are:
- Does the time between repeat injections differ from the 6-month standard when it is based on patient symptoms alone?
- Does symptom control or patient satisfaction change when patients control their own follow up times?
Participants will undergo standard botulinum toxin injection into the bladder for OAB treatment and will then be randomly assigned to follow up either at a standard 6-month interval or whenever they feel their symptoms return.
Read the detailed description
Overactive bladder (OAB) is defined by symptoms of urinary urgency, frequency, or nocturia with or without incontinence in the absence of urinary tract infection or other attributable pathology. This disease affects up to 40% of women in the United States and can have a significant impact on quality of life. It is expected to increase in prevalence with the aging US population. There are a wide variety of treatment options for OAB which range from fluid management and lifestyle modifications (first line therapy), pelvic floor physical therapy and oral medications (second line therapy), and procedural interventions such as neuromodulation or intravesical botulinum toxin (BTX-A) injections (third line therapy).
BTX-A is a potent neurotoxin derived from the anaerobic bacterium Clostridium botulinum that inhibits presynaptic release of acetylcholine from motor neurons at the neuromuscular junction to induce flaccid paralysis of musculature. It has also been found to affect sensory responses of nerve afferent nerve fibers and likely has a complex multifactorial effect on the release of excitatory neurotransmitters. Because of this, injection of BTX-A into the detrusor muscle of the bladder has become a highly effective treatment option for OAB, first approved by the FDA in January 2013. Prior studies have demonstrated superior efficacy of intravesical BTX-A injections compared to anticholinergic medication and a greater reduction in urge urinary incontinence episodes than sacral neuromodulation.
The effect of intravesical BTX-A is temporary due to turnover of presynaptic molecules. Typical chemodenervation of muscular tissue lasts 3 to 6 months based on histologic evidence, however this does not translate directly to duration of OAB symptom control given the gradual nature of neurotransmitter repletion. The largest prior trial of intravesical BTX-A demonstrated a median interval of 350 days between first and second injection, but other studies have shown a wide range of duration from 5 to 15 months. The current FDA recommendation for repeat injection is to be "considered when the clinical effect from the previous injection has diminished" with a median interval in their double-blinded placebo-controlled studies of 169 days.
Despite this recommendation, there is a wide variety in practice patterns for repeat injections, including the use of a "one size fits all" approach with standardized repeat injections at 6-month intervals. Combined with varying rates of tolerability and treatment failure, this has resulted in inconsistent data on continuation and dropout rates for repeat injections, with reported continuation rates of 20-60% in different studies. Additionally, no prior studies have reported whether repeat injection intervals have been provider- or patient-determined, nor with data on patient satisfaction ratings. Further studies are needed to better delineate optimal injection interval as well as incorporate data on what methods lead to the highest patient satisfaction and symptom control.
The purpose of this study is to ascertain the optimal time interval to repeat injection will be when it is purely patient directed based on symptomatology. Investigators will also evaluate patient satisfaction with this approach compared to standardized repeat injection interval of six months. This has the potential to change the way OAB is managed by allowing patients to control the interval to repeat injection in a safe and controlled manner. Investigators hypothesize that a patient-centered approach to repeating BTX-A injections will be similar to the standard FDA 6-month interval while leading to higher patient satisfaction and continuation rates without compromising safety or efficacy.
- Being tested
- Patient-directed follow up
- Keywords
- intradetrusor botulinum toxin, intravesical botox, intradetrusor botox, bladder chemodenervation, botox, chemodenervation, overactive bladder, urge urinary incontinence, intravesical botulinum toxin
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-directed follow upBehavioural
Patients will be instructed to follow up for repeat injection based on bladder symptomatology at their own self-determined time interval.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | Standard 6 month post-operative follow up interval for repeat injection |
| Patient-directed follow up | Experimental | Post-operative follow up interval for repeat injection decided by patient based on OAB symptomatology (3-12 months) Receives: Behavioral: Patient-directed follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Injection interval
time to repeat injection (days)
Measured: Days from initial injection to repeat injection, up to 365 days
Secondary outcomes (2)
Patient Satisfaction
Scores from the Surgical Satisfaction Questionnaire (SSQ-8), which contains 8 questions on satisfaction with a likert scale rating of 1-5. Higher scores indicate higher patient satisfaction.
Measured: 1-2 weeks post-injection
Symptom Control
Scores from the Overactive Bladder Assessment Tool (OAB-Q), which contains 5 questions on symptoms and 5 questions on quality of life with a likert scale rating of 0-5. Higher scores on the symptom section indicate WORSE overactive bladder symptoms and higher scores on the quality of life section indicate higher levels of bother/WORSE quality of life.
Measured: baseline scores immediately pre-injection, post-treatment scores 1-2 weeks post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study startJul 2024 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zachary S Selzler, MD, Louisiana State University Health Sciences Center in New Orleans
- Investigators
- Lisa Peacock, MD, Principal investigator, Louisiana State University Health Science Center - New Orleans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06483217
- Sponsor's protocol ID
- #7564
- Status last verified
- Jul 2024
- First submitted
- 25 Jun 2024
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Int Urogynecol J. 2010 Jan;21(1):5-26. doi: 10.1007/s00192-009-0976-9. Epub 2009 Nov 25.
PubMed 19937315de Groat WC, Yoshimura N. Afferent nerve regulation of bladder function in health and disease. Handb Exp Pharmacol. 2009;(194):91-138. doi: 10.1007/978-3-540-79090-7_4.
PubMed 19655106Amundsen CL, Richter HE, Menefee SA, Komesu YM, Arya LA, Gregory WT, Myers DL, Zyczynski HM, Vasavada S, Nolen TL, Wallace D, Meikle SF. OnabotulinumtoxinA vs Sacral Neuromodulation on Refractory Urgency Urinary Incontinence in Women: A Randomized Clinical Trial. JAMA. 2016 Oct 4;316(13):1366-1374. doi: 10.1001/jama.2016.14617.
PubMed 27701661Amundsen CL, Komesu YM, Chermansky C, Gregory WT, Myers DL, Honeycutt EF, Vasavada SP, Nguyen JN, Wilson TS, Harvie HS, Wallace D; Pelvic Floor Disorders Network. Two-Year Outcomes of Sacral Neuromodulation Versus OnabotulinumtoxinA for Refractory Urgency Urinary Incontinence: A Randomized Trial. Eur Urol. 2018 Jul;74(1):66-73. doi: 10.1016/j.eururo.2018.02.011. Epub 2018 Feb 24.
PubMed 29482936Granese R, Adile G, Gugliotta G, Cucinella G, Saitta S, Adile B. Botox((R)) for idiopathic overactive bladder: efficacy, duration and safety. Effectiveness of subsequent injection. Arch Gynecol Obstet. 2012 Oct;286(4):923-9. doi: 10.1007/s00404-012-2349-8. Epub 2012 May 24.
PubMed 22622849Dowson C, Watkins J, Khan MS, Dasgupta P, Sahai A. Repeated botulinum toxin type A injections for refractory overactive bladder: medium-term outcomes, safety profile, and discontinuation rates. Eur Urol. 2012 Apr;61(4):834-9. doi: 10.1016/j.eururo.2011.12.011. Epub 2011 Dec 13.
PubMed 22204745
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Injection Interval for Intra-Detrusor Botulinum Toxin: A Randomized Controlled Trial Utilizing a Patient-Centered Approach
- ClinicalTrials.gov ID
- NCT06483217
- Acronym / sponsor ID
- #7564
- Keywords
- intradetrusor botulinum toxin, intravesical botox, intradetrusor botox, bladder chemodenervation, botox, chemodenervation, overactive bladder, urge urinary incontinence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Louisiana State University Health Sciences Center in New OrleansUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 3 Jul 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.
The goal of this clinical trial is to see if patients deciding their own follow up times can increase the effectiveness of botulinum toxin (BTX or "Botox") injection for overactive bladder (OAB). The main questions it aims to answer are:
- Does the time between repeat injections differ from the 6-month standard when it is based on patient symptoms alone?
- Does symptom control or patient satisfaction change when patients control their own follow up times?
Participants will undergo standard botulinum toxin injection into the bladder for OAB treatment and will then be randomly assigned to follow up either at a standard 6-month interval or whenever they feel their symptoms return.
Detailed description
Overactive bladder (OAB) is defined by symptoms of urinary urgency, frequency, or nocturia with or without incontinence in the absence of urinary tract infection or other attributable pathology. This disease affects up to 40% of women in the United States and can have a significant impact on quality of life. It is expected to increase in prevalence with the aging US population. There are a wide variety of treatment options for OAB which range from fluid management and lifestyle modifications (first line therapy), pelvic floor physical therapy and oral medications (second line therapy), and procedural interventions such as neuromodulation or intravesical botulinum toxin (BTX-A) injections (third line therapy).
BTX-A is a potent neurotoxin derived from the anaerobic bacterium Clostridium botulinum that inhibits presynaptic release of acetylcholine from motor neurons at the neuromuscular junction to induce flaccid paralysis of musculature. It has also been found to affect sensory responses of nerve afferent nerve fibers and likely has a complex multifactorial effect on the release of excitatory neurotransmitters. Because of this, injection of BTX-A into the detrusor muscle of the bladder has become a highly effective treatment option for OAB, first approved by the FDA in January 2013. Prior studies have demonstrated superior efficacy of intravesical BTX-A injections compared to anticholinergic medication and a greater reduction in urge urinary incontinence episodes than sacral neuromodulation.
The effect of intravesical BTX-A is temporary due to turnover of presynaptic molecules. Typical chemodenervation of muscular tissue lasts 3 to 6 months based on histologic evidence, however this does not translate directly to duration of OAB symptom control given the gradual nature of neurotransmitter repletion. The largest prior trial of intravesical BTX-A demonstrated a median interval of 350 days between first and second injection, but other studies have shown a wide range of duration from 5 to 15 months. The current FDA recommendation for repeat injection is to be "considered when the clinical effect from the previous injection has diminished" with a median interval in their double-blinded placebo-controlled studies of 169 days.
Despite this recommendation, there is a wide variety in practice patterns for repeat injections, including the use of a "one size fits all" approach with standardized repeat injections at 6-month intervals. Combined with varying rates of tolerability and treatment failure, this has resulted in inconsistent data on continuation and dropout rates for repeat injections, with reported continuation rates of 20-60% in different studies. Additionally, no prior studies have reported whether repeat injection intervals have been provider- or patient-determined, nor with data on patient satisfaction ratings. Further studies are needed to better delineate optimal injection interval as well as incorporate data on what methods lead to the highest patient satisfaction and symptom control.
The purpose of this study is to ascertain the optimal time interval to repeat injection will be when it is purely patient directed based on symptomatology. Investigators will also evaluate patient satisfaction with this approach compared to standardized repeat injection interval of six months. This has the potential to change the way OAB is managed by allowing patients to control the interval to repeat injection in a safe and controlled manner. Investigators hypothesize that a patient-centered approach to repeating BTX-A injections will be similar to the standard FDA 6-month interval while leading to higher patient satisfaction and continuation rates without compromising safety or efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | –Standard 6 month post-operative follow up interval for repeat injection |
| Patient-directed follow up | Experimental | Behavioral: Patient-directed follow upPost-operative follow up interval for repeat injection decided by patient based on OAB symptomatology (3-12 months) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosis of overactive bladder, detrusor overactivity, urinary urgency, urinary frequency, nocturnal polyuria, or urge urinary incontinence
- pursuing treatment with intravesical botulinum toxin injections
Key exclusion criteria (1 listed)
- non-OAB diagnosis such as pelvic pain or interstitial cystitis
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 |
|---|---|---|
| Patient-directed follow upPatients will be instructed to follow up for repeat injection based on bladder symptomatology at their own self-determined time interval. | Behavioural | Patient-directed follow up |
Primary outcome
Injection interval
Time frame: Days from initial injection to repeat injection, up to 365 days
time to repeat injection (days)
2 secondary outcomes
Patient Satisfaction
Time frame: 1-2 weeks post-injection
Symptom Control
Time frame: baseline scores immediately pre-injection, post-treatment scores 1-2 weeks post-injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Background: PubMed 19937315Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Int Urogynecol J. 2010 Jan;21(1):5-26. doi: 10.1007/s00192-009-0976-9. Epub 2009 Nov 25.
- Background: PubMed 19655106de Groat WC, Yoshimura N. Afferent nerve regulation of bladder function in health and disease. Handb Exp Pharmacol. 2009;(194):91-138. doi: 10.1007/978-3-540-79090-7_4.
- Background: PubMed 27701661Amundsen CL, Richter HE, Menefee SA, Komesu YM, Arya LA, Gregory WT, Myers DL, Zyczynski HM, Vasavada S, Nolen TL, Wallace D, Meikle SF. OnabotulinumtoxinA vs Sacral Neuromodulation on Refractory Urgency Urinary Incontinence in Women: A Randomized Clinical Trial. JAMA. 2016 Oct 4;316(13):1366-1374. doi: 10.1001/jama.2016.14617.
- Background: PubMed 29482936Amundsen CL, Komesu YM, Chermansky C, Gregory WT, Myers DL, Honeycutt EF, Vasavada SP, Nguyen JN, Wilson TS, Harvie HS, Wallace D; Pelvic Floor Disorders Network. Two-Year Outcomes of Sacral Neuromodulation Versus OnabotulinumtoxinA for Refractory Urgency Urinary Incontinence: A Randomized Trial. Eur Urol. 2018 Jul;74(1):66-73. doi: 10.1016/j.eururo.2018.02.011. Epub 2018 Feb 24.
- Background: PubMed 22622849Granese R, Adile G, Gugliotta G, Cucinella G, Saitta S, Adile B. Botox((R)) for idiopathic overactive bladder: efficacy, duration and safety. Effectiveness of subsequent injection. Arch Gynecol Obstet. 2012 Oct;286(4):923-9. doi: 10.1007/s00404-012-2349-8. Epub 2012 May 24.
- Background: PubMed 22204745Dowson C, Watkins J, Khan MS, Dasgupta P, Sahai A. Repeated botulinum toxin type A injections for refractory overactive bladder: medium-term outcomes, safety profile, and discontinuation rates. Eur Urol. 2012 Apr;61(4):834-9. doi: 10.1016/j.eururo.2011.12.011. Epub 2011 Dec 13.
- FDA Medication Guide for onabotulinumtoxinA, accessed June 28th 2024Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Lisa Peacock, MD principal investigator
Louisiana State University Health Science Center - New Orleans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient-directed follow up in people with Overactive Bladder and Urinary Urgency, run by Louisiana State University Health Sciences Center in New Orleans 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 17 Jul 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zachary Selzler, MD (504-568-2383, zselzl@lsuhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Injection interval (time frame: Days from initial injection to repeat injection, up to 365 days). 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 NCT06483217, which also lists 6 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 17 Jul 2024.