Overactive BladderPhase 4BINDNCT05652036
Procedural Discomfort Related to Number of Intradetrusor Botox Injections
A Phase 4 study testing Intradetrusor Botox Injections in people with Overactive Bladder, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial summary
Injection of intradetrusor OnabotulinumtoxinA (BTX-A) is a highly efficacious therapy with a reliable safety profile and demonstrable improvements in subjective and objective measures for overactive bladder (OAB) symptom control. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Intradetrusor Botox Injections
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2022to 15 May 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women scheduled to undergo 100 units intradetrusor BTX-A injections in the office for the diagnosis of idiopathic overactive bladder within the departments of Urology and Urogynecology
- 18 years of age or older
- Able to give informed consent in English or Spanish
- Understand and are willing to undergo follow-up and complete all questionnaires as described in this protocol
Who cannot join
- Neurogenic bladder related to prior diagnosis of neurological conditions such as cerebral vascular accident within 6 months prior to treatment, Parkinson's Disease, Multiple Sclerosis, myelomeningocele, traumatic neurologic or spinal injury, or idiopathic diagnosis of neurogenic bladder.
- Symptomatic UTI at the time of procedure, defined as positive nitrites or high-volume leukocyte esterase on urine dip in addition to at least one of the following symptoms: dysuria, gross hematuria, suprapubic pain, frequency/urgency above baseline
- Diagnosis of a bladder pain syndrome or other chronic pain syndromes including fibromyalgia, chronic pelvic pain, pelvic floor dysfunction, levator myalgia
- Known bladder malignancy
- Previous history of bladder augmentation or reconstructive surgery not related to prolapse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Procedural Discomfort Related to Number of Intradetrusor Injections of OnabotulinumtoxinA for Idiopathic Overactive Bladder: A Randomized Control Trial of an Alternate Reconstitution Volume and Injection Template Protocol
Injection of intradetrusor OnabotulinumtoxinA (BTX-A) is a highly efficacious therapy with a reliable safety profile and demonstrable improvements in subjective and objective measures for overactive bladder (OAB) symptom control. This procedure can be performed in the office with an evidence-based standard dosing of 100 units for idiopathic OAB. This is a single-blinded, randomized control trial is to evaluate and optimize the technique for performing intradetrusor injections of BTX-A for idiopathic OAB. This trial proposes two different reconstitution and injection schema to study patient-centered outcomes related to procedural discomfort and symptom relief.
Read the detailed description
This will be a single-blinded, parallel randomized control trial (RCT) utilizing two study arms. This trial will be designed and reported as outlined in the CONSORT guidelines
The primary aim of this study is to evaluate perceived discomfort using the Numeric Pain Scale (NPS) during office injection of intradetrusor BTX-A via two different injection techniques and reconstitution volumes.
The secondary aims of this study are to evaluate treatment effectiveness and patient satisfaction of treatment with BTX-A using validated questionnaires. Investigators will also compare procedure time and post-procedure complication rates between the two study groups.
Study Groups: The patients will be randomized in a 1:1 fashion to one of two groups:
- 100 units BTX-A reconstituted in 5 mL normal saline, injected into the bladder in 5 separate injections of 1 mL. One injection will be at the trigone
- 100 units BTX-A reconstituted in 10 mL normal saline, injected into the bladder in 10 separate injections of 1 mL. One injection will be at the trigone
The primary outcome will be measured on the day of the procedure using the NPS scale. Investigators will follow up with patients at 30 days post-procedure to assess treatment effectiveness, overall satisfaction, and post-procedure outcomes using validated questionnaires.
- Conditions
- Overactive Bladder
- Being tested
- Intradetrusor Botox Injections
- Keywords
- Overactive bladder, Urinary urgency, Urgency incontinence, Botox
- 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.
Intradetrusor Botox InjectionsBiological
100 units of OnabotuliumtoxinA is injected into the detrusor muscle in 1 mL aliquots using a cystoscope.
| Study group | Role | What they receive |
|---|---|---|
| 5 mL Group | Active comparator | 100 units BTX-A reconstituted in 5 mL normal saline, injected into the bladder in 5 separate injections of 1 mL. One injection will be at the trigone. Receives: Biological: Intradetrusor Botox Injections |
| 10 mL Group | Active comparator | 100 units BTX-A reconstituted in 10 mL normal saline, injected into the bladder in 10 separate injections of 1 mL. One injection will be at the trigone Receives: Biological: Intradetrusor Botox Injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Discomfort Related to BTX-A Injection
Participants will assess their discomfort using the Numeric Pain Scale (NPS), a validated 11-point scale (0-10) where higher scores indicate greater pain, before and immediately after the procedure. Procedural discomfort will be evaluated by comparing the change in NPS scores from pre- to post-procedure between study groups.
Measured: Immediately post-procedure (up to 45min after intradetrusor BTX-A injections)
Secondary outcomes (4)
Procedural Efficacy - Overactive Bladder Questionnaire Short-Form (OAB-q SF)
Efficacy will be evaluated using the Overactive Bladder Questionnaire Short-Form (OAB-q SF), a validated instrument designed to measure symptom bother (SB) and the impact of OAB on health-related quality of life (HRQL). This questionnaire is administered on the day of the procedure (baseline) and again 30 days post-procedure. Changes in SB and HRQL scores assess improvement in OAB symptoms following BTX-A treatment.
The OAB-q SF includes 19 items divided into two subscales: a 6-item SB scale (Questions 1-6) and a 13-item HRQL scale (Questions 7-19). SB items are scored from 1 ("not at all") to 6 ("a very great deal"), yielding a total SB score range of 6 to 36, with higher scores indicating greater symptom bother. HRQL items are scored from 1 ("none of the time") to 6 ("all of the time"), with total scores ranging from 13 to 78, where higher scores reflect better quality of life.
We report here the mean change in SB and HRQL scores from baseline to 30 days post-treatment.
Measured: Prior to BTX-A injections and 30 days post-procedure
Overall Treatment Satisfaction
Overall treatment satisfaction will be assessed at 30-days post-procedure via a "yes or no" response to inquiry about overall satisfaction with the procedure and results of their BTX-A treatment
Measured: 30 days post-procedure
Impression of Clinical Improvement
Patients impression of clinical improvement after treatment will be assessed at 30-day post-procedure via the Clinical Global Impression - Improvement Scale (CGI-I). The CGI-I is a seven point verbal scale with higher values indicating higher impression of symptomatic improvement related to the treatment. Scale reports values as: Very much improved, Much improved, Minimally improved, No difference.
Measured: 30 days post-procedure
Procedural Outcomes
We will review the electronic medical record to evaluate instances of symptomatic urinary tract infection, bothersome incomplete bladder emptying requiring catheterization, and instances of bleeding requiring evaluation after the procedure.
Measured: 30 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start7 Jul 2022
- Primary completion6 Apr 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rose Khavari, M.D., The Methodist Hospital Research Institute
- Investigators
- Rose Khavari, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05652036
- Sponsor's protocol ID
- PRO00028592
- Acronym
- BIND
- Status last verified
- Mar 2025
- First submitted
- 7 Dec 2022
- Last updated
- 13 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Miceli LM, Antosh DD, Nisar T, Stewart J, Rutledge EC, Khavari R. Pain Related to Intradetrusor BotulinumtoxinA: A Randomized Clinical Trial. Urogynecology (Phila). 2024 Mar 1;30(3):337-344. doi: 10.1097/SPV.0000000000001487.
PubMed 38484251
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procedural Discomfort Related to Number of Intradetrusor Injections of OnabotulinumtoxinA for Idiopathic Overactive Bladder: A Randomized Control Trial of an Alternate Reconstitution Volume and Injection Template Protocol
- ClinicalTrials.gov ID
- NCT05652036
- Acronym / sponsor ID
- BIND / PRO00028592
- Conditions
- Overactive Bladder
- Keywords
- Overactive bladder, Urinary urgency, Urgency incontinence, Botox
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- 6 Apr 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 15 Dec 2022 (actual)
- Results
- Posted 13 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Injection of intradetrusor OnabotulinumtoxinA (BTX-A) is a highly efficacious therapy with a reliable safety profile and demonstrable improvements in subjective and objective measures for overactive bladder (OAB) symptom control. This procedure can be performed in the office with an evidence-based standard dosing of 100 units for idiopathic OAB. This is a single-blinded, randomized control trial is to evaluate and optimize the technique for performing intradetrusor injections of BTX-A for idiopathic OAB. This trial proposes two different reconstitution and injection schema to study patient-centered outcomes related to procedural discomfort and symptom relief.
Detailed description
This will be a single-blinded, parallel randomized control trial (RCT) utilizing two study arms. This trial will be designed and reported as outlined in the CONSORT guidelines
The primary aim of this study is to evaluate perceived discomfort using the Numeric Pain Scale (NPS) during office injection of intradetrusor BTX-A via two different injection techniques and reconstitution volumes.
The secondary aims of this study are to evaluate treatment effectiveness and patient satisfaction of treatment with BTX-A using validated questionnaires. Investigators will also compare procedure time and post-procedure complication rates between the two study groups.
Study Groups: The patients will be randomized in a 1:1 fashion to one of two groups:
- 100 units BTX-A reconstituted in 5 mL normal saline, injected into the bladder in 5 separate injections of 1 mL. One injection will be at the trigone
- 100 units BTX-A reconstituted in 10 mL normal saline, injected into the bladder in 10 separate injections of 1 mL. One injection will be at the trigone
The primary outcome will be measured on the day of the procedure using the NPS scale. Investigators will follow up with patients at 30 days post-procedure to assess treatment effectiveness, overall satisfaction, and post-procedure outcomes using validated questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5 mL Group | Active comparator | Biological: Intradetrusor Botox Injections100 units BTX-A reconstituted in 5 mL normal saline, injected into the bladder in 5 separate injections of 1 mL. One injection will be at the trigone. |
| 10 mL Group | Active comparator | Biological: Intradetrusor Botox Injections100 units BTX-A reconstituted in 10 mL normal saline, injected into the bladder in 10 separate injections of 1 mL. One injection will be at the trigone |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women scheduled to undergo 100 units intradetrusor BTX-A injections in the office for the diagnosis of idiopathic overactive bladder within the departments of Urology and Urogynecology
- 18 years of age or older
- Able to give informed consent in English or Spanish
- Understand and are willing to undergo follow-up and complete all questionnaires as described in this protocol
Key exclusion criteria (5 listed)
- Neurogenic bladder related to prior diagnosis of neurological conditions such as cerebral vascular accident within 6 months prior to treatment, Parkinson's Disease, Multiple Sclerosis, myelomeningocele, traumatic neurologic or spinal injury, or idiopathic diagnosis of neurogenic bladder.
- Symptomatic UTI at the time of procedure, defined as positive nitrites or high-volume leukocyte esterase on urine dip in addition to at least one of the following symptoms: dysuria, gross hematuria, suprapubic pain, frequency/urgency above baseline
- Diagnosis of a bladder pain syndrome or other chronic pain syndromes including fibromyalgia, chronic pelvic pain, pelvic floor dysfunction, levator myalgia
- Known bladder malignancy
- Previous history of bladder augmentation or reconstructive surgery not related to prolapse
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 |
|---|---|---|
| Intradetrusor Botox Injections100 units of OnabotuliumtoxinA is injected into the detrusor muscle in 1 mL aliquots using a cystoscope. | Biological | 10 mL Group, 5 mL Group |
Primary outcome
Participant Discomfort Related to BTX-A Injection
Time frame: Immediately post-procedure (up to 45min after intradetrusor BTX-A injections)
Participants will assess their discomfort using the Numeric Pain Scale (NPS), a validated 11-point scale (0-10) where higher scores indicate greater pain, before and immediately after the procedure. Procedural discomfort will be evaluated by comparing the change in NPS scores from pre- to post-procedure between study groups.
4 secondary outcomes
Procedural Efficacy - Overactive Bladder Questionnaire Short-Form (OAB-q SF)
Time frame: Prior to BTX-A injections and 30 days post-procedure
Overall Treatment Satisfaction
Time frame: 30 days post-procedure
Impression of Clinical Improvement
Time frame: 30 days post-procedure
Procedural Outcomes
Time frame: 30 days post-procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38484251Miceli LM, Antosh DD, Nisar T, Stewart J, Rutledge EC, Khavari R. Pain Related to Intradetrusor BotulinumtoxinA: A Randomized Clinical Trial. Urogynecology (Phila). 2024 Mar 1;30(3):337-344. doi: 10.1097/SPV.0000000000001487.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rose Khavari, MD principal investigator
The Methodist Hospital Research Institute
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 Intradetrusor Botox Injections in people with Overactive Bladder, run by The Methodist Hospital Research Institute 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 13 Apr 2025. 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?
Yes. Results are posted in the registry (first posted 13 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Discomfort Related to BTX-A Injection (time frame: Immediately post-procedure (up to 45min after intradetrusor BTX-A injections)). 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 NCT05652036, which also lists 1 linked publication.
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 13 Apr 2025.