Overactive Bladder SyndromeNCT04982120
Use of Repris Needle in Bladder Injection
A study testing Repris Needle in people with Overactive Bladder Syndrome, run by Uro-1 Medical at 1 site in United States.
Trial summary
Treatment of overactive bladder (OAB) has been treated successfully by the injection of Botox. The Repris injection needle has a deflection that may assist in injection difficult to reach with standard straight needles. This study will assess the success, safety and patient tolerance of this new injection needle. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overactive Bladder Syndrome
- What is being tested?
- Repris Needle
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2018to 14 Jul 2022
- 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
- Adult (18 years of age or older)
- Able to undergo routine cystoscopy
- Willing to provide verbal assessment of her condition within 5 days after the procedure
Who cannot join
- History of urethral strictures
- Presence of a suprapubic catheter or tube due to urethral trauma
- history of interstitial cystitis
- currently being treated for a urinary tract infection (UTI)
- gross hematuria present
- Known allergy or sensitivity to any component of the medication or solution to be injected during the study
Show all 10Show fewer
- is pregnant, lactating, or with child-bearing potential unable or unwilling to use a reliable form of contraception while participating in the study
- cannot empty her bladder on her own and is routinely catheterizing the urethra
- unable to read, understand, and/or provide a ranking of pain level during the procedure,
- unable or unwilling to provide consent
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Georgia Urology
Cartersville, Georgia, 30120
Jeffrey Proctor, MD, 770-607-1893
About this study
Official title: A Post-510(k) Study of Patients With Overactive Bladder (OAB) Treated With OnabotulinumtoxinA (Botox, Allergan PLC) Using the Repris Bladder Injection System
Treatment of overactive bladder (OAB) has been treated successfully by the injection of Botox. The Repris injection needle has a deflection that may assist in injection difficult to reach with standard straight needles. This study will assess the success, safety and patient tolerance of this new injection needle.
Read the detailed description
This is a prospective, multicenter, single arm study of the Repris injection needle to administer Botox to the bladder wall in patients with an overactive bladder. Following advancement of a cystoscope to the patient's bladder, the Repris needle will be advanced to the area of interest and into the bladder wall in order to administer the recommended volume of Botox. After injection, the needle will be removed and the procedure will be concluded. The patient will be asked to rank her tolerance of the procedure and level of discomfort using a standardized pain scale before being released. Five days after the procedure the patient will be contacted by telephone to determine whether any adverse events had occurred since release.
- Conditions
- Overactive Bladder Syndrome
- Being tested
- Repris Needle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repris NeedleDevice
Injection of Botox
| Study group | Role | What they receive |
|---|---|---|
| Repris Needle | Experimental | Reprise sheath and needle Receives: Device: Repris Needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure Success
Percentage of subjects with successful injection of medication
Measured: 1 Day of the procedure
Secondary outcomes (2)
Patient Tolerance of Injection
Level of pain from use of the needle measured on Likert Scale 1 to 5
Measured: 1 Day of the procedure
Adverse Events during Procedure
Incidence and Severity of Adverse events associated with the injection
Measured: Day 0 and Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start15 Oct 2018
- Primary completion14 Jun 2022 (estimated)
- Study completion14 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uro-1 Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Lawson, PhD, Study director, Uro-1 Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04982120
- Sponsor's protocol ID
- Repris Botox Study
- Status last verified
- Jul 2021
- First submitted
- 15 Jul 2021
- Last updated
- 29 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Patient identification will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-510(k) Study of Patients With Overactive Bladder (OAB) Treated With OnabotulinumtoxinA (Botox, Allergan PLC) Using the Repris Bladder Injection System
- ClinicalTrials.gov ID
- NCT04982120
- Acronym / sponsor ID
- Repris Botox Study
- Conditions
- Overactive Bladder Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Uro-1 MedicalIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 14 Jun 2022 (estimated)
- Study completion
- 14 Jul 2022 (estimated)
- First posted
- 29 Jul 2021 (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.
Treatment of overactive bladder (OAB) has been treated successfully by the injection of Botox. The Repris injection needle has a deflection that may assist in injection difficult to reach with standard straight needles. This study will assess the success, safety and patient tolerance of this new injection needle.
Detailed description
This is a prospective, multicenter, single arm study of the Repris injection needle to administer Botox to the bladder wall in patients with an overactive bladder. Following advancement of a cystoscope to the patient's bladder, the Repris needle will be advanced to the area of interest and into the bladder wall in order to administer the recommended volume of Botox. After injection, the needle will be removed and the procedure will be concluded. The patient will be asked to rank her tolerance of the procedure and level of discomfort using a standardized pain scale before being released. Five days after the procedure the patient will be contacted by telephone to determine whether any adverse events had occurred since release.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Repris Needle | Experimental | Device: Repris NeedleReprise sheath and needle |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult (18 years of age or older)
- Able to undergo routine cystoscopy
- Willing to provide verbal assessment of her condition within 5 days after the procedure
Key exclusion criteria (10 listed)
- History of urethral strictures
- Presence of a suprapubic catheter or tube due to urethral trauma
- history of interstitial cystitis
- currently being treated for a urinary tract infection (UTI)
- gross hematuria present
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 |
|---|---|---|
| Repris NeedleInjection of Botox | Device | Repris Needle |
Primary outcome
Procedure Success
Time frame: 1 Day of the procedure
Percentage of subjects with successful injection of medication
2 secondary outcomes
Patient Tolerance of Injection
Time frame: 1 Day of the procedure
Adverse Events during Procedure
Time frame: Day 0 and Day 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.
- Individual participant dataSharing planned: Yes. Patient identification will not be shared
Related trials for Overactive Bladder Syndrome
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
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Migraine Medication Effects on Urinary Symptoms
Overactive Bladder, Bladder Pain 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. This study is not recruiting at the moment.
Thomas Lawson, PhD study director
Uro-1 Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repris Needle in people with Overactive Bladder Syndrome, run by Uro-1 Medical 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 10 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 29 Jul 2021. 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 Thomas Lawson, PhD (5102061794, drthomlawson@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure Success (time frame: 1 Day of the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2021.