Urologic DiseasesNCT03533062
Trigonal vs Non Trigonal Botox Injection in OAB.
A study testing botulinum toxin A in people with Urologic Diseases and Overactive Bladder Syndrome, run by Mansoura University.
Trial summary
The investigators attend to conduct a prospective randomized study to assess safety and efficacy of trigonal-involved vs. trigonal-sparing botox injection technique, quality of life measurement and post-injection anticholinergics use efficacy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urologic Diseases, Overactive Bladder Syndrome, Quality of Life
- What is being tested?
- botulinum toxin A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 14 Jun 2015to 30 May 2018
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with idiopathic OAB refractory to treatment with antimuscarinics for 2 months or intolerable side effects of antimuscrinics
Who cannot join
- Patients who have any of the following were excluded:
- Age less than 18 year old.
- Neurogenic detrusor overactivity.
- Evidence of obstructed flow in absence of prolapse.
- Mixed urinary incontinence
- Associated urethral pathology, e.g. Urethral diverticulum
- Associated bladder pathology e.g. Fistula.
- Active urinary tract infection as evidenced by positive urine culture.
About this study
Official title: Trigonal-sparing Versus Trigonal-involved Intravesical Botulinumtoxin A Injection in Refractory Idiopathic Detrusor Overactivity.
The investigators attend to conduct a prospective randomized study to assess safety and efficacy of trigonal-involved vs. trigonal-sparing botox injection technique, quality of life measurement and post-injection anticholinergics use efficacy.
Assessing safety by identification of side effects like constipation, urine retention....etc.
efficacy is measured using Over Active Bladder Symptoms Score(OABSS) and urodynamics measures after 6 months follow up.
Read the detailed description
Overactive bladder (OAB) is a condition characterized by the presence of urinary urgency, typically joined by frequency and nocturia, with or without urgency urinary incontinence [UUI], in the absence of urinary tract infection (UTI) or other clear pathology.
Frequency is the most commonly reported symptom coming to 85% while 54% complained of urgency and 36% urgency incontinence.
OAB has usually resulted from detrusor over activities. The basic cause could be a neurological disorder (neurogenic type) such as spinal cord injuries, multiple sclerosis. In some cases, no obvious cause could be identified (idiopathic type).
OAB is a prevalent, chronic symptom complex that can impair quality of life (QOL). The prevalence of OAB in the general population was evaluated at 11.8% in a population-based survey conducted across five European countries. Epidemiological studies from North America have reported prevalence of OAB in women of 16.9% and the prevalence increases with age rising to 30.9% in those beyond 65 years.
Treatment objectives are to reduce the occurrence of bothersome symptoms. Several treatment choices are available for OAB including bladder and behavioral training, pharmacologic treatment, and surgical treatment.
Antimuscarinics are well established as pharmacotherapy for reducing OAB symptoms and enhancing QOL.Although, their use is limited in some patients by insufficient response to treatment "refractory OAB", or intolerable side effects , for example , dry mouth , blurred vision , constipation and cognitive impairment.
More recently, a European and Australian trial including about 2000 patients assessed mirabegron (β-3 agonist) (50 mg and 100 mg) in comparison to tolterodine (4 mg ER preparation) and placebo. There was a significant reduction in the number of voids over a 24-hours period, and incontinence episodes, vs. placebo at 12 weeks, at 1.93 vs. 1.34 (P < 0.05) and 1.57 vs. 1.17 (P < 0.05), respectively.
After a trial of pharmacotherapy, if the patient has not had satisfactory improvement in symptoms, intra-vesicle injection of Botox (BTX) can be offered as the following step.
Botulinum toxin (BTX) is a neurotoxin, it contains a heavy chain that binds to the presynaptic terminal of the neuromuscular junction , and this then acts by inhibiting the release of acetylcholine from the presynaptic vesicles at the axon terminal of the motor end plate , that then results in the muscle that is innervated becoming flaccidly paralyzed. BTX is available in different preparations. The current commercially utilized type is BTX type A.
Now, there is cumulative data supporting use of BTX in cases of refractory Detrusor overactivity (DO).
Intradetrusal injection of BTX is followed by a significant improvements in the number of voiding episodes over 24 hours, incontinence episodes, urodynamic variables and quality of life scores. There is a decrease in episodes of urgency and incontinence by 80% and 60%, respectively. The efficacy peaks at 4 weeks, with the effect lasting typically up to 9 months.
Some essential issues for further investigations are the injection site, volume and number of injections. In terms of dosage, there are no firm recommendations, but in practice the advice was for a lower starting dose of 100 units of BTX-A, based on the currently available research. The disadvantage with higher dosing is the reduction in detrusor voiding pressures and an increased risk of voiding problems, while at the same time there is no increased efficacy.
The current AUA and EUA guidelines recommend trigonal sparing technique. During the injection process the trigone is typically spared because of the theoretical risk of de novo VUR from inhibition of the peritrigonal anti-reflux mechanism.
Moreover, trigonal area is rich in sensory fibers, therefore trigonal injection may enhance sensory component of urgency.
- Being tested
- botulinum toxin A
- Keywords
- OAB , Botox , anticholinergics , quality of life
- Medical subject headings
- Urologic Diseases, Anticholinergic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
botulinum toxin ADrug
Also called anticholinergics
botox A injection trigonal or trigonal sparing with trial of anticholinergics 6 months post operative for 3 months
| Study group | Role | What they receive |
|---|---|---|
| trigonal sparing botox injection | Active comparator | Using a 7 gauge needle injection were allocated uniformly and evenly throughout the designed area excluding trigone in other arm Dilution of BOTOX vial (100 u) in 10 ml normal saline (10 u/ml) and injected in 20 sites (0.5ml /site).•then after 6 months postoperative anticholinergics administration . Receives: Drug: botulinum toxin A |
| trigonal involved | Active comparator | Using a 7 gauge needle injection were allocated uniformly and evenly throughout the designed area including the trigone .Dilution of BOTOX vial (100 u) in 10 ml normal saline (10 u/ml) and injected in 20 sites (0.5ml /site).then after 6 months postoperative anticholinergics administration . Receives: Drug: botulinum toxin A |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of Botox injections of the bladder treating OAB using Over active bladder Symptoms score (OABSS).OABSS total score is 15.more score means more symptoms.it is divided into:1-5 &6-10&11-15 means mild &moderate&sever symptoms respectively.
Over active bladder symptoms score (OABSS).
Measured: 3 months
Secondary outcomes (3)
efficacy of anticholinergics post botox injection using Over active bladder symptoms score (OABSS).
Over active bladder symptoms score (OABSS).OABSS total score is 15.more score means more symptoms.it is divided into:1-5 \&6-10\&11-15 means mild \&moderate\&sever symptoms respectively.
Measured: 3 months
quality of life assessment of patients with anticholinergics alone vs patients with botox injections vs combined therapy.
I-QOL Questionnaire
Measured: 3 months
Arabic validation of overactive bladder symptoms score
To validate and translate English form to Arabic version of the over active bladder symptoms score (OABSS)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start14 Jun 2015
- Primary completion30 Oct 2016
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urologic DiseasesStudies 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
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdelbaset, Mansoura University
- Investigators
- Ahmed Shoma, MD, Study chair, Urology and Nephrology Cente. Mansourah, Aldakahlia, Egypt, 35516
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03533062
- Sponsor's protocol ID
- OAB Botox injection
- Status last verified
- Oct 2018
- First submitted
- 29 Apr 2018
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Elbaset MA, Hashem A, Taha DE, Zahran MH, El-Hefnawy AS. Validation of the Arabic linguistic version of the Overactive Bladder Symptoms Score questionnaire. Arab J Urol. 2019 Jun 12;17(4):265-269. doi: 10.1080/2090598X.2019.1627061. eCollection 2019.
PubMed 31723443
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trigonal-sparing Versus Trigonal-involved Intravesical Botulinumtoxin A Injection in Refractory Idiopathic Detrusor Overactivity.
- ClinicalTrials.gov ID
- NCT03533062
- Acronym / sponsor ID
- OAB Botox injection
- Keywords
- OAB , Botox , anticholinergics , quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 14 Jun 2015 (actual)
- Primary completion
- 30 Oct 2016 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 22 May 2018 (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 investigators attend to conduct a prospective randomized study to assess safety and efficacy of trigonal-involved vs. trigonal-sparing botox injection technique, quality of life measurement and post-injection anticholinergics use efficacy.
Assessing safety by identification of side effects like constipation, urine retention....etc.
efficacy is measured using Over Active Bladder Symptoms Score(OABSS) and urodynamics measures after 6 months follow up.
Detailed description
Overactive bladder (OAB) is a condition characterized by the presence of urinary urgency, typically joined by frequency and nocturia, with or without urgency urinary incontinence [UUI], in the absence of urinary tract infection (UTI) or other clear pathology.
Frequency is the most commonly reported symptom coming to 85% while 54% complained of urgency and 36% urgency incontinence.
OAB has usually resulted from detrusor over activities. The basic cause could be a neurological disorder (neurogenic type) such as spinal cord injuries, multiple sclerosis. In some cases, no obvious cause could be identified (idiopathic type).
OAB is a prevalent, chronic symptom complex that can impair quality of life (QOL). The prevalence of OAB in the general population was evaluated at 11.8% in a population-based survey conducted across five European countries. Epidemiological studies from North America have reported prevalence of OAB in women of 16.9% and the prevalence increases with age rising to 30.9% in those beyond 65 years.
Treatment objectives are to reduce the occurrence of bothersome symptoms. Several treatment choices are available for OAB including bladder and behavioral training, pharmacologic treatment, and surgical treatment.
Antimuscarinics are well established as pharmacotherapy for reducing OAB symptoms and enhancing QOL.Although, their use is limited in some patients by insufficient response to treatment "refractory OAB", or intolerable side effects , for example , dry mouth , blurred vision , constipation and cognitive impairment.
More recently, a European and Australian trial including about 2000 patients assessed mirabegron (β-3 agonist) (50 mg and 100 mg) in comparison to tolterodine (4 mg ER preparation) and placebo. There was a significant reduction in the number of voids over a 24-hours period, and incontinence episodes, vs. placebo at 12 weeks, at 1.93 vs. 1.34 (P < 0.05) and 1.57 vs. 1.17 (P < 0.05), respectively.
After a trial of pharmacotherapy, if the patient has not had satisfactory improvement in symptoms, intra-vesicle injection of Botox (BTX) can be offered as the following step.
Botulinum toxin (BTX) is a neurotoxin, it contains a heavy chain that binds to the presynaptic terminal of the neuromuscular junction , and this then acts by inhibiting the release of acetylcholine from the presynaptic vesicles at the axon terminal of the motor end plate , that then results in the muscle that is innervated becoming flaccidly paralyzed. BTX is available in different preparations. The current commercially utilized type is BTX type A.
Now, there is cumulative data supporting use of BTX in cases of refractory Detrusor overactivity (DO).
Intradetrusal injection of BTX is followed by a significant improvements in the number of voiding episodes over 24 hours, incontinence episodes, urodynamic variables and quality of life scores. There is a decrease in episodes of urgency and incontinence by 80% and 60%, respectively. The efficacy peaks at 4 weeks, with the effect lasting typically up to 9 months.
Some essential issues for further investigations are the injection site, volume and number of injections. In terms of dosage, there are no firm recommendations, but in practice the advice was for a lower starting dose of 100 units of BTX-A, based on the currently available research. The disadvantage with higher dosing is the reduction in detrusor voiding pressures and an increased risk of voiding problems, while at the same time there is no increased efficacy.
The current AUA and EUA guidelines recommend trigonal sparing technique. During the injection process the trigone is typically spared because of the theoretical risk of de novo VUR from inhibition of the peritrigonal anti-reflux mechanism.
Moreover, trigonal area is rich in sensory fibers, therefore trigonal injection may enhance sensory component of urgency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| trigonal sparing botox injection | Active comparator | Drug: botulinum toxin AUsing a 7 gauge needle injection were allocated uniformly and evenly throughout the designed area excluding trigone in other arm Dilution of BOTOX vial (100 u) in 10 ml normal saline (10 u/ml) and injected in 20 sites (0.5ml /site).•then after 6 months postoperative anticholinergics administration . |
| trigonal involved | Active comparator | Drug: botulinum toxin AUsing a 7 gauge needle injection were allocated uniformly and evenly throughout the designed area including the trigone .Dilution of BOTOX vial (100 u) in 10 ml normal saline (10 u/ml) and injected in 20 sites (0.5ml /site).then after 6 months postoperative anticholinergics administration . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with idiopathic OAB refractory to treatment with antimuscarinics for 2 months or intolerable side effects of antimuscrinics
Key exclusion criteria (8 listed)
- Patients who have any of the following were excluded:
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 |
|---|---|---|
| botulinum toxin AAlso: anticholinergicsbotox A injection trigonal or trigonal sparing with trial of anticholinergics 6 months post operative for 3 months | Drug | trigonal involved, trigonal sparing botox injection |
Primary outcome
efficacy of Botox injections of the bladder treating OAB using Over active bladder Symptoms score (OABSS).OABSS total score is 15.more score means more symptoms.it is divided into:1-5 &6-10&11-15 means mild &moderate&sever symptoms respectively.
Time frame: 3 months
Over active bladder symptoms score (OABSS).
3 secondary outcomes
efficacy of anticholinergics post botox injection using Over active bladder symptoms score (OABSS).
Time frame: 3 months
quality of life assessment of patients with anticholinergics alone vs patients with botox injections vs combined therapy.
Time frame: 3 months
Arabic validation of overactive bladder symptoms score
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Derived from this study: PubMed 31723443Elbaset MA, Hashem A, Taha DE, Zahran MH, El-Hefnawy AS. Validation of the Arabic linguistic version of the Overactive Bladder Symptoms Score questionnaire. Arab J Urol. 2019 Jun 12;17(4):265-269. doi: 10.1080/2090598X.2019.1627061. eCollection 2019.
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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.
Ahmed Shoma, MD study chair
Urology and Nephrology Cente. Mansourah, Aldakahlia, Egypt, 35516
Questions about this trial
What is this clinical trial studying?
A study testing botulinum toxin A in people with Urologic Diseases and Overactive Bladder Syndrome, run by Mansoura University.
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 1 inclusion and 8 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 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
efficacy of Botox injections of the bladder treating OAB using Over active bladder Symptoms score (OABSS).OABSS total score is 15.more score means more symptoms.it is divided into:1-5 &6-10&11-15 means mild &moderate&sever symptoms respectively. (time frame: 3 months). 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 NCT03533062, 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 9 Oct 2018.