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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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 groups in NCT03533062
Study groupRoleWhat they receive
trigonal sparing botox injectionActive comparatorUsing 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 involvedActive comparatorUsing 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.

  1. 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)
  1. 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

  2. quality of life assessment of patients with anticholinergics alone vs patients with botox injections vs combined therapy.

    I-QOL Questionnaire

    Measured: 3 months

  3. 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.

  1. First posted22 May 2018
  2. Study start14 Jun 2015
  3. Primary completion30 Oct 2016
  4. Study completion30 May 2018

Resources

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)
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

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.

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