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Trial registered on ANZCTR


Registration number
ACTRN12624001415594
Ethics application status
Approved
Date submitted
17/09/2024
Date registered
2/12/2024
Date last updated
2/12/2024
Date data sharing statement initially provided
2/12/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of botulinum neurotoxin A bladder injection on markers associated with inflammation and urinary infections: a human study
Scientific title
Effect of botulinum neurotoxin A bladder injection on markers associated with inflammation and urinary infections in patients with overactive bladder: a pilot, prospective, human study
Secondary ID [1] 312925 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
neurogenic detrusor overactivity 335150 0
urinary infections 335151 0
overactive bladder 335152 0
bladder inflammation 335153 0
Condition category
Condition code
Renal and Urogenital 331645 331645 0 0
Other renal and urogenital disorders
Inflammatory and Immune System 331646 331646 0 0
Other inflammatory or immune system disorders
Infection 331647 331647 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients with neurogenic detrusor overactivity (NDO) associated incontinence refractory to oral pharmacotherapy who received bladder BonT/A injections were recruited. The participants would receive BonT/A treatment regardless of their involvement in this study, as a third line treatment for refractory NDO. As per routine protocol approved by the Hospital Scientific Board all patients were submitted to urodynamic investigation at baseline, 4-6 weeks and 6 months post BoNT/A treatment. Urine specimens were obtained at baseline during the cystoscopy for the BoNT/A treatment, and upon routine urodynamic follow-up visits at 4-6 weeks and at 6 months post treatment.
Intervention code [1] 329512 0
Diagnosis / Prognosis
Comparator / control treatment
Healthy controls, without overactive bladder syndrome and that haven't received any treatment for overactive bladder syndrome in the past, that provided urine samples in similar time intervals - initial sample, in 4-6 weeks and in 6 months.
Control group
Active

Outcomes
Primary outcome [1] 339379 0
The expression of toll-like receptors, TLR2, TLR4 and TLR5, in the urine of patients before and after intradetrusor BoNT/A injections.
Assessment method [1] 339379 0
The expression of the genes of interest in the urine was studied by RNA isolation from urine samples, reverse transcription and Real-Time PCR (qRT-PCR). GAPDH was used as house-keeping gene. The 2ˆ(–delta delta CT) algorithm was used to analyse the relative changes in gene expression.
Timepoint [1] 339379 0
Once before the BoNT/A injection, at the time of their appointment for the injection, once between 4 to 6 weeks after the injection and once at 6 months after the BoNT/A injection.
Secondary outcome [1] 439720 0
The expression of genes for IL1b, IL6 and TNF-a in the urine of patients before and after intradetrusor BoNT/A injections.
Assessment method [1] 439720 0
The expression of the genes of interest in the urine was studied by RNA isolation from urine samples, reverse transcription and Real-Time PCR (qRT-PCR). GAPDH was used as house-keeping gene. The 2ˆ(–delta delta CT) algorithm was used to analyse the relative changes in gene expression.
Timepoint [1] 439720 0
Once before the BoNT/A injection, at the time of their appointment for the injection, once between 4 to 6 weeks after the injection and once at 6 months after the BoNT/A injection.
Secondary outcome [2] 440652 0
Changes in expression of PGE2 in the urine of patients before and after intradetrusor BoNT/A injections.
Assessment method [2] 440652 0
Direct ELISA.
Timepoint [2] 440652 0
Once before the BoNT/A injection, at the time of their appointment for the injection, once between 4 to 6 weeks after the injection and once at 6 months after the BoNT/A injection.
Secondary outcome [3] 440653 0
Presence of bacteriuria.
Assessment method [3] 440653 0
Urine culture.
Timepoint [3] 440653 0
Once before the BoNT/A injection, at the time of their appointment for the injection, once between 4 to 6 weeks after the injection and once at 6 months after the BoNT/A injection.
Secondary outcome [4] 441855 0
Maximum urine flow.
Assessment method [4] 441855 0
Uroflowmetry of the voiding phase of the urodynamic study.
Timepoint [4] 441855 0
Once, approximately one month before the BoNT/A injection, once between 4 to 6 weeks after the injection and once at 6 months after the BoNT/A injection.
Secondary outcome [5] 441856 0
Post-void residual volume of urine.
Assessment method [5] 441856 0
Urodynamic study.
Timepoint [5] 441856 0
Once, approximately one month before the BoNT/A injection, once between 4 to 6 weeks after the injection and once at 6 months after the BoNT/A injection.
Secondary outcome [6] 441857 0
Detrusor function (presence of overactivity).
Assessment method [6] 441857 0
Urodynamic study.
Timepoint [6] 441857 0
Once, approximately one month before the BoNT/A injection, once between 4 to 6 weeks after the injection and once at 6 months after the BoNT/A injection.
Secondary outcome [7] 441858 0
Maximum cystomanometric capacity.
Assessment method [7] 441858 0
Urodynamic study.
Timepoint [7] 441858 0
Once, approximately one month before the BoNT/A injection, once between 4 to 6 weeks after the injection and once at 6 months after the BoNT/A injection.
Secondary outcome [8] 441859 0
Maximum detrusor pressure in filling phase.
Assessment method [8] 441859 0
Urodynamic study.
Timepoint [8] 441859 0
Once, approximately one month before the BoNT/A injection, once between 4 to 6 weeks after the injection and once at 6 months after the BoNT/A injection.
Secondary outcome [9] 441860 0
Maximum detrusor pressure in voiding phase.
Assessment method [9] 441860 0
Urodynamic study.
Timepoint [9] 441860 0
Once, approximately one month before the BoNT/A injection, once between 4 to 6 weeks after the injection and once at 6 months after the BoNT/A injection.

Eligibility
Key inclusion criteria
Patients with overactive bladder symptoms / detrusor overactivity of over 1 year in duration that have received oral treatment for at least 6 months, without sufficient response, as this is defined by their reported symptoms, by bladder diary information and by urodynamic study results. Also, patients with overactive bladder symptoms / detrusor overactivity of over 1 year in duration that have severe adverse reactions to oral pharmacotherapy.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy and breastfeeding, neuromuscular junction disorders (e.g. myasthenia), treatment with drugs that can potentially affect neuromuscular junction (e.g. aminoglycosides), patients not willing to perform intermittent self-catheterisations.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Case control
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
26/03/2021
Date of last participant enrolment
Anticipated
Actual
22/11/2021
Date of last data collection
Anticipated
Actual
8/04/2022
Sample size
Target
32
Accrual to date
Final
28
Recruitment outside Australia
Country [1] 26561 0
Greece
State/province [1] 26561 0
Thessaloniki

Funding & Sponsors
Funding source category [1] 317356 0
University
Name [1] 317356 0
Aristotle University of Thessaloniki
Country [1] 317356 0
Greece
Funding source category [2] 317833 0
Commercial sector/Industry
Name [2] 317833 0
Mavrogenis Hellas
Country [2] 317833 0
Greece
Funding source category [3] 317834 0
Commercial sector/Industry
Name [3] 317834 0
Ariti S.A.
Country [3] 317834 0
Greece
Funding source category [4] 317835 0
Commercial sector/Industry
Name [4] 317835 0
DEMO Pharmaceuticals
Country [4] 317835 0
Greece
Funding source category [5] 317836 0
Commercial sector/Industry
Name [5] 317836 0
HELP Pharmaceuticals
Country [5] 317836 0
Greece
Funding source category [6] 317837 0
Commercial sector/Industry
Name [6] 317837 0
ALLERTEC
Country [6] 317837 0
Greece
Primary sponsor type
University
Name
Aristotle University of Thessaloniki
Country
Greece
Secondary sponsor category [1] 319646 0
None
Name [1] 319646 0
Country [1] 319646 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316087 0
Papageorgiou Hospital Scientific Board
Ethics committee address [1] 316087 0
Ethics committee country [1] 316087 0
Greece
Date submitted for ethics approval [1] 316087 0
09/12/2020
Approval date [1] 316087 0
22/01/2021
Ethics approval number [1] 316087 0
89/22.01.2021

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 136742 0
Prof Apostolos Apostolidis
Address 136742 0
Papageorgiou General Hospital, Ring road, Municipality of Pavlou Mela, Area N. Evkarpia, Thessaloniki 56403
Country 136742 0
Greece
Phone 136742 0
+302310991476
Email 136742 0
zefxis@yahoo.co.uk
Contact person for public queries
Name 136743 0
Apostolos Apostolidis
Address 136743 0
Papageorgiou General Hospital, Ring road, Municipality of Pavlou Mela, Area N. Evkarpia, Thessaloniki 56403
Country 136743 0
Greece
Phone 136743 0
+302310991476
Email 136743 0
zefxis@yahoo.co.uk
Contact person for scientific queries
Name 136744 0
Apostolos Apostolidis
Address 136744 0
Papageorgiou General Hospital, Ring road, Municipality of Pavlou Mela, Area N. Evkarpia, Thessaloniki 56403
Country 136744 0
Greece
Phone 136744 0
+302310991476
Email 136744 0
zefxis@yahoo.co.uk

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24201Ethical approval    Scientific committee approval.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.