Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000172505p
Ethics application status
Submitted, not yet approved
Date submitted
15/11/2023
Date registered
23/02/2024
Date last updated
23/02/2024
Date data sharing statement initially provided
23/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The Efficacy of Diathermy for Recurrent Urinary Tract Infections (UTIs)
Scientific title
The Efficacy of Diathermy of the Trigone for Women with Symptoms of Recurrent Urinary Tract Infections.
Secondary ID [1] 310957 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recurrent urinary tract infections 332035 0
Symptoms of recurrent urinary tract infections with negative urine culture (also referred to a irritative bladder symptoms). 332036 0
Condition category
Condition code
Renal and Urogenital 328763 328763 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention in our study involves the diathermy of the trigone procedure, administered by an experienced urologist, Dr. Dirk Drent. The procedure is a one-time intervention, initiated after an initial hour-long appointment with the urologist, encompassing a comprehensive assessment, including a medical history, clinical examination, bladder ultrasound, flow study, and post void residual volume measurement. During this appointment, details of the diathermy procedure are discussed thoroughly, allowing the patient to make an informed decision. If the patient opts for the intervention, they are scheduled for the procedure, which requires an approximately one-hour session and an overnight hospital stay for observation. A Coviden ValleyLab FT10 mono polar diathermy in used, initially on Cut (Pure, 20W, peak voltage 1287V) for removal of the lesions and followed by Coag (Fulgurate, 20W, peak voltage 3448V) for haemostasis. These two diathermy steps take a combined total of approximately 15minutes, Subsequently, an 8-week follow-up appointment lasting around 30 minutes involves additional assessments, including ultrasound, flow, residual volume measurement, and a urine dipstick test. One year post-procedure, patients complete a survey to evaluate the intervention's long-term outcomes. The intervention is provided individually, and informational materials are supplied to facilitate informed decision-making. During the process we will obtain consent to access the patient medical records and have contact with the patients GP to cross reference past medical history, positive urine tests and antibiotics courses/previous treatments.
Intervention code [1] 327384 0
Treatment: Surgery
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336570 0
The primary outcome to be assessed is the change in quantity and severity of irritative bladder symptoms experienced before and following the procedure.
Timepoint [1] 336570 0
Prior to surgery or the initial consultation and one year following the surgical intervention.
Secondary outcome [1] 428832 0
The number of UTIs necessitating antibiotic prescriptions in the year prior to the procedure compared to the year following the procedure.
Timepoint [1] 428832 0
Prior to procedure taking place and one year following the surgical procedure.

Eligibility
Key inclusion criteria
1. Women with symptoms of recurrent UTIs (three or more times in the last year) or persistent symptoms of bladder irritation.
2. Women with confirmed Trigone pathology (Squamous metaplasia, Cystitis Cystica, Cystitis Glandularis, or Follicular Cystitis) on Cystoscopy.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Women with less than one year of follow-up.
2. Women found to have other potential causes for symptoms (e.g., kidney or bladder stones, bladder malignancy, vaginal infection, sexually transmitted infections, etc.).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/02/2024
Actual
Date of last participant enrolment
Anticipated
27/12/2024
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
350
Accrual to date
Final
Recruitment outside Australia
Country [1] 25966 0
New Zealand
State/province [1] 25966 0

Funding & Sponsors
Funding source category [1] 315216 0
Self funded/Unfunded
Name [1] 315216 0
Country [1] 315216 0
Primary sponsor type
Individual
Name
Leandrie Young
Address
192 PEACHGROVE ROAD, CLAUDELANDS, HAMILTON 3214
Country
New Zealand
Secondary sponsor category [1] 317247 0
None
Name [1] 317247 0
Address [1] 317247 0
Country [1] 317247 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314140 0
Health and Disability Ethics Committees (HDEC)
Ethics committee address [1] 314140 0
Ethics committee country [1] 314140 0
New Zealand
Date submitted for ethics approval [1] 314140 0
09/02/2024
Approval date [1] 314140 0
Ethics approval number [1] 314140 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130558 0
Dr Leandrie Young
Address 130558 0
Dirk Drent Urologist, 183 Pembroke Street, Waikato Hospital, Hamilton 3204
Country 130558 0
New Zealand
Phone 130558 0
+64278671219
Fax 130558 0
Email 130558 0
[email protected]
Contact person for public queries
Name 130559 0
Leandrie Young
Address 130559 0
Dirk Drent Urologist, 183 Pembroke Street, Waikato Hospital, Hamilton 3204
Country 130559 0
New Zealand
Phone 130559 0
+64278671219
Fax 130559 0
Email 130559 0
[email protected]
Contact person for scientific queries
Name 130560 0
Leandrie Young
Address 130560 0
Dirk Drent Urologist, 183 Pembroke Street, Waikato Hospital, Hamilton 3204
Country 130560 0
New Zealand
Phone 130560 0
+64278671219
Fax 130560 0
Email 130560 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



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.