Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000924853
Ethics application status
Approved
Date submitted
3/02/2021
Date registered
15/07/2021
Date last updated
15/07/2021
Date data sharing statement initially provided
15/07/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Safety, efficacy and tolerability of the Novoglan foreskin tissue expander product as a conservative treatment for adult phimosis.
Scientific title
Safety, efficacy and tolerability of the Novoglan foreskin tissue expander product as a conservative treatment for adult phimosis.
Secondary ID [1] 303295 0
None
Universal Trial Number (UTN)
U1111-1264-6051
Trial acronym
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Adult phimosis 320508 0
Condition category
Condition code
Renal and Urogenital 318375 318375 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Novoglan-01 clinical trial is expected to provide evidence for the use of the Novoglan foreskin tissue expander as an alternative to steroid creams in the conservative treatment of adult phimosis. The Novoglan product is a medical device commercially available and listed in Australia but it has never been tested for efficacy in a clinical study.

Treatment with the Novoglan product is carried out by the participant in the comfort of his home over a period of 6 to 8 weeks. Before starting a treatment, the participant cleans his foreskin and glans with the alcohol swabs and cotton buds provided in the Novoglan product pack. The core of the Novoglan device is a latex or silicone balloon which is inserted underneath the foreskin and progressively inflated by the participant. Once inflated, the balloon is left in place for about 15 to 30 minutes. At the end of this daily treatment period, the balloon is deflated, removed and cleaned for further usage with alcohol swabs provided in the Novoglan product pack. By progressively inflating the Novoglan balloon under the foreskin daily over a period of 6 to 8 weeks, new tissue grows at the base of the foreskin which becomes looser and eventually is able to retract over the glans. Insertion of the Novoglan balloon stimulates the growth of new skin cells and increases the circumference of the foreskin, allowing it to retract properly.

The Novoglan product is supplied in a pack containing all the required accessories, including latex and silicone balloons, balloon insertion rods, a squeeze bulb inflator, alcohol swabs, cotton buds and various accessories. Latex balloons are used initially to start the treatment and silicone balloons are used in the final stages of treatment. At all time the balloon inflation is under the control of the participant in order to avoid pain or discomfort.

The Novoglan product pack used by the participants in the study is provided to them by the
Study Investigator, urologists Professor David Gillatt or Associate Professor Eric Chung
or by the Study Clinical Research Nurse following an in-depth face-to-face training
session during Study Visit 1, minimum 1 week post Enrolment Visit, at Macquarie
University Hospital (Prof Gillatt) or Princess Alexandra Hospital (A/Prof Chung).

Progress with the Novoglan treatment is monitored during Study Visit 2 over the
phone at 1 week post Study Visit 1, Study Visit 3 also over the phone at 4 weeks post
Study Visit 1 and Final Study Visit face-to-face with the Study Investigator at 6 to 8
Study Visit 1 and Final Study Visit face-to-face with the Study Investigator at 6 to 8
weeks post Study Visit 1. At any time during the treatment, the participant is invited to call the Study Investigator or Clinical Trial Nurse if he is having any problem or concern with the Novoglan treatment. If required, additional training sessions, over the phone or in person can then be organised.
Intervention code [1] 319599 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326347 0
The primary study objective is to measure the efficacy of the Novoglan treatment by comparing the improvement in the degree of phimosis at the start of the study and at the end of the participant study. The degree of phimosis is measured by the Study Investigator using a Kikiros-inspired phimosis assessment scale in 6 points from grade 1 absolutely no retraction to grade 6 full and free retraction of the foreskin.
Timepoint [1] 326347 0
These measurements are carried out at Visit 1 at the start of the study treatment and at 6-8 weeks post-Study Visit 1 during the Final Study Visit (primary timepoint).
Secondary outcome [1] 391111 0
First secondary endpoint – Safety of the device as evidenced by the reporting of any adverse effect or complication as observed and noted by the clinical trial team during the participant’s treatment. Adverse event reporting is carried out at Study Visit 2, at Study Visit 3 and at Final Study Visit.
Timepoint [1] 391111 0
Adverse event reporting is carried out at Study Visit 2, at Study Visit 3 and at Final Study Visit.
Secondary outcome [2] 392754 0
This Quality of Life questionnaire has been designed specifically for this study. Participant satisfaction with the treatment as confirmed by an improvement in quality of life post-treatment, as reported by the participant. Quality of life improvement is assessed by a standardised questionnaire completed during Final Study Visit and compared to the same questionnaire filled in during Study Visit 1.
Timepoint [2] 392754 0
Final Study Visit
Secondary outcome [3] 397011 0
Treatment Tolerability
Timepoint [3] 397011 0
The Novoglan-01 Treatment Tolerability Questionnaire was designed specifically for the Novoglan-01 clinical study. Participants complete the questionnaire at the end of the Study during the final trial study visit.

Eligibility
Key inclusion criteria
The Novoglan-01 study inclusion criteria are as follows.
1. Male 18 or older referred to the urology clinic
2. Symptoms of adult phimosis with inability to fully retract the foreskin
3. Reporting of pain or discomfort
4. Potential participant may have Balanitis Xerotica Obliterans or undergone prior frenuloplasty
5. Willingness to provide informed consent and willingness to participate and comply with the study requirements.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
The Novoglan-01 study exclusion criteria are as follows.
1. Any known allergy to latex or silicones
2. Any bleeding, ulcer or active infection of the penis
3. Any prior prepuce surgery, except for frenuloplasty
4. Any hypospadia
5. Any severe scaring of the glans or foreskin
6. Any history of penile cancer
7. Participants with a history of a psychological illness or other conditions which may interfere with their ability to understand the study requirements

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)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
None
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
In view of the cohort size of 24 participants and in view of the single arm, observational nature of the Novoglan-01 study, it is reasonable to consider the statistical analysis of the Novoglan-01 study as relatively simple. It has been documented by the study biostatistician in a controlled document stored in the Trial Master File and entitled “Novoglan-01 clinical study – Statistical Plan”.

A power calculation was performed to assess which sample size (N) was appropriate for the Novoglan-01 clinical trial. Calculations show that 29 participants must be recruited to reach N = 24, considering a potential drop-out rate of 20%.

The Novoglan-01 clinical trial involves the following measurement variables, which will be measured pre- and post-treatment: Kikiros-inspired phimosis measurement, tolerability questionnaire and quality of life questionnaire. The trial will also involve descriptive variables collected for each patient such as age, weight, medical history and record of adverse events. The recommended analysis plan for the descriptive variables is to use a univariate analysis to contribute to the descriptive statistics of N. From there, tables showing frequency with medians, range, and standard deviations can be generated to describe the population.
An initial validation of each primary and secondary outcome variable will be applied using the Principal Component Analysis. If this analysis is successful, then each variable will be evaluated in an ordinal regression model. If the outcome variables are to be evaluated at the same time, then a Multivariate Multinomial Logit Model will be applied.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
24/10/2019
Date of last participant enrolment
Anticipated
30/11/2021
Actual
Date of last data collection
Anticipated
31/01/2022
Actual
Sample size
Target
24
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 18516 0
Macquarie University Hospital - Macquarie Park
Recruitment hospital [2] 18517 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 32855 0
2109 - Macquarie Park
Recruitment postcode(s) [2] 32856 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 307711 0
Commercial sector/Industry
Name [1] 307711 0
Platigo Solutions Pty Ltd
Country [1] 307711 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Macquarie University NSW 2109
Country
Australia
Secondary sponsor category [1] 308408 0
None
Name [1] 308408 0
Address [1] 308408 0
Country [1] 308408 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307739 0
Macquarie University HREC Medical Sciences Committee
Ethics committee address [1] 307739 0
Ethics committee country [1] 307739 0
Australia
Date submitted for ethics approval [1] 307739 0
20/05/2019
Approval date [1] 307739 0
11/06/2019
Ethics approval number [1] 307739 0
5201937998816
Ethics committee name [2] 307744 0
Queensland Metro South Health Human Research Ethics Committee (EC00167)
Ethics committee address [2] 307744 0
Ethics committee country [2] 307744 0
Australia
Date submitted for ethics approval [2] 307744 0
01/09/2020
Approval date [2] 307744 0
17/11/2020
Ethics approval number [2] 307744 0
HREC/2020/QMS/66682

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

Contacts
Principal investigator
Name 108342 0
Prof David Gillatt
Address 108342 0
Macquarie University Hospital
3 Technology Place
Macquarie University NSW 2109
Country 108342 0
Australia
Phone 108342 0
+61 415 368 405
Fax 108342 0
Email 108342 0
[email protected]
Contact person for public queries
Name 108343 0
David Gillatt
Address 108343 0
Macquarie University Hospital
3 Technology Place
Macquarie University NSW 2109
Country 108343 0
Australia
Phone 108343 0
+61 415 368 405
Fax 108343 0
Email 108343 0
[email protected]
Contact person for scientific queries
Name 108344 0
David Gillatt
Address 108344 0
Macquarie University Hospital
3 Technology Place
Macquarie University NSW 2109
Country 108344 0
Australia
Phone 108344 0
+61 415 368 405
Fax 108344 0
Email 108344 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10386Study protocolOriginal Study Protocol (V2.0 dated 15 March 2019)   381321-(Uploaded-29-01-2021-12-14-18)-Study-related document.pdf
10387Study protocolUpdated Study Protocol (V2.1 dated 29 September 2020)   381321-(Uploaded-29-01-2021-12-09-24)-Study-related document.pdf
10388Ethical approvalEthical approval - Original protocol - MQ HREC (11 June 2019)    381321-(Uploaded-29-01-2021-12-11-08)-Study-related document.pdf
10389Ethical approvalEthical approval - Updated protocol V2.1 - MQ HREC (16 October 2020)   381321-(Uploaded-29-01-2021-12-15-55)-Study-related document.pdf
10390Ethical approvalEthical approval - Updated protocol V2.1 - MSH-RGO (17 November 2020)   381321-(Uploaded-29-01-2021-12-18-53)-Study-related document.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.