Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000899448p
Ethics application status
Submitted, not yet approved
Date submitted
22/07/2025
Date registered
19/08/2025
Date last updated
19/08/2025
Date data sharing statement initially provided
19/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Use of the Novoglan Device and Steroid Cream in Adult Men With Phimosis
Scientific title
Real-World Evaluation of the Efficacy of the Novoglan Device Combined with Topical Corticosteroid Cream in the Management of Adult Phimosis: A pilot study
Secondary ID [1] 314971 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adult Phimosis 338287 0
Condition category
Condition code
Renal and Urogenital 334590 334590 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive a combination of topical corticosteroid therapy and the Novoglan penile tissue expander as a non-surgical treatment for adult phimosis. The Novoglan device is a CE-marked Class 1 medical device designed to gently stretch the foreskin via controlled pneumatic expansion.

Intervention protocol:
Topical corticosteroid: Betamethasone valerate 0.05% cream will be applied directly to the phimotic ring twice daily (morning and evening).
Mechanical therapy: The Novoglan device, a soft silicone balloon system, is inserted under the foreskin and manually inflated using a handheld pump to gently stretch the phimotic ring. The device will be applied for 10 minutes twice daily, at least 30–60 minutes after corticosteroid application to allow sufficient absorption of the cream.
Treatment will be self-administered at home following standardised verbal and written instructions provided by an urology clinician.
The intervention period is 6-8 weeks, with participants reviewed at baseline, 4 weeks, 6 weeks and 8 weeks in the outpatient urology clinic.
Monitoring adherence:
Adherence to the intervention will be monitored through structured discussions during scheduled outpatient reviews at 4, 6 and 8 weeks. At each visit, clinicians will assess participant-reported use of the cream and device, troubleshoot any difficulties, and reinforce correct technique. A study-specific adherence questionnaire will also be completed at the final visit to document overall adherence and participant experience.
Intervention code [1] 331564 0
Treatment: Devices
Intervention code [2] 331565 0
Treatment: Other
Intervention code [3] 331615 0
Treatment: Drugs
Comparator / control treatment
No control group. This is a single-arm interventional study evaluating the combined use of the Novoglan device and topical corticosteroid (Betamethasone valerate 0.05%) for adult phimosis. All participants receive the same intervention.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342260 0
Successful foreskin retraction - i.e. ability to retract foreskin fully over the glans
Timepoint [1] 342260 0
Baseline, and at 8-10 weeks following commencement of treatment
Secondary outcome [1] 450182 0
Change in urinary symptom scores
Timepoint [1] 450182 0
Baseline, and at 8-10 weeks following commencement of treatment
Secondary outcome [2] 450336 0
Change in sexual symptoms
Timepoint [2] 450336 0
Baseline, and at 8-10 weeks following commencement of treatment
Secondary outcome [3] 450337 0
Change in psychological distress
Timepoint [3] 450337 0
Baseline, and at 8-10 weeks following commencement of treatment
Secondary outcome [4] 450339 0
Change in quality of life
Timepoint [4] 450339 0
Baseline, and at 8-10 weeks following commencement of treatment

Eligibility
Key inclusion criteria
Male, aged 18 years or older
Clinical diagnosis of phimosis
Currently on the Monash Health circumcision waitlist (Category 2 or 3)
Capable of providing informed consent
Able to understand the potential risks and benefits of the study and willing to use the Novoglan device as instructed
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
EXCLUSION CRITERIA
- Active infection or ulceration of the foreskin or glans
- Phimosis with suspected malignancy
- Known allergy to silicone
- Inability to attend the initial and final clinic visit
- Inability to comply with device use

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be analysed using descriptive and comparative statistics.
- Descriptive statistics (means, standard deviations, frequencies, and proportions) will be used to summarise baseline characteristics, symptom burden, treatment adherence, and patient satisfaction etc.
- Ordinal outcomes, including symptom severity, pain, and satisfaction scores (measured on 0–10 numeric rating scales), will be analysed using linear mixed models, ordinal regression, or ANCOVA with covariates.
- Binary outcomes (e.g., presence of ballooning, occurrence of infections, difficulty or pain during use of the Novoglan device) will be analysed using McNemar’s test, whilst adjustments to confounders will be done using a mixed-effects model.
- Exploratory analyses using regression model may be conducted to identify predictors of treatment response, including baseline variables such as age, symptom duration, initial phimosis grade, and history of balanitis or suspected balanitis xerotica obliterans (BXO).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/09/2025
Actual
Date of last participant enrolment
Anticipated
19/09/2025
Actual
Date of last data collection
Anticipated
30/01/2026
Actual
Sample size
Target
49
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 28234 0
Casey Hospital - Berwick
Recruitment postcode(s) [1] 44445 0
3806 - Berwick

Funding & Sponsors
Funding source category [1] 319524 0
University
Name [1] 319524 0
Monash University
Country [1] 319524 0
Australia
Primary sponsor type
Hospital
Name
Monash Health
Address
Country
Australia
Secondary sponsor category [1] 322024 0
None
Name [1] 322024 0
Address [1] 322024 0
Country [1] 322024 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 318098 0
Monash Health Human Research Ethics Committee A
Ethics committee address [1] 318098 0
Ethics committee country [1] 318098 0
Australia
Date submitted for ethics approval [1] 318098 0
02/06/2025
Approval date [1] 318098 0
Ethics approval number [1] 318098 0

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

Contacts
Principal investigator
Name 143114 0
A/Prof Weranja Ranasinghe
Address 143114 0
Monash Health – Department of Urology 246 Clayton Rd, Clayton, VIC 3168
Country 143114 0
Australia
Phone 143114 0
+61 433640337
Fax 143114 0
Email 143114 0
[email protected]
Contact person for public queries
Name 143115 0
Ka Wing Ng
Address 143115 0
Monash Health – Department of Urology 246 Clayton Rd, Clayton, VIC 3168
Country 143115 0
Australia
Phone 143115 0
+61 3 9594 2100
Fax 143115 0
Email 143115 0
[email protected]
Contact person for scientific queries
Name 143116 0
Ka Wing Ng
Address 143116 0
Monash Health – Department of Urology 246 Clayton Rd, Clayton, VIC 3168
Country 143116 0
Australia
Phone 143116 0
+61 3 9594 2100
Fax 143116 0
Email 143116 0
[email protected]

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


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.