Safety, efficacy and tolerability of the Novoglan foreskin tissue expander product as a conservative treatment for adult phimosis.

Not Applicable

Recruiting

• Conditions: Adult phimosis; Renal and Urogenital - Other renal and urogenital disorders

• Registration Number: ACTRN12621000924853
• Lead Sponsor: Macquarie University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-15
• Last Update Posted: 21 July 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 24

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.

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. [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).]