Assessing penile length gain after phalloplasty in children with concealed penis
Gain in Stretched Penile Length After Phalloplasty With & Without Penile Traction in Children.
This study is testing if using a special device after surgery can help boys aged 4 to 13 with a concealed penis grow a longer penis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 4 Years to 13 Years |
| Sex | Male |
| Sponsor | Shaikh Zayed Hospital, Lahore Academic / other |
| Locations | 1 site (Lahore, Punjab) |
| Trial ID | NCT06260241 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of penile traction in increasing stretched penile length following phalloplasty in children aged 4 to 13 years with a concealed penis. The study will involve two groups: one receiving traction treatment post-surgery and the other not receiving traction. The primary outcome will be the comparison of stretched penile length before and after the procedure, analyzed using statistical methods to determine the significance of the results. The trial seeks to address a gap in current treatment approaches for this rare condition.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 4 to 13 years diagnosed with a concealed penis requiring phalloplasty.
Not a fit: Patients with congenital abnormalities of the penis or those unfit for general anesthesia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a method to enhance penile length in children undergoing phalloplasty, improving their cosmetic outcomes and psychological well-being.
How similar studies have performed: While there is limited research specifically on traction post-phalloplasty, preliminary findings from pilot studies suggest potential benefits, indicating this approach may be novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Infants and children aged 4 years to 13 years of age. * Presenting with concealed penis for circumcision. Exclusion Criteria: * Congenital Buried Penis * Webbed penis * Structural abnormalities of the penis such as hypospadias, Epispadias etc. * Existing co-morbid syndromes or conditions * Unfit for general anesthesia * Known bleeding diathesis * Incomplete foreskin * Any previous penile surgery
Where this trial is running
Lahore, Punjab
- Sheikh Zayed Hospital — Lahore, Punjab, Pakistan (Recruiting)
Study contacts
- Study coordinator: Adeel Ahmed, Mbbs Ms
- Email: aadeel93@hotmail.com
- Phone: 00923334958574
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.