Penis/SurgeryNCT07675915
A Novel Suspensory Ligament Penodermal Fixation Technique Versus Dorsal Tunica Albuginea Fixation for Pediatric Buried Penis:
A study testing Group A: Suspensory ligament fixation and Group B: Tunica albuginea fixation in people with Penis/Surgery and Fixation, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of the work to compare the outcomes of suspensory ligament fixation to the sub-dermis and dorsal tunica albuginea fixation in terms of success rate, need for auxiliary procedures, and complication rates in the buried penis. Read more about this study
- Who is it for?
- Ages 2 months to 16 years, men only
- Conditions the study is for
- Penis/Surgery, Fixation, Ligament
- What is being tested?
- Group A: Suspensory ligament fixation and Group B: Tunica albuginea fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jun 2026to 30 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 16 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Children under the age of 18 years diagnosed
- Children with buried penis with parents seeking surgical treatment of this condition.
Who cannot join
- History of previous penile surgery.
- Patients with micro-penis.
- Patients with other congenital anomalies such as hypospadias, epispadias and cryptorchidism.
- Uncontrolled bleeding diathesis or patient who isn't fit for general anesthesia.
- Buried penis due to excessive obesity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Tanta University
Tanta
Youssef Abdelhamid, Resident, 01127728862, yosefgoma99@gmail.com
About this study
Official title: A Novel Suspensory Ligament Penodermal Fixation Technique Versus Dorsal Tunica Albuginea Fixation for Pediatric Buried Penis: A Prospective Comparative Cohort Study
The aim of the work to compare the outcomes of suspensory ligament fixation to the sub-dermis and dorsal tunica albuginea fixation in terms of success rate, need for auxiliary procedures, and complication rates in the buried penis.
Read the detailed description
Buried penis is a congenital penile anomaly in which the penile shaft is hidden beneath the surrounding skin and subcutaneous tissues, despite having a normal-sized underlying structure. It is a relatively uncommon condition in children, but it is clinically significant due to its functional, hygienic, and psychological consequences. Reported incidence varies across populations. The condition is often underrecognized or misdiagnosed, particularly in early childhood .
The etiology of buried penis is multifactorial and not yet fully understood. Several mechanisms have been proposed, including deficient or inelastic penile shaft skin, abnormal fixation of dartos fascia, and inadequate attachment between the penile skin and underlying Buck's fascia. Excess prepubic fat and abnormal ventral displacement of the penis may further contribute to its buried appearance. Additionally, fibrous tethering bands between fascial layers have been implicated in anchoring the penis within surrounding tissues .
Clinically, buried penis presents with variable severity ranging from a partially visible "stumpy" penile shaft to complete concealment beneath the suprapubic or scrotal tissue. Children often present with parental concern regarding penile size, hygiene difficulties, and functional urinary problems. These may include urine spraying, recurrent balanitis, urinary tract infections, and difficulty voiding in a standing position. In more severe or prolonged cases, psychological distress and body image concerns may develop .
Buried penis should be differentiated from other penile conditions such as micropenis, webbed penis, and trapped penis, as each has distinct anatomical and pathological features. Misclassification may lead to inappropriate management strategies and suboptimal outcomes. Accurate clinical assessment is therefore essential, often relying on physical examination and careful evaluation of penile skin deficiency, fascial attachments, and surrounding adiposity. Early diagnosis is important to prevent progressive functional and psychosocial complications .
Surgical correction remains the mainstay of treatment for buried penis, especially in symptomatic or persistent cases. The primary goals of surgery are to achieve adequate penile exposure, restore normal anatomy, and improve both functional and cosmetic outcomes. Multiple surgical techniques have been described; However, no single standardized technique has been universally accepted .
Penodermal fixation sutures utilizing suspensory ligament is a technique used as a complete penile degloving and release of abnormal dartos bands in children with buried penis occurs. Fixation sutures are placed between the penile dermis and the suspensory ligament at the penile base to maintain shaft exposure and recreate normal penopubic angles. It provides stable support, decreases postoperative retraction, and improves cosmetic appearance with low recurrence rates. Recent studies support fixation-based methods as safe and effective options in pediatric buried penis repair .
Another technique is called dorsal tunica albuginea sutures, after penile degloving and release of tethering tissues, fixation sutures are placed between the dermis or subcutaneous tissue and the dorsal tunica albuginea of the penile shaft. The tunica serves as a strong anchoring structure to maintain externalization of the penis. This approach helps secure shaft skin position and reduces recurrence of concealment. It is considered effective with good functional and cosmetic results.
The aim of the work to compare the outcomes of suspensory ligament fixation to the sub-dermis and dorsal tunica albuginea fixation in terms of success rate, need for auxiliary procedures, and complication rates in the buried penis.
- Conditions
- Penis/Surgery, Fixation, Ligament
- Being tested
- Group A: Suspensory ligament fixation, Group B: Tunica albuginea fixation
- Keywords
- Suspensory Ligament, Penodermal, Dorsal Tunica Albuginea Fixation, Pediatric Buried Penis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A: Suspensory ligament fixationProcedure or surgery
All patients will receive a prophylactic antibiotic before beginning of the procedure. The operative area will be cleaned with 10% povidine iodine and draped in sterile manner. We will perform the procedure in the supine position. The technique consists of complete degloving of the penis with release of any tethering tissues and exposure of the suspensory ligament at the base of the penile shaft.
The suspensory ligament is identified, and fixation suture is placed between the ligament and the deep subdermal layer of the suprapubic skin without involving the tunica albuginea. This suture is positioned to secure the penile base and maintain a stable penopubic angle, helping to prevent retraction. Care is taken to ensure appropriate depth and tension of the sutures to avoid over-tightening, followed by re-draping and closure of the skin. This will also be associated with placement of 2 fixation sutures at the penoscrotal junction to identify Penoscrotal angle.
Group B: Tunica albuginea fixationProcedure or surgery
All patients will receive prophylactic antibiotics before the beginning of the procedure. Operative area will be cleaned with 10% povidone iodine and draped in sterile manner. We will perform the procedure in supine position, The technique consists of complete degloving of the penis and release of any tethering tissues, exposure of the base of the penile shaft.
Sutures are then placed between the tunica albuginea on the dorsal aspect of the penile base and the deep dermal (subdermal) layer of the suprapubic skin in the direction of 3 and 9 o'clock to avoid the neurovascular bundle. These sutures are positioned symmetrically to secure the penile shaft in a fixed position relative to the overlying skin. Care is taken to place the sutures at an appropriate depth and tension, followed by re-draping and closure of the skin.
This will also be associated with placement of 2 fixation sutures at the penoscrotal junction to identify penoscrotal angle.
| Study group | Role | What they receive |
|---|---|---|
| Group A : ( suspensory ligament fixation) | Experimental | All patients will receive a prophylactic antibiotic before beginning of the procedure. The operative area will be cleaned with 10% povidine iodine and draped in sterile manner. We will perform the procedure in the supine position. The technique consists of complete degloving of the penis with release of any tethering tissues and exposure of the suspensory ligament at the base of the penile shaft. The suspensory ligament is identified, and fixation suture is placed between the ligament and the deep subdermal layer of the suprapubic skin without involving the tunica albuginea. This suture is positioned to secure the penile base and maintain a stable penopubic angle, helping to prevent retraction. Care is taken to ensure appropriate depth and tension of the sutures to avoid over-tightening, followed by re-draping and closure of the skin.
This will also be associated with placement of 2 fixation sutures at the penoscrotal junction to identify Penoscrotal angle. Receives: Procedure: Group A: Suspensory ligament fixation |
| Group B: Tunica albuginea fixation | Experimental | All patients will receive prophylactic antibiotics before the beginning of the procedure. Operative area will be cleaned with 10% povidone iodine and draped in sterile manner. We will perform the procedure in supine position, The technique consists of complete degloving of the penis and release of any tethering tissues, exposure of the base of the penile shaft.
Sutures are then placed between the tunica albuginea on the dorsal aspect of the penile base and the deep dermal (subdermal) layer of the suprapubic skin in the direction of 3 and 9 o'clock to avoid the neurovascular bundle. These sutures are positioned symmetrically to secure the penile shaft in a fixed position relative to the overlying skin. Care is taken to place the sutures at an appropriate depth and tension, followed by re-draping and closure of the skin.
This will also be associated with placement of 2 fixation sutures at the penoscrotal junction to identify penoscrotal angle. Receives: Procedure: Group B: Tunica albuginea fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate recurrence of buried penis (repair of buried penis)
Measured: 2 weeks, 1 month, 3 months, 6 months postoperatively
Secondary outcomes (1)
Postoperative complications
Measured: 2 weeks, 1 month, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start30 Jun 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Penis/SurgeryStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youssef Ibrahim Abdelhamid, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07675915
- Sponsor's protocol ID
- 36265MS102 / 5/ 26
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It will be available if it needed
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Suspensory Ligament Penodermal Fixation Technique Versus Dorsal Tunica Albuginea Fixation for Pediatric Buried Penis: A Prospective Comparative Cohort Study
- ClinicalTrials.gov ID
- NCT07675915
- Acronym / sponsor ID
- 36265MS102 / 5/ 26
- Conditions
- Penis/Surgery, Fixation, Ligament
- Keywords
- Suspensory Ligament, Penodermal, Dorsal Tunica Albuginea Fixation, Pediatric Buried Penis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the work to compare the outcomes of suspensory ligament fixation to the sub-dermis and dorsal tunica albuginea fixation in terms of success rate, need for auxiliary procedures, and complication rates in the buried penis.
Detailed description
Buried penis is a congenital penile anomaly in which the penile shaft is hidden beneath the surrounding skin and subcutaneous tissues, despite having a normal-sized underlying structure. It is a relatively uncommon condition in children, but it is clinically significant due to its functional, hygienic, and psychological consequences. Reported incidence varies across populations. The condition is often underrecognized or misdiagnosed, particularly in early childhood .
The etiology of buried penis is multifactorial and not yet fully understood. Several mechanisms have been proposed, including deficient or inelastic penile shaft skin, abnormal fixation of dartos fascia, and inadequate attachment between the penile skin and underlying Buck's fascia. Excess prepubic fat and abnormal ventral displacement of the penis may further contribute to its buried appearance. Additionally, fibrous tethering bands between fascial layers have been implicated in anchoring the penis within surrounding tissues .
Clinically, buried penis presents with variable severity ranging from a partially visible "stumpy" penile shaft to complete concealment beneath the suprapubic or scrotal tissue. Children often present with parental concern regarding penile size, hygiene difficulties, and functional urinary problems. These may include urine spraying, recurrent balanitis, urinary tract infections, and difficulty voiding in a standing position. In more severe or prolonged cases, psychological distress and body image concerns may develop .
Buried penis should be differentiated from other penile conditions such as micropenis, webbed penis, and trapped penis, as each has distinct anatomical and pathological features. Misclassification may lead to inappropriate management strategies and suboptimal outcomes. Accurate clinical assessment is therefore essential, often relying on physical examination and careful evaluation of penile skin deficiency, fascial attachments, and surrounding adiposity. Early diagnosis is important to prevent progressive functional and psychosocial complications .
Surgical correction remains the mainstay of treatment for buried penis, especially in symptomatic or persistent cases. The primary goals of surgery are to achieve adequate penile exposure, restore normal anatomy, and improve both functional and cosmetic outcomes. Multiple surgical techniques have been described; However, no single standardized technique has been universally accepted .
Penodermal fixation sutures utilizing suspensory ligament is a technique used as a complete penile degloving and release of abnormal dartos bands in children with buried penis occurs. Fixation sutures are placed between the penile dermis and the suspensory ligament at the penile base to maintain shaft exposure and recreate normal penopubic angles. It provides stable support, decreases postoperative retraction, and improves cosmetic appearance with low recurrence rates. Recent studies support fixation-based methods as safe and effective options in pediatric buried penis repair .
Another technique is called dorsal tunica albuginea sutures, after penile degloving and release of tethering tissues, fixation sutures are placed between the dermis or subcutaneous tissue and the dorsal tunica albuginea of the penile shaft. The tunica serves as a strong anchoring structure to maintain externalization of the penis. This approach helps secure shaft skin position and reduces recurrence of concealment. It is considered effective with good functional and cosmetic results.
The aim of the work to compare the outcomes of suspensory ligament fixation to the sub-dermis and dorsal tunica albuginea fixation in terms of success rate, need for auxiliary procedures, and complication rates in the buried penis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A : ( suspensory ligament fixation) | Experimental | Procedure: Group A: Suspensory ligament fixationAll patients will receive a prophylactic antibiotic before beginning of the procedure. The operative area will be cleaned with 10% povidine iodine and draped in sterile manner. We will perform the procedure in the supine position. The technique consists of complete degloving of the penis with release of any tethering tissues and exposure of the suspensory ligament at the base of the penile shaft. The suspensory ligament is identified, and fixation suture is placed between the ligament and the deep subdermal layer of the suprapubic skin without involving the tunica albuginea. This suture is positioned to secure the penile base and maintain a stable penopubic angle, helping to prevent retraction. Care is taken to ensure appropriate depth and tension of the sutures to avoid over-tightening, followed by re-draping and closure of the skin. This will also be associated with placement of 2 fixation sutures at the penoscrotal junction to identify Penoscrotal angle. |
| Group B: Tunica albuginea fixation | Experimental | Procedure: Group B: Tunica albuginea fixationAll patients will receive prophylactic antibiotics before the beginning of the procedure. Operative area will be cleaned with 10% povidone iodine and draped in sterile manner. We will perform the procedure in supine position, The technique consists of complete degloving of the penis and release of any tethering tissues, exposure of the base of the penile shaft. Sutures are then placed between the tunica albuginea on the dorsal aspect of the penile base and the deep dermal (subdermal) layer of the suprapubic skin in the direction of 3 and 9 o'clock to avoid the neurovascular bundle. These sutures are positioned symmetrically to secure the penile shaft in a fixed position relative to the overlying skin. Care is taken to place the sutures at an appropriate depth and tension, followed by re-draping and closure of the skin. This will also be associated with placement of 2 fixation sutures at the penoscrotal junction to identify penoscrotal angle. |
Who may qualify
- Ages
- 2 months to 16 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children under the age of 18 years diagnosed
- Children with buried penis with parents seeking surgical treatment of this condition.
Key exclusion criteria (5 listed)
- History of previous penile surgery.
- Patients with micro-penis.
- Patients with other congenital anomalies such as hypospadias, epispadias and cryptorchidism.
- Uncontrolled bleeding diathesis or patient who isn't fit for general anesthesia.
- Buried penis due to excessive obesity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group A: Suspensory ligament fixationAll patients will receive a prophylactic antibiotic before beginning of the procedure. The operative area will be cleaned with 10% povidine iodine and draped in sterile manner. We will perform the procedure in the supine position. The technique consists of complete degloving of the penis with release of any tethering tissues and exposure of the suspensory ligament at the base of the penile shaft. The suspensory ligament is identified, and fixation suture is placed between the ligament and the deep subdermal layer of the suprapubic skin without involving the tunica albuginea. This suture is positioned to secure the penile base and maintain a stable penopubic angle, helping to prevent retraction. Care is taken to ensure appropriate depth and tension of the sutures to avoid over-tightening, followed by re-draping and closure of the skin. This will also be associated with placement of 2 fixation sutures at the penoscrotal junction to identify Penoscrotal angle. | Procedure or surgery | Group A : ( suspensory ligament fixation) |
| Group B: Tunica albuginea fixationAll patients will receive prophylactic antibiotics before the beginning of the procedure. Operative area will be cleaned with 10% povidone iodine and draped in sterile manner. We will perform the procedure in supine position, The technique consists of complete degloving of the penis and release of any tethering tissues, exposure of the base of the penile shaft. Sutures are then placed between the tunica albuginea on the dorsal aspect of the penile base and the deep dermal (subdermal) layer of the suprapubic skin in the direction of 3 and 9 o'clock to avoid the neurovascular bundle. These sutures are positioned symmetrically to secure the penile shaft in a fixed position relative to the overlying skin. Care is taken to place the sutures at an appropriate depth and tension, followed by re-draping and closure of the skin. This will also be associated with placement of 2 fixation sutures at the penoscrotal junction to identify penoscrotal angle. | Procedure or surgery | Group B: Tunica albuginea fixation |
Primary outcome
Evaluate recurrence of buried penis (repair of buried penis)
Time frame: 2 weeks, 1 month, 3 months, 6 months postoperatively
1 secondary outcome
Postoperative complications
Time frame: 2 weeks, 1 month, 3 months, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: Yes. It will be available if it needed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A: Suspensory ligament fixation and Group B: Tunica albuginea fixation in people with Penis/Surgery and Fixation, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Youssef Abdelhamid, Resident (01127728862, yosefgoma99@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate recurrence of buried penis (repair of buried penis) (time frame: 2 weeks, 1 month, 3 months, 6 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.