Concealed PenisMPPPS SPL BPLNCT07615439
Surgical Repair of Pediatric Concealed Penis is Generally Safe and Efficacious. Criteria for Pediatric Concealed Penis Surgical Success Are Still Poorly Standardized, so Our Study Presents a Multi-dimensional Framework Consisting of Morphometric Measurements and Subjective Psychometric Parameters.
An observational study of Concealed Penis, run by Eslam Saad Hamza at 1 site in Egypt.
Trial summary
A concealed penis (CP) refers to a condition in which the normally-sized penis appears smaller or completely hidden in the prepubic area. Surgical repair of pediatric concealed penis is generally safe and efficacious. Read more about this study
- Who is it for?
- Ages 1 year to 12 years, men only
- Conditions the study is for
- Concealed Penis
- What is being tested?
- penoplasty by complete penile degloving to release all anomalous restrictive attachments, followed by phallopexy via proper fixation of the penile base
- Type of treatment
- Surgery or procedure
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2023to 1 Dec 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 1 year to 12 years
- Men only
- No healthy volunteers
- Child
Study population: The study included 75 pediatric patients (age ranged from 1 to 12 years) diagnosed with concealed penis
Who may be able to join
- children diagnosed with concealed penis, age ranged from 1 to 12 years
Who cannot join
- children with micropenis, hypospadius, cryptorchidism, and blood coagulation disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Standardized Multidimensional Framework for Long-Term Outcomes Following Pediatric Concealed Penis Repair: A Prospective Cohort Study.
A concealed penis (CP) refers to a condition in which the normally-sized penis appears smaller or completely hidden in the prepubic area. Surgical repair of pediatric concealed penis is generally safe and efficacious. Criteria for pediatric concealed penis surgical success are still poorly standardized, so our study presents a multi-dimensional framework consisting of objective morphometric measurement (CI) and subjective psychometric tools (BP Questionnaire and MPPPS) for comprehensive evaluation of long-term anatomical, functional and aesthetic outcomes following the repair.
Read the detailed description
This prospective cohort study was performed at General Surgery Department of Kafrelsheikh University Hospital between December 2023 and December 2024. The study included 75 pediatric patients (age ranged from 1 to 12 years) diagnosed with concealed penis. We excluded children with micropenis, hypospadius, cryptorchidism, and blood coagulation disorders. Under GA, in the supine position, a 5/0 vicryl traction suture was applied to the glans penis. A circumferential incision was made, leaving about 5 mm of collar mucosa below the coronal sulcus. In subdartos plane, the penis was completely degloved to its base at the peno-pubic angle dorsally and to the peno-scrotal angle ventrally. All dysgenetic dartos attachments were sharply excised using scissors . Hemostasis was maintained using bipolar diathermy. A two-point penile fixation technique was performed utilizing 4/0 PDS (polydioxanone) sutures, as the penile base was anchored to pubic fascia, at 2 and 10 o'clock positions . Then dermis of penile skin is sutured to Buck's fascia at the the penile base and the midshaft using 5/0 PDS sutures on both sides of the dorsal neurovascular bundle. Following the excision of redundant preputial skin, the remaining skin was approximated to collar mucosa by interrupted 6/0 Vicryl stitches . A compression dressing soaked with antibiotic cream was applied and kept for 2 days. Patients were discharged on the day of surgery, with a prescription for oral non-steroidal anti-inflammatory drug (NSAIDs), scheduled for the initial outpatient clinic visit after two days for dressing removal and the initiation of topical antibiotic cream (three times daily). A second evaluation was performed at the end of the first postoperative week to monitor early recovery and detect any immediate complications as penile edema, wound hematoma or infection. Longitudinal assessment was maintained via monthly visits for a total duration of one year. This standardized follow-up facilitated consistent collection of morphometric measurements and psychometric assessment of parental perceptions and satisfaction scores.
Evaluation A. Quantitative Morphometric Assessment: Pre and post-operative measurements of baseline penile length (BPL), and the stretched penile length (SPL) were recorded. The Concealed Index (CI), calculated as the ratio of BPL to SPL, was utilized as a standardized morphometric evaluating parameter. It was calculatedd and recorded at three intervals; preoperatively, immediately postoperatively, and at the one-year follow-up to assess both immediate gains and long-term durability.
- Evaluation of parental perception and satisfaction: Parent-reported outcomes were evaluated at the one-year follow-up mark, using two validated psychometric parameters introduced to parents to assess their feedback and satisfaction level: The first tool was the Buried Penis Questionnaire: a pre-approved questionnaire was applied to evaluate the functional outcomes of the surgical repair as penile length improvement, maintainance of hygiene, resolution of urination difficulties and parental psychosocial burden alleviation. The second was the Modified Paediatric Penile Perception Score (MPPPS)to assess hypospadias repair outcomes, and then was modified to evaluate aesthetic outcomes of concealed penis correction. This tool evaluates three domains: penile length, appearance of penile skin, and overall penile appearance. Each domain was quantified using a 4-point scale (0-3), where 0 denotes 'very dissatisfied', 1 'dissatisfied', 2 'satisfied', and 3 'very satisfied'. Total score (0-9) provided a metric for assessing parental satisfaction with long-term surgical outcome.
- Conditions
- Concealed Penis
- Being tested
- penoplasty by complete penile degloving to release all anomalous restrictive attachments, followed by phallopexy via proper fixation of the penile base
- Keywords
- degloving, satisfaction, concealed
- Medical subject headings
- Degloving Injuries, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
penoplasty by complete penile degloving to release all anomalous restrictive attachments, followed by phallopexy via proper fixation of the penile baseProcedure or surgery
Under GA, in the supine position, a 5/0 vicryl traction suture was applied to the glans penis. A circumferential incision was made, leaving about 5 mm of collar mucosa below the coronal sulcus. In subdartos plane, the penis was completely degloved to its base at the peno-pubic angle dorsally and to the peno-scrotal angle ventrally. All dysgenetic dartos attachments were sharply excised using scissors . Hemostasis was maintained using bipolar diathermy. A two-point penile fixation technique was performed utilizing 4/0 PDS (polydioxanone) sutures, as the penile base was anchored to pubic fascia, at 2 and 10 o'clock positions . Then dermis of penile skin is sutured to Buck's fascia at the the penile base and the midshaft using 5/0 PDS sutures on both sides of the dorsal neurovascular bundle. Following the excision of redundant preputial skin, the remaining skin was approximated to collar mucosa by interrupted 6/0 Vicryl stitches . A compression dressing soaked wit
What is being measured
The primary outcome is the main question the study is designed to answer.
The immediate postoperative period
number of participants with postoperative penile skin edema
Measured: 1-2 weeks
Secondary outcomes (1)
The longterm postoperative results
number of participants with secondary penile retraction in the long-term
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start1 Dec 2023
- Primary completion1 Dec 2024
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concealed PenisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Eslam Saad Hamza
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eslam Saad Hamza, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07615439
- Sponsor's protocol ID
- Approval Number. KFSIRB200-351
- Acronym
- MPPPS SPL BPL
- Status last verified
- May 2026
- First submitted
- 19 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Standardized Multidimensional Framework for Long-Term Outcomes Following Pediatric Concealed Penis Repair: A Prospective Cohort Study.
- ClinicalTrials.gov ID
- NCT07615439
- Acronym / sponsor ID
- MPPPS SPL BPL / Approval Number. KFSIRB200-351
- Conditions
- Concealed Penis
- Keywords
- degloving, satisfaction, concealed
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Eslam Saad HamzaUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 29 May 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.
A concealed penis (CP) refers to a condition in which the normally-sized penis appears smaller or completely hidden in the prepubic area. Surgical repair of pediatric concealed penis is generally safe and efficacious. Criteria for pediatric concealed penis surgical success are still poorly standardized, so our study presents a multi-dimensional framework consisting of objective morphometric measurement (CI) and subjective psychometric tools (BP Questionnaire and MPPPS) for comprehensive evaluation of long-term anatomical, functional and aesthetic outcomes following the repair.
Detailed description
This prospective cohort study was performed at General Surgery Department of Kafrelsheikh University Hospital between December 2023 and December 2024. The study included 75 pediatric patients (age ranged from 1 to 12 years) diagnosed with concealed penis. We excluded children with micropenis, hypospadius, cryptorchidism, and blood coagulation disorders. Under GA, in the supine position, a 5/0 vicryl traction suture was applied to the glans penis. A circumferential incision was made, leaving about 5 mm of collar mucosa below the coronal sulcus. In subdartos plane, the penis was completely degloved to its base at the peno-pubic angle dorsally and to the peno-scrotal angle ventrally. All dysgenetic dartos attachments were sharply excised using scissors . Hemostasis was maintained using bipolar diathermy. A two-point penile fixation technique was performed utilizing 4/0 PDS (polydioxanone) sutures, as the penile base was anchored to pubic fascia, at 2 and 10 o'clock positions . Then dermis of penile skin is sutured to Buck's fascia at the the penile base and the midshaft using 5/0 PDS sutures on both sides of the dorsal neurovascular bundle. Following the excision of redundant preputial skin, the remaining skin was approximated to collar mucosa by interrupted 6/0 Vicryl stitches . A compression dressing soaked with antibiotic cream was applied and kept for 2 days. Patients were discharged on the day of surgery, with a prescription for oral non-steroidal anti-inflammatory drug (NSAIDs), scheduled for the initial outpatient clinic visit after two days for dressing removal and the initiation of topical antibiotic cream (three times daily). A second evaluation was performed at the end of the first postoperative week to monitor early recovery and detect any immediate complications as penile edema, wound hematoma or infection. Longitudinal assessment was maintained via monthly visits for a total duration of one year. This standardized follow-up facilitated consistent collection of morphometric measurements and psychometric assessment of parental perceptions and satisfaction scores.
Evaluation A. Quantitative Morphometric Assessment: Pre and post-operative measurements of baseline penile length (BPL), and the stretched penile length (SPL) were recorded. The Concealed Index (CI), calculated as the ratio of BPL to SPL, was utilized as a standardized morphometric evaluating parameter. It was calculatedd and recorded at three intervals; preoperatively, immediately postoperatively, and at the one-year follow-up to assess both immediate gains and long-term durability.
- Evaluation of parental perception and satisfaction: Parent-reported outcomes were evaluated at the one-year follow-up mark, using two validated psychometric parameters introduced to parents to assess their feedback and satisfaction level: The first tool was the Buried Penis Questionnaire: a pre-approved questionnaire was applied to evaluate the functional outcomes of the surgical repair as penile length improvement, maintainance of hygiene, resolution of urination difficulties and parental psychosocial burden alleviation. The second was the Modified Paediatric Penile Perception Score (MPPPS)to assess hypospadias repair outcomes, and then was modified to evaluate aesthetic outcomes of concealed penis correction. This tool evaluates three domains: penile length, appearance of penile skin, and overall penile appearance. Each domain was quantified using a 4-point scale (0-3), where 0 denotes 'very dissatisfied', 1 'dissatisfied', 2 'satisfied', and 3 'very satisfied'. Total score (0-9) provided a metric for assessing parental satisfaction with long-term surgical outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study included 75 pediatric patients (age ranged from 1 to 12 years) diagnosed with concealed penis
Key inclusion criteria (1 listed)
- children diagnosed with concealed penis, age ranged from 1 to 12 years
Key exclusion criteria (1 listed)
- children with micropenis, hypospadius, cryptorchidism, and blood coagulation disorders.
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 |
|---|---|---|
| penoplasty by complete penile degloving to release all anomalous restrictive attachments, followed by phallopexy via proper fixation of the penile baseUnder GA, in the supine position, a 5/0 vicryl traction suture was applied to the glans penis. A circumferential incision was made, leaving about 5 mm of collar mucosa below the coronal sulcus. In subdartos plane, the penis was completely degloved to its base at the peno-pubic angle dorsally and to the peno-scrotal angle ventrally. All dysgenetic dartos attachments were sharply excised using scissors . Hemostasis was maintained using bipolar diathermy. A two-point penile fixation technique was performed utilizing 4/0 PDS (polydioxanone) sutures, as the penile base was anchored to pubic fascia, at 2 and 10 o'clock positions . Then dermis of penile skin is sutured to Buck's fascia at the the penile base and the midshaft using 5/0 PDS sutures on both sides of the dorsal neurovascular bundle. Following the excision of redundant preputial skin, the remaining skin was approximated to collar mucosa by interrupted 6/0 Vicryl stitches . A compression dressing soaked wit | Procedure or surgery | – |
Primary outcome
The immediate postoperative period
Time frame: 1-2 weeks
number of participants with postoperative penile skin edema
1 secondary outcome
The longterm postoperative results
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Concealed Penis, run by Eslam Saad Hamza 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 29 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The immediate postoperative period (time frame: 1-2 weeks). 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 29 May 2026.