Distal Penile Hypospadias (Disorder)NCT06700629

Distal Hypospadias Repair Outcome

A study testing Distal Penile Hypospadias (Disorder) in people with Distal Penile Hypospadias (Disorder), run by Armia Ezzat Thabet Azer at 2 sites in Egypt.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Aim is : To define the preoperative parameters that may influence the results of distal hypospadias repair Read more about this study

Who is it for?: Ages 1 year and older, men only
Conditions the study is for: Distal Penile Hypospadias (Disorder)
What is being tested?: Distal Penile Hypospadias (Disorder)
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 2 sitesEgypt
Study dates: 1 Jan 2025to 30 Jun 2026
Phase: Interventional

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 and older
Men only
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Child with distal hypospadias, uncircumcised , without meatal stenosis and no previous surgery for hypospadias

Who cannot join

Any surgical manipulation includes circumcision or meatotomy. Patient refusal to be enrolled in the research. Patient lost follow up in the first six months

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Armia Ezzat Thabet Azer, bachelor degree contact

+201096067142

armia.ezzat@yahoo.com

Egypt2 sites

Faculty Of Medicine Assiut University
Asyut, Asyut Governorate, 71511
Noha Elabody
Asyut, 71111
Medhat Ahmed Abdallah, Prof Dr, +20 101 095 1555, medhathawary@gmail.com

Other trials in Egypt

About this study

Official title: Preoperative Predictors of Distal Hypospadias Repair Outcome

Aim is : To define the preoperative parameters that may influence the results of distal hypospadias repair

Read the detailed description

Hypospadias is a congenital deformity where the opening of the urethra (the meatus) is sited on the underside (ventral) part of the penis, anywhere from the glans to the perineum.

It occurs in 1 in 250 live male births. it is often associated with "hooded" foreskin and chordee (ventral curvature of the penis shaft).

Hypospadias can be classified according to the anatomical location of meatus:

Distal-anterior hypospadias (located on the glans or distal shaft of the penis and the most common type of hypospadias) Intermediate-middle (penile). Proximal-posterior (penoscrotal, scrotal, perineal).

Diagnosis includes a description of the local findings:

Position, shape and width of the orifice Presence of atretic urethra and division of corpus spongiosum Appearance of the preputial hood and scrotum Size of the penis Curvature of the penis on erection. Aim of hypospadias surgery :(2) Is to correct penile curvature,to form neo-urethera of an adequate size, to bring the neomeatus to the tip of glans, and offer satisfactory cosmetic results.

The ideal age at surgery for primary hypospadias repair is usually 6-18 months. The complication rate is about 10% in distal hypospadias repair.

Complications include:

uretherocutaneous fistula.
meatal stenosis.
urethral stricture.
Urethral diverticulum. After hypospadias repairs, long-term follow-up is necessary, up to adolescence, to detect urethral stricture, voiding dysfunction and recurrent penile curvature.

Conditions: Distal Penile Hypospadias (Disorder)
Being tested: Distal Penile Hypospadias (Disorder)
Keywords: Penile Hypospadias
Medical subject headings: Hypospadias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Distal Penile Hypospadias (Disorder)Procedure or surgery
Also called Distal Penile Hypospadias repair outcome
Three operations which are Tubularized incised plate urethroplasty (TIP), Mathieu and meatal advancement and glanuplasty (MAGPI).
A three experienced operators with number of operations done by each one more than one hundred operation in the last year.
The operators will be fixed for each surgical technique as follows:
1. Doctor (A) for Matheiu. ( 35 operations)
2. Doctor (M) for MAGPI. ( 35 operations)
3. Doctor (S) for TIP ( 35 operations). Tubularized incised plate urethroplasty:(3,6) Indication: for distal penile hypospadias with or without penile curvature with any width of the uretheral plate and also for any type of distal hypospadias associated with curvature.
Key steps for this operation are as follows:
Glans retraction using stay suture 4-0 or 5-0 silk. Uretheral catheter pass through hypospadic meatus to bladder. Parallel longitudenal incision is done 1-2mm proximal to hypospadic meatus. A circumferential incision is made 2-3 mm below coronal sulcus dorsally

Study groups in NCT06700629
Study group	Role	What they receive
DPH repair outcome	Other	Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, …): A. Preoperative preparation: All patients will be subjected to evaluation including: 1. Measurement of penile length and width (in cm). 2. The shape of glans. (clefted , incomplete ceft, flat) 3. Glans size is measured by cubic centimetres. 4. Presence or absence of chordee and its degree. 5. Urethral plate condition and it's length, width and surface area. 6. Condition of skin over the urethra. 7. Presence of penile torsion. All patients should undergo preoperative surgical fitness including; complete blood picture, prothrombin time, concentration and INR, ECG and renal function test. Prophylactic systemic antibiotics are given intraoperatively. Receives: Procedure: Distal Penile Hypospadias (Disorder)

What is being measured

The primary outcome is the main question the study is designed to answer.

Functional outcome of Distal Penile Hypospadias Repair
Functional Outcome of Distal Hypospadias Repair. Outcome Measure Title: Post-void Residual Volume (PVR) Measured via Abdominal Ultrasound Description: Assessment of urinary function through post-void residual volume using ultrasound, reported in milliliters (mL).
Time Frame: six months postoperatively.
Measured: Six months postoperatively

Secondary outcomes (3)

Cosmetic outcome of Distal Penile Hypospadias Repair
Cosmetic Outcome of Distal Hypospadias Repair. Outcome Measure Title: Aesthetic Evaluation Based on Photographic Documentation Description: Assessment of cosmetic outcomes using photographs taken on postoperative days 0 (immediately after surgery), 3, and 5-7 (during catheter removal), scored on a 5-point Likert scale (1 = poor, 5 = excellent).
Time Frame: Six months postoperatively.
Measured: Six months postoperatively
Complication Rate Following Distal Hypospadias Repair
Complication Rate Following Distal Hypospadias Repair. Outcome Measure Title: Frequency of Postoperative Complications
Description: Detection and quantification of specific complications, including:
Edema of the glans or penile skin. Hematoma. Infection. Wound dehiscence. Urethrocutaneous fistula. Meatal stenosis. Urethral stricture. Urethral diverticula. Data will be reported as the number and percentage of patients experiencing each complication.
Time Frame: Weekly assessments during the first month and monthly assessments for the following five months postoperatively.
Measured: Weekly assessments during the first month and monthly assessments for the following five months postoperatively.
Patient-Reported Outcomes
Patient-Reported Outcomes. Outcome Measure Title: Satisfaction Score as Reported by Patients or Caregivers Description: Patients or their relatives will report satisfaction with surgical outcomes on a Visual Analog Scale (VAS) ranging from 0 (not satisfied) to 10 (very satisfied).
Time Frame: Six months postoperatively.
Measured: Six months postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202530 Jun 2026

First posted22 Nov 2024
Study start1 Jan 2025 (estimated)
Primary completion30 Jun 2026 (estimated)
Study completion30 Jun 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Distal Penile Hypospadias (Disorder)Studies 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: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 50 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06700629
Sponsor's protocol ID: DPH repair outcome
Status last verified: Nov 2024
First submitted: 10 Sep 2024
Last updated: 22 Nov 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

1) Belman AB. Hypospadias and chordee. In: Belman AB, King LR, Kramer SA, eds. Clinical Pediatric Urology. 4th edn. London, Martin Dunitz, 2002, pp. 1061-1092. 2) Mouriquand OD, Mure PY. Hypospadias. In: Gearhart J, Rink R, Mouriquand PDE, eds. Pediatric Urology, Philadelphia, WB Saunders, 2001, pp. 713-728. 3) Snodgrass W (1994) Tubularized, incised plate urethroplasty for distal hypospadias 151: 464-465. 4) Duckett JW Jr, Kaplan GW, Woodard JR, Devine CJ Jr (1980) Panel: complications of hypospadias repair 7: 443-454. 5) Braga LHP, Lorenzo AJ, Pippi Salle JL. Tubularized incised plate urethroplasty for distal hypospadias: A literature review. Indian J Urol 2008 Apr; 24(2)219-25. 6) Allen TD,Spence HM: The Surgical Treatment Of Coronal hypospadias and related problems , J. Urol 100:504, 1968. 7) Holland AJA, Smith GHH, Ross Fl, et al. HOSE: an objective scoring system for evaluating the results of hypospadias surgery. BJU Int 2001;88:255-8. 8) Hinman F. Penis: Plastic operation. In: Atlas of urologic surgery 2nd ed. Philadelphia; WB Saunders, 1998:96-157. 9) Abdul-Ghafoor B, Al-Dabbagh H. Primary distal hypospadias repair: tubularized incised plate urethroplasty (Snodgrass) versus the perimeatal based flap (Mathieu). Iraqi J Com Med 2009; 23-1. Rabnowitz R. and Hulbert W.C: Meatal-based flap Mathieu procedure. Adult and Pediatric. Saunders, Philadelphia, pp 39-43, 1999