[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hypospadias\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hypospadias":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,40,65,94,141,204,230,251,278,307,337,359,388,412,432,460],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":16,"targetDuration":4,"studyType":19,"phases":20,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100580052","improving-parental-support-in-hypospadias-care-100580052",false,"NCT06832280","Improving Parental Support in Hypospadias Care","Inclusion Criteria\n\nA parent must meet all of the following criteria to be included:\n\n* Age ≥ 18 years old\n* Fluent and literate in English or Spanish\n* Parent or legal guardian\n* Ability to consent\n* One eligible parent per child\n* Plan to attend urology consultation\n* Has access to a smart phone, tablet, or computer with reliable internet access\n* Has the ability and agrees to receive unencrypted communications by text or email\n\nA child must meet all of the following criteria to be included:\n\n* 0-5 years old at the time of urology consultation\n* Have an upcoming urology consult with an enrolled pediatric urologist regarding hypospadias\n\nExclusion Criteria\n\nIf a parent meets any of the following criteria they will be excluded:\n\n* Previous participant in hypospadias study\n* Parent has another child with hypospadias or father of the child has a known history of hypospadias\n* Parent is unaware of any penile abnormality with child\n* A final hypospadias treatment decision has been made in discussion with a pediatric urologist\n* Investigator discretion\n\nIf a child meets any of the following criteria they will be excluded:\n\n* Prior hypospadias surgery\n* Upcoming hypospadias urology consult is less than five days away from when the patient was identified","ALL",{"count":17,"type":18},324,"ESTIMATED","INTERVENTIONAL",[21],"NA","The proposed study will enroll parent-child pairs and is designed to obtain new knowledge and improve hypospadias care. Parent-child pairs will be randomized into different groups over 36 months and participate for at least 6 months.",[24],"Hypospadias",[24,26],"Pediatric Urologists","RECRUITING","2026-06-25",{"date":30,"type":31},"2026-06-30","ACTUAL",{"date":33,"type":31},"2025-05-07",{"date":35,"type":18},"2029-12-01",{"name":37,"class":38},"University of North Carolina, Chapel Hill","OTHER",2,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":47,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":19,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":39},"100644888","effect-of-caudal-block-on-urethrocutaneous-fistula-after-distal-hypospadias-repair-100644888","NCT07675798","Effect of Caudal Block on Urethrocutaneous Fistula After Distal Hypospadias Repair","The Effect of Caudal Block on the İncidence of Urethrocutaneous Fistula After Distal Hypospadias Repair: A Multicentre, Randomized Controlled Trial","Inclusion Criteria:\n\n* Male patients aged 6-60 months\n* Diagnosed with distal hypospadias\n* Scheduled for elective hypospadias repair\n* Written informed consent obtained from parent or legal guardian\n\nExclusion Criteria:\n\n* Age \\\u003C 6 months or \\> 60 months\n* Proximal or non-distal hypospadias\n* Previous hypospadias repair\n* Skin lesions at the epidural\u002Fcaudal injection site\n* Coagulopathy\n* Known allergy to anesthetic agents, particularly bupivacaine hydrochloride\n* Spinal anomalies\n* Chronic granulomatous disease\n* Diabetes mellitus\n* Patients receiving corticosteroid therapy\n* Refusal of informed consent by parent or guardian","MALE","6 Months","60 Months",{"count":51,"type":18},80,[21],"Hypospadias is one of the most common congenital urogenital anomalies in males, occurring in approximately 1 in every 200-300 male births. It is characterized by abnormal positioning of the urethral meatus on the ventral surface of the penis. Surgical repair is the standard treatment; however, urethrocutaneous fistula formation remains one of the most frequent and clinically significant postoperative complications, potentially requiring reoperation and causing considerable distress to both the patient and the family.\n\nCaudal nerve block is a widely used regional anesthesia technique in pediatric lower abdominal and genitourinary surgery, valued for its high analgesic efficacy, relative ease of application, and low complication profile. However, emerging evidence suggests that caudal block may be associated with an increased incidence of postoperative complications following hypospadias repair, including fistula formation and wound edema. Notably, Kundra et al. (2012) reported a fistula rate of 19.2% in patients who received caudal block, compared to 0% in those who received penile block, raising important questions about the routine use of caudal block in hypospadias surgery.\n\nThis prospective, multicenter, randomized controlled trial aims to evaluate the effect of caudal block on the incidence of urethrocutaneous fistula following distal hypospadias repair. A total of 80 male patients aged 6-60 months will be randomized 1:1 to either receive general anesthesia with caudal block or general anesthesia alone. The primary outcome is the incidence of urethrocutaneous fistula. Secondary outcomes include perioperative opioid consumption, postoperative pain scores, analgesic duration, and other surgical complications such as wound dehiscence and urethral stricture. Patients will be followed up for 3-6 months postoperatively. The study will be conducted across four centers in Turkey. Results are expected to provide evidence-based guidance on the role of caudal block in pediatric hypospadias repair.",[24,55,56],"Caudal Block","Pediatric Anesthesia","2026-06-23",{"date":30,"type":31},{"date":60,"type":31},"2025-12-01",{"date":62,"type":18},"2026-08-15",{"name":64,"class":38},"Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital",{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":47,"minAge":48,"maxAge":72,"enrollmentInfo":73,"targetDuration":4,"studyType":19,"phases":75,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":93},"100639100","comparison-of-sacral-esp-block-and-caudal-block-in-pediatric-hypospadias-surgery-100639100","NCT07619651","Comparison of Sacral ESP Block and Caudal Block in Pediatric Hypospadias Surgery","Prospective Comparison of Sacral Erector Spinae Plane Block and Caudal Epidural Block for Postoperative Analgesia in Pediatric Hypospadias Surgery","Inclusion Criteria:\n\n1. Male patients aged between 6 months to 7 years\n2. Scheduled for hypospadias repair surgery\n3. ASA physical status I-II\n4. No known allergy to local anesthetic agents\n5. No contraindications to peripheral nerve blocks\n6. Written informed consent obtained from parents or legal guardians\n\nExclusion Criteria:\n\n1. Known congenital coagulopathy\n2. Known allergy to local anesthetic agents\n3. Severe systemic disease (ASA III-IV)\n4. Severe organ failure\n5. Neurological disorders","7 Years",{"count":74,"type":18},60,[21],"Hypospadias surgery in pediatric patients requires effective postoperative analgesia to ensure patient comfort and reduce perioperative stress. Caudal epidural block is widely used for analgesia in pediatric urological procedures; however, alternative regional techniques such as the sacral erector spinae plane (ESP) block have recently gained attention.\n\nThis prospective comparative study aims to compare the analgesic efficacy of sacral ESP block and caudal epidural block in pediatric patients undergoing hypospadias surgery. Participants will be allocated to receive either sacral ESP block or caudal epidural block according to the study protocol.\n\nThe primary outcome will be postoperative pain scores within the first 24 hours after surgery. Secondary outcomes will include total analgesic consumption, time to first rescue analgesia, and block-related complications.",[24,78],"Postoperative Pain",[80,81,82,83,84],"Sacral Erector Spinae Plane Block","Caudal Epidural Block","Hypospadias Surgery","Postoperative Analgesia","Pediatric Urology","2026-06-21",{"date":28,"type":31},{"date":88,"type":31},"2026-01-05",{"date":90,"type":18},"2026-11-01",{"name":92,"class":38},"TC Erciyes University",1,{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":100,"sex":15,"minAge":101,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":19,"phases":104,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":93},"100592143","breaking-silence-through-story-a-narrative-medicine-intervention-for-parents-of-children-with-urogenital-conditions-100592143","NCT06989593","Breaking Silence Through Story: A Narrative Medicine Intervention for Parents of Children With Urogenital Conditions","Inclusion Criteria:\n\n* Parent or legal guardian of a child (age 0-17 years) diagnosed with a urogenital condition (such as differences of sex development or hypospadias)\n* Able to read and understand English\n* Willing to complete a guided journaling intervention (through writing or dictation) over a period of approximately 5 weeks\n* Willing to participate in a 45 minute follow-up interview\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Parent\u002Fguardian with severe psychiatric disorder that would interfere with participation as determined by referring physician\n* Parent\u002Fguardian unable to complete either written journaling activities or dictation\n* Inability to provide informed consent",true,"18 Years",{"count":103,"type":18},20,[21],"The goal of this clinical trial is to learn whether a journaling intervention can reduce stress and anxiety in parents of children with urogenital conditions (such as differences of sex development and hypospadias).\n\nThe main questions it aims to answer are:\n\n* Does guided journaling help to reduce anxiety levels in parents of children with urogenital conditions?\n* What are parents' perspectives on group-based writing interventions for future support programs?\n\nParticipants will:\n\n* Complete a short anxiety questionnaire (the General Anxiety Disorder-7 scale) at the beginning of the study\n* Receive a physical journal with 5 writing prompts designed to help process emotions related to their child's condition\n* Complete 5 journal entries over several weeks, writing about their experiences and feelings\n* Complete the same anxiety questionnaire again after finishing the journal entries\n* Participate in a 45-minute interview to discuss how the journaling affected their stress levels and gather feedback on potential group-based writing programs",[107,24],"DSD",[109,24,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131],"Disorders of Sex Development","Anxiety","Stress, Psychological","Parents","Psychological Adaptation","Writing","Narrative Therapy","Qualitative Research","Patient Participation","Social Support","Mental Health","Interpersonal Relations","Parent-Child Relations","Urogenital Abnormalities","Female Urogenital Diseases","Urogenital Diseases","Penile Diseases","Genital Diseases, Male","Genital Diseases","Male Urogenital Diseases","Congenital Abnormalities","Gonadal Disorders","Endocrine System Diseases","2026-05-14",{"date":134,"type":31},"2026-05-18",{"date":136,"type":31},"2025-10-10",{"date":138,"type":18},"2026-11",{"name":140,"class":38},"Sarah Schlegel",{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":19,"phases":150,"briefSummary":152,"conditions":153,"keywords":4,"overallStatus":194,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":4},"100611443","phase-4-outcomes-from-hyperbaric-oxygen-hbo2-treatment-for-emerging-indications-100611443","NCT07240649","Outcomes From Hyperbaric Oxygen (HBO2) Treatment for Emerging Indications","Emerging Indications for Hyperbaric Oxygen Treatment","Inclusion Criteria:\n\n* Patients referred for HBOT with an emerging indication\n\nExclusion Criteria:\n\n* Contraindication to hyperbaric oxygen treatment (untreated seizures, pneumothorax, significant pulmonary airspace pathology that might lead to pulmonary barotrauma, unmanageable confinement anxiety, chronic obstructive pulmonary disease with CO2 retention)\n* Pregnant persons",{"count":149,"type":18},100,[151],"PHASE4","This study will evaluate the effectiveness of hyperbaric oxygen therapy (HBOT) on treating emerging indications (i.e., conditions that have shown to potentially benefit from HBOT) using the Multicenter Registry for Hyperbaric Oxygen Treatment. The study team aims to collect ongoing data on how well HBOT treats these emerging indications, and to add these data to the growing HBO Registry. The research team hypothesizes that HBOT will result in improvements of the condition of the various emerging indications.",[154,155,156,157,158,159,160,161,24,162,163,164,165,166,167,168,169,170,171,172,173,174,175,176,177,178,179,180,181,182,183,184,185,186,187,188,189,190,191,192,193],"Post-COVID-19 Condition","Ulcerative Colitis","Crohn Disease","Calciphylaxis","Frostbite","Acute COVID-19","Pyoderma Gangrenosum","Pterygium","Head Trauma","Pneumatosis Intestinalis","Ischemic Bowel","Raynaud Syndrome","Malignant Otitis Externa","Nonarteritic Anterior Ischemic Optic Neuropathy","Central Retinal Vein Occlusion","Femoral Head Necrosis","Invasive Fungal Infection","Chronic Anal Fissure","Vasculitic Ulcer","Graft-vs-Host Disease","Decubitus Ulcer","Greater Trochanteric Pain Syndrome","Rectovaginal Fistula","Pouchitis","Tinnitus","Clostridium Enterocolitis","Branch Retinal Artery Occlusion","Axonotmesis","Multiple Sclerosis","Inclusion Body Myositis","Epidermolysis Bullosa (EB)","Osteonecrosis","Ulcer Ischemic","Avascular Necrosis of Bone","Prosthesis Related Infections","Facial Filler Injections","Cystitis Chronic","Ligament Injury","Anastomosis, Leaking","Cartilage Injury","NOT_YET_RECRUITING","2026-05-01",{"date":197,"type":31},"2026-05-05",{"date":199,"type":18},"2026-08",{"date":201,"type":18},"2035-12",{"name":203,"class":38},"Jay C. Buckey Jr.",{"id":205,"slug":206,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":210,"eligibilityCriteria":211,"healthyVolunteers":11,"sex":47,"minAge":212,"maxAge":213,"enrollmentInfo":214,"targetDuration":4,"studyType":19,"phases":215,"briefSummary":216,"conditions":217,"keywords":218,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":228,"locationsCount":93},"100590358","worldwide-yearly-screening-for-hypospadias-100590358","NCT06966375","Worldwide Yearly Screening for Hypospadias","Pilot Testing of the Worldwide Yearly Screening for Hypospadias","WYSH","Inclusion Criteria:\n\n* Males who have a documented history of repaired hypospadias.\n* Age groups targeted, based on recommended standards for user experience data from pilot studies:\n\n  * 3-5 Males, age 5-10 (with parental consent and child assent)\n  * 3-5 Males, age 11-15 (with parental consent and child assent)\n  * 3-5 Males, age 16-20 (with parent consent, child assent until age 18)\n  * 3-5 Males, age 21-65\n\nExclusion Criteria:\n\n\\-","5 Years","65 Years",{"count":103,"type":18},[21],"The purpose of this study is to recruit approximately 20 male participants who have a history of repaired hypospadias to test the feasibility and acceptability of the Care Planning Tool within the Worldwide Yearly Screening for Hypospadias (WYSH) Web Application.",[24],[219,220,221],"Hypospadias Complications","Quality of Life","Patient-Reported Outcomes","2026-03-25",{"date":224,"type":31},"2026-03-27",{"date":226,"type":31},"2025-07-23",{"date":138,"type":18},{"name":229,"class":38},"University of Wisconsin, Madison",{"id":231,"slug":232,"hasResults":11,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":11,"sex":47,"minAge":237,"maxAge":72,"enrollmentInfo":238,"targetDuration":4,"studyType":19,"phases":240,"briefSummary":241,"conditions":242,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":249,"locationsCount":93},"100625753","comparison-of-sacral-esp-block-and-dorsal-penile-nerve-block-in-pediatric-hypospadias-surgery-100625753","NCT07426731","Comparison of Sacral ESP Block and Dorsal Penile Nerve Block in Pediatric Hypospadias Surgery","Comparison of the Effects of Sacral Erector Spinae Plane Block and Dorsal Penile Nerve Block on Postoperative Pain Management in Pediatric Patients Undergoing Hypospadias Surgery","Inclusion Criteria:\n\n* Pediatric male patients aged 1-7 years.\n* ASA (American Society of Anesthesiologists) physical status I or II.\n* Scheduled for elective hypospadias surgery.\n* Written informed consent obtained from parents\u002Fguardians\n\nExclusion Criteria:\n\n* History of neurological deficit or developmental delay.\n* Bleeding diathesis or known coagulopathy.\n* History of allergy to local anesthetics.\n* Infection or skin lesion at the block injection site.\n* Congenital spinal anomaly.\n* Mental retardation or history of psychiatric disease.\n* Liver or kidney dysfunction","1 Year",{"count":239,"type":18},70,[21],"This randomized controlled trial aims to compare the postoperative analgesic efficacy of ultrasound-guided Sacral Erector Spinae Plane (ESP) block versus Dorsal Penile Nerve Block (DPNB) in pediatric patients aged 1-7 years undergoing hypospadias surgery. The primary outcome is the pain score assessed by the FLACC scale at the 12th postoperative hour",[78,24],"2026-03-19",{"date":245,"type":31},"2026-03-20",{"date":247,"type":31},"2026-02-13",{"date":195,"type":18},{"name":250,"class":38},"Medipol University",{"id":252,"slug":253,"hasResults":11,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":4,"eligibilityCriteria":257,"healthyVolunteers":11,"sex":47,"minAge":48,"maxAge":258,"enrollmentInfo":259,"targetDuration":4,"studyType":19,"phases":261,"briefSummary":262,"conditions":263,"keywords":4,"overallStatus":194,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":93},"100624060","urethral-plate-flap-vs-tunica-vaginalis-flap-for-residual-severe-ventral-curvature-in-hypospadias-100624060","NCT07404722","Urethral Plate Flap vs. Tunica Vaginalis Flap for Residual Severe Ventral Curvature in Hypospadias","Urethral Plate Flap Versus Tunica Vaginalis Flap Corporoplasty for the Correction of Residual Severe Ventral Curvature After Urethral Plate Transection in Hypospadias Repair: A Single-Center, Randomized, Controlled, Non-Inferiority Study","Inclusion Criteria:\n\n* Age: 6 months to 14 years.\n* Diagnosis: Primary hypospadias (no history of prior hypospadias repair).\n* Intraoperative Condition: Residual ventral curvature ≥ 30° confirmed by artificial erection test after transection of the urethral plate.\n* Consent: Signed informed consent provided by the participant's legal guardian.\n\nExclusion Criteria:\n\n① Glans diameter \\\u003C 1 cm; ② Combined with cryptorchidism; ③ Combined with severe bleeding disorders or coagulation dysfunction.","14 Years",{"count":260,"type":18},90,[21],"The correction of ventral curvature in hypospadias follows a stepwise principle. Clinically, in some cases of hypospadias, residual severe ventral curvature (VC ≥ 30°) persists even after thorough skin degloving and transection of the urethral plate, due to the unbalanced development of the ventral and dorsal tunica albuginea of the corpus cavernosum. In such cases, ventral tunica albuginea incision and corporoplasty with a graft are mandatory.\n\nAlthough the currently commonly used pedicled Tunica Vaginalis Flap (TVF) corporoplasty can effectively correct the curvature, it requires additional dissection of the scrotum and tunica vaginalis sac. This prolongs the operative time and poses risks of donor-site complications, such as testicular retraction and scrotal hematoma.\n\nThe novel Urethral Plate Flap (UPF) corporoplasty utilizes local pedicled urethral plate tissue for homologous repair. This study adopts a prospective, single-center, randomized, controlled, double-blind, non-inferiority trial design, enrolling 90 subjects. The aim is to verify that the therapeutic efficacy of the UPF technique in correcting such residual severe ventral curvature is non-inferior to that of TVF, while demonstrating significant advantages in surgical efficiency and donor-site safety.\n\nThis study aims, through a single-center, double-blind, RCT design, and under the strict indication of \"residual severe ventral curvature after urethral plate transection,\" to verify efficacy via a \"non-inferiority\" hypothesis, and to verify safety and efficiency via a \"superiority\" hypothesis. The goal is to provide Level I evidence for the update of hypospadias guidelines, while simultaneously exploring the establishment of postoperative imaging evaluation standards.",[264,265,266,267,268,24],"Residual Severe Ventral Curvature","Transection of the Urethral Plate","Corporoplasty","Pedicled Tunica Vaginalis Flap (TVF)","Novel Urethral Plate Flap (UPF)","2026-02-08",{"date":271,"type":31},"2026-02-11",{"date":273,"type":18},"2026-02-23",{"date":275,"type":18},"2029-02-22",{"name":277,"class":38},"The Children's Hospital of Zhejiang University School of Medicine",{"id":279,"slug":280,"hasResults":11,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":284,"eligibilityCriteria":285,"healthyVolunteers":11,"sex":47,"minAge":48,"maxAge":286,"enrollmentInfo":287,"targetDuration":4,"studyType":19,"phases":288,"briefSummary":289,"conditions":290,"keywords":292,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":302,"completionDateStruct":303,"leadSponsor":305,"locationsCount":39},"100617527","fibrin-enhanced-tip-versus-grafted-tip-urethroplasty-in-distal-hypospadias-100617527","NCT07319780","Fibrin-Enhanced TIP Versus Grafted TIP Urethroplasty in Distal Hypospadias","A Multicenter Randomized Controlled Trial Comparing Fibrin-Enhanced Tubularized Incised Plate (F-TIP) and Grafted Tubularized Incised Plate (G-TIP) Urethroplasty in Distal Hypospadias With Unfavorable Urethral Plates","FTIP-RCT","Inclusion Criteria:\n\n* Male children aged 6 months to 84 months\n* Primary or redo distal hypospadias\n* Unfavorable urethral plate\n* Penile curvature less than 45 degrees after degloving\n* Eligibility for tubularized incised plate urethroplasty\n\nExclusion Criteria:\n\n* Disorders of sex development or ambiguous genitalia\n* Severe penile curvature requiring urethral plate transection\n* Previous graft-based urethroplasty\n* Active local or systemic infection at the time of surgery\n* Known bleeding or platelet disorders\n* Inability to comply with postoperative follow-up","84 Months",{"count":149,"type":18},[21],"Hypospadias is a common congenital condition in boys in which the opening of the urethra is located on the underside of the penis. Distal hypospadias is the most common form and is usually treated surgically using tubularized incised plate (TIP) urethroplasty. In boys with an unfavorable urethral plate, graft-augmented techniques (G-TIP) are often used; however, postoperative complications such as urethrocutaneous fistula and narrowing of the urethral opening (meatal stenosis) may still occur.\n\nPlatelet-rich fibrin (PRF) is a biological material obtained from the patient's own blood that contains natural growth factors and may help improve tissue healing. This study aims to evaluate whether the use of PRF during surgery can reduce postoperative complications and improve surgical outcomes in children undergoing hypospadias repair.",[291,24],"Distal Hypospadias",[293,294,295,296,297,298],"Hypospadias repair","Tubularized incised plate","Platelet-rich fibrin","PRF","Grafted TIP","Pediatric urology","2026-01-28",{"date":301,"type":31},"2026-01-30",{"date":88,"type":31},{"date":304,"type":18},"2028-12-25",{"name":306,"class":38},"National Children's Medical Center, Uzbekistan",{"id":308,"slug":309,"hasResults":11,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":313,"eligibilityCriteria":314,"healthyVolunteers":100,"sex":15,"minAge":315,"maxAge":4,"enrollmentInfo":316,"targetDuration":4,"studyType":318,"phases":4,"briefSummary":319,"conditions":320,"keywords":321,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":93},"100564376","a-multimodal-study-of-the-relationship-between-exposure-to-endocrine-disruptors-and-occurrence-of-hypospadias---hypollut-100564376","NCT06628375","A Multimodal Study of the Relationship Between Exposure to Endocrine Disruptors and Occurrence of Hypospadias - HYPOLLUT","Exposure to Endocrine Disruptors and Occurrence of Hypospadias: Toxicological, Environmental and Hormonal Imbalance Study","HYPOLLUT","Non-specific Inclusion Criteria :\n\n* Parents of legal age having signed a free and informed consent for the participation of their child\n* Biological mother of a boy aged between 1 and 6 months\n* Biological mother with a minimum hair length of 18 cm\n* Biological mother who has signed a free and informed consent for her participation\n* Biological mother and child affiliated with or beneficiaries of a national health insurance plan\n* Biological mother who is fluent in written and spoken French\n\nSpecific Inclusion Criteria for Case Group:\n\n\\- The child has an isolated anterior or middle hypospadias, without any other complex variations of genital development (borderline penile size, unilateral or bilateral cryptorchidism, retractile testes), without malformation syndrome and without identified genetic etiology\n\nSpecific Inclusion Criteria for Control Group:\n\n\\- The child must not present any complex variations in genital development (hypospadias, borderline penis size, unilateral or bilateral cryptorchidism, retractile testes)\n\nExclusion Criteria:\n\n* Child with another congenital anomaly or malformative syndrome\n* Child with an endocrine pathology\n* Biological mother or child under legal protection, guardianship, or curatorship\n* Biological mother or child in the exclusion period of a previous study\n* Biological mother or child included in another clinical study involving a drug\n\nSpecific Exclusion Criteria for Case Group:\n\nBiological mother\u002Fchild pairs if a genetic variant explaining hypospadias is found during genetic analysis.","1 Month",{"count":317,"type":18},200,"OBSERVATIONAL","This study aims to demonstrate the impact of Endocrine-Disrupting Chemicals (EDCs) on the risk of hypospadias incidence. It is a multicenter comparative case-control study, involving two groups. The first group consists of biological mothers who have given birth to children with hypospadias (Case Group), while the second group consists of biological mothers who have given birth to children without any malformations (Control Group). Through an integrative approach that combines a direct toxicological study of numerous pollutants present during pregnancy, and a comprehensive exposome assessment using validated tools, this study can significantly enhance our understanding and prevention of this malformation.",[24],[322,323,324,325,326,327],"Endocrine-disrupting chemicals","Birth defect","Environment","Hormones minipuberty","Exposome","Toxicology hair","2025-11-20",{"date":330,"type":31},"2025-11-26",{"date":332,"type":31},"2024-10-03",{"date":334,"type":18},"2027-10-03",{"name":336,"class":38},"University Hospital, Montpellier",{"id":338,"slug":339,"hasResults":11,"nctId":340,"briefTitle":341,"officialTitle":341,"acronym":4,"eligibilityCriteria":342,"healthyVolunteers":11,"sex":47,"minAge":237,"maxAge":343,"enrollmentInfo":344,"targetDuration":4,"studyType":19,"phases":346,"briefSummary":348,"conditions":349,"keywords":4,"overallStatus":194,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":4},"100608103","phase-3-comparison-of-caudal-block-and-sacral-erector-spinae-plane-block-with-dexmedetomidine-in-pediatric-penile-hypospadias-repair-100608103","NCT07197203","Comparison of Caudal Block and Sacral Erector Spinae Plane Block With Dexmedetomidine in Pediatric Penile Hypospadias Repair","Inclusion Criteria:\n\n* pediatric patients, aged 1-6 years, ASA physical statusI- II, scheduled for elective hypospadias repair surgery under general anesthesia.\n\nExclusion Criteria:\n\n* • Parental refusal.\n\n  * Allergy to local anesthetics or dexmedetomidine.\n  * Coagulation disorders.\n  * Local infection at the site of injection.\n  * Anatomical abnormalities (e.g., spina bifida, sacralmalformations).\n  * Neurological disease.","6 Years",{"count":345,"type":18},66,[347],"PHASE3","Hypospadias is one of the most common congenital anomalies in childhood, requiring surgical reconstruction (1). It is a penile malformation with a more proximal or ventral location beyond the usual localization of the urethra. Hypospadias is a common congenital urogenital anomaly in male children, and its incidence is reported to be approximately one in every 300 births. However, it is suggested that hypospadias may increase in developed countries (2, 3). Postoperative pain management followinghypospadias repair is of great importance, as inadequatepain control may lead to adverse endocrine, metabolic, and inflammatory stress responses, resulting in higher morbidity and poor recovery(4).\n\nRegional anesthesia has gained increasing attention in pediatric surgery as a valuable tool for managing perioperative pain and improving surgical outcomes(5). The caudal epidural block has long been considered the gold standard technique fo infraumbilical surgeries, including hypospadias repair, due to its proven efficacy and safety (4). However, its limitations include a relatively short durationof analgesia, the need for larger local anesthetic volumes, and potential adverse effects such as motor block, urinary retention, and inadvertent dural puncture. These drawbacks have led anesthesiologists to explore alternative regional techniques(6-8) Recently, the sacral erector spinae plane (ESPB) block has been introduced as a novel technique for postoperative analgesia in children(9, 10). It is an emerging regional anesthetic technique with significant potential for clinical benefit Nevertheless, its exact mechanism(s) of action have been much debated. These mechanisms include neural blockade and central inhibition from direct spread of local anesthetic to the paravertebral or epidural space, and analgesia mediated by elevated local anesthetic plasma concentrations due to systemic absorption(11).\n\nEvidence suggests sacral ESP block can give excellent analgesia in surgical procedures (12-14). Few studies have examined its use to alleviate acute pain after hypospadias surgery (15, 16). There is a lack of data on the postoperative analgesic efficacy in hypospadias surgery.\n\nThe addition of adjuvant agents to local anesthetics has been shown to enhance the quality and duration of regiona anesthesia(17).\n\nDexmedetomidine, an alpha-2 adrenergic agonist, has gained significant attention for its sedative, analgesic, and anxiolytic properties in pediatric anesthesia(18).\n\nDexmedetomidine, a highly selective α 2- α 2-adrenergic agonist, has demonstrated sedative and analgesic properties without significant respiratory depression, making it particularly attractive in pediatric anesthesia. When used as an adjuvan to local anesthetics, dexmedetomidine prolongs block duration and reduces rescue analgesic requirements(17).\n\nDespite the established role of caudal block and the emerging potential of sacral ESPB, there is a lack of randomized controlled trials directly comparing their analgesic efficacy in pediatric patients when combined with dexmedetomidine",[24],"2025-09-20",{"date":352,"type":31},"2025-09-29",{"date":354,"type":18},"2025-10-01",{"date":356,"type":18},"2026-12-01",{"name":358,"class":38},"Assiut University",{"id":360,"slug":361,"hasResults":11,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":4,"eligibilityCriteria":365,"healthyVolunteers":11,"sex":47,"minAge":237,"maxAge":212,"enrollmentInfo":366,"targetDuration":4,"studyType":19,"phases":367,"briefSummary":368,"conditions":369,"keywords":372,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":386,"locationsCount":93},"100600597","ultrasound-guided-sacral-erector-spinae-plane-block-versus-ultrasound-guided-caudal-block-in-pediatric-undergoing-hypospadias-surgery-100600597","NCT07099560","Ultrasound Guided Sacral Erector Spinae Plane Block Versus Ultrasound Guided Caudal Block in Pediatric Undergoing Hypospadias Surgery","Comparison of Preemptive Analgesic Effect of Ultrasound Guided Sacral Erector Spinae Plane Block Versus Ultrasound Guided Caudal Block in Pediatric Undergoing Hypospadias Surgery","Inclusion Criteria\n\n* Male children aged 1-5 years\n* ASA physical status I-II\n* Scheduled for elective hypospadias repair under general anesthesia\n* Parent or legal guardian provides written informed consent\n* Able to complete postoperative assessments through 24 hours after surgery Exclusion Criteria\n* Parent\u002Fguardian refusal of participation\n* Coagulopathy or current anticoagulant therapy\n* Infection at the intended injection site (sacral\u002Fcaudal region) or systemic infection\n* Allergy\u002Fhypersensitivity to amide local anesthetics (e.g., bupivacaine) or study medications\n* Neurologic or spinal disorders or congenital sacral anomalies affecting block safety\n* Significant hepatic, renal, or cardiac disease\n* Any other condition that, in the investigator's judgment, contraindicates caudal block or sacral ESPB or could interfere with safe participation",{"count":239,"type":18},[21],"Randomized, parallel-group, assessor-blinded clinical trial at Tanta University Hospitals comparing ultrasound-guided sacral erector spinae plane block (sESPB) versus ultrasound-guided caudal epidural block for postoperative analgesia in male children (1-5 years) undergoing hypospadias repair. Seventy participants will be randomized 1:1 to receive sESPB or caudal block with 0.25% bupivacaine (0.5-1 mL\u002Fkg; maximum 20 mL) after induction of general anesthesia. The primary outcome is pain over the first 24 hours, assessed using the FLACC scale at prespecified time points. Secondary outcomes include total opioid consumption, time to first rescue analgesia, postoperative nausea and vomiting, parent\u002Fguardian satisfaction, hemodynamic trends, and predefined adverse effects (e.g., motor weakness, urinary retention, respiratory depression, hematoma, infection at injection site). Perioperative care is standardized; rescue pethidine is administered when FLACC ≥4. The trial evaluates whether sESPB provides superior or comparable analgesia with fewer adverse effects than caudal block.",[24,55,370,371],"Erector Spinae Plane Block","Pain, Postoperative",[373,374,375,376,377,378],"hypospadias","nerve block","erector spinae plane block","caudal block","pain","ultra-sound","2025-09-06",{"date":381,"type":31},"2025-09-09",{"date":383,"type":31},"2025-04-01",{"date":385,"type":18},"2026-04",{"name":387,"class":38},"Tanta University",{"id":389,"slug":390,"hasResults":11,"nctId":391,"briefTitle":392,"officialTitle":393,"acronym":4,"eligibilityCriteria":394,"healthyVolunteers":11,"sex":47,"minAge":48,"maxAge":395,"enrollmentInfo":396,"targetDuration":4,"studyType":19,"phases":398,"briefSummary":399,"conditions":400,"keywords":401,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":404,"startDateStruct":406,"completionDateStruct":408,"leadSponsor":410,"locationsCount":93},"100599628","is-dorsal-inlay-graft-dig-with-tip-repair-superior-to-tip-alone-for-primary-hypospadias-100599628","NCT07086963","Is Dorsal Inlay Graft (DIG) With TIP Repair Superior to TIP Alone for Primary Hypospadias?","Is Dorsal Inlay Graft (DIG) With TIP Repair Superior to TIP Alone for Primary Hypospadias? A Randomized Clinical Trial","Inclusion Criteria:\n\n* Primary hypospadias candidates for one-stage repair\n* Uncircumcised cases\n* Pediatric age group\n* Patients with regular follow up\n\nExclusion Criteria:\n\n* The presence of chordee or urethral anomalies requiring division of the urethral plate or staged repair\n* Small glans \\\u003C 11mm\n* glanular hypospadias","120 Months",{"count":397,"type":18},584,[21],"This prospective, randomized study included all patients who presented with primary hypospadias without chordee, Patients were randomized into two groups as group 1 or group 2,Group 1: Repaired with standard TIP repair as described by Snodgrass Group 2: Repaired with TIP with GIP using preputial graft. In both groups the functional outcomes were primarily compared regarding meatal position, shape, and the functional outcomes of the neourethra, in addition to other complications such as UCF, wound complications, cosmetic results and the need for a second surgery.\n\nthe investigators aimed to investigate whether GIP with TIP repair is superior to TIP, as described by Snodgrass in different types of UP and to provide an overview of the technical aspects of current TIP repair practices.",[24],[297,402],"Tabularized Incised Plate","2025-07-17",{"date":405,"type":31},"2025-07-25",{"date":407,"type":31},"2023-01-02",{"date":409,"type":18},"2025-08-08",{"name":411,"class":38},"Mohammad Daboos",{"id":413,"slug":414,"hasResults":11,"nctId":415,"briefTitle":416,"officialTitle":416,"acronym":417,"eligibilityCriteria":418,"healthyVolunteers":11,"sex":47,"minAge":237,"maxAge":419,"enrollmentInfo":420,"targetDuration":48,"studyType":318,"phases":4,"briefSummary":422,"conditions":423,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":427,"completionDateStruct":428,"leadSponsor":430,"locationsCount":93},"100594315","predict-h-study-prospective-research-on-essential-determinants-influencing-complication-trends-in-hypospadias---a-landmark-prospective-multicenter-cohort-study-aimed-at-improving-outcome-prediction-in-hypospadias-surgery-100594315","NCT07017842","PREDICT-H Study: Prospective Research on Essential Determinants Influencing Complication Trends in Hypospadias - a Landmark Prospective Multicenter Cohort Study Aimed at Improving Outcome Prediction in Hypospadias Surgery","PREDICT-H","\\* Inclusion Criteria:\n\nMale patients aged 1 to 12 years\n\nDiagnosed with hypospadias (distal, midpenile, proximal)\n\nUndergoing primary surgical repair\n\nParent\u002Flegal guardian consent obtained\n\n\\* Exclusion Criteria:\n\nPrior hypospadias or penile surgery (revision cases)\n\nMajor associated genital anomalies (e.g., ambiguous genitalia, severe DSD)\n\nRefusal of consent or inability to complete follow-up","12 Years",{"count":421,"type":18},1300,"Hypospadias is a common congenital anomaly with complex anatomy that influences surgical outcomes. Despite numerous surgical techniques, a lack of standardized preoperative assessment protocols and consensus on anatomical risk factors limits prediction of complications. This study aims to systematically evaluate key anatomical features identified in previous meta-analyses-such as urethral plate width and length, glans size, chordee severity, meatal position, and others-in a large, prospective multicenter cohort. The ultimate goal is to develop and validate an objective nomogram predicting the risk of postoperative complications, enabling individualized surgical planning and improved patient counseling.",[24],"2025-06-04",{"date":426,"type":31},"2025-06-12",{"date":424,"type":31},{"date":429,"type":18},"2028-02-28",{"name":431,"class":38},"Sidra Medicine",{"id":433,"slug":434,"hasResults":11,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":4,"eligibilityCriteria":438,"healthyVolunteers":11,"sex":47,"minAge":48,"maxAge":439,"enrollmentInfo":440,"targetDuration":4,"studyType":19,"phases":441,"briefSummary":442,"conditions":443,"keywords":447,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":457,"locationsCount":459},"100548135","caudal-anesthesia-versus-local-anesthesia-in-hypospadias-100548135","NCT06417060","Caudal Anesthesia Versus Local Anesthesia in Hypospadias","THE IMPACT OF CAUDAL BLOCK ANESTHESIA ON POSTOPERATIVE COMPLICATIONS IN DISTAL HYPOSPADIAS SURGERY: A MULTI-CENTER RANDOMIZED CONTROLLED TRIAL","Inclusion Criteria:\n\n* Aged between 6 and 48 months\n* Distal hypospadias\n* Acceptance of participation\n\nExclusion Criteria:\n\n* Midpenil hypospadias\n* Proximal hypospadias\n* Prior surgery\n* Comorbidity (diabetes, hypertention, cardiac pathology)","48 Months",{"count":317,"type":18},[21],"Hypospadias is among the most common congenital genital malformations in boys and is typically treated through surgical intervention. During pediatric urological surgery, caudal anesthesia, also known as a caudal block, is frequently employed as a regional anesthetic technique. It has proven to be a safe and effective anesthetic approach in children, with a low rate of anesthesia-related complications. However, despite the low incidence of complications directly associated with the caudal block, there is limited and inconclusive evidence regarding its impact on surgical complications. Therefore, this randomized controlled superiority trial aims to evaluate whether the use of caudal anesthesia, compared to the dorsal penile block, is associated with an increased incidence of urethrocutaneous fistulas and glans dehiscence following hypospadias repair.",[24,444,445,446],"Hypospadias, Coronal","Caudal Anesthesia","Children",[24,448,449],"Caudal anesthesia","Urethrocutanous fistula","2024-08-19",{"date":452,"type":31},"2024-08-20",{"date":454,"type":31},"2023-05-25",{"date":456,"type":18},"2024-08-30",{"name":458,"class":38},"Necmi Kadıoğlu Hospital",3,{"id":461,"slug":462,"hasResults":11,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":466,"eligibilityCriteria":467,"healthyVolunteers":11,"sex":47,"minAge":101,"maxAge":4,"enrollmentInfo":468,"targetDuration":4,"studyType":318,"phases":4,"briefSummary":470,"conditions":471,"keywords":476,"overallStatus":194,"whyStopped":4,"lastUpdateSubmitDate":481,"lastUpdatePostDateStruct":482,"startDateStruct":484,"completionDateStruct":486,"leadSponsor":488,"locationsCount":4},"100339378","urothelium-tissue-engineering-using-biopsies-from-transurethral-resection-of-prostate-100339378","NCT03698721","Urothelium Tissue Engineering Using Biopsies From Transurethral Resection of Prostate","Urothelium Tissue Engineering Using Bladder Mucosa From Transurethral Resection of Prostate","IMOPU","Inclusion Criteria:\n\n* Patient needing a Transurethral Resection of Prostate (TURP)\n* Weight of prostate (evaluated by ultrasonography)greater than or equal to 30 grams\n* Affiliation to a social security system\n* Patient over the age of majority\n* Patient receiving complete information on research organization without opposition to the use of biological specimen\n\nExclusion Criteria:\n\n* Patient for whom no TURP is realized during endoscopic procedure\n* Patient for whom no resection is realized on the bladder neck\n* Patient with prostate weight estimated under 30 grams\n* Patient who opposed to the realization of the study",{"count":469,"type":18},365,"Different clinical conditions can require urinary bladder augmentation or replacement. Tissue engineered bladder has been clinically evaluated but is not recommended due to diverse side effects. Thus, there is a real interest for the development of regenerative approach with innovative scaffolds and cell transplantation.\n\nThe investigators propose the use of urothelial cells obtained by Trans-Urethral Resection of Prostate or bladder (TURP) to obtain a tissue engineered urothelium in association with different scaffolds.",[472,473,474,475,24],"Spina Bifida","Urothelial Neoplasm","Bladder, Neurogenic","Bladder Exstrophy",[477,478,479,480],"Tissue engineering","Collagen scaffold","Alginate scaffold","Urothelial cells","2018-10-04",{"date":483,"type":31},"2018-10-09",{"date":485,"type":18},"2018-10",{"date":487,"type":18},"2026-10",{"name":489,"class":38},"Central Hospital, Nancy, France"]