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Hypospadias is a congenital condition affecting the development of the urethra and its opening. Clinical trials related to hypospadias primarily explore surgical techniques and long-term functional outcomes to improve care and quality of life. Studie...

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Found 19 Actively Recruiting clinical trials

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Actively Recruiting

Healthy Volunteer

Researchers are studying the impact of exposure to Endocrine-Disrupting Chemicals EDCs on the risk of hypospadias, a common birth defect affecting the external genital organs in boys. This multicenter case-control study compares biological mothers of boys with hypospadias Case Group to mothers of boys without malformations Control Group to better understand environmental and hormonal factors that might contribute to this condition. The study aims to clarify how exposure to these chemicals during pregnancy might influence hormonal changes in newborns. The study involves a single consultation visit where a pediatric urologist or endocrinologist will confirm the presence or absence of hypospadias. Mothers will complete a validated European questionnaire and an occupationexposure matrix to assess environmental and occupational exposure to EDCs during pregnancy. Hair samples will be collected from mothers to analyze accumulated toxic substances, and blood samples will be taken from the children to evaluate hormone levels during the neonatal mini-puberty period. For cases, an additional blood sample will be collected for DNA analysis. Participants will attend one visit where clinical examinations, interviews, and sample collections occur. Researchers will measure toxic exposures through hair analysis, assess environmental exposures using questionnaires and models, and evaluate hormonal levels in the children. The study will help improve understanding and prevention of hypospadias by linking environmental exposures and hormonal changes. The total participation involves this single visit, with careful monitoring and data collection during that time.

Age: 1Month +All Genders
1 location
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Actively Recruiting

Healthy Volunteer

This research aims to find out whether a guided journaling program can reduce stress and anxiety in parents of children with urogenital conditions, such as differences of sex development and hypospadias. The study seeks to understand if journaling helps lower anxiety levels and gather parents views on group-based writing support programs for the future. Participants will receive a physical journal containing five writing prompts designed to help them process emotions related to their childs condition. They will complete five journal entries over several weeks, spending 15 to 20 minutes on each writing session at least once per week. This single-arm study includes baseline and follow-up anxiety assessments, plus a 30 to 45-minute interview after finishing the journaling to discuss effects on stress and gather feedback. During the study, parents will complete the General Anxiety Disorder-7 GAD-7 questionnaire at the start and after the journaling period, about six weeks later. They will also participate in an interview to assess changes in anxiety and coping strategies. Researchers will evaluate changes in anxiety scores and the acceptability of the journaling program. Total participation lasts about six weeks.

Age: 18Years +All GendersPhase Not Applicable
1 location
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Actively Recruiting

Hypospadias is a common genital malformation in boys that is usually treated with surgery. Researchers are evaluating whether caudal anesthesia compared to dorsal penile block anesthesia affects the rate of surgical complications like urethrocutaneous fistulas and glans dehiscence after hypospadias repair. This pilot randomized controlled trial aims to determine if one anesthesia method leads to fewer complications and to test the feasibility of a larger study. Participants aged 6 to 48 months undergoing distal hypospadias repair will be randomly assigned to receive either a caudal block or a dorsal penile block anesthesia. Both methods use inhalation induction with airnitrous oxide and sevoflurane followed by an injection of bupivacaine without epinephrine. Additional pain management includes fentanyl, dexamethasone, ondansetron, acetaminophen, morphine, and post-discharge medications such as oral morphine, Ditropan, Tylenol, ibuprofen, and trimethoprim until catheter removal. During the study, children will be closely monitored for postoperative complications for up to one year. Researchers will assess safety and complication rates, medication usage, and recovery progress. This double-blind, randomized trial will provide detailed data on the impact of anesthesia type on surgical outcomes and help guide future treatment decisions.

Age: 6Months - 48MonthsMALEPhase Not Applicable
3 locations
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Actively Recruiting

Hypospadias is a common congenital urogenital condition in children that often requires surgical correction in early childhood. Effective pain relief after surgery is important to keep young patients comfortable and reduce stress during the recovery period. This study compares two methods of regional anesthesiasacral erector spinae plane ESP block and caudal epidural blockin children undergoing hypospadias repair to evaluate which provides better postoperative pain control. Participants will receive general anesthesia and then be assigned to one of two groups. One group will receive an ultrasound-guided sacral ESP block with 0.25% bupivacaine at 0.5 mLkg injected beneath the erector spinae muscle near the sacral vertebra. The other group will receive a caudal epidural block with the same dose of bupivacaine administered into the caudal epidural space using standard anatomical landmarks. Both procedures are done under general anesthesia before surgery. Childrens pain will be assessed at multiple points up to 24 hours after surgery using the FLACC scale. Researchers will also track total pain medication use, the time before the first additional pain relief is needed, and any complications related to the nerve blocks such as motor weakness or nausea. The study aims to provide detailed information on pain control effectiveness and safety of these two anesthesia techniques in young patients.

Age: 6Months - 7YearsMALEPhase Not Applicable
1 location
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Actively Recruiting

Researchers are evaluating the postoperative pain relief effectiveness of two regional anesthesia techniquesthe ultrasound-guided Sacral Erector Spinae Plane ESP block and the Dorsal Penile Nerve Block DPNBin male children aged 1 to 7 years undergoing hypospadias surgery. This randomized, double-blind trial aims to determine which block provides better pain control after surgery, focusing on pain scores measured with the FLACC scale at multiple time points, with special attention to the 12th postoperative hour. Participants will be randomly assigned to receive either the Sacral ESP block or the DPNB while under general anesthesia. The Sacral ESP block involves injecting 0.4 mLkg of 0.25% bupivacaine bilaterally in the plane between the multifidus muscle and sacral lamina with the child in a lateral position. The DPNB involves injecting the same dose of bupivacaine bilaterally under Bucks fascia at the penile base while the child is supine. Both procedures are performed with ultrasound guidance to enhance precision and safety. During the 24 hours following surgery, researchers will assess pain using the FLACC scale at 30 minutes, 1, 2, 6, 12, and 24 hours. They will also monitor total analgesic consumption and any postoperative complications within this period. The study involves close monitoring of pain and safety outcomes to compare the two nerve block methods. Participation includes anesthesia, nerve block administration, pain assessments, and observation during the first day after surgery.

Age: 1Year - 7YearsMALEPhase Not Applicable
1 location
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Actively Recruiting

This research aims to compare two surgical methods for treating palpable undescended testis in male children under 10 years old. The study focuses on evaluating operative time, cosmetic outcomes, and post-operative complications to determine differences between the approaches. It is a randomized, interventional trial conducted at Children Hospital Faisalabad to assess these surgical techniques in young patients. Participants are randomly assigned to one of two groups. One group undergoes single incision scrotal orchidopexy, where the surgery is done through a single scrotal cut. The other group receives the standard two incision inguinal orchidopexy, involving separate cuts in the inguinal and scrotal areas. Both procedures are conventional orchidopexies aimed at repositioning the testis. During the study, children will be monitored for post-operative complications from 24 hours up to one month after surgery. Cosmetic outcomes will be evaluated two weeks post-surgery. The study includes follow-up visits to assess healing and surgical results, and all data will be collected to compare the two methods. Participation involves surgery, follow-up assessments, and monitoring for safety and effectiveness throughout the study period.

Age: 12Months - 10YearsMALEPhase Not Applicable
1 location
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Actively Recruiting

Hypospadias is a common congenital condition in males where the urethral opening is abnormally located on the underside of the penis. This trial evaluates the effect of caudal nerve block, a regional anesthesia technique, on the rate of urethrocutaneous fistula, a frequent and significant complication after surgical repair of distal hypospadias in young boys aged 6 to 60 months. The study is a prospective, multicenter, randomized controlled trial conducted in Turkey to provide evidence on the safety and outcomes of caudal block use in this surgery. Participants are randomly assigned to one of two groups one group receives general anesthesia combined with caudal block using bupivacaine hydrochloride, while the other group receives general anesthesia alone with intravenous analgesics per standard care. The study follows patients for 3 to 6 months after surgery to monitor fistula formation, wound healing, and other complications. Data such as anesthesia and surgery duration, pain scores, analgesic use, and hospital stay length are collected. During the study, patients undergo surgery and receive assigned anesthesia procedures. Researchers assess postoperative pain during the first 24 hours, record any complications up to 3 months after surgery, and track the need for additional pain medication. The main outcome is the incidence of urethrocutaneous fistula within 3 months. Safety and effectiveness of pain control techniques are also evaluated. The total participation includes surgery and follow-up visits for several months postoperatively.

Age: 6Months - 60MonthsMALEPhase Not Applicable
2 locations
C

Actively Recruiting

This research evaluates surgical methods for treating distal hypospadias, a common condition in boys where the urethral opening is on the underside of the penis. The study compares the standard graft-augmented tubularized incised plate G-TIP urethroplasty with a newer approach using fibrin-enhanced TIP F-TIP that applies the patients own platelet-rich fibrin PRF during surgery. The goal is to see if PRF reduces complications like urethrocutaneous fistula and narrowing of the urethral opening after surgery. Participants are male children aged 6 months to 7 years with primary or redo distal hypospadias and an unfavorable urethral plate. They will be randomly assigned to receive either F-TIP urethroplasty with PRF applied to the incised urethral plate or standard G-TIP urethroplasty without PRF. The PRF is prepared during surgery from the childs own blood using a specific centrifugation process and fixed in place before tubularization. After surgery, children will be monitored for complications, urinary function, and cosmetic outcomes over six months. Researchers will assess the occurrence of urethral complications, urethral narrowing, urinary flow rates, and cosmetic appearance using standardized scoring. The study is conducted at multiple centers and aims to provide clearer information on which surgical approach may improve healing and results in boys with this condition.

Age: 6Months - 84MonthsMALEPhase Not Applicable
2 locations
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Actively Recruiting

Researchers are studying why people with Turner Syndrome, galactosemia, premature ovarian insufficiency POI, variations in sex characteristics, and those receiving high-risk gonadotoxic therapy have trouble getting pregnant or experience early menopause. The study aims to understand these conditions better and evaluate if freezing gonadal tissue can help preserve fertility in affected individuals. This observational study also explores the biological mechanisms causing follicle loss through advanced tissue analysis. Participants may undergo physical exams, blood tests, body measurements, and pelvic ultrasounds. Some may have surgery to remove gonadal tissue, which will be frozen and stored for future use. A portion of this tissue will be used for research to study follicles and gametes before and after freezing. The study includes multiple groups children and adolescents with various conditions at risk for ovarian dysfunction, including those who respond poorly to ovarian stimulation and those undergoing prophylactic gonadectomy. Participants will have follow-up visits including a checkup six weeks after surgery and additional visits up to 18 months post-surgery, with phone follow-ups every 12 to 24 months. Researchers will assess tissue quality, hormone levels, and gene expression to understand follicle loss and preservation. The study lasts 30 years, tracking long-term outcomes and potential complications related to fertility preservation and gonadal tissue cryopreservation.

Age: 2Years - 35YearsAll Genders
1 location
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Actively Recruiting

Proximal hypospadias, including penoscrotal and scrotal types, represent about 20% of all hypospadias cases and present surgical challenges in achieving a straight, functional, and cosmetically favorable penis. This research compares two surgical techniques used in two-stage repair of primary proximal penile hypospadias. The study aims to address the ongoing debate about the best method to substitute the urethral plate in these complex cases. The trial evaluates outcomes of two different surgical approaches the inner preputial graft and the transverse preputial island flap, both used in the first stage of a two-stage repair for proximal penile hypospadias. These methods are compared to see which yields better results in terms of complications and success rates. The inner preputial graft is noted for its versatility, especially in cases with limited healthy local skin, while the flap method offers a reliable blood supply potentially reducing strictures or contractures. Participants will undergo surgery with one of the two techniques and be closely monitored for complications and outcomes. Researchers will measure the rate of complications six months after the end of treatment to evaluate the success of each method. The study includes careful follow-up to assess both functional and cosmetic results, with the total participation spanning the treatment and post-treatment monitoring periods.

Age: 6Months +MALEPhase Not Applicable
1 location

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