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 18 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 occupation/exposure 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
B

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 child's 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
I

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 air/nitrous 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
P

Actively Recruiting

Hypospadias is a common congenital urogenital condition in children that often requires surgical correction during early childhood. Effective pain relief after surgery is important to improve comfort, reduce stress, and prevent complications. This study compares two methods of pain control, sacral erector spinae plane (ESP) block and caudal epidural block, in young male patients undergoing hypospadias repair to find which provides better postoperative analgesia. Participants aged 6 months to 7 years will receive either an ultrasound-guided sacral ESP block or a caudal epidural block under general anesthesia before surgery. Both blocks use 0.25% bupivacaine at a dose of 0.5 mL/kg. The sacral ESP block involves an in-plane needle technique guided by ultrasound over the sacral region, while the caudal epidural block is performed using anatomical landmarks to access the caudal epidural space. Pain levels will be measured using the FLACC scale at several times within 24 hours after surgery. Researchers will also track total pain medication use, time until first additional pain relief is needed, and any complications related to the blocks such as motor weakness, nausea, or bleeding. The study aims to assess and compare the effectiveness and safety of these two regional anesthesia techniques during the postoperative period.

Age: 6Months - 7YearsMALEPhase Not Applicable
1 location
C

Actively Recruiting

Researchers are comparing two methods for managing postoperative pain in boys aged 1 to 7 years undergoing hypospadias surgery. This study evaluates the pain relief effectiveness of an ultrasound-guided Sacral Erector Spinae Plane (ESP) block versus the standard Dorsal Penile Nerve Block (DPNB). The primary focus is on the pain score measured by the FLACC scale at 12 hours after surgery. Seventy pediatric patients will be randomly assigned to receive either the Sacral ESP block or the DPNB while under general anesthesia. Both procedures involve ultrasound guidance and use 0.25% bupivacaine at a dose of 0.4 mL per kilogram, administered bilaterally. The Sacral ESP block is performed with the patient in the side-lying position targeting the erector spinae plane at the sacral level, while the DPNB is done with the patient lying on their back, injecting under Buck's fascia at the penile base. Participants will have their postoperative pain assessed at multiple time points including 30 minutes, 1, 2, 6, 12, and 24 hours using the FLACC scale. Researchers will also monitor total analgesic use and any postoperative complications within 24 hours. The study includes careful pain and safety monitoring to evaluate which block provides better or comparable pain relief following hypospadias surgery.

Age: 1Year - 7YearsMALEPhase Not Applicable
1 location
C

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
A

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 patient's 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 child's 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
G

Actively Recruiting

Researchers are studying fertility challenges in individuals with Turner Syndrome, galactosemia, premature ovarian insufficiency (POI), and variations in sex characteristics. The study aims to understand why these conditions lead to early loss of ovarian function and whether freezing gonadal tissue can help preserve fertility for future use. The investigation includes examining the number and quality of follicles and gametes in the tissue and exploring the underlying biological reasons for follicle loss using advanced genetic sequencing techniques. Participants include children and adolescents aged 2 to 35 years who meet various condition-specific criteria. They may undergo medical history screening, physical exams, blood tests, body measurements, and ultrasound imaging. Some participants will have surgery to remove gonadal tissue, which will be frozen and stored for fertility preservation and used for research. The tissue storage is funded by NIH for one year, after which participants may be responsible for ongoing costs. Follow-up care includes checkups six weeks after surgery and periodic visits or phone calls for up to 30 years. During the study, participants will complete surveys about quality of life and health, and researchers will track hormone levels and analyze tissue samples before and after freezing. The study will monitor surgical outcomes and long-term effects of tissue freezing. Researchers will also develop a national database to better understand outcomes and explore treatments to improve follicle preservation. Participation involves extensive evaluations, long-term follow-up, and contributes to advancing knowledge on fertility preservation in these conditions.

Age: 2Years - 35YearsAll Genders
1 location
I

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
H

Actively Recruiting

Proximal hypospadias is a serious condition affecting infants and their caregivers, involving an abnormality of the urethra. Researchers are comparing two surgical methods to repair this condition: the hybrid Duckett urethroplasty, a staged procedure, and the modified Duckett urethroplasty, which is completed in a single surgery. This randomized clinical trial aims to evaluate which technique better restores urethral continuity and improves cosmetic appearance. Infants and children diagnosed with proximal hypospadias will be randomly assigned to one of two groups. Group A will undergo the hybrid Duckett procedure, involving initial placement of a double-face Duckett tube on the ventral penis, with the final connection to the urethra scheduled six months later. Group B will receive the modified Duckett procedure, where the tube is placed and connected to the proximal urethral opening in a single operation. Participants will be followed for at least six months after surgery to assess the success of the repair, focusing on absence of fistula and restoration of urethral continuity as the main outcome. Researchers will also evaluate the cosmetic appearance after surgery. The study includes assessments during the operative period and follow-up visits to monitor healing and surgical results. The total participation period varies depending on individual treatment schedules and recovery.

Age: 6Months - 18YearsMALEPhase Not Applicable
1 location

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