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Bladder Exstrophy clinical trials

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NCT ID: NCT05690594 Completed - Bladder Exstrophy Clinical Trials

Long-term Outcomes of Patients Treated for Bladder Exstrophy by Questionnaires.

QUALEXSTRO
Start date: April 20, 2023
Phase:
Study type: Observational

The bladder exstrophy epispadias complex (BEEC) is a rare spectrum of congenital conditions due to abnormal development of the cloacal membrane. Of these conditions, bladder exstrophy (BE) represent a mild form and requires several complex surgical corrections to gain access to a urinary and fecal acceptable continence and a normal sexual function at adulthood. Despite the surgeries, patients may suffer, in the long term, from functional impairments (incontinence, sexuality disorders) which can impact severely their quality of life. However, only a few studies investigate long term issues of bladder exstrophy patients, with heterogenous population and small samples. The department of pediatric surgery of the Hospices Civils of Lyon is an expert center in the management of patients born with bladder exstrophy. At adulthood, departments of adult urology continue the follow-up and treat residual complications. Thus, a large cohort of adults and adolescents' patients with bladder exstrophy is currently followed at our institution. Therefore, the aim of this study is to evaluate urinary continence, fecal continence, sexuality and quality of life among a large cohort of patients treated for bladder exstrophy, using questionnaires. All patients over 15 years old and treated for bladder exstrophy at our institution are included in the study. Exclusion's criteria are : patients treated for epispadias or cloacal exstrophy, patients initially treated of their bladder exstrophy abroad with no access to the surgical report, patients under a guardianship measure. All included patients are contacted by e-mail or phone to answer the questionnaire. The purpose of statistical analysis is to evaluate the average score in each field of investigation: - Mean ICIQ score for urinary continence - Mean FLQI score for fecal continence - Mean FSFI score for sexuality in women - Mean IIEF-5 score for sexuality in men - Mean SF-12 score for quality of life, in comparison of mean SF-12 score in general French population based on literature Secondary objectives are to assess the impact of different surgical strategies used for bladder exstrophy reparation on urinary continence, fecal continence, sexuality and quality of life ; to describe the population from a sociological point of view (level of study, profession, marital status) and to describe the population reproductive status (pregnancy, delivery modalities, paternity and maternity status, use of medically assisted procreation).

NCT ID: NCT04935918 Recruiting - Bladder Exstrophy Clinical Trials

EVALUATION OF THE SAFETY AND EFFICACY OF ADJUSTABLE CONTINENCE THERAPY BALLOONS IN BLADDER EXSTROPHY AND INCONTINENT EPISPADIAS PATIENTS

ACT
Start date: April 16, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the effectiveness and safety of a minimally invasive surgical procedure with ACT (Adjustable Continence Therapy) balloons implantation for the treatment of urinary incontinence in children with bladder exstrophy or isolated epispadias. The ACT therapy consists of two small adjustable silicone balloons connected with a tubing to a port, surgically placed around the bladder neck, one on each side of the urethra.

NCT ID: NCT04626167 Recruiting - Clinical trials for Chronic Kidney Diseases

Concomitant Renal and Urinary Bladder Allograft Transplantation

Start date: June 1, 2021
Phase: Early Phase 1
Study type: Interventional

The purpose of this study is to establish if concomitant renal and vascularized urinary bladder allograft transplantation is feasible.

NCT ID: NCT04580186 Not yet recruiting - Bladder Exstrophy Clinical Trials

Outcome Of Classic Bladder Exstrophy Repair, Assiut University Experience

Start date: May 15, 2021
Phase:
Study type: Observational [Patient Registry]

1. To review surgical and medical outcomes of the previous repaired bladder exstrophy cases. 2. To present recent developments in surgical techniques and care of these patients.

NCT ID: NCT03698721 Not yet recruiting - Spina Bifida Clinical Trials

Urothelium Tissue Engineering Using Biopsies From Transurethral Resection of Prostate

IMOPU
Start date: October 2018
Phase:
Study type: Observational

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. The 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.

NCT ID: NCT03685955 Withdrawn - Hypospadias Clinical Trials

Efficacy of Amniotic Membranes in Complex Genitourinary Reconstruction

Start date: March 2020
Phase:
Study type: Observational [Patient Registry]

Urinary fistulas are unfortunately one of the most common post operative complications in hypospadias repairs and bladder neck transections on pediatric and adult populations, an estimated 20%, resulting in multiple repeat operations with prolonged hospitalization. The negative sequelae of these fistulas have significant financial and psychosocial impact and the aim of this study is to evaluate if the fresh frozen preserved amniotic membrane tissue studied, which have live cells and intact naturally occurring growth hormones and peptides that augment healing that have been shown in early studies to be effective facilitating previous failed fistula repairs and leg ulcer healing, respectively, will help reduce the incidence of urinary fistulas in subject populations.

NCT ID: NCT03061084 Recruiting - Spina Bifida Clinical Trials

Prospective Cohort of Transitional Urology Patients

Start date: August 27, 2015
Phase:
Study type: Observational

A transitional Urology database was created in parallel with National Spina Bifida registry to follow patients with complex congenital urogenital anomalies and be able to prospectively evaluate them. The investigators obtained the standardized questionnaires to collect long-term data regarding patients' genitourinary status including urine and fecal continence, sexuality, fertility, and pelvic health.

NCT ID: NCT02759705 Withdrawn - Fertility Clinical Trials

Bladder Exstrophy (FIVES FertIlity Vesical Exstrophy Sexuality)

FIVES
Start date: September 2017
Phase:
Study type: Observational

This analytical descriptive study aims to describe the fertility and sexuality male adult subjects carrying classic bladder exstrophy or epispadias and to highlight infertility risk factors. A questionnaire on paternity, urinary status, erections, ejaculations and sexual self-esteem and a semen analysis will be realized at first consultation, semen analysis results wil be explained at second consultation. It is assumed that fertility and sexuality exstrophic men are impaired.

NCT ID: NCT02192801 Not yet recruiting - Proteinuria Clinical Trials

Kidney Function in Patients With Bladder Exstrophy

Start date: April 2014
Phase: N/A
Study type: Observational

Patients with classical bladder exstrophy undergo many surgical interventions with secondary urinary tract infections complicating their course. lately primary definitive surgical correction of this congenital anomaly has been implemented with satisfactory results. Although bladder exstrophy patients are born with normal kidneys, infectious and mechanical surgical complications can potentially damage their kidneys in the long-term. therefore we decided to evaluate renal function in the long-term in these patients.

NCT ID: NCT02075216 Recruiting - Clinical trials for Urinary Incontinence

Transurethral Myoblast Injection for Urinary Incontinence in Children With Bladder Exstrophy

Start date: December 2013
Phase: Phase 1/Phase 2
Study type: Interventional

Muscle precursor cells constantly regenerate striated muscles, and include the quiescent satellite cells located beneath the basal lamina of skeletal myofibers, which are responsible for repair of the terminally differentiated striated muscle tissue. Transurethral implantation of autologous myoblasts may represent an improved alternative to synthetic bulking agents, with the unique ability to compensate for the deficient muscle fibers in the urethral sphincter. Clinical studies of cell therapy based treatment of sphincter insufficiency, using muscle derived stem cell transplantation was carried out in patients with stress incontinence revealed and confirmed the ability of cell therapy to improve the structure and contractile function of the sphincter. In this study autologous heterotopic myoblasts will be transurethrally injected in patients with bladder extrophy epispadias complex who remained incontinent after staged bladder reconstruction and bladder neck reconstruction. The aim of this study is to investigate the potential therapeutic effects of autologous myoblast injection for the treatment of children presenting with urinary incontinence after modern staged repair and bladder neck reconstruction of extrophy-epispadias complex as well as studying the safety, efficacy and durability of the procedure, and health related quality of life.