Division of Urology

Clinical Research

The goal of our clinical research program is to better understand the natural history of some of the conditions we treat, as well as the outcomes for patients following our interventions. We firmly believe it is important to critically examine the work we do every day to ensure we are providing optimal care.

The clinical research program utilizes both prospective (starting with the present and collecting data into the future) and retrospective (reviewing medical charts after the completion of treatment) data analysis to answer important questions about how urologic problems in children are treated.

We are currently involved in projects looking at several groups of children seen in our practice:

Stone disease

We have a large database of past and present patients with information about:

The purpose of this project is to identify factors that may be associated with recurrent stone disease and to determine whether there are interventions that may prevent stones from recurring.

Presentations from this data have been made at the American Academy of Pediatrics' national meeting, the annual meeting of the American Urological Association, and the annual meeting of the Pediatric Urology Nurse Specialists.

Exstrophy and epispadias

Exstrophy of the bladder, cloacal exstrophy and epispadias are rare conditions. Given our expertise in caring for these children, we treat a sizeable number of patients each year. We are monitoring the number and kinds of surgical interventions needed for these children, their continence rates and other factors associated with successful outcomes.

Our data has been presented at the national meeting of the American Urological Association and internationally at the annual meeting of the European Society of Pediatric Urology.

Minimally invasive surgery (MIS)

At CHOP, we offer the full continuum of surgical care, including minimally invasive robotic and laparoscopic procedures. We are tracking:

We are leaders in publishing in this new area of intervention. The following are a sample of our recent publications:

Disorders of sex development

The care of children with disorders of sex development (DSD) has changed in recent years, and what comprises optimal care is still the subject of debate. At CHOP, we are focused on trying to ensure that families receive an accurate diagnosis as efficiently as possible and with the minimum amount of tests and procedures necessary. We also want to understand the decisions parents make regarding surgical care in the wake of their children’s diagnosis.

We have an ongoing study looking at the process of diagnosing patients with DSDs so we can work on a diagnostic protocol that maximizes information while minimizing unnecessary or redundant tests and procedures.

Long-term outcomes of cryptorchidism

Over the past 25 years our Division has carefully documented the initial presentation of children with cryptorchidism (undescended testes). Our databank of biopsy samples from cryptorchid testes has led to numerous presentations and articles which have advanced our understanding of this complex condition.

This work has primarily focused on understanding cryptorchidism at the molecular or basic science level. The current aim of the study is to link the basic science to the long-term clinical outcome of these patients.

We are recruiting young men over the age of 18 who were treated for cryptorchidism in early childhood to provide a semen analysis so we can compare semen parameters in adulthood to the tissue samples we obtained when they were younger. Our goal is to identify and better understand the aspects of cryptorchidism that may play a role in future fertility. By comparing factors present at diagnosis with long-term outcomes, we will better be able to counsel patients and their families.

Cryptorchidism research study recognized

Dr. Kraft and Dr. Kolon’s research study earned the clinical research prize during the October 2011 meeting of the American Academy of Pediatrics in Boston.

In this study, Kate Kraft, MD, and Thomas Kolon, MD, presented our series of 91 patients with unilateral undescended testis (UUDT) and 19 patients with bilateral undescended testes (BUDT) who underwent testis biopsies during orchiopexy and had both hormonal testing and semen analysis during follow-up visits in adulthood. We hypothesized that results of the biopsy obtained in childhood would be correlated with the results of semen analysis and hormone testing in adulthood.

Biopsies were classified using two parameters:

  1. Total germ cells per tubule (GC/T; classified as mild, moderate or severe pathology)
  2. Adult dark spermatogonia per tubule (Ad/T; classified as normal or abnormal).

From the adult hormone profile we examined FSH, LH, total testosterone, and inhibin B, as well as sperm count and motility from the semen analysis.

Research findings

We found no significant differences in semen analysis parameters based on GC/T in either the UUDT or BUDT group.

In patients with UUDT, sperm density and sperm count in the abnormal Ad/T group were within the normal range, but significantly lower when compared to the normal group. FSH levels were significantly higher in patients with abnormal Ad/T but remained within normal range.

In BUDT patients, sperm density was both lower than the normal range and significantly decreased in the abnormal Ad/T group. FSH, sperm count, and percent motility in the abnormal Ad/T group were outside normal clinical range, but these results are not statistically significant when compared to patients in the normal Ad/T group.

Based on these results, we concluded that germ cell histopathology at the time of orchiopexy is not associated with significant changes in hormone levels or semen analysis results in adulthood. Testis biopsy at orchiopexy may be limited in predicting future fertility in UUDT but more clinically useful in predicting fertility potential for those with BUDT.

Randomized intervention for children with vesicoureteral reflux (RiVUR)

We are participants in this national randomized clinical trial looking at the efficacy of using antibiotics in the treatment of vesicoureteral reflux. Please see the RiVUR study website for more information.

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