Petition to the Boards of Urology
Subject: Demanding a More Detailed Informed Consent Process Prior to Any Hypospadias Surgical Intervention
Dear Members of the American Board of Urology, American Urological Association, American Board of Medical Specialities, Federation of State Medical Boards, Canadian Urological Association, Pediatric Urologists of Canada, Royal College of Physicians and Surgeons of Canada, Societies for Pediatric Urology, State and Federal Legislators, and other associated parties,
We, the undersigned, call upon the Boards of Urology to mandate that urologists implement a more comprehensive and transparent informed consent process for hypospadias surgery.
Background:
Hypospadias is a congenital condition where the opening of the urethra is located on the underside of the penis instead of at the tip. The condition is relatively common, occurring in approximately 1/200 males. The condition exists on a spectrum from mild to severe, where mild hypospadias refers to a urethral opening close to the tip (“distal hypospadias”), and where severe hypospadias refers to a urethral opening near the base of a penis (“proximal hypospadias”). Curvature of the penis can also be present (“chordee”).
Surgery is often recommended to correct this condition. The goal of surgery is to bring the urethral meatus to the tip, and to correct any curvature if present. The intention is to normalize the appearance of the penis, to improve urine flow allowing a male to stand to urinate with a direct stream, and to facilitate procreation by ensuring sperm will be deposited in the appropriate location.
Hypospadias repair however is technically challenging, and many surgical techniques exist without any widely accepted gold standard approach. Surgical complication rates are high, in the literature cited to be approximately 10 - 20% for distal hypospadias and up to 50 - 70% for proximal. The chance of success of the surgery may be dependent on the level of experience of the surgical team. These complications can result in long term debilitating medical and psychological consequences.
Parents are to act as surrogate decision makers for their infants born with hypospadias, tasked with the choice of whether to operate, when to intervene, and whom to choose as the treating physician.
Concerns:
- 1. Rushed Decision-Making:
- Parents are frequently pressured into making decisions about surgery without adequate time to fully understand the implications. Surgeons routinely recommend initiating these life altering surgeries prior to age one.
- 2. Lack of Medical Information:
- Parents are often not adequately counseled on:
- a) the option of no surgical intervention or delayed intervention until the child himself can consent
- b) the different surgical techniques available, and the specific surgical technique that will be used in their case
- c) the possible postoperative complications (fistula, urethral stricture, urethral diverticulum, urinary tract infections, glans dehiscence etc.) and the high rates of occurrence reported in the literature, as well as the surgeon’s own complication rates based on their practice to date
- d) how these complications would be managed (for example, additional surgery)
- e) their surgeon’s level of experience in repairing hypospadias, specifically how many procedures they perform per year
- f) whether or not there would be late complications at the time of puberty, during sexual function, at the time of reproduction, or later in life, and how these would be addressed as well as whom the treating team would be when the patient is no longer under the care of a pediatric urologist
- 3. Implications on Mental Health and Body Image:
- There is usually insufficient discussion about the need for mental health support. Numerous surgeries beginning at a young age can be traumatic for the child and family, causing fear related to the medical system. Given that hypospadias affects the genitals, some may feel that it is “taboo” and they are unable to share their feelings or experiences with family and friends resulting in isolation and shame. Teens and affected adults may avoid relationships or sexual activity due to fear of judgment. Anxiety and depression may ensue. In our experience, the above issues are underrecognized by the treating urologist and there is currently no routine referral for mental health counseling.
Demands:
Comprehensive Informed Consent:
Implement a thorough, standardized verbal, written, or video informed consent process for parents and/or patients that includes detailed information such as
- the nature of hypospadias, including the implications, if any, on health if unrepaired
- reasons for choosing surgery, including a discussion on reasons for delaying or forgoing surgery
- the experience level of the surgeon, demonstrated by how many cases he/she has approximately performed to date (or performs per year), compared to the number of cases that the average urologist performs
- the surgical technique that will be utilized in the patient’s specific case
- possible complications of this surgery including the expected rates reported in the literature, and the surgeon’s personal rates of complication based on their practice to date
Extended Decision-Making Period:
Allow parents and patients ample time to consider their options and seek additional information or second opinions before making a decision about surgery.
Access to Support Services:
Routinely discuss the psychological impact of hypospadias and hypospadias surgery throughout the life cycle. Routinely provide access to mental health support services for parents and patients before and/or after surgery to address any concerns that may arise.
- Long Term Follow Up and Monitoring of Results:
Shift from the belief that hypospadias is a pediatric condition to an understanding that this stays with the individual life-long, even post-surgery. Ensure ongoing long term follow up with patients to monitor and address early and late complications. Insist that urologists review and analyze their results in a standardized fashion, then adjust techniques based on their findings, thereby honoring their commitment to patient safety and quality improvement. Organize a reliable transition from pediatric to adult care.
Governing and Adherence:
We further urge that these standards and guidelines be enforced and governed by the respective boards of urology and/or regulatory bodies.
Conclusion:
We urge the boards of urology to take immediate action to improve the informed consent process for hypospadias surgery. By providing parents and patients with comprehensive information and support, along with transparency in practice, we can ensure that decisions about treatment are made with full awareness and consideration of all relevant factors.