Patient Story ID: 1419911

Background

In the past few decades there has been a push to engage the community in the research process from start to finish. Prior to that and still to this day, research is mostly “researcher” driven. In 2010, the Patient-Centered Outcomes Research Institute (PCORI) was authorized by Congress as part of the Patient Protection and Affordable Care Act to help ensure that patients and other relevant stakeholders “have a seat” at the table throughout the research process—helping to prioritize research topics, design and conduct the studies, and share the results.¹

Inspiration for research can come from many places. We present the story of a patient, Jada, whose curiosity about her condition led her to conduct her own research which laid the foundation for further research currently being conducted as our institution.

The following narrative is from Jada.

My name is Jada, and I am a woman who was born with a rare birth defect called cloacal exstrophy. This complex condition severely affects my bowel, bladder, and reproductive systems. Because of these complications, I self-catheterize through a Mitrofanoff stoma on my abdomen and have had significant bladder repairs and augmentation operations as a young child. I am writing to share about a very unique experience in my life that has led to further investigation by both myself and eventually medical research professionals.

Several years ago, in the spring of 2018, I experienced something not completely uncommon to the college-aged woman—a slightly late menstrual cycle. Of course, I did the first thing one would expect in such a situation. I headed to a drug store to buy a pregnancy test. To my absolute shock, the test came back faintly positive. I was unable to accept my eyes, seeing as how my medical team had told me from a young age that pregnancy would likely be a very difficult reality for me. So, I went back to the store in an absolute panic and bought one of every single brand of over-the-counter tests that they sold. I took about 20 tests total and had varying results. A small handful were completely negative, but the majority were positive with a wide variance of the boldness in the positive test line. I couldn’t figure out any sort of pattern. I then followed up at a nearby ob-gyn office, where they agreed that it was one of the strangest things they had ever seen and immediately did an ultrasound which confirmed that I was never pregnant at all. My menstrual cycle showed up a few days later and I put the whole extremely stressful scenario behind me, writing it off as a strange fluke.

Several months later I was in Colorado as a volunteer summer camp counselor at Youth Rally. Youth Rally is a summer camp for kids with a wide variety of bladder- or bowel-related medical conditions. One of the special aspects of this organization is that the volunteer staff are entirely made up of adults who live with the same conditions as the kids do. This gives us a beautiful and inclusive environment full of support and peer mentorship. Of course, after the kids go to sleep, the adult counselors get a chance to visit with one another. After several other women heard my story, they responded that they had had nearly identical situations happen to them over the years! After comparing stories and medical backgrounds, we started to form a hypothesis that maybe these false positive pregnancy tests had to do with the chemical makeup of our urine. We suspected that it may be due to surgery to have our bladders augmented with a variety of non-bladder tissues. And what better place and rare opportunity to just test the theory right there and then! I headed to the store to buy as many over the counter urine tests as I could afford and we conducted our own official scientific study.

Our Experiment

Home pregnancy tests were bought uniformly as the Target generic brand (although based on our experiences at home and follow-up personal testing later, this proves true of any home test including the Clearblue digital tests). I have included the results from a dozen patients; however, almost 20 people participated. Since then, many campers performed tests at home after hearing about the counselor experiments, which also yielded false positive results. Since participants had a wide range of urinary complications, each person collected urine in a cup and dipped the test stick in for more consistent results. We followed the instructions on the test package and waited for 2 minutes to view the results. We included several male participants, and people whose bladders were augmented with various tissue types to try and narrow down the factor to being bladder augmentation specifically and eliminate any doubt about female hormone factors. We also included 2 tests from people without bladder augmentations as controls. Tests were done at the same time around 11 pm in the same area.

After obtaining the results, I tabulated them and took photos of them as well to document the findings (see Figure). The trend seems to be that it doesn’t matter what the bladder had been augmented with—the gender of the person, whether they catheterize or urinate from their urethra, or what their primary diagnosis is. The common factor seems to be that when a bladder is surgically augmented using non-bladder tissue, the urine is somehow affected to cause false positives on store-bought stick tests.

Figure. Original results of the Youth Rally counselor pregnancy test experiment.

Approach

Years later, in the summer of 2021, I attended a virtual exstrophy support group. I was there to talk to fellow patients about my recent pregnancy experience. I had finally proven many a doctor wrong and become one of the only few cloacal exstrophy patients to naturally conceive and carry a whole pregnancy. The topic of the false positive tests once more came about, and this time Dr Vasquez, a pediatric urologist, was present. She contacted me afterward to tell me that she found the information extremely interesting and would love to follow up for more elaborate research on the subject. I really appreciated that she seemed to respect our effort for self-advocacy and research among my peers and me. She wanted to hear more about my perspective, life experiences, and opinions. Based on my pilot study, and what I had to say about the topic, she framed her own research with her medical team at the Children’s Hospital of Los Angeles. Dr Vasquez seemed to understand that the best way to learn more details about topics that are important to patients is to actually talk to the patients and ask them. I really wish that more doctors and researchers would use this approach to focus studies on what we, who are most directly impacted, actually want to learn more about. We are the experts in the unique challenges and experiences of our own lives. We would love a larger voice in the process.

Maintenance

Research is an ongoing effort. Truly patient-centered research requires long-term collaboration. After hearing about Jada’s pilot study, we proceeded to perform a similar study at our institution and obtained similar results to Jada and her “colleagues,” validating Jada’s pilot study.

Working with Jada, who became a voice for her teammates, we (Jada) determined that “the tests at the actual doctor’s office seem to be more specific and tend to give an accurate result.” Jada goes on to say, “We believe that more testing needs to be done by urologists regarding what the actual chemical difference is that causes this phenomenon. We also strongly believe that for the best long-term care of patients who have undergone this procedure it should become common practice for urologists to inform all patients about this situation. The only way a person with an augmented bladder can have an accurate pregnancy test with full confidence is to go to the doctor’s office and have a blood test or ultrasound performed.”

With this in mind, we are seeking to further understand the mechanism of the results obtained, and future studies are planned. During the planning process and performance of these studies, we have been reaching out to keep Jada abreast of the progress and findings, for which she has expressed appreciation. This allows the patient whom this research affects to continue to have input and provide feedback as needed. We have contacted the manufacturer of the pregnancy test to include a warning on the package insert that patients who have had surgery on their bladder may get false positive results and should contact their medical provider to confirm tests results. Unfortunately, the manufacturer was not interested in changing the package insert.

Quality of Life

Clinical translational research attempts to accelerate the process of research so that life-altering findings can be disseminated and implemented faster. With a patient-centered approach to this research, research that is meaningful to the patient is given priority. For bladder augment patients, the uncertainty of false positive pregnancy tests can have widespread effects, and thus it is incumbent upon clinicians, especially urologists, to be aware of this phenomenon.

Jada writes, “Dr Vasquez and I agreed that this information, if proven true, needed to be brought to light and become common knowledge to all urologists who perform these procedures. This way patients can be informed about this kind of side effect during preop conversations. This will give people a better understanding of their own anatomy, improve self-empowerment, and make one less likely to have an experience which can be highly stressful and emotionally detrimental. Affected women who are suspicious of a pregnancy need to be informed that their options for pregnancy confirmation are more limited than the average person. A blood test or ultrasound is highly recommended as the only official way to accurately determine the pregnancy status of someone who has had one of these operations. While it may seem a somewhat silly research topic at first, I firmly believe that it will greatly improve the quality of life for many women who have received bladder augmentation surgery in the future.”