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  5. A Trip to the Emergency Room Prompts One Man To Join a Clinical Trial for the Treatment of Kidney Stones

A Trip to the Emergency Room Prompts One Man To Join a Clinical Trial for the Treatment of Kidney Stones

Bob Schwarz
Bob Schwarz

The weather in Washington, DC, was crisp the December afternoon in 2014 when Bob Schwarz walked back to his office after having lunch with a friend. Bob had a long career working with the Peter Pan bus lines, overseeing the company’s legislative interests, customer service, marketing, and real estate for 26 years. In his time with the family‑owned business, he’d met five U.S. Presidents and been invited to the White House.

Now 67, Bob continues his work in the area of transportation as a government affairs representative for Greyhound Bus Lines and the American Highway Users Alliance. Although he works in Washington, Bob considers Wilbraham, MA, “home,” as does his wife of 27 years, who lives there year round.

As Bob settled back into his office and surveyed the stacks of papers on his desk, he was struck with a sharp, shooting pain in his lower back. “It was unlike anything I had ever experienced before. It felt like someone was putting a hot poker right into my back,” he says. Although intense, the pain was also fleeting, leaving just 5 minutes after it arrived.

Bob was working late that evening, and around 8 p.m. his back pain returned, though this time it was worse and accompanied by abdominal pain. “It felt like someone had kicked me and totally knocked the wind out of me,” he says. The pain was so intense he walked over to the sofa in his office to lie down, hoping that this second round of pain would pass as quickly as the first. A colleague, concerned about Bob’s obvious discomfort, suggested that he go to the emergency room, but Bob demurred, describing himself as “stubborn.” Instead, he placed a call to his primary care physician’s office in Massachusetts. After hearing his symptoms, Bob’s doctor said, “I think what you’re describing is a kidney stone.” Bob decided that he would wait until the next morning to go to the emergency room. After all, he describes himself as having been “blessed with very good health” throughout his life, only missing a single day of work in his 40‑year career due to illness. Certainly, whatever he was experiencing could wait until the next day. How bad could a kidney stone possibly be?

Reflecting on whether it was a good idea to wait until the next morning before seeking medical treatment for his suspected kidney stone, Bob notes dryly, “Knowing now what I didn’t know then, I certainly would not have done that.”

Reflecting on whether it was a good idea to wait until the next morning before seeking medical treatment for his suspected kidney stone, Bob notes dryly, “Knowing now what I didn’t know then, I certainly would not have done that.”

The Urinary Tract and Kidney Stones

If the circulatory system can be thought of as the body’s plumbing, the urinary tract represents the body’s waste management system. It consists of two kidneys, which filter the blood to remove waste, salts, and excess fluid; the ureters, the two tubes that connect the kidneys to the bladder that stores urine; and a urethra, through which the urine in the bladder is excreted from the body. A kidney stone is a crystal that forms when substances in the urine become highly concentrated and can no longer stay dissolved. Once formed, a stone may remain in the kidney or travel through the urinary tract and be passed out of the body in the urine.

Kidney stones vary in size, but the severity of symptoms is influenced by factors other than simply the size of the stone. Some people who have small kidney stones may pass them relatively easily and have mild or no symptoms at all. Larger stones can sometimes also pass with little difficulty, if they are smooth and rounded. However, if stones are irregularly shaped or have sharp edges, even small ones can cause great pain, because they can irritate or lodge in the ureter. In severe cases, where the stone cannot be passed, approaches including shockwave therapy to break up the stone into smaller pieces or surgery to remove it may be required.

The Next Morning

A neighbor accompanied Bob to the emergency room at George Washington University Hospital (GW) the next morning. Once there, the staff took his medical history and questioned him about his symptoms. They determined that he was dehydrated, and started an intravenous drip that included fluids and pain‑relieving medications. An abdominal scan revealed a relatively small stone, approximately 3 millimeters, or about one‑tenth of an inch, in diameter. As Bob confirms, even a stone of this size can cause “excruciating” pain.

“If I can do something to help future people with kidney stones not go through what I went through, let’s do it,” he said. With that decision, Bob became a volunteer in the STONE clinical trial.

At this point, he was approached by the patient coordinator for a National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)‑ supported clinical study of treatment for kidney stones that was underway at GW. This trial was testing whether a drug could help stones pass more quickly and/or with less pain; would he be willing to participate? Bob didn’t need to think long about his reply. “If I can do something to help future people with kidney stones not go through what I went through, let’s do it,” he said. With that decision, Bob became a volunteer in the STONE clinical trial.

The STONE Trial

Study TamsulOsiNfor urolithiasis in the Emergency department (STONE) is an ongoing, multi‑center clinical trial of the drug tamsulosin to treat kidney stones. STONE expects to enroll 500 people through four participating hospitals - the George Washington University Hospital (in Washington, DC), the University of Pittsburgh, the Thomas Jefferson Hospital (in Philadelphia, PA) and the University of Alabama at Birmingham - who come to the emergency room with symptoms of a kidney stone. If the presence of a stone is confirmed via an abdominal scan, patients are asked whether they would like to enroll in the study.

Tamsulosin (which is marketed under the brand name Flomax® and also is available in generic form) is already approved for the treatment of difficult urination caused by an enlarged prostate in men. It is a member of a class of drugs known as “alpha blockers.” This medication relaxes the muscles in the bladder neck, the prostate gland, and the ureter, making it easier for urine to pass. Given these effects, many researchers and physicians think that this drug might also increase the rate at which people with kidney stones might successfully pass their stones.

Over the past 10 years or so, several trials have examined the usefulness of this drug in the treatment of kidney stones, with varying results. Many of these studies, however, were small or had other limitations. The STONE clinical trial is larger and more robust than these earlier studies. It is a randomized and placebo‑controlled study, meaning that patients are randomly assigned to receive either a placebo (sugar pill) or tamsulosin. Additionally, it is a double‑blind trial, meaning that neither the researchers who are examining the patients nor the study participants themselves will know into which arm of the study the patients have been enrolled until the study ends. Furthermore, STONE is testing the effectiveness of tamsulosin in both men and women who have kidney stones. This is important, because tamsulosin has historically been used to treat difficult urination in men with enlarged prostates, and has not been widely studied in women.

Enrollment, Follow‑up, and Resolution

After Bob agreed to enroll in the STONE study, he was given medications and sent home. As with all volunteers, follow‑up consisted of contact via telephone, email, or text message several times over the next 29 days, when the participants are asked whether or not they have passed their stone and whether they have experienced any complications or side effects, such as additional medical visits related to their stone, urinary tract infections, dizziness, or headaches. A subsequent abdominal scan is scheduled on or around day 29 to determine definitively whether the stone has passed. A final follow‑up conversation takes place on day 90.

Bob was conscientious about his participation in the study. The day‑29 scan at GW revealed no sign of a stone in his urinary tract, and he was declared stone‑free. Bob reports that he has felt fine ever since his participation in the trial ended. Moving forward, he has been advised to drink more water and cut back on coffee, in order to stay more hydrated and decrease the risk of a subsequent stone.

Because STONE is not yet complete, as of November 2015, neither Bob nor his doctor know whether he was given the placebo or tamsulosin. If, at the end of the trial, tamsulosin is shown to be effective, more widespread use of the drug in treating kidney stones could result in a significant improvement in the quality of life for patients with stones by reducing pain, shortening the time taken to expel the stone, and potentially decreasing the number of patients who require surgery to remove their stones. It could also reduce the so‑called “indirect” (i.e., non‑medical) costs related to kidney stones, such as days lost from work waiting for the stone to pass. If tamsulosin is shown to be not effective, then patients could be saved the unwanted side effects of the medication, and health care dollars would be saved.

Because Bob splits his time between Washington and Massachusetts, he admits to feeling a bit like “a stranger in a community” when his kidney stone developed. He credits the staff at GW for helping him navigate his diagnosis and treatment, saying that they were welcoming and efficient, even working around his schedule when he had an early morning meeting on Capitol Hill the same day as his day‑29 scan. “I can’t say enough about the follow‑up of staff at the hospital,” Bob says, noting that he especially appreciated the team “just being there when I needed them. They treated me like a platinum card carrier.” Six months after his kidney stone, Bob happily reported that he had not suffered a recurrence of a stone…and that he had still not taken a sick day off from work.

In addition to this trial, the NIDDK supports a broad range of studies in urology, including basic research urinary tract biology and clinical trials of novel therapies. The NIDDK supports a George M. O’Brien Urology Cooperative Research Center Program to improve stone disease treatment and a Rare Kidney Stone Consortium. To discuss and prioritize research needs and identify strategies to address those needs, the NIDDK held a workshop titled “Urinary Stone Disease Research Challenges and Opportunities” on April 1‑2, 2015, and intends to fund a Urinary Stone Disease Research Network in 2016.

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This content is provided as a service of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health. The NIDDK translates and disseminates research findings through its clearinghouses and education programs to increase knowledge and understanding about health and disease among patients, health professionals, and the public. Content produced by the NIDDK is carefully reviewed by NIDDK scientists and other experts.