For almost two months I have participated in a clinical trial that seeks to find out if a nutritional supplement is effective in combating the symptoms of overactive bladder syndrome. This disease, which, according to trial director Marcela Gonzalez-Gross, affects 12% of the population, can present with different manifestations: urgent and sudden need to urinate that is difficult to control; involuntary loss of urine; needing to go to the bathroom frequently (eight or more times in a 24-hour period) or waking up two or more times at night to urinate.
Once the group that carried out the trial accepted me as a volunteer, I had to fill out thirteen forms online, in addition to another two in the Biochemistry laboratory of the Faculty of Physical Activity and Sports Sciences (INEF) of the University Polytechnic University of Madrid where part of the group conducting the test works. They have done stress and balance tests, they have weighed me, they have measured me, I have completed two voiding diaries and for six weeks I have taken two daily capsules of the investigated product. In addition to the contribution that my data will make for the essay, personally, it has helped me to know more about myself.
The voiding diaries, recording for three consecutive days each time I urinated, with the time, degree of urgency and quantity, and all the liquid drunk during 24 hours, have helped me to see that what was just an intuition (that something was not working well in my body) became an absolute certainty. I had to do the first of the daily ones during the three days before I started taking the two daily capsules. The second, just at the end of the six weeks in which I took them. In all cases, my need to go to the bathroom is above what the American Mayo Clinic, a world reference in health care, establishes as symptoms of overactive bladder syndrome. The first day of the first voiding diary I went twelve times in 24 hours and that means a period of less than an hour and a half between visits if I subtract the hours that I am sleeping from the day.
It is easy to understand what this alteration of normal life means. When I walk into any room, almost the first thing I do is ask where the bathroom is. It’s been happening to me for a long time, but in recent years it has worsened. It started after giving birth to my daughter, seventeen years ago. I consulted the midwife shortly after and she told me that it was normal for it to happen and to solve it she gave me a photocopy with pelvic floor exercises. I don’t know how long I did those exercises, but it wasn’t long. I also don’t know if if it had been constant I wouldn’t now have overactive bladder syndrome. What I do know is that until very recently I had not discussed it with anyone, not even my family doctor. And it is that overactive bladder syndrome is associated with a stigma. It is not talked about. No one wants to appear to others as a peeper or a peeper. And that fact has also affected the trial: “It has been very difficult for us to find volunteers to participate,” Gonzalez-Gross explained to me. “We think it’s because it’s taboo to talk about it,” she adds. Another of the researchers participating in the group conducting the trial, Maria Jose Castro, a researcher at the University of Valladolid, anticipates another possible cause for the difficulty in recruiting volunteers: “It has been more difficult to find men who participated and we believe that behind it there may be a gender difference in how this syndrome is treated. We think that men are treated more than women when they explain to their doctors what is happening to them”.
Taboo or gender difference in treatments? What I’ve also discovered since I started participating in the trial is that I’m not the only one this happens to, far from it. The response of most of the friends my age to whom I have told that I was participating in the overactive bladder clinical trial and what this syndrome consists of has been: “It happens to me too.” One of them told me that when she told her gynecologist that it was happening to her, he replied that “it was anatomical.” Which is almost the same as saying that there is no solution and that it will endure.
Marcela Gonzalez-Gross explains to me another of the possible causes for the difficulty in finding volunteers: “We needed them to be women and men with overactive bladder syndrome without medication. In 2019, the primary care protocol for people with this problem changed and since then they have been medicated.
That the volunteers do not take medication is essential to measure the efficacy of the product being studied in the clinical trial. To find out if it works or not, half of the volunteers, the group known in the trial as the sample, receive the product to be evaluated. The other half, known as the control group, receive a placebo, a harmless product, but it also has no positive effect on the disease. The results of the test consist of comparing what has happened to both groups. If the sample group’s symptoms improve, compared to the control group’s, this is proof that the product works. The greater the improvement, the greater the effectiveness of the product.
There are different types of clinical trial, but the most solid are those known as “blind”. They can be blind, double blind or triple blind. In the first of them, the only ones who do not know if what they are taking is a product or a placebo are the volunteers who participate in it. In the second, neither does the observing researcher, the one who maintains contact with the volunteers, have that information. And in the triple blind, neither the volunteers nor the observing researchers nor the researchers analyzing the data know who has taken the product and who has taken the placebo.
The trial in which I have participated in these two months was double blind. I did not know until the end of my participation if what I was taking was or not the product evaluated, but neither did Jaime Lopez-Seoane, the observing researcher in this trial, know. When, towards the middle of my participation period, Jaime called me to find out how I was doing, I had to tell him that he didn’t notice much of an effect. He explained to me that some of the volunteers took a few weeks to begin to notice improvement. The week after his call I did notice an improvement: for several nights in a row I did not get up to go to the bathroom. But it was not permanent; after four or five nights, I was back to my annoying routine of having to get up in the middle of the night at least once. And the second voiding diary, the one I filled out when the six-week period in which I took the capsules ended, is very similar to the one I filled out before I started taking them: I urinated ten times on the first day and nine times each on the other two. In the first, after the twelve times on the first day, there were eleven on the second and eight on the third.
So whatever I had been taking didn’t seem to have any effect on my overactive bladder syndrome. When Jaime Lopez-Seoane informed me if what he had taken had been a product or a placebo, it was when I perfectly understood what a clinical trial is. I had been taking the product, and it had not worked for me. Although this fact is very significant for me, it is not really significant for the trial because it is only the data from one of the volunteers. Once each of the two hundred people who collaborate in it has finished their participation, the research group will have to study all the data provided, from the time the capsules were taken to aspects such as the relative humidity of the air during the time in which they were taken, the amount of liquid that was drunk or the physical conditions of the participants. And from there, yes, the information sought on the possible efficacy of the product will be obtained. Meanwhile I have finally decided to go to my family doctor to tell him that this is happening to me.
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Source: EL PAIS