For many years, it has been difficult to evaluate the effectiveness of kidney stone treatment, especially assessing long-term HRQoL of patients. Some researchers evaluated the impact of urolithiasis on quality of life using the NIH-sponsored PROMIS-43 questionnaire [16]. Others used The Medical Outcome Study Short-Form 36-item survey (SF-36) [17]. However, neither instrument is specific for urolithiasis. On the other hand, WISQOL scores were found to significantly correlate with, and had good predictive validity for HRQoL [18].
In our study the changes in the QoL of patients with urolithiasis in the control and treatment group was measured throughout the duration of the study while the participants underwent Thermobalancing therapy and it was measured using the WISQoL. All four domains of the WISQoL, social influence, emotional influence, health effect and influence on vital activity, were reviewed 3 times in the control group and 8 times in the treatment groups.
The results differed in patients with stones up to 10 mm in size (group 1) and in patients with stones larger than 10 mm (group 2). It was recorded that in patients with stones less than 10 mm, a significant increase in all domains of WISQOL was detected in the 2nd month of using Dr Allen Device. In group 2, the rise in all domains developed gradually, with a significant increase in all domains of WISQoL after 3 months. The numbers in all domains increased to their maximum possible score at the end of treatment, i.e., in Group 1, SI was 16.6 (max = 20), EI was 21.3 (max = 25), HE was 26.4 (max = 30) and IVA was 12.6 (max = 15). In Group 2 after treatment, SI was 16.3, EI was 20.8, HE was 26.4 and IVA was 12.8.
The use of the WISQoL questionnaire in different countries has proven that it is a consistent, reliable, and valid instrument to assess HRQoL. Its efficacy was demonstrated in Spanish-speaking patients with kidney stones in a study [19]. The validation of the Turkish version of the WISQoL questionnaire showed the effectiveness of this questionnaire only in patients with symptomatic urolithiasis [20].
In our study, the improvement in HRQoL correlated with a reduction in kidney stone size. Thus, Dr Allen's Device reduced the size of kidney stones in the treatment group and thereby improved their HRQoL. Our study also highlights the efficacy of the body's energy with Dr Allen's device in the treatment of urolithiasis by showing a reduction in the size of stones and by improving HRQoL. In the past, two clinical studies demonstrated a decrease in prostate volume and a reduction in urinary symptoms in men with enlarged prostate and chronic prostatitis by improving the blood circulation in the prostate gland [21]. This type of therapy allows treatment without the risk of adverse effects and complications commonly associated with the use of surgical modalities of treatment.
After ESWL was introduced into practice, it was supposed that 85% of all patients with kidneys stones could be cured by this surgical procedure [22]. The initial promising results of ESWL were challenged by adverse effects such as bleeding, pain, and urinary tract infections [23], rare complications, such as spleen rupture or intrarenal hematoma [24, 25], and long-term consequences such as hypertension and diabetes mellitus [26, 27].
PCNL, which was established in the 1970s to replace open surgery [28] is usually used for removing kidney stones over 2 cm in size, and may produce various complications, such as bleeding, extravasation or urine, pleural drain, renal embolization etc. [29] RIRS, considering the severe complications after PCNL, can be an effective treatment alternative to PCNL, particularly in lower pole stones larger than 2 cm [30]. As RIRS affords a comparable success rate to PNL and is associated with fewer complications, it should be used as the primary treatment for renal stones [31].
However, the prevalence of infectious complications among patients undergoing RIRS for kidney stones is 7.7%, and it is impossible to predict which patients will develop these complications [32]. Whereas, Dr Allen's Device has shown to be completely safe in all patients with kidney stones, small or large. Improvement in QoL during Thermobalancing therapy was recorded in all patients, even in the absence of significant changes in the size of kidney stones. This demonstrates that Dr Allen's Device improves kidney health.
We recognise that the presence of a "placebo" group as control could have provided more statistical rigor concerning results. 6 months may be considered an appropriate time for oral medication as placebo, but not for using a belt required to be worn for most of the day for 6 months. Therefore, this trial was conducted without the use of a placebo and we consider this a limitation of our study.