Thermobalancing therapy with Dr Allen's Device dissolves kidney stones improving health-related quality of life measured by the Wisconsin Stone Quality of Life questionnaire (WISQOL) – a randomised clinical trial

Author(s): Simon Allen, Muhammad Akram, Ariana Adjani, Shahid Kamal, Abid Rashid, Akram Malik, Muhammad Talha Khalil, Sherwani Rehan.

Introduction: Kidney stone disease (KSD) is associated with recurring pain, renal colic, and other debilitating symptoms, decreasing healthrelated quality of life (HRQoL) in patients.

Objective: The purpose of this study is to investigate the efficacy of Dr Allen’s Device and Thermobalancing therapy in dissolving kidney stones and in improving the quality of life in patients with nephrolithiasis.

Methods: A randomised, interventional, parallel group clinical trial investigated 54 patients aged 18-60 years with nephrolithiasis. 29 of the 54 patients with kidney stones under 10 mm were randomised (1:1) into a treatment group of 15 patients (Group 1) and a control group of 14 patients. The remaining 25 patients (Group 2) were treated but not randomised as they had stones larger than 10 mm. Both treatment groups used Dr Allen’s Device for 6 months. Changes in the size of kidney stones were recorded using ultrasound. Patients’ quality of life was measured using the Wisconsin Stone Quality of Life Questionnaire (WISQoL) at regular intervals and compared between the groups.

Results: Dr Allen's Device showed a significant improvement in HRQoL across all domains of the WISQoL and a significant reduction in the size of kidney stones in both treatment groups (p<0.001). There was no significant change in the stone size in the control group, and HRQoL improved only slightly across WISQoL domains. No side effects or complications were reported by patients in both treatment groups during the 6-month period.

Conclusions: The use of Thermobalancing therapy with Dr Allen's Device for Kidney Treatment is effective in dissolving kidney stones and in improving the quality of life of patients. This out-of-hospital treatment dissolves kidney stones of various composition non-invasively and without adverse events. Thus, Dr Allen’s Device is an effective and safe at-home treatment option for kidney stone disease.

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