NIPH Clinical Trials Search

STRESS-FREE Trial

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Nocturia
Date of first enrollment	18/11/2025
Target sample size	50
Countries of recruitment
Study type	Interventional
Intervention(s)	Stress-free therapy: A therapy that uses a moxa device to intermittently stimulate acupressure points on the body surface.

Outcome(s)

Primary Outcome

Difference between groups in change from baseline (before the start of the study) in nocturnal urine volume measured by urination diary 4 weeks after the start of the study (5 weeks)

Secondary Outcome

(1) Between-group difference in change from baseline in nocturnal urination frequency over 5 weeks (2) Between-group difference in change from baseline in N-QOL (Nocturia Quality of Life Questionnaire) over 5 weeks (3) Between-group difference in change from baseline in Pittsburgh Sleep Questionnaire over 5 weeks (4) Between-group difference in change from baseline in IPSS (International Prostate Symptom Score) over 5 weeks (men only) (5) Between-group difference in change from baseline in OABSS over 5 weeks (6) Between-group difference in change from baseline in CLSS (Core Lower Urinary Tract Symptom Score) over 5 weeks (women only) (7) Between-group difference in change from baseline in urinary sodium and urinary osmolality from random urine over 5 weeks (8) Between-group differences in changes from baseline in urinary flow and residual urine volume over 5 weeks (9) Between-group differences in changes from baseline in prostate volume measured by prostate ultrasound over 5 weeks (men only) (10) Between-group differences in changes from baseline in endocrinological tests and prostate-specific antigen (PSA) over 5 weeks (men only) (11) Between-group differences in changes from baseline in telomere strength and fatigue score over 5 weeks

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	<= 85age old
Gender	Both
Include criteria	(1) Patients who have voluntarily provided written consent to participate in this study. (2) Patients aged 20 to 85 years (regardless of gender) on the day of consent. (3) Patients who have been diagnosed with nocturia based on a urination diary within the three months prior to consent. (4) Patients who are receiving behavioral therapy or lifestyle guidance for nocturia, and these have not changed for at least four weeks prior to consent. (5) Patients who have not changed the dosage of medication effective for nocturia or started new medication for nocturia within four weeks prior to consent acquisition.
Exclude criteria	(1) Patients with the following conditions requiring hospitalization: heart disease, abnormal blood pressure, acute orthopedic disease, organ failure. (2) Patients with loss of temperature sensation or sensory abnormalities due to severe peripheral circulatory disorders. (3) Patients with heart failure who are deemed to need to limit excessive exercise. (4) Patients with chronic kidney disease who are planning to start dialysis or who are already undergoing hemodialysis or peritoneal dialysis. (5) Patients with untreated or poorly controlled sleep apnea syndrome. (6) Patients with severe sleep disorders that interfere with daily life. (7) Patients who have difficulty complying with the research protocol due to severe mental illness or severe dementia. (8) Patients with active urinary tract infection. (9) Patients with obvious skin abnormalities (infection, wound, etc.) in the area where the thermal conductor will be attached. (10) Patients currently using an implantable medical device (pacemaker, implantable cardioverter-defibrillator, etc.) in the area where the thermal conductor will be attached. (11) Patients with malignant tumors undergoing active treatment, such as anticancer drugs (however, patients who have not received anticancer drug treatment within one year prior to consent acquisition and who are not scheduled to receive anticancer drug treatment during the study period, as determined by the physician, are eligible for the study). (12) Female patients who are pregnant, breastfeeding, or wish to become pregnant during the study period. (13) Patients who have participated in other clinical trials or interventional clinical research within three months prior to consent acquisition. (14) Patients who are otherwise deemed inappropriate for this study by the investigator.