Abstract
The clinical trial evaluated the safety and efficacy of the HUE&JOY non-invasive biofeedback device for treating stress urinary incontinence (SUI). Conducted at Samsung Medical Center and Seoul Asan Medical Center, the study involved 100 SUI patients, with 70 completing the trial. The intervention consisted of pelvic floor muscle training using the biofeedback device, providing real-time visual feedback to enhance training accuracy.

Results showed significant improvement in urinary incontinence symptoms and pelvic floor muscle strength after 12 weeks of treatment, with a complete cure rate of 52%. The Incontinence Severity Visual Analog Scale (VAS) score decreased from 6.5 to 3.6 (p < 0.0001). Quality of life metrics, including avoidance behavior and social insecurity, significantly improved (p < 0.0001).

Most patients (98%) reported the treatment as effective, with 94% expressing satisfaction. The device showed a favorable safety profile, with no unexpected significant side effects. Minor adverse events, such as musculoskeletal discomfort and mild urinary symptoms, were unrelated to the device. These results support the biofeedback device as a safe and effective option for managing SUI.

The trial evaluated the safety and efficacy of the HUE&JOY non-invasive biofeedback device for stress urinary incontinence (SUI). Conducted at Samsung Medical Center and Seoul Asan Medical Center (June 2008 - November 2009), it used a prospective, open-label, single-arm design to assess pelvic floor muscle training effectiveness.

Selection Criteria:
Eligible patients had SUI with at least 2g of urine leakage on a standardized pad test. Exclusions included urge incontinence, overflow incontinence, recent bladder-impacting treatments, neurological disorders, pelvic organ prolapse (Grade 2 or higher), pacemaker use, pregnancy, and non-compliance risks.

Participants:
Of 111 subjects, 106 began treatment, and 70 completed the protocol, ensuring statistical significance (69% improvement ratio, 17% dropout rate).

Intervention:
Patients attended the clinic twice weekly for one month, then weekly for two months. Each 25-minute session used the biofeedback device for pelvic floor training with real-time visual feedback, with similar home exercises.

The clinical trial demonstrated significant improvements in quality of life (QoL) metrics for patients using the HUE&JOY biofeedback device. Avoidance behavior scores improved from 56.4 to 74.5, psychological and social impact from 57.7 to 77.2, and social insecurity from 46.3 to 66.9, all showing statistical significance (p < 0.0001). Pelvic floor muscle strength also increased significantly, with perineometry measurements rising from 19.6 ± 12.3 to 25.0 ± 13.5. The proportion of patients classified as having "good" or "strong" muscle strength on the Oxford scale increased from 25.7% before treatment to 54.3% after the intervention.

Patient satisfaction was notably high, with 98% of participants reporting positive treatment outcomes and 94% expressing satisfaction and willingness to recommend the therapy. Minor adverse events, unrelated to the device, included musculoskeletal discomfort and mild urinary symptoms, but no significant or unexpected side effects were observed, indicating a favorable safety profile.

The HUE&JOY biofeedback device has proven to be a safe and effective non-invasive treatment for stress urinary incontinence (SUI). The device significantly improved urinary incontinence symptoms, pelvic floor muscle strength, and quality of life, with a complete cure rate of 52% and notable symptom reduction. 

The non-invasive biofeedback technology enabled patients to perform targeted pelvic floor muscle training with real-time visual feedback, enhancing the training process. Most patients (98%) reported positive outcomes, and 94% expressed satisfaction and willingness to recommend the therapy. 

The device's safety profile was favorable, with no significant adverse events directly related to the treatment. Minor side effects reported were deemed unrelated to the device. Given its high efficacy, patient satisfaction, and minimal side effects, the HUE&JOY device represents a promising non-surgical option for managing SUI, supporting its use in clinical practice.