Hypothesis / aims of study
Overactive bladder (OAB) is associated with social impairment, psychological issues such as anxiety and depression, and significantly reduced quality of life. While traditional acupuncture has demonstrated efficacy in alleviating lower urinary tract symptoms (e.g., urinary frequency and urgency) with minimal side effects [1,2]., its invasive nature and positional requirements challenge patient compliance. This study proposes non-invasive transcutaneous acupoint electrical stimulation (TEAS) as an alternative intervention. Key acupoints (Baliao [BL31-BL34] and Sanyinjiao [SP6]) were selected through data mining, and a randomized controlled trial (RCT) was conducted to evaluate the clinical efficacy and safety of TEAS.
Study design, materials and methods
A prospective RCT was conducted with 50 OAB patients randomized into TEAS (n = 25) and transcutaneous tibial nerve stimulation (TTNS) groups (n = 25). The TEAS group received 400 Hz stimulation at SP6 and BL31-BL34 using the YQ-T0802 electronic pulse device, while the TTNS group underwent 20 Hz stimulation along the tibial nerve pathway using the TTNS-W1 wearable stimulator. Both groups received comfortable-intensity stimulation for 30 minutes per session, 3 sessions weekly, over 8 weeks. The primary outcome was the change in 24-hour urinary frequency from baseline to 8 weeks. Secondary outcomes included changes in average urine volume, urgency episodes, nocturia frequency, and scores on the PPBC-S, AUA-SI, QOL, and OABSS scales. Data were analyzed using SPSS 25.0 with intention-to-treat principles.
Results
A total of 50 patients were enrolled, with 40 completing the 8-week intervention (20 in the TEAS group and 20 in the TTNS group; baseline comparability confirmed). ① Primary Outcome: After 8 weeks, both groups showed reduced 24-hour urinary frequency. The TEAS group exhibited a mean reduction of -4.0 (95% CI: -5.6 to -2.4, P < 0.001), while the TTNS group showed a reduction of -1.4 (95% CI: -2.7 to -0.1, P = 0.033). The intergroup difference was -2.6 (95% CI: -4.6 to -0.6, P = 0.011). ② Secondary Outcomes: The TEAS group increased average urine volume by 17.79 mL (95% CI: 5.05–30.53, P = 0.009), whereas the TTNS group showed no significant change (-3.19 mL, 95% CI: -21.43–15.06, P = 0.719). The TEAS group demonstrated significant reductions at 4 weeks (P = 0.014) and 8 weeks (P < 0.001), with a statistically significant intergroup difference at 8 weeks (P < 0.001). What’s more, The TEAS group showed progressive reductions in 72-hour urgency episodes (all P = 0.001), while the TTNS group showed no improvement. For PPBC-S, AUA-SI, QOL, and OABSS scores, the TEAS group exhibited superior improvements compared to the TTNS group at 8 weeks (all P < 0.05).
Interpretation of results
The intergroup differences in outcome measures may be associated with variations in stimulation intensity. In the treatment group, the SP6 acupoint is located in the tibial nerve pathway, while the BL31-BL34 anatomically correspond to the sacral foramina, directly stimulating afferent and efferent pathways of pelvic nerves such as the S3 nerve. From a neuroregulatory perspective, TEAS may deliver greater stimulation intensity compared to TTNS, which could explain the superior efficacy of the treatment group. Regarding subjective indicators, the TEAS group showed overall superiority over TTNS group, likely because TEAS modulates systemic Qi dynamics through traditional Chinese medicine theory, thereby enhancing patients’ overall quality of life and satisfaction.