A Pilot Randomized Placebo Controlled Trial of Electroacupuncture for Women with Pure Stress Urinary Incontinence

Abstract

BackgroundAcupuncture is a potential conservative therapy for women with stress urinary incontinence (SUI). There is limited evidence to support its effectiveness due to the poor quality of existing studies.MethodsWe performed a pilot randomized, controlled trial to preliminarily assess the efficacy of electroacupuncture (EA) in women with pure SUI. A total of 80 women with pure SUI were randomly assigned to receive EA with deep needling at BL33 and BL35 (n = 40) or sham EA with non-penetrating needling at sham acupoints (n = 40) three sessions per week for 6 weeks. The women were followed for 24 weeks. The primary outcome was the change from baseline in the amount of urine leakage measured by a 1-hour pad test after 6 weeks. The secondary outcomes included the 72-hour incontinence episode frequency (IEF), International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) score, and patient self-evaluation of therapeutic effect. Adverse events (AEs) were monitored throughout the trial.ResultsThe median decrease from baseline of urine leakage measured by the 1-hour pad test was 2.5 g [interquartile range (IQR): 1.80–14.6 in the EA group, which was greater than the median decrease of 0.05 g (IQR: -2.80–+0.50) in the sham EA group after 6 weeks (p<0.01). The differences between groups in the decrease from baseline of 72-hour IEF became statistically significant at week 30 with a median decrease of 3.25 g (IQR: 1.25–5.69) in the EA group, and a median decrease of 1.00 g (IQR: -0.69–+2.88) in the sham EA group (p = 0.01). The participants in the EA group showed greater decreases in ICIQ-SF score and higher ratings in the help they received from the treatment than those in the sham EA group at weeks 6,18 and 30 (all p<0.05). No obvious AEs were observed in either group.ConclusionEA may effectively and safely relieve urinary incontinence symptoms and improve quality of life in women with pure SUI. EA demonstrated more than a placebo effect. Since this is a pilot study, results should be interpreted with caution.Trial RegistrationClinicalTrials.gov NCT02445573.

Comparing the effect of electroacupuncture treatment on obese and non‐obese women with stress urinary incontinence or stress‐predominant mixed urinary incontinence: A secondary analysis of two randomised controlled trials

“…Our results are in agreement with the findings of a previous pilot randomised controlled trial treating general female SUI patients with EA, 36 which showed that the change in the ICIQ-SF score from baseline ranged from 1.75 to 5.89. In summary, the results suggest that both groups were able to benefit from a 6-week EA treatment for improving UI symptoms, regardless of BMI category.…”

“…The change in the ICIQ‐SF score from baseline to week 2 through week 36 in the obesity group ranged from 2.12 to 7.78, compared with 2.31‐7.41 in the non‐obesity group with a between‐difference of −0.49 to −0.03 (all P > .05). Our results are in agreement with the findings of a previous pilot randomised controlled trial treating general female SUI patients with EA, which showed that the change in the ICIQ‐SF score from baseline ranged from 1.75 to 5.89. In summary, the results suggest that both groups were able to benefit from a 6‐week EA treatment for improving UI symptoms, regardless of BMI category.…”

“…The evidence around the role of acupuncture for UI is increasing, and positive trials exist for the management of SUI . However, the explicit mechanisms and factors affecting such efficacy remain unknown.…”

“…The evidence around the role of acupuncture for UI is increasing, and positive trials exist for the management of SUI. 16,17,36 However, the explicit mechanisms and factors affecting such efficacy remain unknown. Causing muscle contraction and simulating PFMT by stimulating S3 via BL33 (Zhongliao) and the pudendal nerve via BL35 (Huiyang) have been considered as a plausible explanation of acupuncture for SUI.…”

Electroacupuncture for women with stress urinary incontinence

“…It is essential to make sure whether electroacupuncture is a good option for the patients who are unable to have surgery, and whether it is as effective as other conservative or drug therapies. Studies have demonstrated that electroacupuncture can effectively reduce the symptoms of SUI, [ 16 , 20 ] but its efficacy has not been evaluated scientifically and systematically. We have developed a protocol of systematic evaluation to assess the effectiveness and safety of electroacupuncture treatment on women with SUI, and the process is shown in the flow diagram in Fig.…”