NCT05505526

Electroacupuncture vs Sham Electrocupuncture for Mixed Urinary Incontinence

Electroacupuncture for Women With Mixed Urinary Incontinence: a Sham-controlled Randomised Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 222 (estimated)
• Sponsor: Shi Hangyu · Academic / Other
• Sex: Female
• Age: 35 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The investigators plan to conduct this randomized sham-controlled clinical trial to evaluate the efficacy and safety of electroacupuncture (EA), compared with sham electroacupuncture (SA) on women with mixed urinary incontinence (MUI).

Detailed description

MUI tends to present with more severe symptoms and put greater burden on the health of individual and economy of society. Current European Association of Urology (EAU) guideline on incontinence recommends to initiate treatment targeted at predominant component of MUI. Electroacupuncture has been proved not inferior to pelvic floor muscle training plus solifenacin in decreasing the 72-hour IEF and shows promise as an effective alternative for the treatment of MUI. The purpose of the study is to assess the efficacy and safety of electroacupuncture on mixed urinary incontinence among women.

Conditions

• Mixed Urinary Incontinence

Interventions

Type	Name	Description
OTHER	Electroacupuncture	BL33 is located in the third posterior sacral foramen; BL35, 0.5 cun (≈10mm) lateral to the extremity of the coccyx; and SP6 posterior to the medial border of the tibia, 3 cun superior to the prominence of the medial malleolus. BL33 will be inserted by needles of 0.30×75mm size at the angle of 45°, inward and downward, till the depth of 60-70mm. BL35 will be inserted by needles of 0.30×75mm size, slightly outward and upward, till the depth of 60-70mm. SP6 will be inserted by needles of 0.30×40mm till the depth of 25-30mm. All the needles will be lifted, thrust and twisted evenly for three times, right after insertion, to induce the sensation of deqi. Electronic acupuncture apparatus (Yingdi KWD 808 I electro pulse acupuncture therapeutic apparatus, Changzhou Yingdi Electronic Medical Device Co., Ltd) will be connected to the three pairs of needles transversally, with continuous wave of 20 Hertz (Hz), electric current of 2-6.5 milliampere (mA) for BL33 and BL35, and 1mA-3.5mA for SP6.
OTHER	Sham electroacupuncture	Sham BL33 is in the area of 1 cun (≈20mm) horizontally outside BL33; sham BL35, 1 cun (≈20mm) horizontally outside BL35; Sham SP6, in the middle of SP6 and tendons. The three pairs of acupoints will be inserted by needles of 0.30×40mm size to a depth of 2-3mm till the needles can stand still. No manipulations will be conducted, and the sensation of deqi will not be induced. Electronic acupuncture apparatus (Yingdi KWD 808 I electro pulse acupuncture therapeutic apparatus, Changzhou Yingdi Electronic Medical Device Co., Ltd) will be connected to the three pairs of needles transversally, with continuous wave of 20Hz and minimal electric current (ideally at a degree which participant can just percept). In about 30 seconds, the electric current will be turned down, leaving the indicator light and ticking sound on.

Timeline

• Start date: 2022-08-18
• Primary completion: 2024-03-31
• Completion: 2024-12-31
• First posted: 2022-08-17
• Last updated: 2022-08-17

Locations

1 site across 1 country: China