Chinese Herbal Therapy Combined With Acupuncture for Female Mixed Urinary Incontinence

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status and phase: Completed; Phase 2

Conditions: Urinary Incontinence

Treatments: Combination Product: Chinese herb & sham acupuncture; Other: Placebo & sham acupuncture; Combination Product: Chinese herb & acupuncture; Combination Product: Placebo & acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT03450902

Z161100000516156

Details and patient eligibility

About

The purpose of this study is to determine whether combination therapy with Chinese herbal formula, Yiqi Suoquan granule, and acupuncture is effective in the treatment of female mixed urinary incontinence.

Full description

This factorial, randomized, controlled trial is aimed to assess the effectiveness of combination therapy with Chinese herbal formula, Yiqi Suoquan granule, and acupuncture in the treatment of female mixed urinary incontinence (MUI). Eligible participants will be randomly allocated to receiving combination therapy with Yiqi Suoquan granule and acupuncture, Yiqi Suoquan ganule plus sham acupuncture, placebo plus acupuncture, or placebo plus sham acupuncture.

To minimize the evaluation bias, the outcome assessors and statisticians will be masked to treatment allocation besides participants.

Enrollment: 136 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• (1) female, leaking with urgency and with physical activity, coughing or sneezing (MUI) for more than 1 year; (2) recorded more than 1 incontinent episode per 24 hours in their bladder diary

Exclusion criteria

• (1) with acute urinary tract infection; (2) with bladder outlet obstruction, (3) with neurogenic bladder (4) with interstitial cystitis, (5) with pelvic organ prolapse more than stage 2 (6) previous anti-incontinence surgery or a post-void residual urine volume more than 100 mL.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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136 participants in 4 patient groups, including a placebo group

Chinese herb & acupuncture

Experimental group

Description:

Participants will take Yiqi Suoquan granule and receive acupuncture.

Treatment:

Combination Product: Placebo & acupuncture

Other: Placebo & sham acupuncture

Combination Product: Chinese herb & sham acupuncture

Chinese herb & sham acupuncture

Active Comparator group

Description:

Participants will take Yiqi Suoquan granule and receive sham acupuncture.

Treatment:

Combination Product: Placebo & acupuncture

Combination Product: Chinese herb & acupuncture

Other: Placebo & sham acupuncture

Placebo & acupuncture

Active Comparator group

Description:

Participants will take placebo granule and receive acupuncture.

Treatment:

Combination Product: Chinese herb & acupuncture

Other: Placebo & sham acupuncture

Combination Product: Chinese herb & sham acupuncture

Placebo & sham acupuncture

Placebo Comparator group

Description:

Participants will take placebo granule and receive sham acupuncture.

Treatment:

Combination Product: Placebo & acupuncture

Combination Product: Chinese herb & acupuncture

Combination Product: Chinese herb & sham acupuncture