Chinese Herbal Therapy Combined With Acupuncture for Female Mixed Urinary Incontinence
- Conditions
- Urinary Incontinence
- Interventions
- Combination Product: Chinese herb & acupunctureCombination Product: Placebo & acupunctureCombination Product: Chinese herb & sham acupunctureOther: Placebo & sham acupuncture
- Registration Number
- NCT03450902
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 136
- (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
- (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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Chinese herb & acupuncture Placebo & acupuncture Participants will take Yiqi Suoquan granule and receive acupuncture. Placebo & sham acupuncture Chinese herb & sham acupuncture Participants will take placebo granule and receive sham acupuncture. Chinese herb & sham acupuncture Placebo & acupuncture Participants will take Yiqi Suoquan granule and receive sham acupuncture. Chinese herb & sham acupuncture Chinese herb & acupuncture Participants will take Yiqi Suoquan granule and receive sham acupuncture. Placebo & acupuncture Placebo & sham acupuncture Participants will take placebo granule and receive acupuncture. Placebo & sham acupuncture Chinese herb & acupuncture Participants will take placebo granule and receive sham acupuncture. Chinese herb & acupuncture Chinese herb & sham acupuncture Participants will take Yiqi Suoquan granule and receive acupuncture. Chinese herb & acupuncture Placebo & sham acupuncture Participants will take Yiqi Suoquan granule and receive acupuncture. Placebo & acupuncture Chinese herb & sham acupuncture Participants will take placebo granule and receive acupuncture. Chinese herb & sham acupuncture Placebo & sham acupuncture Participants will take Yiqi Suoquan granule and receive sham acupuncture. Placebo & acupuncture Chinese herb & acupuncture Participants will take placebo granule and receive acupuncture. Placebo & sham acupuncture Placebo & acupuncture Participants will take placebo granule and receive sham acupuncture.
- Primary Outcome Measures
Name Time Method Change in incontinence episode per 24 h 8 week (post-treatment) and 12 week (follow-up) assessed by 72 h bladder diary
- Secondary Outcome Measures
Name Time Method proportion of participants with more than 50% improvement in incontinence episodes per 24h 8 week (post-treatment) assessed by 72 h bladder diary
Change in I-QOL questionnaire 8 week (post-treatment) and 12 week (follow-up) assessed by I-QOL questionnaire
Change in ICIQ-SF questionnaire 8 week (post-treatment) and 12 week (follow-up) assessed by ICIQ-SF questionnaire
Trial Locations
- Locations (1)
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
🇨🇳Beijing, Beijing, China