Combination Therapy With Chinese Herbal Formula, Yiqi Suoquan Granule, and Acupuncture for Female Mixed Urinary Incontinence
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Urinary Incontinence
- Sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Enrollment
- 136
- Locations
- 1
- Primary Endpoint
- Change in incontinence episode per 24 h
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Ran Pang
Associate Professor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Change in incontinence episode per 24 h
Time Frame: 8 week (post-treatment) and 12 week (follow-up)
assessed by 72 h bladder diary
Secondary Outcomes
- proportion of participants with more than 50% improvement in incontinence episodes per 24h(8 week (post-treatment))
- Change in I-QOL questionnaire(8 week (post-treatment) and 12 week (follow-up))
- Change in ICIQ-SF questionnaire(8 week (post-treatment) and 12 week (follow-up))