Urinary Incontinence
Conditions
Keywords
Urinary incontinence, Chinese herb, Acupuncture
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.
Interventions
COMBINATION_PRODUCTChinese herb & acupuncture
Participants will take Chinese herbal formula, Yiqi Suoquan granule, which is composed of Radix Astragali 30 g, Radix Codonopsis pilosula 10g, Radix Angelica sinensis 10g, Radix Atractylodis Macrocephalae 10g, Fructus Alpiniae Oxyphyllae 10g, Radix Lindera aggregata 6g, Rhizoma Dioscoreae 10g, pericarpium citri reticulatae 10g, Rhizoma Cimicifuga 10g, Radix Bupleuri 10g, Fructus Rubi 15g, and Semen raphani 10g and prepared by the Department of Pharmacy, Guang'anmen Hospital, China Academy of Chinese Medical Sciences. Besides, Participants will receive acupuncture, three times a week. The selected acupoints include bilateral BL33, BL35, SP6, and ST36.
COMBINATION_PRODUCTChinese herb & sham acupuncture
Participants will take Chinese herbal formula, Yiqi Suoquan granule, which is composed of Radix Astragali 30 g, Radix Codonopsis pilosula 10g, Radix Angelica sinensis 10g, Radix Atractylodis Macrocephalae 10g, Fructus Alpiniae Oxyphyllae 10g, Radix Lindera aggregata 6g, Rhizoma Dioscoreae 10g, pericarpium citri reticulatae 10g, Rhizoma Cimicifuga 10g, Radix Bupleuri 10g, Fructus Rubi 15g, and Semen raphani 10g and prepared by the Department of Pharmacy, Guang'anmen Hospital, China Academy of Chinese Medical Sciences. Besides, Participants will receive sham acupuncture, three times a week. The sham BL33, BL35, SP6, and ST36, which are 25 mm outward to BL33, BL35, SP6, and ST36, will be inserted with a depth of 2 to 3 mm.
COMBINATION_PRODUCTPlacebo & acupuncture
Participants will take Chinese herbal placebo which is prepared by the Department of Pharmacy, Guang'anmen Hospital, China Academy of Chinese Medical Sciences. Besides, Participants will receive acupuncture, three times a week. The selected acupoints include bilateral BL33, BL35, SP6, and ST36.
OTHERPlacebo & sham acupuncture
Participants will take Chinese herbal placebo which is prepared by the Department of Pharmacy, Guang'anmen Hospital, China Academy of Chinese Medical Sciences. Besides, Participants will receive sham acupuncture, three times a week. The sham BL33, BL35, SP6, and ST36, which are 25 mm outward to BL33, BL35, SP6, and ST36, will be inserted with a depth of 2 to 3 mm.
Sponsors
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in incontinence episode per 24 h | 8 week (post-treatment) and 12 week (follow-up) | assessed by 72 h bladder diary |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in ICIQ-SF questionnaire | 8 week (post-treatment) and 12 week (follow-up) | assessed by ICIQ-SF questionnaire |
| Change in I-QOL questionnaire | 8 week (post-treatment) and 12 week (follow-up) | assessed by I-QOL questionnaire |
| proportion of participants with more than 50% improvement in incontinence episodes per 24h | 8 week (post-treatment) | assessed by 72 h bladder diary |
Countries
China
Outcome results
None listed