Chinese Herbal Therapy Combined With Acupuncture for Female Mixed Urinary Incontinence

Overview

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 Title of Study: “Combination Therapy With Chinese Herbal Formula, Yiqi Suoquan Granule, and Acupuncture for Female Mixed Urinary Incontinence”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 2019

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 Product: Chinese 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 Product: Chinese 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 Product: Placebo & 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.
  • Other: Placebo & 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.

Arms, Groups and Cohorts

  • Experimental: Chinese herb & acupuncture
    • Participants will take Yiqi Suoquan granule and receive acupuncture.
  • Active Comparator: Chinese herb & sham acupuncture
    • Participants will take Yiqi Suoquan granule and receive sham acupuncture.
  • Active Comparator: Placebo & acupuncture
    • Participants will take placebo granule and receive acupuncture.
  • Placebo Comparator: Placebo & sham acupuncture
    • Participants will take placebo granule and receive sham acupuncture.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Change in ICIQ-SF questionnaire
    • Time Frame: 8 week (post-treatment) and 12 week (follow-up)
    • assessed by ICIQ-SF questionnaire
  • Change in I-QOL questionnaire
    • Time Frame: 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
    • Time Frame: 8 week (post-treatment)
    • assessed by 72 h bladder diary

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Guang’anmen Hospital of China Academy of Chinese Medical Sciences
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ran Pang, Associate Professor – Guang’anmen Hospital of China Academy of Chinese Medical Sciences
  • Overall Official(s)
    • Ran Pang, MD, Principal Investigator, Guang’anmen hospital
  • Overall Contact(s)
    • Ran Pang, MD, +861088001040, pangran2002@sina.com

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