Chinese Herbal Therapy Combined With Acupuncture for Female Mixed Urinary Incontinence

Phase 2

Completed

• Conditions: Urinary Incontinence

• Registration Number: NCT03450902
• Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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.

Study Timeline

• Study First Submitted: 2018-02-23
• Study First Submitted QC: 2018-02-23
• Study First Posted: 2018-03-01
• Study Start: 2018-03-14
• Primary Completion: 2021-04-18
• Study Completion: 2021-04-18
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-28
• Last Update Posted: 2021-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 136

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

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