Clinical observation on the treatment of moderate female stress urinary incontinence with optimized formula of Qishi granules based on the theory of spleen kidney correlatio

Not Applicable

Recruiting

• Conditions: Female stress urinary incontinence

• Registration Number: ITMCTR2024000008
• Lead Sponsor: Xiyuan Hospital, China Academy of Chinese Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients who meet the Western and Traditional Chinese Medicine diagnosis criteria for moderate SUI in women;

2. Women aged between 18 and 70 years old;

3. Not using any traditional Chinese or Western medicine for treating SUI in the past week;

Exclusion Criteria

1. Urinary incontinence patients caused by neurogenic bladder, psychological urinary incontinence, urgent urinary incontinence, mixed urinary incontinence, urethral sphincter insufficiency requiring surgical treatment, ectopic ureter, uncontrolled urinary tract infection, etc;

2. Those with serious cardiovascular diseases, liver diseases, kidney diseases, hematological diseases, lung diseases, or serious diseases that affect their survival, such as cancer or AIDS, which the researchers consider not suitable for inclusion. Liver function ALT, AST, kidney function BUN exceeding 50% of the upper limit of normal value, and kidney function Cr exceeding the upper limit of normal value will not be selected;

3. Allergy. Duloxetin enteric coated capsules are prohibited for patients who are known to be allergic to any non active ingredients in Duloxetin enteric coated capsules or products;

4. For patients who have previously used duloxetine enteric coated capsules and have shown poor efficacy

5. Simultaneously using monoamine oxidase inhibitors. Prohibition of combination with monoamine oxidase inhibitors (MAOIs);

6. Untreated narrow angle glaucoma. Clinical trials have shown that duloxetine increases the risk of pupil dilation, therefore, untreated narrow angle glaucoma patients should avoid using duloxetine;

7. Those who do not meet the inclusion criteria, do not use medication according to regulations, cannot determine the efficacy, or have incomplete information that affects the efficacy judgment;

8. Legally disabled patients (blind, deaf, mute, intellectually disabled), and mentally ill patients;

9. Pregnant or lactating patients;

10. Patients who have been determined by the researchers to be unable to cooperate in completing the study.

11. Patients who are currently receiving acupuncture and moxibustion and other physical therapy.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ICS 1-hour urine cushion test;Pelvic three-dimensional ultrasound;

Secondary Outcome Measures

Name	Time	Method
ICI-Q-SF score;24-hour urination diary;I-QOL score;