Correlation Between Changes in Sex Hormone Levels and Stress Urinary Incontinence in Women

Urinary Incontinence,Stress Clinical Trial

Official title:

Study on the Correlation Between Changes in Steroid Hormone Levels and Stress Urinary Incontinence in Women

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06109623
• Other study ID #: IIT-2023-0135
• Status: Not yet recruiting
• Start date: November 15, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: October 2023
• Source: RenJi Hospital
• Contact: Zhang Jing-Yan
• Phone: +8619117170882
• Email: windsor0525[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this observational study is to learn about the relationship between stress urinary incontinence and endogenous steroids in women, especially its occurrence and severity with androgens and estrogens. The main questions it aims to answer are:

• Association between stress urinary incontinence and endogenous steroids in women

• Risk factors associated with stress urinary incontinence in women Participants will be asked to provide basic clinical information as well as results of measurements of serum steroid hormone levels.

Researchers will compare Stress urinary incontinence group and control group to see if the changes of sex hormone levels were statistically significant.

Description:

By comparing the differences of six hormones between female patients with stress urinary incontinence (SUI) and non-SUI patients (patients without pelvic floor muscle dysfunction and lower urinary tract dysfunction) aged ≥20 years, especially the changes of androgen and estrogen levels, the correlation between the changes of hormone levels and stress urinary incontinence was obtained. Multivariate logistic regression analysis was used to analyze the relationship between hormones and urinary incontinence, and further correlation analysis was performed for statistically significant hormones. Estrogen and androgen were divided into four groups: normal estrogen/normal androgen group, decreased estrogen/normal androgen group, normal estrogen/decreased androgen group, decreased estrogen/decreased androgen group. Stratified analysis was performed to analyze whether there was an interaction between the two hormones and exclude confounding effects. Finally, the data were further analyzed by sensitivity analysis of baseline characteristics, and the known risk factors were verified in this trial, including age, parity, menopausal status, genetic factors, obesity, and on this basis, the correlation between pelvic surgery history, diabetes, hypertension, smoking and stress urinary incontinence was explored.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1226
• Est. completion date: December 1, 2023
• Est. primary completion date: November 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Experimental Group

1. women aged =20 years

2. Stress urinary incontinence diagnosed in our hospital;

3. Six hormone tests were performed in our hospital; Control group

(1) women aged =20 years; (2) diseases other than stress urinary incontinence diagnosed by our hospital; (2) Six hormone tests were performed in our hospital;

Exclusion Criteria:

1. Pelvic organ prolapse, overactive bladder, urge urinary incontinence, overflow urinary incontinence, mixed urinary incontinence;

2. patients who received hormone replacement therapy within 6 months;

3. estrogen-dependent diseases, such as endometriosis, uterine leiomyoma, ovarian tumors;

4. the presence of gynecological malignant tumors or other diseases affecting hormone secretion;

5. the presence of nervous system diseases.

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence
• Urinary Incontinence, Stress
• Urinary Incontinence,Stress

Intervention

Other:
• observation
To observe the changes and differences of steroid hormones between stress urinary incontinence group and control group.
• sex hormone
Six indicators of steroid hormones (estrogen, testosterone, follicle stimulating hormone, luteinizing hormone, pituitary prolactin, progesterone)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline characteristics	The results of this study were described by statistical methods. Descriptive statistical analysis was performed on the baseline characteristics of patients in the SUI group and the control group. Categorical variables were described by frequency (%), and Pearson chi-square test or Fisher Exact test was used. Continuous variables describe their mean (SD) or median data (interquartile range) according to their normality, and comparisons between groups were performed using the independent t-test (normal) or Mann Whitney test (non-normal).	baseline, pre-procedure
Primary	Association analysis between stress urinary incontinence and androgen levels	The association between stress urinary incontinence and the lowest quartile of serum testosterone was examined by a weighted, multivariate logistic regression model. Odds ratios and 95% confidence intervals were calculated for each outcome of interest. All models were adjusted for age, BMI, parity, menopausal status, history of pelvic surgery, hypertension, and diabetes. Two-sided p values of 0.05 or less were considered to indicate statistical significance.	immediately after the procedure
Secondary	Sensitivity analysis or stratified analysis	The association between hormone levels and stress urinary incontinence is affected by many uncertain factors, such as population characteristics and disease history. In order to avoid bias of results caused by uncertain factors, sensitivity analysis or stratified analysis of these factors is required. This project planned to perform sensitivity or stratified analyses by grouping the subjects into multiple subgroups (grouped by age, history of childbirth, history of hypertension, history of diabetes, history of pelvic surgery, etc.).	through study completion, an average of 6 month