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

Not yet recruiting

• Conditions: Urinary Incontinence,Stress
• Interventions: Other: observation; Other: sex hormone

• Registration Number: NCT06109623
• Lead Sponsor: RenJi Hospital

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-10
• Study First Submitted QC: 2023-10-28
• Last Update Submitted: 2023-10-28
• Study First Posted: 2023-10-31
• Last Update Posted: 2023-10-31
• Study Start: 2023-11-15
• Primary Completion: 2023-11-15
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 1226

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SUI group	observation	Female patients diagnosed with stress urinary incontinence in our hospital, who met the inclusion and exclusion criteria, and received six sex hormone tests.
control group	sex hormone	Patients with non-stress urinary incontinence
control group	observation	Patients with non-stress urinary incontinence
SUI group	sex hormone	Female patients diagnosed with stress urinary incontinence in our hospital, who met the inclusion and exclusion criteria, and received six sex hormone tests.

Primary Outcome Measures

Name	Time	Method
Baseline characteristics	baseline, pre-procedure	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).
Association analysis between stress urinary incontinence and androgen levels	immediately after the procedure	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.

Secondary Outcome Measures

Name	Time	Method
Sensitivity analysis or stratified analysis	through study completion, an average of 6 month	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.).