Clinical trial NCT06109623: Correlation Between Changes in Sex Hormone Levels and Stress Urinary Incontinence in Women
Official title: Study on the Correlation Between Changes in Steroid Hormone Levels and Stress Urinary Incontinence in Women
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Urinary Incontinence,Stress
Keywords: Stress Urinary Incontinence
Steroid Hormone
Case-Control Study
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 1226
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients aged ≥20 years with stress urinary incontinence and patients without stress urinary incontinence. Both inclusion and exclusion criteria were met.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Baseline characteristics
timeFrame: baseline, pre-procedure
measure: Association analysis between stress urinary incontinence and androgen levels
timeFrame: immediately after the procedure
Secondary outcomes:
measure: Sensitivity analysis or stratified analysis
timeFrame: through study completion, an average of 6 month
Other outcomes:
Locations:
Study officials:
affiliation: Renji Hospital, School of Medicine, Shanghai Jiao Tong University,
name: Chun-Wu Pan, professor
role: PRINCIPAL_INVESTIGATOR
References: