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

NCT ID: NCT06109623

Last Updated: 2023-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1226 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-15

Study Completion Date

2023-12-01

Brief Summary

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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

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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.

Conditions

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Urinary Incontinence,Stress

Keywords

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Stress Urinary Incontinence Steroid Hormone Case-Control Study

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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SUI group

Female patients diagnosed with stress urinary incontinence in our hospital, who met the inclusion and exclusion criteria, and received six sex hormone tests.

observation

Intervention Type OTHER

To observe the changes and differences of steroid hormones between stress urinary incontinence group and control group.

sex hormone

Intervention Type OTHER

Six indicators of steroid hormones (estrogen, testosterone, follicle stimulating hormone, luteinizing hormone, pituitary prolactin, progesterone)

control group

Patients with non-stress urinary incontinence

observation

Intervention Type OTHER

To observe the changes and differences of steroid hormones between stress urinary incontinence group and control group.

sex hormone

Intervention Type OTHER

Six indicators of steroid hormones (estrogen, testosterone, follicle stimulating hormone, luteinizing hormone, pituitary prolactin, progesterone)

Interventions

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observation

To observe the changes and differences of steroid hormones between stress urinary incontinence group and control group.

Intervention Type OTHER

sex hormone

Six indicators of steroid hormones (estrogen, testosterone, follicle stimulating hormone, luteinizing hormone, pituitary prolactin, progesterone)

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chun-Wu Pan

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chun-Wu Pan, professor

Role: PRINCIPAL_INVESTIGATOR

Renji Hospital, School of Medicine, Shanghai Jiao Tong University,

Central Contacts

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Zhang Jing-Yan

Role: CONTACT

Phone: +8619117170882

Email: [email protected]

Other Identifiers

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IIT-2023-0135

Identifier Type: -

Identifier Source: org_study_id