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

NCT06109623 | Unknown

• 1 other identifier: IIT-2023-0135
• Study Type: observational
• Target: 1,226
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Urinary Incontinence,Stress

Keywords

Stress Urinary Incontinence; Steroid Hormone; Case-Control Study

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Sensitivity analysis or stratified analysis

  through study completion, an average of 6 month

Study Arms (2)

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.

Other: observation; Other: sex hormone

control group

Patients with non-stress urinary incontinence

Other: observation; Other: sex hormone

Interventions

observation OTHER

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

SUI group; control group

sex hormone OTHER

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

SUI group; control group

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- Experimental Group
• women aged ≥20 years
• Stress urinary incontinence diagnosed in our hospital;
• 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;

You may not qualify if:

• Pelvic organ prolapse, overactive bladder, urge urinary incontinence, overflow urinary incontinence, mixed urinary incontinence;
• patients who received hormone replacement therapy within 6 months;
• estrogen-dependent diseases, such as endometriosis, uterine leiomyoma, ovarian tumors;
• the presence of gynecological malignant tumors or other diseases affecting hormone secretion;
• the presence of nervous system diseases.

Sponsors & Collaborators

• RenJi Hospital: lead

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Observation; Gonadal Steroid Hormones

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Chun-Wu Pan, professor

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhang Jing-Yan

CONTACT

+8619117170882; windsor0525@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 31, 2023
• Study Start: November 15, 2023
• Primary Completion: November 15, 2023
• Study Completion: December 1, 2023
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: We plan to share the primary results within 6 months after the trial ends so that other investigators can understand the results of the trial.
• Access Criteria: We plan to share the findings of the trial through journal publications, conference presentations, or other appropriate channels of scientific communication. We will consider establishing mechanisms for sharing data and samples, such as data sharing platforms or collaborating with other research teams to share data and samples.