Urinary Incontinence,StressNCT06109623
Correlation Between Changes in Sex Hormone Levels and Stress Urinary Incontinence in Women
An observational study of Urinary Incontinence,Stress, run by RenJi Hospital.
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. Read more about this study
- Who is it for?
- Ages 20 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence,Stress
- What is being tested?
- observation and sex hormone
- How many people
- 1,226 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2023to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Female patients aged ≥20 years with stress urinary incontinence and patients without stress urinary incontinence. Both inclusion and exclusion criteria were met.
Who may be able to join
- Experimental Group
- women aged ≥20 years
- Stress urinary incontinence diagnosed in our hospital;
- Six hormone tests were performed in our hospital; Control group
- women aged ≥20 years; (2) diseases other than stress urinary incontinence diagnosed by our hospital; (2) Six hormone tests were performed in our hospital;
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Study on the Correlation Between Changes in Steroid Hormone Levels and Stress Urinary Incontinence in Women
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.
Read the 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.
- Conditions
- Urinary Incontinence,Stress
- Being tested
- observation, sex hormone
- Keywords
- Stress Urinary Incontinence, Steroid Hormone, Case-Control Study
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationOther
To observe the changes and differences of steroid hormones between stress urinary incontinence group and control group.
sex hormoneOther
Six indicators of steroid hormones (estrogen, testosterone, follicle stimulating hormone, luteinizing hormone, pituitary prolactin, progesterone)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: observation; Other: sex hormone | |
| control group | Patients with non-stress urinary incontinence Receives: Other: observation; Other: sex hormone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: immediately after the procedure
Secondary outcomes (1)
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.).
Measured: through study completion, an average of 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start15 Nov 2023 (estimated)
- Primary completion15 Nov 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence,StressStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,226 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun-Wu Pan, RenJi Hospital
- Investigators
- Chun-Wu Pan, professor, Principal investigator, Renji Hospital, School of Medicine, Shanghai Jiao Tong University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06109623
- Sponsor's protocol ID
- IIT-2023-0135
- Status last verified
- Oct 2023
- First submitted
- 10 Oct 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share the primary results of the trial, including data on the primary and secondary end points, after completion. We will consider sharing raw data and samples collected in the trial to facilitate further research and validation.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Correlation Between Changes in Steroid Hormone Levels and Stress Urinary Incontinence in Women
- ClinicalTrials.gov ID
- NCT06109623
- Acronym / sponsor ID
- IIT-2023-0135
- Conditions
- Urinary Incontinence,Stress
- Keywords
- Stress Urinary Incontinence, Steroid Hormone, Case-Control Study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,226 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 15 Nov 2023 (estimated)
- Primary completion
- 15 Nov 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 31 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SUI group | – | Other: observation, Other: sex hormoneFemale patients diagnosed with stress urinary incontinence in our hospital, who met the inclusion and exclusion criteria, and received six sex hormone tests. |
| control group | – | Other: observation, Other: sex hormonePatients with non-stress urinary incontinence |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients aged ≥20 years with stress urinary incontinence and patients without stress urinary incontinence. Both inclusion and exclusion criteria were met.
Key inclusion criteria (5 listed)
- Experimental Group
- women aged ≥20 years
- Stress urinary incontinence diagnosed in our hospital;
- Six hormone tests were performed in our hospital; Control group
- women aged ≥20 years; (2) diseases other than stress urinary incontinence diagnosed by our hospital; (2) Six hormone tests were performed in our hospital;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observationTo observe the changes and differences of steroid hormones between stress urinary incontinence group and control group. | Other | SUI group, control group |
| sex hormoneSix indicators of steroid hormones (estrogen, testosterone, follicle stimulating hormone, luteinizing hormone, pituitary prolactin, progesterone) | Other | SUI group, control group |
Primary outcome
Baseline characteristics
Time frame: 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
Time frame: 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.
1 secondary outcome
Sensitivity analysis or stratified analysis
Time frame: through study completion, an average of 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Individual participant dataSharing planned: Yes. We plan to share the primary results of the trial, including data on the primary and secondary end points, after completion. We will consider sharing raw data and samples collected in the trial to facilitate further research and validation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chun-Wu Pan, professor principal investigator
Renji Hospital, School of Medicine, Shanghai Jiao Tong University.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence,Stress, run by RenJi Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhang Jing-Yan (+8619117170882, windsor0525@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline characteristics (time frame: baseline, pre-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.