HRT on Overactive Bladder Symptoms, Sexual Function, Depressive Symptoms, Autonomic Function, and Arterial Stiffness

Study Overview
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Brief Summary
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Therefore, the aim of this study is to assess the therapeutic effect on overactive bladder symptoms, sexual function, heart rate variability, arterial stiffness, atherosclerosis, sleep, and depression between tibolone and E2V/MPA. From the results, the investigators will compare the effect of tibolone versus E2V/MPA on overactive bladder symptoms, sexual function, autonomic function, arterial stiffness, atherosclerosis, sleep and depression.

Detailed Description
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Menopausal syndromes include overactive bladder symptom, autonomic symptoms, and even sexual dysfunction. Hormone therapy (HT) is widely used for controlling menopausal symptoms. Common HT for menopausal syndrome with intact uterus includes tibolone, estradiol valerate (E2V) 1mg & medroxyprogesterone acetate (MPA), and conjugated equine estrogens (CEE) & MPA. However, only a few literatures mentioned about the therapeutic effect of tibolone, but lack of comparison research about their therapeutic effect on overactive bladder symptoms, sexual function, heart rate variability, arterial stiffness, atherosclerosis, sleep and depression. The knowledge of the above therapeutic effects should be important for choosing a suitable medication. Therefore, the aim of this study is to assess the therapeutic effect on overactive bladder symptoms, sexual function, heart rate variability and arterial stiffness between tibolone and E2V/MPA. All female patients with intact uterus who underwent treatment for menopausal syndrome at Far Eastern Memorial Hospital from October 2021 will be included. An open-labeled, prospective, comparative study design will be used. HT included tibolone (2.5 mg/day) or E2V (1mg) & MPA (2.5 mg) per day. The enrolled women will be requested to complete the Greene climacteric scale, Urgency Severity Scale, Overactive Bladder Symptom Score, the International Prostate Symptom Score (IPSS), the Female Sexual Function Index (FSFI), the Pittsburgh Sleep Quality Index, Center for Epidemiological Studies Depression questionnaire, heart rate variability, arterial stiffness and atherosclerosis examinations at baseline, and 4 weeks (visit 2) and 12 weeks (visit 3) after treatment. From the results, the investigators will compare the effect of tibolone versus E2V/MPA on overactive bladder symptoms, sexual function, autonomic function, arterial stiffness, atherosclerosis, sleep and depression. Currently, there is no similar research as our current study.

Official Title
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The Impact of Different Hormone Therapy Regimens on Overactive Bladder Symptoms, Sexual Function, Depressive Symptoms, Autonomic Function, and Arterial Stiffness

Conditions
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Menopausal Syndrome

Intervention / Treatment
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* Drug: Tibolone 2.5 mg
* Drug: Estradiol valerate 1 mg/medroxyprogesterone acetate 2.5 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >20 years old female Menopausal symptoms, still have a uterus, and no breast or other cancers, and no vascular-blocking disease such as stroke. Exclusion Criteria: Nil.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tibolone<br>Tibolone 2.5 mg per day | Drug: Tibolone 2.5 mg<br>* Tibolone 2.5 mg per day<br>* Other names: Livial;|
| Indivina<br>Estradiol valerate (E2V) 1mg & medroxyprogesterone acetate 2.5 mg (MPA) per day | Drug: Estradiol valerate 1 mg/medroxyprogesterone acetate 2.5 mg<br>* Estradiol valerate 1 mg/medroxyprogesterone acetate 2.5 mg per day<br>* Other names: Indivina;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overactive bladder symptoms | Compare the effect of tibolone versus E2V/MPA on the total score of Overactive Bladder symptoms Score Total scores:0-15, the minimum values and whether lowest scores mean a better outcome | 3 months | 
| Sexual function index | Compare the effect of tibolone versus E2V/MPA on total score of the Female Sexual Function Index Total scores:4-95, the maximum values and whether higher scores mean a better outcome. | 3 months | 
| Autonomic function | Compare the effect of tibolone versus E2V/MPA on heart rate variability parameters | 3 months | 
| Arterial stiffness | Compare the effect of tibolone versus E2V/MPA on cardio-ankle vascular index | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atherosclerosis | Compare the effect of tibolone versus E2V/MPA on ankle-brachial pressure index | 3 months |