HRT on Overactive Bladder Symptoms, Sexual Function, Depressive Symptoms, Autonomic Function, and Arterial Stiffness
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tibolone 2.5 mg, Estradiol valerate 1 mg/medroxyprogesterone acetate 2.5 mg.
- Who it may be relevant to
- Registry conditions: Menopausal Syndrome. Basic parameters: from 20 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Impact of Different Hormone Therapy Regimens on Overactive Bladder Symptoms, Sexual Function, Depressive Symptoms, Autonomic Function, and Arterial Stiffness
Overview
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
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.
Interventions
- Drug Tibolone 2.5 mg
Tibolone 2.5 mg per day - Drug Estradiol valerate 1 mg/medroxyprogesterone acetate 2.5 mg
Estradiol valerate 1 mg/medroxyprogesterone acetate 2.5 mg per day
Primary outcome measures
- Overactive bladder symptoms [Time frame: 3 months]
- Sexual function index [Time frame: 3 months]
- Autonomic function [Time frame: 3 months]
- Arterial stiffness [Time frame: 3 months]
Secondary outcome measures (1)
- Atherosclerosis [Time frame: 3 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Taiwan · 1 center
- Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital — Banqiao District
Identifiers
NCT: NCT05280028 · 110262-F