Clinical trial NCT05280028: HRT on Overactive Bladder Symptoms, Sexual Function, Depressive Symptoms, Autonomic Function, and Arterial Stiffness
Official title: The Impact of Different Hormone Therapy Regimens on Overactive Bladder Symptoms, Sexual Function, Depressive Symptoms, Autonomic Function, and Arterial Stiffness
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Menopausal Syndrome
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2022-03-15
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with menopausal symptoms

Brief summary: 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.

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.

Primary outcomes:
measure: Overactive bladder symptoms
timeFrame: 3 months
measure: Sexual function index
timeFrame: 3 months
measure: Autonomic function
timeFrame: 3 months
measure: Arterial stiffness
timeFrame: 3 months
Secondary outcomes:
measure: Atherosclerosis
timeFrame: 3 months
Other outcomes:
Locations:
city: Banqiao
country: Taiwan
facility: Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital
state: New Taipei
Study officials:
affiliation: Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital
name: Sheng-Mou Hsiao, MD
role: PRINCIPAL_INVESTIGATOR
References: