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

Far Eastern Memorial Hospital

Status: Enrolling

Conditions: Menopausal Syndrome

Treatments: Drug: Estradiol valerate 1 mg/medroxyprogesterone acetate 2.5 mg; Drug: Tibolone 2.5 mg

Study type: Observational

Funder types: Other

Identifiers

NCT05280028

110262-F

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 2 patient groups

Tibolone

Description:

Tibolone 2.5 mg per day

Treatment:

Drug: Tibolone 2.5 mg

Indivina

Description:

Estradiol valerate (E2V) 1mg \& medroxyprogesterone acetate 2.5 mg (MPA) per day

Treatment:

Drug: Estradiol valerate 1 mg/medroxyprogesterone acetate 2.5 mg