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

Recruiting

• Conditions: Menopausal Syndrome
• Interventions: Drug: Tibolone 2.5 mg; Drug: Estradiol valerate 1 mg/medroxyprogesterone acetate 2.5 mg

• Registration Number: NCT05280028
• Lead Sponsor: Far Eastern Memorial Hospital

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.

Study Timeline

• Study Start: 2022-02-07
• Study First Submitted: 2022-02-23
• Study First Submitted QC: 2022-03-04
• Study First Posted: 2022-03-15
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-13
• Last Update Posted: 2024-06-17
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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.

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Exclusion Criteria

• Nil.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tibolone	Tibolone 2.5 mg	Tibolone 2.5 mg per day
Indivina	Estradiol valerate 1 mg/medroxyprogesterone acetate 2.5 mg	Estradiol valerate (E2V) 1mg \& medroxyprogesterone acetate 2.5 mg (MPA) per day

Primary Outcome Measures

Name	Time	Method
Autonomic function	3 months	Compare the effect of tibolone versus E2V/MPA on heart rate variability parameters
Arterial stiffness	3 months	Compare the effect of tibolone versus E2V/MPA on cardio-ankle vascular index
Sexual function index	3 months	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.
Overactive bladder symptoms	3 months	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

Secondary Outcome Measures

Name	Time	Method
Atherosclerosis	3 months	Compare the effect of tibolone versus E2V/MPA on ankle-brachial pressure index

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital; 🇨🇳 Banqiao, New Taipei, Taiwan