Perimenopause and Menopause in Women With Spinal Cord Injury

Not yet recruiting

• Conditions: Menopause; Spinal Cord Injury

• Registration Number: NCT06709664
• Lead Sponsor: James Cooper

Brief Summary

A lot of information is known about how the perimenopause and menopause affects able bodied women. However there is very little information about how these affects women with spinal cord injury. This questionnaire study aims to collect information from women with a spinal cord injury on their experiences of going through the perimenopause and/or the menopause.

Detailed Description

There is widespread knowledge and information about the perimenopause and menopause, its symptoms and treatment; all of this is for people without spinal cord injury (women will be used to denote all people who can or have undergone the perimenopause and menopause). There is paucity of data about this condition in women with spinal cord injury. These women are living longer lives and should be supported to live a healthy life.

Some studies have suggested that women with Spinal Cord Injury (wSCI) may undergo the perimenopause and menopause earlier than those without, however others have concluded that the age at the perimenopause and menopause is no different. wSCI may suffer less with vasomotor symptoms due to their ability to manage the symptoms of autonomic dysreflexia; however they may have more genito-urinary symptoms; also due to the need for self-catheterisation.

Hormone Replacement Therapy (HRT) has many benefits including reduction in risk of fractures by slowing down the development of osteoporosis, thereby reducing fracture risk and morbidity. Reduced mobility also puts them at an increased risk of cardio-vascular disease.

This study aims to gain information about these characteristics of the perimenopause and menopause in wSCI; the age at which they become menopausal and the most bothersome symptoms for them, treatment options offered to them as well as details of their spinal cord injury.

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-11-26
• Last Update Submitted: 2024-11-26
• Study First Posted: 2024-11-28
• Last Update Posted: 2024-11-28
• Study Start: 2025-01
• Primary Completion: 2025-08
• Study Completion: 2025-10

Recruitment & Eligibility

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

Inclusion Criteria

• • Patient is willing and able to give informed consent for participation in the study (or verbally confirm they wish to take part if someone completing on their behalf)

  • Who has undergone or currently experiencing the perimenopause or menopause
  • Aged 18 years old or older
  • Clinically diagnosed with a spinal cord Injury at least 3 months ago
  • Is either a) currently going through the perimenopause and menopause or b) has been through the perimenopause and menopause.

Exclusion Criteria

• • Individuals who have yet to go through the perimenopause and/or menopause

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To collect more information on determine signs, symptoms and severity of these signs and symptoms of the perimenopause and menopause in women with spinal cord injury	1 time point	* Information on menstrual cycle; * Frequency of autonomic dysreflexia; * Typical signs of autonomic dysreflexia; * Menopausal symptoms; * Treatment for menopausal symptoms; * Satisfaction of medication (for menopausal symptoms); * Satisfaction of support for the perimenopause and menopause

Secondary Outcome Measures

Name	Time	Method
To collect more information on establish how SCI affects the experience of the perimenopause and menopause	1 time point	* Patterns between level of injury and the perimenopause and menopause symptoms; * Patterns between neurological level and the perimenopause and menopause symptoms