Perimenopause and Menopause in Women With Spinal Cord Injury

Experiences of the Perimenopause and Menopause in Women With Spinal Cord Injury

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Menopause; Spinal Cord Injury
• Intervention / Treatment: Behavioral: Questionnaire

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Sucheta Iyengar, BM; Phone Number: 01296 831378; Email: bht.research@nhs.net
• Study Contact Backup: Name: James Cooper, BSc, MSc; Phone Number: 07816020305; Email: james.cooper9@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

women will be used to denote all people who can or have undergone the perimenopause and menopause and have a clinical diagnosis of a spinal cord injury

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Women with Spinal Cord Injury; Women with Spinal Cord Injury who are currently going through or have gone through the Perimenopause/Menopause	Behavioral: Questionnaire; Questionnaire study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	1 time point

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To collect more information on establish how SCI affects the experience of the perimenopause and menopause	Patterns between level of injury and the perimenopause and menopause symptoms; Patterns between neurological level and the perimenopause and menopause symptoms	1 time point

Collaborators and Investigators

• Sponsor: James Cooper

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: November 26, 2024
• First Submitted That Met QC Criteria: November 26, 2024
• First Posted (Actual): November 29, 2024

Study Record Updates

• Last Update Posted (Actual): November 29, 2024
• Last Update Submitted That Met QC Criteria: November 26, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: RXQ 1192

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No