Genitourinary Syndrome of Menopause in Thai Gynecologic Cancer Survivors

NCT06305494 | Recruiting

• 1 other identifier: HE671008
• Study Type: observational
• Target: 425
• Locations: 1 country
• Sites: 1

Brief Summary

Women often face common cancers like ovarian, uterine, and cervical cancers. Improvements in cancer detection and treatment mean more women survive. However, survivors can encounter challenges like ongoing pain, treatment complications, and fertility issues. Treating these cancers often involves surgeries that might include removing ovaries or using pelvic radiation. This can trigger menopause in younger women, causing problems like vaginal dryness, itching, and urinary issues. Women who've gone through menopause often deal with these symptoms, affecting their daily lives, confidence, and intimate relationships. Though treatments are available, lack of awareness, embarrassment, and not discussing these issues with doctors can make managing them difficult. The main treatment for these symptoms is using vaginal estrogen, but it might not be suitable for some cancer survivors. Non-hormonal options like lubricants and moisturizers are alternatives. This study in Thailand aiming to explore how common these issues are among gynecological cancer survivors, their feelings about it, and how it affects their quality of life.

Conditions

Atrophic Vaginitis; Gynecologic Cancer; Lower Urinary Tract Symptoms

Keywords

Genitourinary syndrome of menopause; Gynecologic cancer

Outcome Measures

Primary Outcomes (1)

• Prevalence of genitourinary syndrome of menopause

  Prevalence of genitourinary syndrome of menopause among gynecologic cancer survivor (percent)

  Baseline

Secondary Outcomes (3)

• Severity of genitourinary syndrome of menopause

  Baseline

• Quality of life of gynecologic cancer survivor

  Baseline

• Attitude toward genitourinary syndrome of menopause in gynecologic cancer survivor

  Baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Gynecologic cancer survivors, age more than 18 years old that came to the Gynecology Clinic at Khon Kaen University Hospital for routine cancer surveillance.

You may qualify if:

• Participant with gynecologic cancer (cancer of ovary, fallopian tube, uterus, cervix, vagina, and vulva.)
• Time passed more than 6 months since last cancer treatment.

You may not qualify if:

• Participant not entering menopause after cancer treatment.
• Participant with cancer progression.
• Participant currently suffer from severe pain, fatigue, or discomfort.
• Participant deny to participate.

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (1)

Faculty of Medicine, Khon Kaen University

Khon Kaen, 40002, Thailand

RECRUITING

MeSH Terms

Conditions

Atrophic Vaginitis; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Apiwat Jongjakapun, MD

  Khon Kaen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Apiwat Jongjakapun, MD

CONTACT

+66642546560; apiwjo@kku.ac.th

Teerayut Temtanakitpaisan, MD

CONTACT

teerte@kku.ac.th

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 3, 2024
• First Posted: March 12, 2024
• Study Start: March 14, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)