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RecruitingNCT06305494Updated Apr 25, 2024

Genitourinary Syndrome of Menopause in Thai Gynecologic Cancer Survivors

An observational study in Atrophic Vaginitis, Gynecologic Cancer and Lower Urinary Tract Symptoms, sponsored by Khon Kaen University. Recruiting at 1 site in Thailand. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-25.

Sponsored by Khon Kaen University · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 11 months ago, but the record still lists the study as recruiting.
  • Started Mar 2024; still recruiting 2 years 7 months later.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
425
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the detailed description

Gynecological cancers, encompassing ovarian, endometrial, and cervical cancers, stand as significant health concerns for women. In 2017, a total of 12,354 new cases were diagnosed in Thailand, underlining the prevalence and impact of these conditions. Advances in cancer screening and treatment have notably improved outcomes, resulting in a growing number of survivors. By 2016, the United States alone recorded 15.5 million cancer survivors, with projections indicating a surge to 26.1 million by 2040. However, even with increased survival rates, challenges persist for survivors, encompassing chronic pain, complications from treatment, and disruptions to fertility, menopause, sexual function, and cognitive health.

The treatment landscape for gynecological cancers is diverse, with the general principle for ovarian and endometrial cancers involving surgical staging. This comprehensive approach includes the removal of the uterus, fallopian tubes, both ovaries, peritoneum, pelvic lymph nodes, and any visible lesions. For cervical cancer, treatment varies based on disease stage. Early-stage cases often undergo surgery, potentially followed by pelvic irradiation. In advanced-stage cervical cancer, a combination of pelvic radiation and chemotherapy is commonly employed. In summary, many gynecological cancer treatments involve the removal of both ovaries or pelvic irradiation, inducing menopause in reproductive-age women.

The female lower reproductive system, including the lower urinary tract, is intricately responsive to estrogenic stimulation. When estrogen is lacking, structural changes occur, giving rise to a cluster of symptoms collectively termed the genitourinary syndrome of menopause (GSM). Estrogen deficiency results in thinning of the vaginal epithelium lining, diminished collagen and elastin fibers, reduced blood supply, and moisture decline. These changes manifest as vaginal symptoms, including burning, itching, and pain during intercourse.

Similarly, the urinary tract, deprived of estrogenic stimulation, undergoes alterations such as urethral shortening, thinning of the urethral epithelium, weakened urethral sphincter contractions, and reduced elasticity of the urinary bladder. This cascade of changes results in lower urinary tract symptoms, comprising dysuria, urinary urgency, incontinence, frequency, nocturia, and recurrent urinary tract infections.

Postmenopausal women commonly experience these symptoms, and systematic literature reviews reveal a prevalence ranging from 13 to 87%. Furthermore, the chronic nature of these symptoms tends to intensify over time. Women who undergo early bilateral oophorectomy are more likely to enter menopause sooner, increasing the risk of developing various urogenital symptoms at a younger age.

The impact of these symptoms on women's lives is profound, affecting daily activities, self-confidence, and intimate relationships. Vaginal symptoms, in particular, can lead to sexual dysfunction, exacerbating challenges in family relationships. Concurrently, urinary symptoms contribute to decreased quality of life, with frequency, nocturia, and urgency correlating with the risk of falls and bone fractures. Additionally, these symptoms are associated with depressed mood, anxiety, and embarrassment, further disrupting aspects of life such as sleep, daily commute, social interactions, and sexual relationships.

Despite the significant impact on quality of life, the effective management of vaginal and genitourinary symptoms is impeded by various factors. These include a lack of knowledge and understanding of the diseases and available treatment options, feelings of embarrassment, and the notable observation that medical personnel often fail to inquire about these specific issues during patient consultations.

The primary treatment for genitourinary symptoms is typically the use of vaginal estrogen. However, certain gynecological cancers, such as leiomyosarcoma, endometrial stromal sarcoma, and specific ovarian cancers, preclude the use of estrogen therapy. In such cases, non-hormonal alternatives like vaginal lubricants, moisturizers, and energy-based devices come into consideration.

This study aim to explore the prevalence of GSM among gynecological cancer survivors. The investigation extends to understanding the magnitude of the problem, examining women's attitudes towards the condition, and assessing its broader impact on their quality of life. This comprehensive exploration seeks to contribute valuable insights to the understanding and management of the complex challenges faced by gynecological cancer survivors.

02

Conditions studied

  • Atrophic Vaginitis
  • Gynecologic Cancer
  • Lower Urinary Tract Symptoms

Keywords

  • Genitourinary syndrome of menopause
  • Gynecologic cancer
03

In context

Atrophic Vaginitis

45 studies on the registry are indexed under Atrophic Vaginitis; 7 are open to participants now.

Browse Atrophic Vaginitis studies →

Lead sponsor

Khon Kaen University is the lead sponsor of 161 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Participant not entering menopause after cancer treatment.
  • Participant with cancer progression.
  • Participant currently suffer from severe pain, fatigue, or discomfort.
  • Participant deny to participate.
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
425 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Prevalence of genitourinary syndrome of menopause

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

    Time frame: Baseline

Secondary outcomes

  1. Severity of genitourinary syndrome of menopause

    Severity of genitourinary syndrome of menopause measured using visual analog scale (range 0-10; 0 is the least severe, 10 is the most severe)

    Time frame: Baseline

  2. Quality of life of gynecologic cancer survivor

    Quality of life score measured using a visual analog scale (range 0-10; 0 is the least negative effect on quality of life, 10 is the most negative effect on quality of life)

    Time frame: Baseline

  3. Attitude toward genitourinary syndrome of menopause in gynecologic cancer survivor

    Assessment of attitude toward genitourinary syndrome of menopause by asking whether participant agreed with the statement or not (yes or no)

    Time frame: Baseline

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06305494
Responsible party
Apiwat Jongjakapun (Principal Investigator, Khon Kaen University) — Principal investigator
First posted
Mar 12, 2024
Start date
Mar 14, 2024
Primary completion
Dec 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
Apr 25, 2024

Study contacts

Apiwat Jongjakapun, MD
Contact
apiwjo@kku.ac.th
+66642546560
Teerayut Temtanakitpaisan, MD
Contact
teerte@kku.ac.th
Apiwat Jongjakapun, MD
principal investigator · Khon Kaen University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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