Evaluation of the effectiveness of a combined protocol with pelvic floor muscle retraining, use of relaxation techniques, and vaginal dilators to improve health and quality of life in women with sexual dysfunction after treatment for breast cancer

Not Applicable

• Conditions: Genitourinary Syndrome of Menopause and symptoms of vaginal dryness and sexual dysfunction in women survivors after breast cancer; Urological and Genital Diseases

• Registration Number: ISRCTN99894276
• Lead Sponsor: niversity of West Attica

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-15
• Last Update Posted: 29 July 2024
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

Women aged 35-65 years with :
1. Pain during and/or after vaginal intercourse, greater than 7/10, based on the Visual Analogue Pain Scale (VAS).
2. Also, women who have undergone immunosuppressive chemotherapy, received or are receiving adjuvant hormone therapy with tamoxifen (TAM), or aromatase inhibitors (AIs) and report symptoms of vaginal dryness and dyspareunia will also be included.
3. Willing to be assigned to the study

Exclusion Criteria

1. Metastatic breast cancer
2. Vaginal or intravaginal stenosis
3. Pelvic surgery
4. Allergy to lubricating oils and moisturizers
5. Women using hormone replacement therapy (HRT)
6. Women who are on long-term use of birth control pills
7. Women who are on some type of drug intervention for dyspareunia
8. Diabetes
9. Hypertension
10. Obesity
11. Hypothyroidism
12. Urogynaecological infections
13. Psychiatric conditions
14. Vascular conditions
15. In addition after enrollment, patients who present with difficulty understanding how to coordinate their pelvic floor muscles

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measured at the initial visit and at the end of the study protocol:<br>1. Sexual function will be measured using the Female Sexual Function Index (FSFI-Gr), <br>2. The effects of vaginal symptoms, associated sexual matters and impact on quality of life (QoL) will be measured with the subscale of the International Consultation on Incontinence Questionaire vaginal Symptoms Module in Greek (ICIQ-VS-GR)<br>3. Pain assessment will be recorded with the Visual Analog Pain Scale (VAS).<br>4. Baseline muscle tone at rest will be assessed with the method of manometry at initial visit and at the end of the study protocol.

Secondary Outcome Measures

Name	Time	Method
There are no secondary outcome measures