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

Exploring the level of efficacy of pelvic floor physiotherapy intervention for the treatment of Genitourinary Syndrome of Menopause (GSM) in women after the treatment of breast cancer

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN99894276

Enrollment

Registered

2022-06-15

Start date

2022-06-01

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Initially, the intervention will include a thorough medical examination, all relevant laboratory and diagnostic tests will be recorded, as well as pathological psychosocial factors and disorders that

Eligibility

Sex/Gender

Female

Age

35 Years to 65 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Measured at the initial visit and at the end of the study protocol: 1. Sexual function will be measured using the Female Sexual Function Index (FSFI-Gr), 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) 3. Pain assessment will be recorded with the Visual Analog Pain Scale (VAS). 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.	—

Measure

Time frame

Measured at the initial visit and at the end of the study protocol: 1. Sexual function will be measured using the Female Sexual Function Index (FSFI-Gr), 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) 3. Pain assessment will be recorded with the Visual Analog Pain Scale (VAS). 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

Measure	Time frame
There are no secondary outcome measures	—

Countries

Greece

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 11, 2026