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
| ISRCTN | ISRCTN99894276 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99894276 |
- Submission date
- 27/03/2022
- Registration date
- 15/06/2022
- Last edited
- 16/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Urological and Genital Diseases
Plain English Summary
Background and study aims
The most common symptoms of the genitourinary syndrome of menopause (GSM) that lead women who have had breast cancer (BC) to seek treatment are vaginal dryness and dyspareunia (painful intercourse).
Pelvic floor physical therapy (PFMT) is recommended by the International Continence Society (ICS) as a first-line treatment for the management of GSM symptoms. However, despite its promising results, PFMT is not well known and widespread among patients or health professionals and as a result, it is not recommended and not widely used. The aim of this randomized clinical control study is to evaluate the effectiveness of combined physiotherapy intervention in female patients after treatment for breast cancer with GSM symptoms, such as vaginal dryness and dyspareunia. The main hypothesis of the study is that the combined implementation of a programme of physical therapy (PT) and use of vaginal dilators improves symptoms of sexual dysfunction as well as quality of life (QoL). In particular, vaginal dryness, dyspareunia and pelvic pain will be assessed and the effects on quality of life will be investigated.
Who can participate?
Eligible for the study will be BC survivors who will be in a sexually active relationship aged 35-65 with vaginal dryness and dyspareunia. In addition, amenorrheaic women for at least 6 months (if pre-menopausal at diagnosis) those taking aromatase inhibitors (AI), (if postmenopausal at diagnosis), or had undergone adjuvant chemotherapy and report symptoms of vaginal dryness and dyspareunia will be included in the study.
What does the study involve?
Participants will be randomly allocated to two groups. Group A (intervention group) will follow the combined physiotherapy treatment protocol including retraining of the pelvic floor muscles, use of relaxation techniques and vaginal dilators. Group B (control group) will follow a "usual treatment" protocol with the application of specific lubricating and moisturizing applications and counseling. Thereafter, the progress of the two groups will be monitored and recorded. Then the results of the two groups will be recorded and correlated.
What are the possible benefits and risks of participating?
There are no risks at participating in the study protocol. Benefits of participating in the study is the alleviation of symptoms of GSM for women survivors from BC who undergo hormonal therapy, hence improving the health and quality of their life (HRQL).
Where is the study run from?
University of West Attica (Greece)
When is the study starting and how long is it expected to run for?
September 2021 to December 2025
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Mimi Marcellou, mimimarcellou@gmail.com
Contact information
Scientific
1 Pefkon Street
3 Rd Floor
Athens
14235
Greece
| Phone | +30 6944831219 |
|---|---|
| efmarsellou@uniwa.gr |
Study information
| Study design | Single-centre randomized single-blind controlled cross-over study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | 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 |
| Study hypothesis | Pelvic floor physiotherapy may contribute effectively in the management of Genitourinary Syndrome of Menopause (GSM) and symptoms of sexual dysfunction, such as vaginal dryness and dyspareunia, therefore improving the quality of life of women breast cancer survivors. |
| Ethics approval(s) | Approved 15/11/2021, Aretaiio Hospital (ΕΚΠΑ/Medical School) Research Ethics Committee (76 Vassilissis Sofias street, 11528 Athens, Greece; +30 210 728 6128; bxeir@aretaieio.uoa.gr), ref: #380 |
| Condition | Genitourinary Syndrome of Menopause and symptoms of vaginal dryness and sexual dysfunction in women survivors after breast cancer |
| Intervention | 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 require drug intervention to exclude any other cause of vaginal dryness and dyspareunia. For the purpose of the study, validated questionnaires will be administered in the Greek language. The intervention will include, conducting a digital evaluation and recording of muscle tone of the pelvic floor (PF) at rest, by manometry. Then, a randomized separation of patients into two groups will be performed: In Group A (intervention group), the therapeutic protocol will be implemented with manual relaxation techniques, pelvic floor muscle retraining (PTMT) and use of vaginal dilators. The therapeutic intervention programme for Group A will be completed in 12 weeks with one session per week. In Group B (control group), standard treatment practice with vaginal lubrication and moisturizing products and counseling assistance will be implemented. Participants in Group B, will attend a next scheduled session at week 12 for necessary new measurement recordings and data updating. After the completion of the therapeutic interventions, a final pelvic floor physical therapy re-evaluation will follow with measurement and recording of all parameters and variables (outcomes) under study, data will be collected and possible differences between the two groups will be investigated. |
| Intervention type | Mixed |
| Primary outcome measure | 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 outcome measures | There are no secondary outcome measures |
| Overall study start date | 21/09/2021 |
| Overall study end date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 35 Years |
| Upper age limit | 65 Years |
| Sex | Female |
| Target number of participants | Total target number: 60 participants. (Each of the two study groups will include 30 participants) |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 01/06/2022 |
| Recruitment end date | 31/12/2024 |
Locations
Countries of recruitment
- Greece
Study participating centre
Physiotherapy Department
School of Health and Caring Sciences
28 Ag. Spyridonos Street
Egaleo – Attica
12243
Greece
Sponsor information
University/education
Laboratory of Neuromuscular and Cardiovascular Study of Motion (LANECASM) Physiotherapy Department School of Health and Caring Sciences
28 Ag. Spyridonos Street
Egaleo – Attica
12243
Greece
| Phone | +30 (0) 210 5385228 |
|---|---|
| gpapa@uniwa.gr | |
| Website | https://lanecasm.uniwa.gr |
"ROR" |
https://ror.org/00r2r5k05 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 21/09/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | Individual participant data collected during the trial will be available after de-identification (text, tables, figures, and appendices), beginning 9 months and ending 36 months following article publication. Access will be granted to researchers who provide a methodologically sound proposal, in order for them to achieve aims in the approved proposal. Proposals should be directed to Ms. Mimi Marcellou (mimimarcellou@gmail.com). To gain access, data requestors will need to sign a data access agreement. After 36 months the data will not be applicable. During recruitment, patients are informed of the purposes of our study. Upon acceptance, and prior to baseline measurements, participants give their written informed consent (document in Greek). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other files | Cross-sectional study poster | 16/07/2024 | No | No |
Additional files
- ISRCTN99894276_Poster.pdf
- Cross-sectional study poster
Editorial Notes
16/07/2024: The following changes were made to the study record:
1. Poster uploaded.
2. The recruitment end date was changed from 01/09/2024 to 31/12/2024.
3. The overall study end date was changed from 31/05/2024 to 31/12/2025.
4. The intention to publish date was changed from 21/09/2025 to 21/09/2026.
26/08/2022: The sponsor email was updated.
14/06/2022: Trial's existence confirmed by Aretaiio Hospital (ΕΚΠΑ/Medical School) Research Ethics Committee
