Physiotherapy Treatment in Women With Dyspareunia Following Gynecological Cancer: a Pilot Study

Study Overview
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Brief Summary
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Gynecological cancers represent more than half of female cancers. It has been clearly established that cancer survivors suffer from important health issues such as pain during sexual intercourse (dyspareunia) and sexual dysfunctions which sorely impact their quality of life. Although it affects more than 63% of cancer survivors, the available treatments remain limited and poorly studied. Cancer survivors are thus confronted with these health issues as well as relationship difficulties and psychological consequences, with limited treatment avenues. Addressing pelvic floor muscle dysfunctions and loss of vaginal elasticity, pelvic floor physiotherapy was shown to be effective in reducing or even alleviating dyspareunia and improving sexual function. Until now, no study investigated this treatment in gynecological cancer survivors with dyspareunia. Therefore, there is a need to examine pelvic floor physiotherapy to determine whether or not gynecological cancer survivors with dyspareunia could benefit from this treatment. The objectives of this single-arm mixed-method study are to evaluate the acceptability and feasibility of a physiotherapy treatment in gynecological cancer survivors suffering from dyspareunia and to explore treatment effects. This single-arm study using mixed methods will involve three data collections (pre- and post-treatment assessments). These assessments will be carried out by physiotherapists. Participants will receive physiotherapy treatment weekly in individual 60-minute sessions for 12 weeks. Thirty-one gynecological cancer survivors with vulvovaginal pain during sexual intercourse for at least 3 months will be recruited. The results of this study will bring new information regarding physiotherapy treatment for this population in preparation for a definitive randomized controlled trial.

Official Title
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Physiotherapy Treatment in Gynecological Cancer Survivors Suffering From Dyspareunia: a Mixed-Method Pilot Study

Conditions
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Gynecological Cancer, Dyspareunia

Intervention / Treatment
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* Other: Physiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of gynecological cancer (endometrial, cervical, vaginal or other parts of the uterus) Scheduled oncological treatments completed with no signs of cancer for at least 3 months Vulvovaginal pain during sexual intercourse for at least 3 months Exclusion Criteria: Vulvovaginal pain before cancer and not related to sexual intercourse Medication recognized to affect pain Refuse to stop other treatments until post-treatment assessment Other conditions interfering with assessment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Pre-treatment assessment - Intervention (12 weeks) - Post-treatment assessment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physiotherapy<br>12 weekly 60-minute individual sessions of multimodal physiotherapy including education, stretching techniques, pelvic floor muscle biofeedback as well as home exercises. | Other: Physiotherapy<br> <br> * Other names: Pelvic floor rehabilitation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence rates | To determine acceptability. | Pre- to 2-week post-treatment assessment | 
| Retention rate | To determine feasibility. | Pre- to 2-week post-treatment assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in pain | To explore changes in pain during sexual intercourse (Numerical Rating Scale, ranging from 0 to 10, where 0 is no pain at all, and 10 is the worst pain ever). | Pre- to 2-week post-treatment assessment | 
| Change from baseline in sexual function | To explore changes in sexual function (Female Sexual Function Index). | Pre- to 2-week post-treatment assessment | 
| Change from baseline in pelvic floor muscle function | To explore changes in pelvic floor muscle function at rest and during contraction (dynamometry and ultrasound). | Pre- to 2-week post-treatment assessment | 
| Change from baseline in quality of life | To explore changes in quality of life (questionnaire). | Pre- to 2-week post-treatment assessment | 
| Patient's global impression of change | To determine patient self-reported improvement (Patient's Global Impression of Change). | 2-week post-treatment assessment | 
| Adverse events | To document any adverse events. | Pre- to 2-week post-treatment assessment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pilot study, Feasibility study, Dyspareunia, Gynecological cancer survivors, Physiotherapy