An interventional study of Physiotherapy in Gynecological Cancer and Dyspareunia, sponsored by Université de Sherbrooke. Completed at 1 site in Canada. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-27.
Sponsored by Université de Sherbrooke · Not applicable, Interventional, and Treatment
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.
114 studies on the registry are indexed under Dyspareunia; 32 are open to participants now.
This study's enrollment of 31 is below the median of 57 across 92 interventional studies indexed under Dyspareunia.
Browse Dyspareunia studies →Université de Sherbrooke is the lead sponsor of 296 studies on the registry; 67 are open to participants now.
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Exclusion Criteria:
12 weekly 60-minute individual sessions of multimodal physiotherapy including education, stretching techniques, pelvic floor muscle biofeedback as well as home exercises.
Other: Physiotherapy
Also known as: Pelvic floor rehabilitation
Adherence rates
To determine acceptability.
Time frame: Pre- to 2-week post-treatment assessment
Retention rate
To determine feasibility.
Time frame: Pre- to 2-week post-treatment assessment
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).
Time frame: Pre- to 2-week post-treatment assessment
Change from baseline in sexual function
To explore changes in sexual function (Female Sexual Function Index).
Time frame: 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).
Time frame: Pre- to 2-week post-treatment assessment
Change from baseline in quality of life
To explore changes in quality of life (questionnaire).
Time frame: 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).
Time frame: 2-week post-treatment assessment
Adverse events
To document any adverse events.
Time frame: Pre- to 2-week post-treatment assessment
Plan to share: No
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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