Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4, Canada
NCT Number: NCT03935698
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.
Looking for future studies?
Notify Me18 year and older
Female
Interventional
Not applicable
Sherbrooke, Quebec, J1H 5N4, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: Pelvic floor rehabilitation
Time frame: Pre- to 2-week post-treatment assessment
To determine acceptability.
Time frame: Pre- to 2-week post-treatment assessment
To determine feasibility.
Time frame: Pre- to 2-week post-treatment assessment
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
To explore changes in sexual function (Female Sexual Function Index).
Time frame: Pre- to 2-week post-treatment assessment
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
To explore changes in quality of life (questionnaire).
Time frame: 2-week post-treatment assessment
To determine patient self-reported improvement (Patient's Global Impression of Change).
Time frame: Pre- to 2-week post-treatment assessment
To document any adverse events.
Université de Sherbrooke
Other
Physiotherapy Treatment in Gynecological Cancer Survivors Suffering From Dyspareunia: a Mixed-Method Pilot Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07701252
Behavior, Digital Health Literacy
Al Mansurah, Dakahlia Governorate, Egypt
View Trial DetailsNCT06574256
Gynecological Cancer
Manisa, Turkey (Türkiye)
View Trial DetailsNCT04694508
General Anesthesia, Gynecological Cancer
Barcelona, Spain
View Trial DetailsNCT03553784
Gynecological Cancer, Neoplasms
Chester, Cheshire, United Kingdom
View Trial Details