Clinical trial NCT03935698: Physiotherapy Treatment in Women With Dyspareunia Following Gynecological Cancer: a Pilot Study
Official title: Physiotherapy Treatment in Gynecological Cancer Survivors Suffering From Dyspareunia: a Mixed-Method Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecological Cancer
Dyspareunia
Keywords: Pilot study
Feasibility study
Dyspareunia
Gynecological cancer survivors
Physiotherapy
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
name: Institut Universitaire de Gériatrie de Montréal
name: Jewish General Hospital
name: Centre hospitalier de l'Université de Montréal (CHUM)
First posted: 2019-05-02
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre-treatment assessment - Intervention (12 weeks) - Post-treatment assessment
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Adherence rates
timeFrame: Pre- to 2-week post-treatment assessment
measure: Retention rate
timeFrame: Pre- to 2-week post-treatment assessment
Secondary outcomes:
measure: Change from baseline in pain
timeFrame: Pre- to 2-week post-treatment assessment
measure: Change from baseline in sexual function
timeFrame: Pre- to 2-week post-treatment assessment
measure: Change from baseline in pelvic floor muscle function
timeFrame: Pre- to 2-week post-treatment assessment
measure: Change from baseline in quality of life
timeFrame: Pre- to 2-week post-treatment assessment
measure: Patient's global impression of change
timeFrame: 2-week post-treatment assessment
measure: Adverse events
timeFrame: Pre- to 2-week post-treatment assessment
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
Study officials:
References:
citation: Cyr MP, Dumoulin C, Bessette P, Pina A, Gotlieb WH, Lapointe-Milot K, Mayrand MH, Morin M. Changes in pelvic floor morphometry and muscle function after multimodal physiotherapy for gynaecological cancer survivors suffering from dyspareunia: a prospective interventional study. Physiotherapy. 2022 Mar;114:54-62. doi: 10.1016/j.physio.2021.09.003. Epub 2021 Sep 30.