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

Dyspareunia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03935698
• Other study ID #: MP-31-2016-1322
• Status: Completed
• Phase: N/A
• Start date: September 8, 2016
• Est. completion date: January 25, 2022

Study information

• Verified date: January 2022
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: January 25, 2022
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyspareunia
• Gynecological Cancer

Intervention

Other:
• Physiotherapy

Locations

Country	Name	City	State
Canada	Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec

Sponsors (5)

Lead Sponsor	Collaborator
Université de Sherbrooke	Centre de recherche du Centre hospitalier universitaire de Sherbrooke, Centre hospitalier de l'Université de Montréal (CHUM), Institut Universitaire de Gériatrie de Montréal, Jewish General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence rates	To determine acceptability.	Pre- to 2-week post-treatment assessment
Primary	Retention rate	To determine feasibility.	Pre- to 2-week post-treatment assessment
Secondary	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
Secondary	Change from baseline in sexual function	To explore changes in sexual function (Female Sexual Function Index).	Pre- to 2-week post-treatment assessment
Secondary	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
Secondary	Change from baseline in quality of life	To explore changes in quality of life (questionnaire).	Pre- to 2-week post-treatment assessment
Secondary	Patient's global impression of change	To determine patient self-reported improvement (Patient's Global Impression of Change).	2-week post-treatment assessment
Secondary	Adverse events	To document any adverse events.	Pre- to 2-week post-treatment assessment