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

Not Applicable

Completed

• Conditions: Gynecological Cancer; Dyspareunia
• Interventions: Other: Physiotherapy

• Registration Number: NCT03935698
• Lead Sponsor: Université de Sherbrooke

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-08
• Study First Submitted: 2019-04-10
• Study First Submitted QC: 2019-04-30
• Study First Posted: 2019-05-02
• Primary Completion: 2020-12-31
• Status Verified: 2022-01
• Study Completion: 2022-01-25
• Last Update Submitted: 2022-01-26
• Last Update Posted: 2022-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Physiotherapy	Physiotherapy	12 weekly 60-minute individual sessions of multimodal physiotherapy including education, stretching techniques, pelvic floor muscle biofeedback as well as home exercises.

Primary Outcome Measures

Name	Time	Method
Retention rate	Pre- to 2-week post-treatment assessment	To determine feasibility.
Adherence rates	Pre- to 2-week post-treatment assessment	To determine acceptability.

Secondary Outcome Measures

Name	Time	Method
Patient's global impression of change	2-week post-treatment assessment	To determine patient self-reported improvement (Patient's Global Impression of Change).
Change from baseline in sexual function	Pre- to 2-week post-treatment assessment	To explore changes in sexual function (Female Sexual Function Index).
Change from baseline in pain	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).
Change from baseline in pelvic floor muscle function	Pre- to 2-week post-treatment assessment	To explore changes in pelvic floor muscle function at rest and during contraction (dynamometry and ultrasound).
Change from baseline in quality of life	Pre- to 2-week post-treatment assessment	To explore changes in quality of life (questionnaire).
Adverse events	Pre- to 2-week post-treatment assessment	To document any adverse events.

Trial Locations

Locations (1)

Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada