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

January 26, 2022 updated by: Mélanie Morin, Université de Sherbrooke

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Centre de recherche du Centre hospitalier Universitaire de Sherbrooke

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Physiotherapy
12 weekly 60-minute individual sessions of multimodal physiotherapy including education, stretching techniques, pelvic floor muscle biofeedback as well as home exercises.
Other: Physiotherapy
Other Names:
  • Pelvic floor rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence rates
Time Frame: Pre- to 2-week post-treatment assessment
To determine acceptability.
Pre- to 2-week post-treatment assessment
Retention rate
Time Frame: Pre- to 2-week post-treatment assessment
To determine feasibility.
Pre- to 2-week post-treatment assessment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in pain
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).
Pre- to 2-week post-treatment assessment
Change from baseline in sexual function
Time Frame: Pre- to 2-week post-treatment assessment
To explore changes in sexual function (Female Sexual Function Index).
Pre- to 2-week post-treatment assessment
Change from baseline in pelvic floor muscle function
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).
Pre- to 2-week post-treatment assessment
Change from baseline in quality of life
Time Frame: Pre- to 2-week post-treatment assessment
To explore changes in quality of life (questionnaire).
Pre- to 2-week post-treatment assessment
Patient's global impression of change
Time Frame: 2-week post-treatment assessment
To determine patient self-reported improvement (Patient's Global Impression of Change).
2-week post-treatment assessment
Adverse events
Time Frame: Pre- to 2-week post-treatment assessment
To document any adverse events.
Pre- to 2-week post-treatment assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Sherbrooke

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 8, 2016

Primary Completion (ACTUAL)

December 31, 2020

Study Completion (ACTUAL)

January 25, 2022

Study Registration Dates

First Submitted

April 10, 2019

First Submitted That Met QC Criteria

April 30, 2019

First Posted (ACTUAL)

May 2, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 27, 2022

Last Update Submitted That Met QC Criteria

January 26, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP-31-2016-1322

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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