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

Primary Purpose

Gynecological Cancer, Dyspareunia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Physiotherapy
Sponsored by
Université de Sherbrooke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gynecological Cancer focused on measuring Pilot study, Feasibility study, Dyspareunia, Gynecological cancer survivors, Physiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Physiotherapy

Arm Description

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

Outcomes

Primary Outcome Measures

Adherence rates
To determine acceptability.
Retention rate
To determine feasibility.

Secondary Outcome Measures

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

Full Information

First Posted
April 10, 2019
Last Updated
January 26, 2022
Sponsor
Université de Sherbrooke
Collaborators
Centre de recherche du Centre hospitalier universitaire de Sherbrooke, Institut Universitaire de Gériatrie de Montréal, Jewish General Hospital, Centre hospitalier de l'Université de Montréal (CHUM)
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1. Study Identification

Unique Protocol Identification Number
NCT03935698
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
September 8, 2016 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
January 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Sherbrooke
Collaborators
Centre de recherche du Centre hospitalier universitaire de Sherbrooke, Institut Universitaire de Gériatrie de Montréal, Jewish General Hospital, Centre hospitalier de l'Université de Montréal (CHUM)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gynecological Cancer, Dyspareunia
Keywords
Pilot study, Feasibility study, Dyspareunia, Gynecological cancer survivors, Physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pre-treatment assessment - Intervention (12 weeks) - Post-treatment assessment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physiotherapy
Arm Type
Experimental
Arm Description
12 weekly 60-minute individual sessions of multimodal physiotherapy including education, stretching techniques, pelvic floor muscle biofeedback as well as home exercises.
Intervention Type
Other
Intervention Name(s)
Physiotherapy
Other Intervention Name(s)
Pelvic floor rehabilitation
Primary Outcome Measure Information:
Title
Adherence rates
Description
To determine acceptability.
Time Frame
Pre- to 2-week post-treatment assessment
Title
Retention rate
Description
To determine feasibility.
Time Frame
Pre- to 2-week post-treatment assessment
Secondary Outcome Measure Information:
Title
Change from baseline in pain
Description
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
Title
Change from baseline in sexual function
Description
To explore changes in sexual function (Female Sexual Function Index).
Time Frame
Pre- to 2-week post-treatment assessment
Title
Change from baseline in pelvic floor muscle function
Description
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
Title
Change from baseline in quality of life
Description
To explore changes in quality of life (questionnaire).
Time Frame
Pre- to 2-week post-treatment assessment
Title
Patient's global impression of change
Description
To determine patient self-reported improvement (Patient's Global Impression of Change).
Time Frame
2-week post-treatment assessment
Title
Adverse events
Description
To document any adverse events.
Time Frame
Pre- to 2-week post-treatment assessment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35093737
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.
Results Reference
derived

Learn more about this trial

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

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