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

NCT ID: NCT03935698

Last Updated: 2022-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-08

Study Completion Date

2022-01-25

Brief Summary

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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

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Conditions

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Gynecological Cancer Dyspareunia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Pre-treatment assessment - Intervention (12 weeks) - Post-treatment assessment
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Physiotherapy

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

Group Type EXPERIMENTAL

Physiotherapy

Intervention Type OTHER

Interventions

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Physiotherapy

Intervention Type OTHER

Other Intervention Names

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Pelvic floor rehabilitation

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre de recherche du Centre hospitalier universitaire de Sherbrooke

OTHER

Sponsor Role collaborator

Institut Universitaire de Gériatrie de Montréal

OTHER

Sponsor Role collaborator

Jewish General Hospital

OTHER

Sponsor Role collaborator

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role collaborator

Université de Sherbrooke

OTHER

Sponsor Role lead

Responsible Party

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Mélanie Morin

Researcher and Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 35093737 (View on PubMed)

Other Identifiers

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MP-31-2016-1322

Identifier Type: -

Identifier Source: org_study_id

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