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

NCT03935698 | Completed

• 1 other identifier: MP-31-2016-1322
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecological Cancer; Dyspareunia

Keywords

Pilot study; Feasibility study; Dyspareunia; Gynecological cancer survivors; Physiotherapy

Outcome Measures

Primary Outcomes (2)

• Adherence rates

  To determine acceptability.

  Pre- to 2-week post-treatment assessment

• Retention rate

  To determine feasibility.

  Pre- to 2-week post-treatment assessment

Secondary Outcomes (6)

• Change from baseline in pain

  Pre- to 2-week post-treatment assessment

• Change from baseline in sexual function

  Pre- to 2-week post-treatment assessment

• Change from baseline in pelvic floor muscle function

  Pre- to 2-week post-treatment assessment

• Change from baseline in quality of life

  Pre- to 2-week post-treatment assessment

• Patient's global impression of change

  2-week post-treatment assessment

Study Arms (1)

Physiotherapy

EXPERIMENTAL

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

Other: Physiotherapy

Interventions

Physiotherapy OTHER

Also known as: Pelvic floor rehabilitation

Physiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Related Publications (1)

• 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.

  PMID: 35093737 DERIVED

MeSH Terms

Conditions

Dyspareunia

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher and Associate Professor

Model Details: Pre-treatment assessment - Intervention (12 weeks) - Post-treatment assessment

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: May 2, 2019
• Study Start: September 8, 2016
• Primary Completion: December 31, 2020
• Study Completion: January 25, 2022
• Last Updated: January 27, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)