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Completed

NCT Number: NCT03935698

Physiotherapy Treatment in Women With Dyspareunia Following Gynecological Cancer: a 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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physiotherapy

Other

Other names: Pelvic floor rehabilitation

Primary outcomes

  1. Adherence rates

    Time frame: Pre- to 2-week post-treatment assessment

    To determine acceptability.

  2. Retention rate

    Time frame: Pre- to 2-week post-treatment assessment

    To determine feasibility.

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. Change from baseline in quality of life

    Time frame: Pre- to 2-week post-treatment assessment

    To explore changes in quality of life (questionnaire).

  5. 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).

  6. Adverse events

    Time frame: Pre- to 2-week post-treatment assessment

    To document any adverse events.

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2022
First posted
May 2, 2019
Registry last updated
Jan 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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