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

U

Université de Sherbrooke

Status

Completed

Conditions

Dyspareunia
Gynecological Cancer

Treatments

Other: Physiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03935698
MP-31-2016-1322

Details and patient eligibility

About

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.

Enrollment

31 patients

Sex

Female

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

31 participants in 1 patient group

Physiotherapy
Experimental group
Description:
12 weekly 60-minute individual sessions of multimodal physiotherapy including education, stretching techniques, pelvic floor muscle biofeedback as well as home exercises.
Treatment:
Other: Physiotherapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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