NCT03935698

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

Completed NA Last updated 27 January 2022

What this trial tests

NA trial testing Physiotherapy in Gynecological Cancer in 31 participants. Completed in 25 January 2022.

Timeline

8 September 2016

Primary endpoint
31 December 2020

25 January 2022

Quick facts

Lead sponsor	Université de Sherbrooke
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	31
Start date	8 September 2016
Primary completion	31 December 2020
Estimated completion	25 January 2022
Sites	1 location across Canada

Drugs / interventions tested

• Physiotherapy — full drug profile →

Conditions studied

• Gynecological Cancer — all drugs for Gynecological Cancer →
• Dyspareunia — all drugs for Dyspareunia →

Sponsor

Université de Sherbrooke — full company profile →

Who can join

18 and older, female only, with Gynecological Cancer or Dyspareunia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Improvements following multimodal pelvic floor physical therapy in gynecological cancer survivors suffering from pain during sexual intercourse: Results from a one-year follow-up mixed-method study.
   Cyr MP, Dostie R, Camden C, Dumoulin C, et al · · 2022 · cited 21× · PMID 35077479 · DOI 10.1371/journal.pone.0262844
2. Changes in pelvic floor morphometry and muscle function after multimodal physiotherapy for gynaecological cancer survivors suffering from dyspareunia: a prospective interventional study.
   Cyr MP, Dumoulin C, Bessette P, Pina A, et al · · 2022 · cited 9× · PMID 35093737 · DOI 10.1016/j.physio.2021.09.003
3. Acceptability of multimodal pelvic floor physical therapy to treat dyspareunia after gynecological malignancies: a qualitative study of women's views and experiences.
   Cyr MP, Dostie R, Camden C, Dumoulin C, et al · · 2023 · cited 2× · PMID 35947187 · DOI 10.1007/s00192-022-05304-4