Investigating the Effectiveness of PelvicSense(R) on Pain and Sexual Outcomes in Provoked Vestibulodynia

Provoked Vestibulodynia Clinical Trial

Official title:

Investigating the Effectiveness of PelvicSense(R) on Pain and Sexual Outcomes in Provoked Vestibulodynia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05909514
• Other study ID #: 379631-1
• Status: Recruiting
• Phase: N/A
• Start date: February 25, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: January 2024
• Source: Queen's University
• Contact: Caroline Pukall, PhD
• Phone: 613 533 3200
• Email: caroline.pukall[@]queensu.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will examine the effectiveness of the PelvicSense 3-month online program on pain and other outcomes in those with provoked vestibulodynia. This study is prospective in nature and will involve several assessment points: baseline, immediately post-treatment (at the end of the 3 month program), and 3-month follow up. All aspects of the study will be conducted remotely (e.g., online, email, video calls), and participants will be at least 18 years of age, fluent in English, and experience pain due to provoked vestibulodynia for at least 3 months with a physician diagnosis. Participants are expected to continue their treatment as usual and this information will be documented throughout the study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 31, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older

• fluent in English

• have a formal diagnosis of PVD for at least 3 months

Exclusion Criteria:

• younger than 18 years of age

• nonfluent in English

• self-identified diagnosis

• PVD duration of less than 3 months

Related Conditions & MeSH terms

• Provoked Vestibulodynia
• Vulvar Vestibulitis
• Vulvodynia

Intervention

Behavioral:
• PelvicSense(R)
PelvicSense® is a home-based physiotherapy program integrating multiple techniques, including relaxation, breathing, stretching, strengthening and at-home manual therapy. This program also educates participants about the anatomy and physiology of the pelvis and teaches strategies to strengthen the mind-muscle connection to the pelvis.

Locations

Country	Name	City	State
Canada	Sexual Health Research Laboratory, Department of Psychology, Queen's University	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Caroline Pukall

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sexual distress	Sexual Distress Scale, Short Form (SDS-SF). 5 items rated on 5 point scales from 0 (never) to 4 (always). Total scores range from 0-20. Higher scores are worse.	Baseline
Other	Sexual distress	Sexual Distress Scale, Short Form (SDS-SF). 5 items rated on 5 point scales from 0 (never) to 4 (always). Total scores range from 0-20. Higher scores are worse.	At the end of the 3 month program
Other	Sexual distress	Sexual Distress Scale, Short Form (SDS-SF). 5 items rated on 5 point scales from 0 (never) to 4 (always). Total scores range from 0-20. Higher scores are worse.	3 months after the end of the program
Other	Pain self-efficacy	Pain Self-Efficacy Questionnaire (PSEQ). 10 items rated on 7 point scales from 0 (not at all confident) to 6 (completely confident). Total scores range from 0-60. Higher scores are better.	Baseline
Other	Pain self-efficacy	Pain Self-Efficacy Questionnaire (PSEQ). 10 items rated on 7 point scales from 0 (not at all confident) to 6 (completely confident). Total scores range from 0-60.	At the end of the 3 month program
Other	Pain self-efficacy	Pain Self-Efficacy Questionnaire (PSEQ). 10 items rated on 7 point scales from 0 (not at all confident) to 6 (completely confident). Total scores range from 0-60.	3 months after the end of the program
Primary	Pain intensity	Pain Intensity Numerical Rating Scale (NRS). Participants will be asked to report their pain intensity on an 11-point numerical scale of 0 (no pain) to 10 (worst pain ever felt).	Baseline
Primary	Pain intensity	Pain Intensity Numerical Rating Scale (NRS). Participants will be asked to report their pain intensity on an 11-point numerical scale of 0 (no pain) to 10 (worst pain ever felt).	At the end of the 3 month program
Primary	Pain intensity	Pain Intensity Numerical Rating Scale (NRS). Participants will be asked to report their pain intensity on an 11-point numerical scale of 0 (no pain) to 10 (worst pain ever felt).	3 months after the end of the program
Secondary	Pain catastrophizing	Pain Catastrophizing Scale (PCS). 13 items rated on 5 point scales from 0 (not at all) to 4 (all the time). Total scores range from 0-52. Higher scores are worse.	Baseline
Secondary	Pain catastrophizing	Pain Catastrophizing Scale (PCS). 13 items rated on 5 point scales from 0 (not at all) to 4 (all the time). Total scores range from 0-52. Higher scores are worse.	At the end of the 3 month program
Secondary	Pain catastrophizing	Pain Catastrophizing Scale (PCS). 13 items rated on 5 point scales from 0 (not at all) to 4 (all the time). Total scores range from 0-52. Higher scores are worse.	3 months after the end of the program