NCT05909514

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 25, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

May 6, 2026

Status Verified

April 1, 2025

Enrollment Period

1.5 years

First QC Date

May 5, 2023

Last Update Submit

April 30, 2026

Conditions

Provoked Vestibulodynia

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (3)

  • Pain catastrophizing

    Baseline

  • Pain catastrophizing

    At the end of the 3 month program

  • Pain catastrophizing

    3 months after the end of the program

Other Outcomes (6)

  • Sexual distress

    Baseline

  • Sexual distress

    At the end of the 3 month program

  • Sexual distress

    3 months after the end of the program

  • +3 more other outcomes

Study Arms (1)

3 month PelvicSense(R) program

EXPERIMENTAL

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.

Behavioral: PelvicSense(R)

Interventions

PelvicSense(R)BEHAVIORAL

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.

3 month PelvicSense(R) program

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAll identities accepted with female pelvic anatomy.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • fluent in English
  • have a formal diagnosis of PVD for at least 3 months

You may not qualify if:

  • younger than 18 years of age
  • nonfluent in English
  • self-identified diagnosis
  • PVD duration of less than 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sexual Health Research Laboratory, Department of Psychology, Queen's University

Kingston, Ontario, K7L 3N6, Canada

Location

Study Officials

  • Caroline Pukall, PhD

    Queen's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 5, 2023

First Posted

June 18, 2023

Study Start

February 25, 2023

Primary Completion

August 31, 2024

Study Completion

May 31, 2025

Last Updated

May 6, 2026

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

De-identified data will be available to other researchers after publication of the results.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
De-identified data will be available to other researchers for 2 years after publication of the results.
Access Criteria
Please email the PI at caroline.pukall@queensu.ca

Locations

CA(1)