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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05909514

Enrollment

Registered

2023-06-18

Start date

2023-02-25

Completion date

2025-05-31

Last updated

2026-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Provoked Vestibulodynia

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.

Interventions

BEHAVIORALPelvicSense(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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Pain intensity	Baseline	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).

Secondary

Measure	Time frame	Description
Pain catastrophizing	Baseline	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.

Countries

Canada

Contacts

PRINCIPAL_INVESTIGATORCaroline Pukall, PhD

Queen's University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 7, 2026