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

NCT ID: NCT05909514

Last Updated: 2025-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-25

Study Completion Date

2025-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Provoked Vestibulodynia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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3 month PelvicSense(R) program

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.

Group Type EXPERIMENTAL

PelvicSense(R)

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Dr. Caroline Pukall

OTHER

Sponsor Role lead

Responsible Party

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Dr. Caroline Pukall

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Caroline Pukall, PhD

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Locations

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

Kingston, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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379631-1

Identifier Type: -

Identifier Source: org_study_id

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