Provoked VestibulodyniaNCT05909514
Investigating the Effectiveness of PelvicSense(R) on Pain and Sexual Outcomes in Provoked Vestibulodynia
A study testing PelvicSense(R) in people with Provoked Vestibulodynia, run by Dr. Caroline Pukall at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Provoked Vestibulodynia
- What is being tested?
- PelvicSense(R)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 25 Feb 2023to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- fluent in English
- have a formal diagnosis of PVD for at least 3 months
Who cannot join
- younger than 18 years of age
- nonfluent in English
- self-identified diagnosis
- PVD duration of less than 3 months
Trial locations and contacts
1 site in 1 country.
Canada1 site
Sexual Health Research Laboratory, Department of Psychology, Queen's University
Kingston, Ontario, K7L 3N6
About this study
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.
- Conditions
- Provoked Vestibulodynia
- Being tested
- PelvicSense(R)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PelvicSense(R)Behavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: PelvicSense(R) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 3 months after the end of the program
Secondary outcomes (3)
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.
Measured: Baseline
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.
Measured: At the end of the 3 month program
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.
Measured: 3 months after the end of the program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start25 Feb 2023
- Primary completion31 Aug 2024
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Provoked VestibulodyniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Caroline Pukall
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Caroline Pukall, Queen's University
- Investigators
- Caroline Pukall, PhD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05909514
- Sponsor's protocol ID
- 379631-1
- Status last verified
- Apr 2025
- First submitted
- 5 May 2023
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be available to other researchers after publication of the results.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effectiveness of PelvicSense(R) on Pain and Sexual Outcomes in Provoked Vestibulodynia
- ClinicalTrials.gov ID
- NCT05909514
- Acronym / sponsor ID
- 379631-1
- Conditions
- Provoked Vestibulodynia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Dr. Caroline PukallUniversity, hospital or other
- Study start
- 25 Feb 2023 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3 month PelvicSense(R) program | Experimental | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- fluent in English
- have a formal diagnosis of PVD for at least 3 months
Key exclusion criteria (4 listed)
- younger than 18 years of age
- nonfluent in English
- self-identified diagnosis
- PVD duration of less than 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | 3 month PelvicSense(R) program |
Primary outcome
Pain intensity
Time frame: 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).
Pain intensity
Time frame: At the end of the 3 month program
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).
Pain intensity
Time frame: 3 months after the end of the program
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 secondary outcomes
Pain catastrophizing
Time frame: Baseline
Pain catastrophizing
Time frame: At the end of the 3 month program
Pain catastrophizing
Time frame: 3 months after the end of the program
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: Yes. De-identified data will be available to other researchers after publication of the results.
Related trials for Provoked Vestibulodynia
Active, not recruitingPhase 2
A Phase 2 Study to Evaluate the Efficacy and Safety of Pudafensine in Vulvodynia (Provoked Vestibulodynia)
Vulvodynia
RecruitingObservational study
Rigid Hymenal Ring as a Cause for Insertional Dyspareunia
Dyspareunia (Female)
Recruiting
Efficacy of Dry Needling in Reducing Pain During Sexual Intercourse
Provoked Vestibulodynia
Recruiting
Biomodulation and Rehabilitation Interventions to tarGet Pelvic Health
Vulvodynia, Provoked Vestibulodynia
RecruitingPhase 2
IncobotulinumtoxinA for Provoked Vestibulodynia With Overactive Pelvic Floor Muscle Dysfunction
Provoked Vestibulodynia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline Pukall, PhD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PelvicSense(R) in people with Provoked Vestibulodynia, run by Dr. Caroline Pukall at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.