Provoked VestibulodyniaNCT05797480
Dry Needling for Provoked Vestibulodynia
A study testing Real Dry needling and Non penetrating dry needling in people with Provoked Vestibulodynia, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
This is a randomized and controlled study investigating the feasibility and acceptability of a dry needling treatment for women suffering from provoked vestibulodynia. Following their enrollment in the study, participants will undergo a gynecological examination for confirmation of their diagnoses of provoked… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Provoked Vestibulodynia
- What is being tested?
- Real Dry needling and Non penetrating dry needling
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteCanada
- Study dates
- 27 Feb 2023to 17 Jul 2024
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of provoked vestibulodynia according to a standardised gynaecologic exam
- Moderate to severe pain (≥ 5/10) in at least 90% of sexual intercourses or attempted sexual intercourse for at least 3 months
Who cannot join
- Other causes of vulvo-vaginal pain (e.g., spontaneous vulvovaginal pain not related to sexual intercourse/contact, dermatological condition, herpes, vulvo-vaginal atrophy)
- Post-menopausal state
- Actual or past pregnancy in the last year
- Urogynecological conditions (e.g., pelvic organs prolapse (POP) ≥ 3, urinary/vaginal infection active or in the last 3 months)
- Previous vulvar, vaginal or pelvic surgery (e.g., vestibulectomy, corrective pelvic organs prolapse surgery)
- Prior use of dry needling or acupuncture treatments
Show all 9Show fewer
- Fear of needles or any contraindication to needling therapies
- Changes of medication that could influence pain perception (e.g., analgesic, antidepressant) in the last 3 months
- Other medical conditions that could interfere with the study
Trial locations and contacts
1 site in 1 country.
Canada1 site
Research Center of the Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H5N4
About this study
Official title: Dry Needling for Women With Provoked Vestibulodynia: A Feasibility and Acceptability Randomized Controlled Study
This is a randomized and controlled study investigating the feasibility and acceptability of a dry needling treatment for women suffering from provoked vestibulodynia. Following their enrollment in the study, participants will undergo a gynecological examination for confirmation of their diagnoses of provoked vestibulodynia. Women diagnosed with provoked vestibulodynia will be randomized into the dry needling group or the sham-needle group. The dry needling group will receive 6 sessions of real dry needling for 6 consecutive weeks. The sham group will receive 6 sessions of sham needling for 6 consecutive weeks, using a validated sham-needle. Outcomes measures will be assessed at baseline and at post-treatment and will include: feasibility and acceptability variables, pain intensity and quality, pain during palpation and pressure pain threshold, psychosexual variables, perceived improvement and satisfaction after the treatment as well as pelvic floor muscle stiffness and function.
Read the detailed description
Up to 18% of reproductive-aged women experience chronic pain in the vulvar region during sexual intercourse. This chronic pain condition is called vulvodynia. The main subtype of this pain condition is provoked vestibulodynia (PVD), which is characterized by a sharp or burning pain at the vaginal opening when there is a pressure applied to the vulvar vestibule or attempting vaginal penetration. Women suffering from PVD suffer from sexual dysfunctions, psychological distress and worsened quality of life. The treatment options currently available are still quite limited and some women still experience pain despite undertaking all options available. We, therefore, proposed a randomized and controlled study to investigate the feasibility and acceptability of a dry needling treatment for women suffering from PVD. Women diagnosed with provoked vestibulodynia will be randomized into the dry needling group or the sham-needle group. Participants and evaluators will be blinded. The dry needling group will receive 6 sessions of real dry needling for 6 consecutive weeks. For the first three sessions, the dry needling/or sham techniques will be aimed at the muscles of the trunk, lower back, hips and SI joints. For the last 3 treatment sessions, the dry needling/or sham techniques will aimed at the pelvic floor muscles. The sham group will receive the same 6 sessions of sham needling for 6 consecutive weeks, using a validated sham-needle. Outcomes measures will be assessed at baseline and 2 weeks post-treatment and will include: feasibility (adherence to treatment, retention rates, adverse effects, recruitment rates and data on dry needling (needles, # of insertions, pain related) and acceptability variables. Secondary outcomes will include pain intensity during intercourse (numeric scale) and quality (McGill pain questionnaire), pain during palpation and pressure pain threshold (Pressure algometer), psychosexual variables (sexual distress and sexual function), change in pain catastrophizing, change in quality of life in domains associated with chronic pelvic pain (Pelvic Pain Impact questionnaire, severity of symptoms related to central sensitization), perceived improvement and satisfaction after the treatment as well as pelvic floor muscle stiffness (shearwave elastography and dynamometric speculum)and function (dynamometric speculum), blinding efficacy.
- Conditions
- Provoked Vestibulodynia
- Being tested
- Real Dry needling, Non penetrating dry needling
- Keywords
- Dyspareunia, Vulvodynia
- Medical subject headings
- Dyspareunia, Vulvodynia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real Dry needlingOther
Also called Needling
Real dry needling will be applied to the pelvic floor, hip and lower back muscles.
Non penetrating dry needlingOther
Also called Sham, Control
Sham non penetrating dry needling (fixed needle in an introducer tube) will be applied to the pelvic floor, hip and lower back muscles.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Real Dry needling | Experimental | 1 dry needling treatment per week for 6 consecutive weeks Receives: Other: Real Dry needling |
| Sham: Non penetrating dry needling | Sham comparator | 1 non penetrating dry needling per week for 6 consecutive weeks Receives: Other: Non penetrating dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to treatment sessions
- To determine feasibility, the patients' adherence to treatment sessions will be recorded (present vs absent) as well as reasons for non-attendance.
Measured: Through treatment completion (session 1 to 6; 6 weeks of treatment)
Adherence to treatment protocol
- To determine feasibility by assessing adherence to treatment sessions.
Measured: Through treatment completion (session 1 to 6; 6 weeks of treatment)
Retention rate
- To determine feasibility by assessing the percentage of participants completing the post-treatment assessment. Reason for dropouts will be compiled
Measured: Baseline to Post-treatment assessment (2-week post-treatment)
Adverse effects
- Adverse effects observed and reported will be documented at each treatment session and at the post-treatment assessment.
Measured: Through treatment completion (session 1 to 6; 6 weeks of treatment)
Adverse effects
- Adverse effects observed and reported will be documented at each treatment session and at the post-treatment assessment.
Measured: Post-treatment assessment (2-week post-treatment)
Recruitment rate
- To determine feasibility by assessing the percentage of participants included versus the participants screened. The barriers and reasons for refusing to participate as well as the reasons for exclusion will be documented
Measured: Baseline
Intervention Acceptability Questionnaire
- The Intervention Acceptability Questionnaire will be used to assess the participants' acceptability of the interventions. This questionnaire consists of 6 items measured on a VAS scale (Minimum value: 0; Maximum Value: 10). Each item is analyzed separately, with a greater score meaning higher acceptability of the intervention.
Measured: Baseline
Intervention Acceptability Questionnaire
- The Intervention Acceptability Questionnaire will be used to assess the participants' acceptability of the interventions. This questionnaire consists of 6 items measured on a VAS scale (Minimum value: 0; Maximum Value: 10). Each item is analyzed separately, with a greater score meaning higher acceptability of the intervention.
Measured: After treatment session 3 (week 3)
Intervention Acceptability Questionnaire
- The Intervention Acceptability Questionnaire will be used to assess the participants' acceptability of the interventions. This questionnaire consists of 6 items measured on a VAS scale (Minimum value: 0; Maximum Value: 10). Each item is analyzed separately, with a greater score meaning higher acceptability of the intervention.
Measured: Post-treatment assessment (2-week post-treatment)
Secondary outcomes (15)
Change in pain intensity during intercourse
To explore changes in pain intensity during intercourse (Numerical Rating Scale (NRS)). Ranging from 0 to 10, where 0 is no pain at all, and 10 is the worst pain ever.
Measured: Baseline to Post-treatment assessment (2-week post-treatment)
Change in pain quality
To explore changes on the sensory, affective, and evaluative components of pain (McGill-Melzack Questionnaire). Ranging from 0 to 78, higher scores mean worst outcome (higher pain).
Measured: Baseline to Post-treatment assessment (2-week post-treatment)
Change in pain catastrophizing
To explore changes on pain catastrophizing (Pain catastrophizing scale (PCS)). Ranging from 0 to 52, higher scores mean worse outcome (higher pain catastrophizing).
Measured: Baseline to Post-treatment assessment (2-week post-treatment)
Change in fear of pain
To explore changes in fear of pain (Pain anxiety Symptoms Scale (PASS-20). Ranging from 0 to 100, higher scores mean worse outcome (higher fear of pain).
Measured: Baseline to Post-treatment assessment (2-week post-treatment)
Change in sexual function
To explore changes in sexual function (Female Sexual Function Index - FSFI). Ranging from 2 to 36, lower scores mean wort outcome (low sexual function).
Measured: Baseline to Post-treatment assessment (2-week post-treatment)
Change in sexual distress
To explore changes in sexual distress (Female Sexual Distress Scale - FSDS). Ranging from 0 to 52, higher scores mean worse outcome (higher sexually related distress).
Measured: Baseline to Post-treatment assessment (2-week post-treatment)
Change in quality of life in the domains associated with chronic pelvic pain
To explore changes in quality of life Pelvic Pain Impact Questionnaire (PPIQ). Ranging from 0 to 32, higher scores mean worse outcome (less quality of life associated with pelvic pain).
Measured: Baseline to Post-treatment assessment (2-week post-treatment)
Severity of symptoms related with central sensitization
To explore changes in symptoms related to central sensitization (Central Sensitization Inventory). Ranging from 0 to 100, a higher scores indicates higher central sensitivity.
Measured: Baseline to Post-treatment assessement (2-week post-treatment)
Satisfaction with treatment
To determine acceptability by measuring the participants' satisfaction with the treatment on a Numeric Rating Scale (NRS) ranging from 0 (completely dissatisfied) to 10 (complete satisfied).
Measured: Post-treatment assessment (2-week post-treatment)
Patient's global impression of change
To examine patient self-reported improvement (Patient's Global Impression of Change). Ranging from "very much worse" to "very much improved" on a 7-point scale.
Measured: Post-treatment assessment (2-week post-treatment)
Blinding effectiveness
To assess the feasibility of maintaining blinding to group allocation for the participants. Evaluated by asking the question: ''What treatment do you think you have received? ''
Measured: Post-treatment assessment (2-week post-treatment)
Changes in pelvic floor muscle stiffness
To explore changes in pelvic floor muscle stiffness (Shearwave elastography)
Measured: Baseline to Post-treatment assessment (2-week post-treatment)
Changes in pelvic floor muscle function
To explore changes in pelvic floor muscle function (Dynamometric speculum)
Measured: Baseline to Post-treatment assessment (2-week post-treatment)
Changes in pain at palpation
To explore changes at intravaginal palpation of the internal obturators and the levator ani muscles following a standardized procedure (Numerical Rating Scale). Ranging from 0 to 10, where 0 is no pain at all, and 10 is the worst pain ever.
Measured: Baseline to Post-treatment assessment (2-week post-treatment)
Changes in pressure pain threshold
To explore changes in pressure pain threshold if predetermined areas of the pelvis (Wagner algometer)
Measured: Baseline to Post-treatment assessment (2-week post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start27 Feb 2023
- Primary completion17 Jul 2024
- Study completion17 Jul 2024
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.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Baseline evaluation - Randomization to real dry needling or sham dry needling (6 sessions for 6 consecutive weeks) - post-treatment evaluation (2-week post-treatment)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mélanie Morin, Université de Sherbrooke
- Investigators
- Melanie Morin, PhD, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05797480
- Sponsor's protocol ID
- 2023-4686
- Status last verified
- Feb 2025
- First submitted
- 27 Feb 2023
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dry Needling for Women With Provoked Vestibulodynia: A Feasibility and Acceptability Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05797480
- Acronym / sponsor ID
- 2023-4686
- Conditions
- Provoked Vestibulodynia
- Keywords
- Dyspareunia, Vulvodynia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 17 Jul 2024 (actual)
- Study completion
- 17 Jul 2024 (actual)
- First posted
- 4 Apr 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 is a randomized and controlled study investigating the feasibility and acceptability of a dry needling treatment for women suffering from provoked vestibulodynia. Following their enrollment in the study, participants will undergo a gynecological examination for confirmation of their diagnoses of provoked vestibulodynia. Women diagnosed with provoked vestibulodynia will be randomized into the dry needling group or the sham-needle group. The dry needling group will receive 6 sessions of real dry needling for 6 consecutive weeks. The sham group will receive 6 sessions of sham needling for 6 consecutive weeks, using a validated sham-needle. Outcomes measures will be assessed at baseline and at post-treatment and will include: feasibility and acceptability variables, pain intensity and quality, pain during palpation and pressure pain threshold, psychosexual variables, perceived improvement and satisfaction after the treatment as well as pelvic floor muscle stiffness and function.
Detailed description
Up to 18% of reproductive-aged women experience chronic pain in the vulvar region during sexual intercourse. This chronic pain condition is called vulvodynia. The main subtype of this pain condition is provoked vestibulodynia (PVD), which is characterized by a sharp or burning pain at the vaginal opening when there is a pressure applied to the vulvar vestibule or attempting vaginal penetration. Women suffering from PVD suffer from sexual dysfunctions, psychological distress and worsened quality of life. The treatment options currently available are still quite limited and some women still experience pain despite undertaking all options available. We, therefore, proposed a randomized and controlled study to investigate the feasibility and acceptability of a dry needling treatment for women suffering from PVD. Women diagnosed with provoked vestibulodynia will be randomized into the dry needling group or the sham-needle group. Participants and evaluators will be blinded. The dry needling group will receive 6 sessions of real dry needling for 6 consecutive weeks. For the first three sessions, the dry needling/or sham techniques will be aimed at the muscles of the trunk, lower back, hips and SI joints. For the last 3 treatment sessions, the dry needling/or sham techniques will aimed at the pelvic floor muscles. The sham group will receive the same 6 sessions of sham needling for 6 consecutive weeks, using a validated sham-needle. Outcomes measures will be assessed at baseline and 2 weeks post-treatment and will include: feasibility (adherence to treatment, retention rates, adverse effects, recruitment rates and data on dry needling (needles, # of insertions, pain related) and acceptability variables. Secondary outcomes will include pain intensity during intercourse (numeric scale) and quality (McGill pain questionnaire), pain during palpation and pressure pain threshold (Pressure algometer), psychosexual variables (sexual distress and sexual function), change in pain catastrophizing, change in quality of life in domains associated with chronic pelvic pain (Pelvic Pain Impact questionnaire, severity of symptoms related to central sensitization), perceived improvement and satisfaction after the treatment as well as pelvic floor muscle stiffness (shearwave elastography and dynamometric speculum)and function (dynamometric speculum), blinding efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Baseline evaluation - Randomization to real dry needling or sham dry needling (6 sessions for 6 consecutive weeks) - post-treatment evaluation (2-week post-treatment)
| Arm | Type | Receives |
|---|---|---|
| Experimental: Real Dry needling | Experimental | Other: Real Dry needling1 dry needling treatment per week for 6 consecutive weeks |
| Sham: Non penetrating dry needling | Sham comparator | Other: Non penetrating dry needling1 non penetrating dry needling per week for 6 consecutive weeks |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosis of provoked vestibulodynia according to a standardised gynaecologic exam
- Moderate to severe pain (≥ 5/10) in at least 90% of sexual intercourses or attempted sexual intercourse for at least 3 months
Key exclusion criteria (9 listed)
- Other causes of vulvo-vaginal pain (e.g., spontaneous vulvovaginal pain not related to sexual intercourse/contact, dermatological condition, herpes, vulvo-vaginal atrophy)
- Post-menopausal state
- Actual or past pregnancy in the last year
- Urogynecological conditions (e.g., pelvic organs prolapse (POP) ≥ 3, urinary/vaginal infection active or in the last 3 months)
- Previous vulvar, vaginal or pelvic surgery (e.g., vestibulectomy, corrective pelvic organs prolapse surgery)
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 |
|---|---|---|
| Real Dry needlingAlso: NeedlingReal dry needling will be applied to the pelvic floor, hip and lower back muscles. | Other | Experimental: Real Dry needling |
| Non penetrating dry needlingAlso: Sham, ControlSham non penetrating dry needling (fixed needle in an introducer tube) will be applied to the pelvic floor, hip and lower back muscles. | Other | Sham: Non penetrating dry needling |
Primary outcome
Adherence to treatment sessions
Time frame: Through treatment completion (session 1 to 6; 6 weeks of treatment)
a. To determine feasibility, the patients' adherence to treatment sessions will be recorded (present vs absent) as well as reasons for non-attendance.
Adherence to treatment protocol
Time frame: Through treatment completion (session 1 to 6; 6 weeks of treatment)
a. To determine feasibility by assessing adherence to treatment sessions.
Retention rate
Time frame: Baseline to Post-treatment assessment (2-week post-treatment)
a. To determine feasibility by assessing the percentage of participants completing the post-treatment assessment. Reason for dropouts will be compiled
Adverse effects
Time frame: Through treatment completion (session 1 to 6; 6 weeks of treatment)
a. Adverse effects observed and reported will be documented at each treatment session and at the post-treatment assessment.
Adverse effects
Time frame: Post-treatment assessment (2-week post-treatment)
a. Adverse effects observed and reported will be documented at each treatment session and at the post-treatment assessment.
Recruitment rate
Time frame: Baseline
a. To determine feasibility by assessing the percentage of participants included versus the participants screened. The barriers and reasons for refusing to participate as well as the reasons for exclusion will be documented
Intervention Acceptability Questionnaire
Time frame: Baseline
a. The Intervention Acceptability Questionnaire will be used to assess the participants' acceptability of the interventions. This questionnaire consists of 6 items measured on a VAS scale (Minimum value: 0; Maximum Value: 10). Each item is analyzed separately, with a greater score meaning higher acceptability of the intervention.
Intervention Acceptability Questionnaire
Time frame: After treatment session 3 (week 3)
a. The Intervention Acceptability Questionnaire will be used to assess the participants' acceptability of the interventions. This questionnaire consists of 6 items measured on a VAS scale (Minimum value: 0; Maximum Value: 10). Each item is analyzed separately, with a greater score meaning higher acceptability of the intervention.
Intervention Acceptability Questionnaire
Time frame: Post-treatment assessment (2-week post-treatment)
a. The Intervention Acceptability Questionnaire will be used to assess the participants' acceptability of the interventions. This questionnaire consists of 6 items measured on a VAS scale (Minimum value: 0; Maximum Value: 10). Each item is analyzed separately, with a greater score meaning higher acceptability of the intervention.
15 secondary outcomes
Change in pain intensity during intercourse
Time frame: Baseline to Post-treatment assessment (2-week post-treatment)
Change in pain quality
Time frame: Baseline to Post-treatment assessment (2-week post-treatment)
Change in pain catastrophizing
Time frame: Baseline to Post-treatment assessment (2-week post-treatment)
Change in fear of pain
Time frame: Baseline to Post-treatment assessment (2-week post-treatment)
Change in sexual function
Time frame: Baseline to Post-treatment assessment (2-week post-treatment)
Change in sexual distress
Time frame: Baseline to Post-treatment assessment (2-week post-treatment)
Change in quality of life in the domains associated with chronic pelvic pain
Time frame: Baseline to Post-treatment assessment (2-week post-treatment)
Severity of symptoms related with central sensitization
Time frame: Baseline to Post-treatment assessement (2-week post-treatment)
Satisfaction with treatment
Time frame: Post-treatment assessment (2-week post-treatment)
Patient's global impression of change
Time frame: Post-treatment assessment (2-week post-treatment)
Blinding effectiveness
Time frame: Post-treatment assessment (2-week post-treatment)
Changes in pelvic floor muscle stiffness
Time frame: Baseline to Post-treatment assessment (2-week post-treatment)
Changes in pelvic floor muscle function
Time frame: Baseline to Post-treatment assessment (2-week post-treatment)
Changes in pain at palpation
Time frame: Baseline to Post-treatment assessment (2-week post-treatment)
Changes in pressure pain threshold
Time frame: Baseline to Post-treatment assessment (2-week post-treatment)
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 7 Feb 2025.
- Individual participant dataSharing planned: No
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.
Melanie Morin, PhD principal investigator
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real Dry needling and Non penetrating dry needling in people with Provoked Vestibulodynia, run by Université de Sherbrooke 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 2 inclusion and 9 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 7 Feb 2025. 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. Some participants in this study may receive a placebo. 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?
Adherence to treatment sessions (time frame: Through treatment completion (session 1 to 6; 6 weeks of treatment)). The study lists 9 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 7 Feb 2025.