Interventions for managing pelvic health issues in women
Official title: Is Multimodal Physiotherapy and/or Photobiomodulation Therapy Effective for Pain Reduction Among Those Who Experience Provoked Vestibulodynia: a Randomized Controlled Trial
Run by University of Ottawa · NCT06660212 · Data updated 2026-11-12
This study is testing whether light therapy and physical therapy can help women with vulvar pain feel better over 14 weeks.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 240 (estimated) |
| Sponsor | University of Ottawa Academic / other |
| Locations | 2 sites (Ottawa, Ontario and 1 other locations) |
| Status | Recruiting |
| Started | March 17, 2025 |
| Main results expected | October 2027 |
| Study ends | November 2028 |
| Registry record updated | May 5, 2026 |
| Trial ID | NCT06660212 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are premenopausal women over eighteen years old experiencing symptoms of provoked vestibulodynia.
✕Probably not a fit
Patients with other gynecologic conditions or those unable to tolerate intravaginal assessments may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial aims to evaluate the effectiveness of photobiomodulation (PBM) and multimodal physiotherapy (mPT) in managing pain associated with provoked vestibulodynia (PVD). Participants will be randomly assigned to one of four groups: PBM, sham PBM, PBM combined with mPT, or mPT with sham PBM. The study will assess changes in vulvar pain severity using the Vulvar Pain Assessment Questionnaire (VPAQ) over a 14-week intervention period. Given the high prevalence of PVD and its significant impact on women's health, this research seeks to provide evidence-based management strategies for this condition.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for women suffering from provoked vestibulodynia.
How similar studies have gone: While there is limited research specifically on this combination of interventions, the use of multimodal approaches in pelvic pain management has shown promise in other studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Willing to travel to Ottawa area or Quebec City area * Biologically born female older than eighteen years * Pre-menopausal * Not currently pregnant or pregnancy/given birth in the past six months * Experiencing signs and symptoms consistent with provoked vestibulodynia alone or provoked vestibulodynia plus vaginismus Exclusion Criteria: * gynaecologist cannot insert a single digit intravaginally and thus the participant would be unlikely able to tolerate the assessment procedures * other gynaecologic conditions such as lichen sclerosus, fissures, endometriosis, adenomyosis, or pelvic organ prolapse
Where it's running
-
Motor Function Measurement Lab
Ottawa, Ontario, Canada Recruiting -
Bernard Lab
Québec, Quebec, Canada Recruiting
Study contacts
- Principal investigator: Linda McLean, PhD — University of Ottawa
- Study coordinator: Linda McLean, PhD
- Email: Linda.Mclean@uottawa.ca
- Phone: 613-562-5800
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Topical ketotifen 0.25% for secondary vestibulodynia
This Phase 2 trial will test whether applying ketotifen 0.25% cream to the vulvar vestibule reduces pain in adult women with secondary provoked vestibulodynia.
-
Sexual Health in Spanish-Speaking Adults: A Large Online Survey
A large online survey will test sexual health, sexual behavior, and sexual function in Spanish-speaking adults to see how common these experiences are and to explore unusual states of consciousness during orgasm.
-
F-GYN injection for vaginal dryness and vaginal/vestibular atrophy
This study tests whether a one-time F-GYN injection can relieve vaginal dryness and related symptoms in adult women with atrophic vaginitis/vestibulovaginal atrophy compared with standard non-hormonal care.
-
Four-session focal shock wave therapy for vulvodynia in women
This study looks at whether four weekly sessions of low-intensity focal shock wave therapy help women with vulvodynia in real-life clinical practice.
-
Dry needling to reduce pain during intercourse for provoked vestibulodynia
This trial will test whether dry needling can reduce pain during intercourse in women with provoked vestibulodynia.
-
Radiofrequency combined with ultrasound for postpartum sexual pain
This study will try a combined radiofrequency and ultrasound treatment (BTL Exilis) to reduce pain during sex in women who developed dyspareunia after a vaginal delivery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.