PelvicSense Program for Vulvodynia

Overseen By Caroline Pukall, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Dr. Caroline Pukall

Disqualifiers: Under 18, Nonfluent English, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a 3-month online program called PelvicSense to determine its effectiveness in reducing pain and improving outcomes for individuals with provoked vestibulodynia, a condition causing vulvar pain upon touch. The program includes exercises such as relaxation, breathing, stretching, and strengthening, and provides education about the pelvic area to enhance the mind-muscle connection. Conducted entirely online, it offers convenience for participants. This trial suits those diagnosed with provoked vestibulodynia by a doctor and who have lived with the condition for at least three months. As an unphased trial, it presents a unique opportunity to explore a new, convenient approach to managing the condition from home.

Will I have to stop taking my current medications?

No, you will not have to stop taking your current medications. Participants are expected to continue their treatment as usual during the study.

What prior data suggests that the PelvicSense program is safe for individuals with provoked vestibulodynia?

Research shows that PelvicSense, a home-based physiotherapy program, helps manage pelvic pain, such as vulvodynia, which affects many women. PelvicSense includes relaxation, breathing, stretching, and strengthening exercises, and educates participants about the pelvis.

The program is generally easy to use and involves non-invasive methods, requiring neither surgery nor medication. Its similarity to other physical therapy programs for pelvic pain suggests it is likely safe.

Participants in similar therapies have reported few side effects, usually mild, such as temporary discomfort after exercises. Serious side effects are not commonly linked to these treatments.

PelvicSense aims to empower individuals by teaching self-care skills and focuses on reducing pain through safe exercises that can be done at home. Always consult a healthcare provider before starting new treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for vulvodynia, which often involve medications, surgery, or in-office physical therapy, the PelvicSense® program is a home-based approach. Researchers are excited about this program because it combines multiple techniques like relaxation, breathing, stretching, strengthening, and at-home manual therapy, empowering participants to engage in their own care. This method not only aims to improve physical symptoms but also strengthens the mind-muscle connection to the pelvis, offering a comprehensive understanding and control over pelvic health. This holistic and self-directed approach could be a game-changer for those seeking non-invasive and empowering solutions.

What evidence suggests that the PelvicSense program is effective for vulvodynia?

Research shows that the PelvicSense program, which participants in this trial will follow, might help reduce pain for people with provoked vestibulodynia. Studies have found that combining techniques like relaxation, breathing, and stretching is effective for women with long-term pelvic pain. PelvicSense uses these methods, along with education about pelvic anatomy and exercises to strengthen the connection between the mind and pelvic muscles. Past participants reported significant improvements in symptoms, such as pain during sex and bladder problems. These findings suggest that the PelvicSense program could help manage pain and improve daily life for those with this condition. ^{1 6 7 8 9}

Who Is on the Research Team?

Caroline Pukall, PhD

Principal Investigator

Queen's University

Are You a Good Fit for This Trial?

This trial is for adults over 18 who speak English and have been diagnosed with provoked vestibulodynia, a condition causing pain in the vulvar region, for at least three months. Participants will engage in an online program called PelvicSense and must continue their usual treatment during the study.

Inclusion Criteria

Fluent in English

I have been diagnosed with peripheral vascular disease for at least 3 months.

Exclusion Criteria

Self-identified diagnosis

My peripheral vascular disease has lasted less than 3 months.

I am not fluent in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in the PelvicSense 3-month online program focusing on physiotherapy techniques

12 weeks

Remote sessions (online, email, video calls)

Follow-up

Participants are monitored for pain and sexual outcomes 3 months after the end of the program

3 months

Remote assessments

What Are the Treatments Tested in This Trial?

Interventions

• PelvicSense(R)

Trial Overview The effectiveness of PelvicSense, a 3-month online program designed to help manage pain and improve sexual outcomes for those suffering from provoked vestibulodynia, is being tested. The study includes assessments before starting, after completing the program, and three months later.

How Is the Trial Designed?

Group I: 3 month PelvicSense(R) program Experimental Treatment 1 Intervention

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 Is Running the Clinical Trial?

Dr. Caroline Pukall

Lead Sponsor

Trials

3

Recruited

130+

Dr. Caroline Pukall

Lead Sponsor

Trials

3

Recruited

130+

Queen's University

Lead Sponsor

Trials

382

Recruited

122,000+

Published Research Related to This Trial

In a study of 25 female adolescents with idiopathic scoliosis (AIS) and 12 controls, significant differences in pelvic dynamics were observed, particularly in pelvic alignment during various trunk-pelvis movements, indicating that scoliosis affects pelvic mobility and overall biomechanics.

The study found that the initial three-dimensional alignment of the pelvis is crucial for movement dynamics, with patients having distinct pelvic responses based on the type of scoliosis, particularly showing increased pelvic sagittal tilt in those with right thoracic-left lumbar curves during lateral bending and axial rotation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing pelvis dynamics in adolescent with idiopathic scoliosis. Pasha, S., Sangole, AP., Aubin, CE., et al.[2013]

A study using MRI and ultrasound to analyze pelvic landmarks in different seating positions found that internal and external landmark coordinates are generally statistically different, influenced by soft tissue thickness and posture changes.

Despite these differences, the accuracy of estimating pelvic orientation indexes (like tilt and rotation) was not significantly affected, suggesting that linear regressions can be used to correlate internal and external landmark positions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differences between pelvic skin and bone landmark identification in different seated positions on spinal-cord injured subjects. Lalonde, NM., Dansereau, J., Aissaoui, R., et al.[2019]

A study involving 102 women found that those with dysmenorrhea (menstrual pain) had a greater pelvic torsion (2.4 degrees) compared to those without dysmenorrhea (1.7 degrees), indicating a potential link between pelvic alignment and menstrual pain.

The research utilized advanced measurement techniques (Formetric 4D) to assess pelvic alignment, suggesting that pelvic torsion may play a role in the experience of dysmenorrhea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The relationship between pelvic alignment and dysmenorrhea. Kim, MJ., Baek, IH., Goo, BO.[2020]

Patient Assisted Laparoscopy (PAL) significantly reduced the negative laparoscopy rate for patients with pelvic pain to less than 3%, compared to the typical 35% seen with traditional laparoscopic procedures under general anesthesia.

Out of 100 patients assessed, 88 were successfully evaluated, revealing that a majority (61 patients) had endometriosis, highlighting PAL's effectiveness in diagnosing specific causes of chronic pelvic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect on negative laparoscopy rate in chronic pelvic pain patients using patient assisted laparoscopy. Demco, LA.[2023]

A new 3-D numerical model of the pelvic cavity was created using magnetic resonance images, which helps in understanding the complex anatomy and mobility of the female pelvis.

This model allows for the non-destructive identification of pelvic structures, paving the way for better diagnosis and treatment of pelvic imbalances in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simulation of normal pelvic mobilities in building an MRI-validated biomechanical model. Cosson, M., Rubod, C., Vallet, A., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05909514

Investigating the Effectiveness of PelvicSense(R) on Pain ... This study will examine the effectiveness of the PelvicSense 3-month online program on pain and other outcomes in those with provoked vestibulodynia. This ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0002937824008275

Systematic Reviews Effectiveness of nonpharmacological ... This systematic review with meta-analysis revealed that multimodal physical therapy is effective in women with chronic pelvic pain with a high certainty of ...

3. ctv.veeva.com ctv.veeva.com/study/investigating-the-effectiveness-of-pelvicsense-r-on-pain-and-sexual-outcomes-in-provoked-vestibulod

Investigating the Effectiveness of PelvicSense(R) on Pain and ... This study will examine the effectiveness of the PelvicSense 3-month online program on pain and other outcomes in those with provoked

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12085484/

Vulvodynia and Chronic Vulvar Pain: Influencing Factors and ... This study provides evidence for the long-term effectiveness of TLA in women with vulvodynia, as well as potential obstacles to healing.

5. auctoresonline.org auctoresonline.org/article/significant-improvement-noted-in-vulvodynia-when-pelvic-neurogenic-inflammation-is-addressed

Significant Improvement Noted in Vulvodynia when Pelvic ... The most significant improvements were seen with intercourse, sleeping, and bladder symptoms. As our protocol directly treats the pelvic nerve inflammation and ...

6. scispace.com scispace.com/pdf/long-term-efficacy-of-physical-therapy-for-localized-33ifgaq9hm.pdf

long-term-efficacy-of-physical-therapy-for-localized- ... This study included women diagnosed with PV and referred by their primary physicians to Maccabi physical therapy clinic for physical therapy for pelvic floor ...

7. researchgate.net researchgate.net/publication/396012553_Vulvodynia_still_a_dramatically_neglected_condition_A_position_statement_on_pathogenetic_mechanisms_from_the_Italian_Society_of_Andrology_and_Sexual_Medicine_SIAMS

Vulvodynia: still a dramatically neglected condition. ... 8–10% of women experience vulvar pain. We aim to summarize the current literature on pathogenetic mechanisms of vulvodynia, and highlight ...

8. pelvicsense.com pelvicsense.com/

PelvicSense Learn pain science and self-healing skills to enhance recovery from chronic pelvic pain by a Master Clinician of Pelvic Physical Therapy.

9. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/10.1111/jog.15829

Individualized multidisciplinary therapy for vulvodynia - 2024 Our study is a pioneer in the development of models that allow the individualization of multidisciplinary therapy for vulvodynia.