Vestibulectomy Techniques for Vulvodynia

Overseen By Women's Health Research Unit Confidential Recruitment Line

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Disqualifiers: Pregnancy, Endometriosis, Chronic pelvic pain, others

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

Compensation: Varies

Number of Visits: 4

118 Participants Needed

Trial Summary

What is the purpose of this trial?

Vestibulectomy Surgical Techniques Comparison Study

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Vestibulectomy Techniques for Vulvodynia?

Research shows that modified vestibulectomy is a simple and effective surgery for treating vulvar vestibulitis, and vestibulectomy is one of the few proven treatments for provoked vulvodynia, with studies indicating both short-term and long-term success. ^{1 2 3 4 5}

How is the vestibulectomy treatment for vulvodynia different from other treatments?

Vestibulectomy is unique because it is one of the only proven surgical treatments specifically for provoked vulvodynia, focusing on removing painful tissue in the vulvar area. This approach is different from other treatments that may involve medication or physical therapy, as it directly addresses the source of pain through surgery. ^{1 2 3 5 6}

Research Team

Catherine Leclair, MD

Principal Investigator

Oregon Health and Science University

Eligibility Criteria

This trial is for adults over 18 with vulvodynia, experiencing tenderness in the vestibule area for at least 3 months. Participants must have a certain level of pain during cotton swab and tampon tests, access to phone and internet, and be willing to undergo pelvic floor physical therapy. Those who've had previous vestibulectomy or hymen surgery, use testosterone for gender affirmation, are pregnant, or have other causes of dyspareunia like endometriosis can't join.

Inclusion Criteria

Baseline Tampon Test verbal pain score ≥430

I am over 18, not pregnant, and have had pain in the vulvar area for at least 3 months.

Phone and internet access

Exclusion Criteria

Pregnancy

I have had surgery on my vestibule or hymen.

Unable or unwilling to complete baseline assessments

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo either traditional or modified vestibulectomy surgery

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in pain scores using the Tampon Test at 3, 6, and 12 months after surgery

12 months

3 visits (in-person)

Treatment Details

Interventions

• Modified Technique
• Traditional Technique

Trial Overview The study compares two surgical techniques used in vestibulectomy (surgery for vulvodynia) - the Traditional Technique versus a Modified Technique. The goal is to see which method provides better outcomes for patients suffering from this condition.

Participant Groups

Group I: Traditional Vestibulectomy Active Control 1 Intervention

Group II: Modified Vestibulectomy Active Control 1 Intervention

Modified Technique is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Vestibulectomy for:

• Provoked Vestibulodynia
• Vulvar Pain Disorders

Approved in United States as Vestibulectomy for:

• Provoked Vestibulodynia
• Vulvar Pain Disorders

Approved in Canada as Vestibulectomy for:

• Provoked Vestibulodynia
• Vulvar Pain Disorders

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

Findings from Research

In a study of 59 patients with vulvar vestibulitis who did not respond to nonsurgical treatments, a simple modified vestibulectomy resulted in a 73.6% complete response rate, indicating its effectiveness as a surgical option.

The modified vestibulectomy is less invasive and technically simpler than more extensive surgical methods, yet it provides comparable postoperative outcomes, making it a favorable choice for treating this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modified vulvar vestibulectomy: simple and effective surgery for the treatment of vulvar vestibulitis. Lavy, Y., Lev-Sagie, A., Hamani, Y., et al.[2006]

Vestibulectomy, performed on patients with provoked vulvodynia (PVD) 12-24 years prior, resulted in a significant reduction in penetration pain from an average of 9.13 to 0.47 on a scale of 0-10, demonstrating its long-term efficacy.

The majority of participants (94%) reported high satisfaction with the surgery, and 97% would choose to undergo the procedure again, indicating strong support for vestibulectomy as a treatment option for PVD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Long-Term Surgical Success and Satisfaction of Patients After Vestibulectomy. David, A., Bornstein, J.[2021]

In a study of 202 women treated with modified vestibulectomy for localized provoked vestibulodynia, 90.4% of those who attempted tampon insertion after surgery reported moderate to substantial improvement in pain.

Among patients who experienced pain during intercourse before surgery, 84.1% reported similar improvements post-surgery, indicating that modified vestibulectomy is an effective long-term treatment with high patient satisfaction and minimal complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Localized provoked vestibulodynia: outcomes after modified vestibulectomy. Swanson, CL., Rueter, JA., Olson, JE., et al.[2022]

In a study of 24 patients with incapacitating Meniere disease, vestibular neurectomy effectively eliminated vertigo crises in all but one patient, demonstrating a high success rate for this surgical intervention.

Vestibular evaluations showed complete loss of function on the operated side, confirming that vestibular neurectomy can achieve total vestibular deafferentation, which is crucial for understanding the surgery's efficacy and potential complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vestibular function outcomes after vestibular neurectomy in Meniere disease: can vestibular neurectomy provide complete vestibular deafferentation? Leveque, M., Seidermann, L., Tran, H., et al.[2010]

The retrolabyrinthine approach for vestibular neurectomy or vascular loop decompression is a significant advancement in surgical techniques for treating vertigo, as highlighted in updated research since the original 1981 publication.

Preliminary reports suggest promising outcomes with this new technique, indicating a need for further research to fully understand its efficacy and safety in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgery for vertigo: update 1985. Hughes, GB., Hahn, JF.[2004]

Selective vestibular nerve section is highly effective in controlling vertigo for patients with Menière's disease, and the retrosigmoid intracanalicular approach is a promising alternative to the more commonly used retrolabyrinthine method.

The paper reviews the surgical technique and rationale for this new approach, along with initial results and complications observed during the first 18 months of its use, indicating a focus on improving patient outcomes in vestibular surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrosigmoid intracanalicular vestibular nerve section: an alternative surgical approach for Menière's disease. Millen, SJ., Meyer, G.[2007]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Modified vulvar vestibulectomy: simple and effective surgery for the treatment of vulvar vestibulitis. [2006]

2. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Long-Term Surgical Success and Satisfaction of Patients After Vestibulectomy. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Localized provoked vestibulodynia: outcomes after modified vestibulectomy. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Vestibular function outcomes after vestibular neurectomy in Meniere disease: can vestibular neurectomy provide complete vestibular deafferentation? [2010]

5. United States pubmed.ncbi.nlm.nih.gov

Surgery for vertigo: update 1985. [2004]

6. United States pubmed.ncbi.nlm.nih.gov

Retrosigmoid intracanalicular vestibular nerve section: an alternative surgical approach for Menière's disease. [2007]