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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two surgical techniques to determine which is more effective for treating vulvodynia, a condition causing pain in the vulva, especially when touched. The trial includes two groups: one undergoing a traditional surgery (Traditional Technique) and the other a modified version (Modified Technique). It targets individuals who have experienced painful tenderness in the vulva for at least three months and have a strong reaction to a cotton swab test in that area. Participants must be comfortable using tampons and willing to try pelvic floor physical therapy. As an unphased trial, this study allows participants to contribute to important research that may improve treatment options for vulvodynia.

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 prior data suggests that these vestibulectomy techniques are safe for vulvodynia?

Research has shown that both modified and traditional vestibulectomy methods are generally safe for treating vulvodynia, a chronic pain in the vulva area. Studies have found that the modified vestibulectomy is safe, with a manageable rate of complications, and many patients report long-term satisfaction. The traditional method is also effective, with few complications, most of which are minor and can be resolved. However, some rare cases of pudendal neuralgia, a nerve pain, have occurred with more extensive procedures. Overall, both methods are well-tolerated, and many patients experience positive results. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial comparing vestibulectomy techniques for vulvodynia because it could provide valuable insights into improving surgical outcomes for this challenging condition. Traditional vestibulectomy is a common approach, but this trial introduces a modified technique that might enhance recovery or effectiveness. By comparing these two techniques directly, the trial aims to identify potential benefits such as reduced pain, faster healing, or improved quality of life for patients. The findings might lead to refined surgical practices that offer better relief for those suffering from vulvodynia.

What evidence suggests that this trial's treatments could be effective for vulvodynia?

This trial will compare two surgical techniques for treating vulvodynia: the modified vestibulectomy and the traditional vestibulectomy. Research has shown that both surgeries effectively treat vulvodynia, a condition causing pain in the vulvar area. Studies indicate that the modified vestibulectomy completely relieves pain in about 74% of patients, with some experiencing partial improvement. The traditional technique also proves effective, with success rates ranging from 52% to 97%, depending on the criteria for success. Both methods carry a low risk of complications, and patients often report satisfaction after surgery. These findings suggest that both surgical techniques can significantly reduce vulvar pain for many patients. ^{2 4 6 7 8}

Who Is on the Research Team?

Catherine Leclair, MD

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

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

Phone and internet access

I am willing to participate in pelvic floor physical therapy.

Exclusion Criteria

Pregnancy

I have had surgery on my vestibule or hymen.

Unable or unwilling to complete baseline assessments

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/31809431/

Patient-Centered Outcomes After Modified Vestibulectomy

Vulvodynia patients report improvement in pain and high overall satisfaction after modified vestibulectomy, but more variable long-term effects on sexual ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0301211504004841

Modified vulvar vestibulectomy: simple and effective ...

Thirty-nine (73.6%) patients reported complete response, 7 (13.2%) had partial response, and 7 (13.2%) were non-responsive to surgery. Conclusion: Surgery is an ...

3.

aetna.com

aetna.com/cpb/medical/data/700_799/0759.html

Vulvodynia and Vulvar Vestibulitis Treatments

Thirty-nine (73.6 %) patients reported complete response, 7 (13.2 %) had partial response, and 7 (13.2 %) failed surgery. The authors concluded that surgery is ...

4.

obgyn.onlinelibrary.wiley.com

obgyn.onlinelibrary.wiley.com/doi/10.1111/j.1600-0412.2011.01248.x

Long‐term follow up of posterior vestibulectomy for treating ...

Ninety-one per cent were satisfied with the outcome. The VAS for dyspareunia decreased from a median of 9 to 3 (66.7% decrease; p<0.001).

5.

withpower.com

withpower.com/trial/phase-vulvodynia-5-2022-84a44

Vestibulectomy Techniques for Vulvodynia

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 ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6415354/

Combination of Treatments With or Without Surgery in ...

Vestibulectomy seems to be a safe treatment modality for LPV with an acceptable complication rate. This is in line with the previous review by Tommola et al.

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1553465016310135

Effect of Vestibulectomy for Intractable Vulvodynia

Measurements and Main Results. In this study we analyzed 31 patients' overall reported pain scores and Q-tip test scores before and after vestibulectomy.

8.

pelviperineology.org

pelviperineology.org/pdf/07d42497-fb2b-47e0-be2f-8805fa940376/articles/PPj.2021.40.02.2021-8-10/Pelviperineology-40-120-En.pdf

Surgical treatment for provoked vulvodynia

The complication rate is low, cosmetic results are good, and vaginal delivery seems possible. Vestibulectomy is a safe and effective treatment for vulvodynia ...