Randomized CO2 vs Sham Laser Treatment of Provoked Vestibulodynia

Status Withdrawn

Clinical Trial Summary

Vulvodynia is a debilitating chronic vulvar pain lasting at least 3 months without a clear identifiable cause that is challenging to treat effectively. Vulvodynia is a common pain condition: its prevalence is estimated at 7-8% in women between the ages of 18 and 40. Vulvodynia that is provoked and localized to the vestibule (provoked vestibulodynia [PVD]) appears to be the most commonly seen in clinical practice. The current treatment approach for PVD follows a trial-and-error strategy from one intervention to another if symptoms fail to remit. Treatment options include reducing vulvar irritation (e.g., by stopping the use of detergents), topical agents (e.g., lidocaine), oral medications, pelvic floor physical therapy, psychotherapy, locally injectable agents (e.g., botulinum toxin A), and surgery (vestibulectomy). Despite the number of available treatment options, treatment failure is common.

Fractional carbon-dioxide (CO2) laser is a technology widely used in dermatology for the treatment of various skin conditions. It has also been found to be an effective and safe treatment modality for symptoms of the genitourinary syndrome of menopause. A recent pilot study explored the use of fractional CO2 laser for the treatment of vestibulodynia in 37 subjects, 67.6% of which reported that their symptoms were "improved" or "very improved" after 3 fractional CO2 laser sessions. In addition, the subjects reported statistically-significant decreases in vulvar pain and dyspareunia scores. Though the results of this pilot study are promising, it was of small sample size and did not control for the placebo effect. In cases of PVD, the placebo effect has been found to have a significant impact on self-reported outcomes. Sham procedures, when performed correctly, can be ethically administered and can significantly reduce study bias.

The primary aim of this study, therefore, is to assess the difference in vulvar pain intensity scores, at baseline and at 6, 12, 16, and 24 weeks post-randomization, in women with refractory PVD assigned to fractional CO2 laser vs sham laser. This study will provide information about the efficacy of this treatment modality in women with a challenging clinical condition. Hypothesis: Administration of 3 sessions of fractional carbon-dioxide laser to the vulvar vestibule of women with refractory provoked vestibulodynia will result in a clinically-significant greater reduction in vulvar pain intensity scores than placebo (sham laser).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03390049
Study type	Interventional
Source	Wake Forest University Health Sciences
Contact
Status	Withdrawn
Phase	N/A
Start date	August 2018
Completion date	November 2019

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05478746` - Effects of Flourish HEC on Localized Provoked Vulvodynia	N/A
Completed	`NCT01455350` - Efficacy of a Physiotherapy Treatment in Women Suffering From Provoked Vestibulodynia	N/A
Completed	`NCT01304589` - Savella in Treatment for Provoked Vestibulodynia	Phase 3
Completed	`NCT03844412` - Vestibulodynia: Understanding Pathophysiology and Determining Appropriate Treatments	Phase 2
Completed	`NCT02858219` - A Pilot Study of the Effects of Botulinum Toxin in the Treatment of Provoked Vestibulodynia	Phase 3
Completed	`NCT01582373` - Pilot Study to Assess the Efficacy of Cognitive-behavioral Couple Therapy for Provoked Vestibulodynia	N/A
Completed	`NCT05342402` - Feasibility Study for Provoked Vestibulodynia	N/A
Recruiting	`NCT05805696` - Treatment and Mapping of Impostor Phenomenon	N/A
Completed	`NCT01935063` - Study to Compare the Efficacy of Cognitive-behavioral Couple Therapy and Lidocaine for Provoked Vestibulodynia	N/A
Completed	`NCT02204319` - Cold Laser: A Modality to Promote Vulvar Healing and Pain Relief	N/A
Completed	`NCT02858375` - Long-Term Assessment of Quality of Life and Effectiveness of Onabotulinumtoxina Injections in Provoked Vestibulodynia	N/A
Completed	`NCT02362763` - The Use of Acupuncture for the Treatment of Vulvar Vestibulitis	N/A
Withdrawn	`NCT01741948` - Hormonal Contraceptive Use and the Risk of Provoked Vestibulodynia	N/A
Terminated	`NCT02854670` - A Study of the Effects of Topical Capsaicin in the Treatment of Provoked Vestibulodynia	Phase 2/Phase 3
Recruiting	`NCT04613713` - Somatocognitive Therapy in Treatment of Provoked (Localized) Vestibulodynia - Randomized Clinical Trial (ProLoVe Study)	N/A
Terminated	`NCT01295268` - Study of Emu Oil vs. Placebo for Vulvar Pain in Women.	N/A
Terminated	`NCT03682601` - Sexual Penetration Pain in Postmenopausal Women: A Topical Botanical Drug Treatment	Phase 2
Completed	`NCT00496184` - Efficacy Study of Topical Application of Nifedipine Cream to Treat Vulvar Vestibulitis	Phase 3
Completed	`NCT03431779` - Lipofilling as a Treatment for Vestibulodynia	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.