Feasibility Study for Provoked Vestibulodynia

Status Completed

Clinical Trial Summary

The feasibility and acceptability of a somatosensory rehabilitation program and an educational pain management program will be investigated in women with provoked vestibulodynia. Forty-four women will be randomized into the two groups. The secondary objective is to explore the effects of the somatosensory rehabilitation program compared to the pain management program. Each participant will receive 12 weekly sessions with a physiotherapist. The somatosensory rehabilitation program includes minimizing contact with the painful zone of the vulva and uses repeated tactile stimulation at a tolerated distance, proximal to the vulva. The pain management program includes teaching participants about vulvar hygiene, chronic pain mechanisms, relaxation techniques, and approaches to reduce skin irritations in painful regions. Participants in both groups will also receive advice on sexual function and steps toward resuming sexual activities with vaginal penetration. Feasibility and acceptability outcomes will be assessed and analyzed using descriptive statistics for the adherence rates to treatment sessions and home exercises, the recruitment rate, retention rate, satisfaction, and adverse effects. The results will be compared to predetermined thresholds to determine the feasibility and acceptability of a future clinical trial. Secondary measures will be assessed at baseline, two weeks after the treatment, and at three months follow-up. These outcomes will be assessed using validated questionnaires (pain, sexual function, global impression of change, psychological variables, quality of life) as well as evaluations of tactile and pressure sensitivity in vulvar regions using monofilaments, a 2-point aesthesiometer and an algometer. Linear mixed models for repeated measurements (2 groups, 3 measurement times) will be used to explore the treatment effects and will contribute to determining the feasibility of a future clinical trial. Hypothesis and expected results: It is expected that both programs will meet the pre-determined criteria for acceptability and feasibility in women with provoked vestibulodynia. This study will provide guidance for a future randomized clinical trial.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05342402
Study type	Interventional
Source	Université de Sherbrooke
Contact
Status	Completed
Phase	N/A
Start date	May 16, 2022
Completion date	July 31, 2023

View Details

See also
Status	Clinical Trial	Phase
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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
Active, not recruiting	`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
Not yet 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
Withdrawn	`NCT03390049` - Randomized CO2 vs Sham Laser Treatment of Provoked Vestibulodynia	N/A
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.