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Feasibility Study for Provoked Vestibulodynia

N/A

Waitlist Available

Research Sponsored by Université de Sherbrooke

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change in the scores from pre- to 2-week post-treatment, from 2-week post-treatment to 3-month post-treatment, and from pre-treatment to 3-month post-treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing two programs to help women with chronic vulva pain. One program uses gentle touch near the painful area to reduce sensitivity, while the other teaches about hygiene, pain, and relaxation. The goal is to see if these programs are practical and helpful for these women.

Eligible Conditions

Vulvodynia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change in the surface from pre- to 2-week post-treatment, from 2-week post-treatment to 3-month post-treatment, and from pre-treatment to 3-month post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change in the surface from pre- to 2-week post-treatment, from 2-week post-treatment to 3-month post-treatment, and from pre-treatment to 3-month post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and change in the surface from pre- to 2-week post-treatment, from 2-week post-treatment to 3-month post-treatment, and from pre-treatment to 3-month post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adherence rate to assessment sessions

Adherence rate to home exercises

Patients' adherence rate to treatment sessions

+3 more

Secondary study objectives

12-item Short Form Survey (SF-12 v2)

Adverse events

Beck Depression Inventory questionnaire (BDI-II)

+16 more

Other study objectives

Short-Leeds Assessment for Neuropathic Symptoms and Signs (S-LANSS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Somatosensory Rehabilitation ProgramExperimental Treatment1 Intervention

Includes minimizing contact with the painful zone of the vulva and uses tactile stimulation at a tolerated distance from the vulva. Each participant will also receive advice on resuming sexual activities with vaginal penetration.

Group II: Educational Pain Management Program (PMP)Active Control1 Intervention

Includes education on decreasing irritative contacts with the vulva and relaxation techniques. Each participant will also receive advice on resuming sexual activities with vaginal penetration.

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