THE VULVA STUDY: Online psychotherapy and TENS@HOME for patients with provoked vulvodynia.

THE VULVA STUDY: Online psychotherapy and TENS@HOME for patients with provoked vulvodynia. - THE VULVA STUDY

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50940

Enrollment

Registered

2021-05-25

Start date

2024-01-01

Completion date

Unknown

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dyspareunia painful intercourse Vestibulodynia vulvodynia

Interventions

Transcutaneous electric nerve stimulation (TENS) Transcutaneous electrical nerve stimulation (TENS) is a therapy that uses low voltage electrical current to provide pain relief. A TENS unit consists

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: women (age > 18) diagnosed with provoked vestibulodynia, based on dyspareunia > / = 3 months and provoked pain at vestibulum vaginae.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Current active psychiatric disease, psychiatric history is no exclusion criterium - Gynecological malignancy (in history) - Current active vulvovaginal disease (eg. lichen sclerosis, infection) - Prior pelvic radiotherapy / brachytherapy - Neuromuscular disease - Presence of other electrical devices (pacemaker (ICD), neurostimulator) - Current pregnancy - History of cardiac arrhythmia - History of epilepsy

Design outcomes

Primary

Measure	Time frame
Primary outcome: Decrease of pain during (attempt to) penetration, measured by a decrease in visual analog scale (VAS) score (VAS score 0-10) with 3 points after 24 months (T24), compared to VAS score at randomization (T0)	—

Secondary

Measure	Time frame
Secondary outcomes: - VAS score during (attempt to) penetration after 3 months (T3), 6 months (T6), and 12 months (T12) compared to VAS score at randomization (T0) and at the end of follow-up (T24) - The use and therapy compliance: TENS and/or online psycho-education - Quality of life measured with validated questionnaires: pelvic floor distress inventory (PFDI-20), hospital anxiety and depression scale (HADS), sexual function and distress (FSFI and FSDS) and the global impression of improvement (PGI-I) - Patient would recommend the treatment to fellow patient: scale 1-5 - Patient feels autonomous in her treatment and recovery: scale 1-5 - Penetration is possible: Yes/No	—

Measure

Time frame

Secondary outcomes: - VAS score during (attempt to) penetration after 3 months (T3), 6 months (T6), and 12 months (T12) compared to VAS score at randomization (T0) and at the end of follow-up (T24) - The use and therapy compliance: TENS and/or online psycho-education - Quality of life measured with validated questionnaires: pelvic floor distress inventory (PFDI-20), hospital anxiety and depression scale (HADS), sexual function and distress (FSFI and FSDS) and the global impression of improvement (PGI-I) - Patient would recommend the treatment to fellow patient: scale 1-5 - Patient feels autonomous in her treatment and recovery: scale 1-5 - Penetration is possible: Yes/No

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)