Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Pain intensity with Brief pain inventory (BPI) |
Intensity of pain measured with BPI using the mean of the 4 subscales (current, averaged, maximum and minimum pain during the last week) on a 0-10 numerical rating scale (0 minimum and 10 maximum pain) |
Baseline, 3 months and 6 months (change) |
|
Secondary |
Pain intensity with Brief pain inventory (BPI) |
Intensity of pain measured with BPI using the mean of the 4 subscales (current, averaged, maximum and minimum pain during the last week) on a 0-10 numerical rating scale (0 minimum and 10 maximum pain) |
Baseline, 3 months, 6 months and 12 months (change) |
|
Secondary |
Pain intensity with tampon test |
Intensity of pain with tampon insertion and removal (tampon test) measured on a 0-10 numerical rating scale (0 minimum and 10 maximum pain) |
Baseline and 6 months (change) |
|
Secondary |
Pain intensity with tampon test |
Intensity of pain with tampon insertion and removal (tampon test) measured on a 0-10 numerical rating scale (0 minimum and 10 maximum pain) |
Baseline, 6 months and 12 months (change) |
|
Secondary |
Vulvar pressure pain threshold with vulvalgesiometer |
Vulvar pressure pain threshold in Newton measured with a cotton tipped vulvalgesiometer |
Baseline and 6 months (change) |
|
Secondary |
Vulvar pressure pain threshold with vulvalgesiometer |
Vulvar pressure pain threshold in Newton measured with a cotton tipped vulvalgesiometer |
Baseline, 6 months and 12 months (change) |
|
Secondary |
Pain intensity with Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) |
Pain intensity measured by a 22-Item NRS-based (0-10) questionnaire (SF-MPQ-2). Both total and subscale (continuous, intermittent, neuropathic, and affective pain) mean scores. |
Baseline and 6 months (change) |
|
Secondary |
Pain intensity with Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) |
Pain intensity measured by a 22-Item NRS-based (0-10) questionnaire (SF-MPQ-2). Both total and subscale (continuous, intermittent, neuropathic, and affective pain) mean scores. |
Baseline, 6 months and 12 months (change) |
|
Secondary |
Sexual distress with Female Sexual Distress Scale - revised (FSDS) |
Sexual distress measured with a 13-item Likert scale-based (0-4) questionnaire (FSDS). Mean score. |
Baseline and 6 months (change) |
|
Secondary |
Sexual distress with Female Sexual Distress Scale - revised (FSDS) |
Sexual distress measured with a 13-item Likert scale-based (0-4) questionnaire (FSDS). Mean score. |
Baseline, 6 months and 12 months (change) |
|
Secondary |
Affective symptoms with Hospital Anxiety and Depression Scale (HADS) |
Affective symptoms measured with a 14-item Likert scale-based (0-3) questionnaire (HADS). Both total and subscale (depression and anxiety) scores. |
Baseline and 6 months (change) |
|
Secondary |
Affective symptoms with Hospital Anxiety and Depression Scale (HADS) |
Affective symptoms measured with a 14-item Likert scale-based (0-3) questionnaire (HADS). Both total and subscale (depression and anxiety) scores. |
Baseline, 6 months and 12 months (change) |
|
Secondary |
Illness perception with Brief Illness Perception Questionnaire (BIPQ) |
Illness perception measured with a 8-Item NRS-based (0-10) questionnaire. Mean score of total scale. |
Baseline and 6 months (change) |
|
Secondary |
Illness perception with Brief Illness Perception Questionnaire (BIPQ) |
Illness perception measured with a 8-Item NRS-based (0-10) questionnaire. Mean score of total scale. |
Baseline, 6 months and 12 months (change) |
|
Secondary |
Pain catastrophizing with Pain Catastrophizing Scale (PCS) |
Pain catastrophizing measured with a 13-Item Likert scale-based (0-4) questionnaire (PCS). Total score. |
Baseline and 6 months (change) |
|
Secondary |
Pain catastrophizing with Pain Catastrophizing Scale (PCS) |
Pain catastrophizing measured with a 13-Item Likert scale-based (0-4) questionnaire (PCS). Total score. |
Baseline, 6 months and 12 months (change) |
|
Secondary |
Levator hiatal area |
Ultrasound-measured difference in levator hiatal area (cm^2) between rest and contraction and between rest and valsalva maneuver |
Baseline and 6 months (change) |
|
Secondary |
Levator hiatal area |
Ultrasound-measured difference in levator hiatal area (cm^2) between rest and contraction and between rest and valsalva maneuver |
Baseline, 6 months and 12 months (change) |
|