NCT Number: NCT04711369
The study aims to assess the efficacy, acceptance and safety profile of vulvovaginal laser therapy in women with vulvodynia.
Interested in participating?
Request Info18 year–80 year
Female
Interventional
Not applicable
Graz, 8036, Austria
Location status: Recruiting
Daniela Gold, MD
CONTACT
+43 316 385 ext. 81437
Gerda Trutnovsky, MD
CONTACT
+43 316 385 ext. 81081
Gerda Trutnovsky, MD
PRINCIPAL_INVESTIGATOR
Randomized double blinded sham-controlled clinical study
Main hypothesis:
Laser therapy will be more effective than sham laser therapy in vulvar pain reduction measured by Q-tip test and tampon test
Secondary study hypotheses Laser therapy, in comparison to sham laser therapy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Vulvovaginal laser therapies will be performed with the non-ablative 2940 nm Er:YAG laser (Smooth XS, Fotona, Slovenia) in the Renova mode according to the manufacturer's guidelines and recommendations. The spot size (diameter of the laser beam) is 7 mm, with a pulse at a frequency of 1.6 Hz, and a fluence (laser energy delivered per unit area) of 5.0 to 10.0 J/cm2.
All sensitive/painful areas of the introitus will be treated, using 1-3 repetitions.
In postmenopausal women with signs of atrophy, additional irradiation of the vaginal wall will be performed.
Clinical examination and preparations will be identical to the intervention group. Sham laser treatments will be performed with the same laser and the same procedures. However, a specially devised placebo probe with a steel shutter, which blocks the emission of radiation, will be used. Women will therefore receive no therapeutic irradiation. Before treatment, a study assistant, who is aware of the study allocation, will prepare the laser with the placebo probe, which looks identically to the "normal" probe. The treating physician will not be aware of the study allocation and the type of probe in use.
Time frame: Baseline and final assessment (3 months).
The Vestibular pain index is derived from the Q-tip test and the tampon test. A standardized Q-Tip test (MRC Systems GmbH, Heidelberg, Germany), developed for quantitative sensoric testing, will be used. Pain on six defined anatomical regions of the vulvar vestibule (at 2 ,5,6,7,10 and 12 o clock) will be assessed. Patients will be asked to rate the level of vulvar pain on a numeric rating scale (NRS) of 0 "none at all" to 10 "worst imaginable".
The tampon test is a standardized tampon insertion and removal test.
The vestibular pain index will be calculated as follows:
(mean NRS score of the standardized Q-tip test (6 sites) + NRS score during the tampon test) / 2
Time frame: Baseline and final assessment (3 months).
The Modified Oxford Scale (MOS) will be used to score maximal PFM contraction strength, ranging from 0 (no contraction) to 5 (strong contraction and lift).
Time frame: Baseline and final assessment (3 months).
PFM tone will be scored on a 7-point PFM tone scale ranging from -3 (very hypotonic) to +3 (very hypertonic), with 0 representing a "normal" pelvic muscle tone.
Time frame: Baseline and final assessment (3 months).
3D perineal ultrasound will be used to measure levator hiatal dimensions at rest
Time frame: Baseline and final assessment (3 months).
3D perineal ultrasound will be used to measure levator hiatal dimensions at maximal voluntary contraction
Time frame: Baseline and final assessment (3 months).
3D perineal ultrasound will be used to measure levator hiatal dimensions at maximal Valsalva maneuver
Time frame: Baseline and final assessment (3 months).
In postmenopausal women the VHSI will be performed to assess elasticity, fluid volume, pH, epithelial integrity and a moisture on a scale from 1 (none) to 5 (excellent) each. The sum score will be recorded.
Time frame: Baseline and final assessment (3 months).
Participants will be asked to complete a study diary and record whether they experienced sexual intercourse. Possible answers are: #1-"No, too painful" indicating that the woman could not accept an approach to physical intimacy because of pain, #2 -"No, not interested", indicating that the subject was not in the mood for sexual intimacy, #3-"No,no opportunity", indicating that her partner was not available, #4-"Yes" meaning that an attempt at sexual intercourse was made. If intercourse was attempted the level of pain during intercourse should be rated on a 0 - 10 NRS pain scale.
Time frame: Baseline and final assessment (3 months).
The German version of the Female Sexual Function Index (FSFI-d) will be used to assess women´s sexuality. The validated 19-item questionnaire examines several aspects of female sexuality, i.e. sexual arousal, orgasm and dyspareunia.
Time frame: Baseline and final assessment (3 months).
The EHP-30 consists of five scales -pain, control and powerlessness, emotional well-being, social support, and self-image (30 items) and a module with 23 items. The modular part consists of six scales - work, relationship with children, sexual intercourse, infertility, medical profession, and treatment.
Time frame: Baseline and final assessment (3 months).
The DSF was developed for the comprehensive assessment and therapy planning of patients with chronic pain conditions. The modules on pain assessment (e.g. pain characteristics, relieving and aggravating factors) and on demographic information will be used.
Time frame: Baseline and final assessment (3 months).
The PHQ-D is a sensitive screening tool for detecting depressive symptoms in a general patient population. The 9-item tool assesses the degree and severity of depression, and has been found to be a valid and useful tool for therapy evaluation
Time frame: Baseline and final assessment (3 months).
The PSQ is an instrument for the assessment of pain sensitivity based on pain intensity self ratings of daily life situations
Time frame: Baseline and final assessment (3 months).
The Patient Global Impression of Improvement (PGI-I), a valid instrument with a 7-step Likert type response scale, will be used to assess subjective improvement after treatment. After three months, i.e. one month after the second laser therapy, women will be asked to rate the change in vulvar pain.
Time frame: Baseline and final assessment (3 months).
Treatment satisfaction will be assessed using an adopted version of the "Fragebogen zur Patientenzufriedenheit - ZUF8". The questionnaire, the German version of the original "Client Satisfaction Questionnaire-CSQ8", is a tool for measuring global patient satisfaction at the end of inpatient treatment
Time frame: Twice after treatment, one and two months after baseline
At the end of each treatment session patients are asked to indicate the degree of discomfort during laser therapy on a NRS ranging from 0 "no discomfort" to 10 "worst possible discomfort"
Time frame: Twice after treatment, one and two months after baseline
At the end of each treatment session patients are asked to indicate the degree of pain during laser therapy on a NRS ranging from 0 "no pain" to 10 "worst possible pain".
Contact information is provided by the study sponsor or research team.
Gerda Trutnovsky, MD
CONTACT
+43 316 385 ext. 81081
Karl Tamussino, MD
CONTACT
+43 316 385 ext. 81068
Medical University of Graz
Other
Acronym: Lydia
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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