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Lasertherapy for Vulvodynia (Lydia)

Primary Purpose

Vulvodynia

Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Erbium:Yag laser
Sham Erbium:Yag laser
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vulvodynia focused on measuring Erbium:Yag laser

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women with vulvodynia (diagnosed according to the 2015 Consensus Terminology)
  • multidisciplinary treatment for at least 3 months
  • Informed consent

Exclusion Criteria:

  • Current genital infection (i.e. candidiasis, herpes )
  • Inflammatory vulvar disease/ dermatosis (i.e. lichen sclerosus, lichen planus)
  • Neoplastic vulvar disease (e.g. HSIL Vulva, Paget disease)
  • Recent vulvar trauma (i.e. bleeding, erosion or ulceration)
  • Pudendal neuralgia
  • Pregnancy, delivery <6 months
  • Epilepsy or major neurologic or psychiatric morbidity
  • Active systemic infection
  • Previous treatment with ionizing radiation in the area to be treated
  • History of wound healing disorders (i.e. hyperpigmentation, abnormal scarring)
  • Fever
  • Systemic or local autoimmune disorders
  • History of photosensitivity disorder

Sites / Locations

  • Department of Obstetrics and Gynecology/ Medical University of GrazRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Intervention group (laser therapy)

Control group (sham laser therapy)

Arm Description

Participants allocated to the laser-therapy group will receive 2 laser treatments over a period of 3 months. Laser therapy will be performed according to a standardized protocol.

Participants allocated to the control group will receive 2 sham laser treatments over a period of 3 months. Laser therapy will be performed according to a standardized protocol.

Outcomes

Primary Outcome Measures

Change of Vestibular pain index
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

Secondary Outcome Measures

Change of pelvic floor muscle (PFM) function- PFM contraction strength
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).
Change of pelvic floor muscle (PFM) function- PFM tone
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.
Change of levator hiatal dimensions at rest
3D perineal ultrasound will be used to measure levator hiatal dimensions at rest
Change of levator hiatal dimensions at maximal voluntary contraction
3D perineal ultrasound will be used to measure levator hiatal dimensions at maximal voluntary contraction
Change of levator hiatal dimensions at maximal Valsalva maneuver
3D perineal ultrasound will be used to measure levator hiatal dimensions at maximal Valsalva maneuver
Change of Vaginal health score index (VHSI)
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.
Change of Sexual activity
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.
Change of Sexual Function
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.
Change in Endometriosis Health Profile (EHP-30)
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.
Change in German Pain Assessment (assessed by Deutscher Schmerzfragebogen/DSF)
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.
Change in Patient Health Questionnaire (PHQ-D)
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
Change in Pain sensitivity questionnaire (PSQ)
The PSQ is an instrument for the assessment of pain sensitivity based on pain intensity self ratings of daily life situations
Change in Patient Global Impression of Improvement (PGI-I)
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.
Change in Patient treatment satisfaction
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
Change in Treatment discomfort
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"
Change in Treatment pain
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".

Full Information

First Posted
December 15, 2020
Last Updated
July 6, 2023
Sponsor
Medical University of Graz
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1. Study Identification

Unique Protocol Identification Number
NCT04711369
Brief Title
Lasertherapy for Vulvodynia
Acronym
Lydia
Official Title
Lasertherapy for Vulvodynia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2021 (Actual)
Primary Completion Date
June 15, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study aims to assess the efficacy, acceptance and safety profile of vulvovaginal laser therapy in women with vulvodynia.
Detailed Description
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 will lead to more improvement of Sexual Health and HrQoL will have similar rates of side effects

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvodynia
Keywords
Erbium:Yag laser

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized double blinded sham-controlled clinical study
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Sham-controlled
Allocation
Randomized
Enrollment
92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group (laser therapy)
Arm Type
Active Comparator
Arm Description
Participants allocated to the laser-therapy group will receive 2 laser treatments over a period of 3 months. Laser therapy will be performed according to a standardized protocol.
Arm Title
Control group (sham laser therapy)
Arm Type
Sham Comparator
Arm Description
Participants allocated to the control group will receive 2 sham laser treatments over a period of 3 months. Laser therapy will be performed according to a standardized protocol.
Intervention Type
Device
Intervention Name(s)
Erbium:Yag laser
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham Erbium:Yag laser
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of Vestibular pain index
Description
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).
Secondary Outcome Measure Information:
Title
Change of pelvic floor muscle (PFM) function- PFM contraction strength
Description
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).
Title
Change of pelvic floor muscle (PFM) function- PFM tone
Description
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).
Title
Change of levator hiatal dimensions at rest
Description
3D perineal ultrasound will be used to measure levator hiatal dimensions at rest
Time Frame
Baseline and final assessment (3 months).
Title
Change of levator hiatal dimensions at maximal voluntary contraction
Description
3D perineal ultrasound will be used to measure levator hiatal dimensions at maximal voluntary contraction
Time Frame
Baseline and final assessment (3 months).
Title
Change of levator hiatal dimensions at maximal Valsalva maneuver
Description
3D perineal ultrasound will be used to measure levator hiatal dimensions at maximal Valsalva maneuver
Time Frame
Baseline and final assessment (3 months).
Title
Change of Vaginal health score index (VHSI)
Description
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).
Title
Change of Sexual activity
Description
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).
Title
Change of Sexual Function
Description
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).
Title
Change in Endometriosis Health Profile (EHP-30)
Description
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).
Title
Change in German Pain Assessment (assessed by Deutscher Schmerzfragebogen/DSF)
Description
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).
Title
Change in Patient Health Questionnaire (PHQ-D)
Description
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).
Title
Change in Pain sensitivity questionnaire (PSQ)
Description
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).
Title
Change in Patient Global Impression of Improvement (PGI-I)
Description
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).
Title
Change in Patient treatment satisfaction
Description
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
Baseline and final assessment (3 months).
Title
Change in Treatment discomfort
Description
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
Title
Change in Treatment pain
Description
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".
Time Frame
Twice after treatment, one and two months after baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women with vulvodynia (diagnosed according to the 2015 Consensus Terminology) multidisciplinary treatment for at least 3 months Informed consent Exclusion Criteria: Current genital infection (i.e. candidiasis, herpes ) Inflammatory vulvar disease/ dermatosis (i.e. lichen sclerosus, lichen planus) Neoplastic vulvar disease (e.g. HSIL Vulva, Paget disease) Recent vulvar trauma (i.e. bleeding, erosion or ulceration) Pudendal neuralgia Pregnancy, delivery <6 months Epilepsy or major neurologic or psychiatric morbidity Active systemic infection Previous treatment with ionizing radiation in the area to be treated History of wound healing disorders (i.e. hyperpigmentation, abnormal scarring) Fever Systemic or local autoimmune disorders History of photosensitivity disorder
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gerda Trutnovsky, MD
Phone
+43 316 385
Ext
81081
Email
gerda.trutnovsky@medunigraz.at
First Name & Middle Initial & Last Name or Official Title & Degree
Karl Tamussino, MD
Phone
+43 316 385
Ext
81068
Email
karl.tamussino@medunigraz.at
Facility Information:
Facility Name
Department of Obstetrics and Gynecology/ Medical University of Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerda Trutnovsky, MD
Phone
+43 316 385
Ext
81081
Email
gerda.trutnovsky@medunigraz.at
First Name & Middle Initial & Last Name & Degree
Daniela Gold, MD
Phone
+43 316 385
Ext
81437
Email
daniela.gold@medunigraz.at
First Name & Middle Initial & Last Name & Degree
Gerda Trutnovsky, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Lasertherapy for Vulvodynia

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