Provoked VestibulodyniaNCT04545255
The Use of Low Intensity Shock Wave Therapy for the Treatment of Provoked Vestibulodynia Disorder (PVD)
A study testing Shockwave treatment in people with Provoked Vestibulodynia, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Provoked vestibulodynia (PVD) is an exhausting pain syndrome that immensely affects quality of sexual life, and consequently negatively affects quality of life. Low intensity shock wave therapy produces physical forces that lead to pain relief. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Provoked Vestibulodynia
- What is being tested?
- Shockwave treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteIsrael
- Study dates
- 21 Jun 2018to 20 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Above age 18 years
- Diagnosis of provoked vestibulodynia by a gynecologist at least 3 month prior to study date
- Positive cotton swab test
- Pain during intercourse/ tampon insertion, gynecologic examination
- Cognitively and physically adapted for undergoing treatment
Who cannot join
- Pregnancy or lactating
- History of pelvic or external genitalia irradiation during the past year
- Any chronic neurological disorder causing local pain
- Any pelvic inflammatory process
- Any psychiatric disorders
- Investigators impression of patient being eligible for the study (non compliance etc..)
Trial locations and contacts
1 site in 1 country.
About this study
Provoked vestibulodynia (PVD) is an exhausting pain syndrome that immensely affects quality of sexual life, and consequently negatively affects quality of life. Low intensity shock wave therapy produces physical forces that lead to pain relief.
Aim: To evaluate the feasibility, safety and efficacy of low-intensity shockwave therapy in patients with provoked vestibulodynia.
Methods: A double-blinded, randomized, sham-controlled, prospective study of 32 women. The treatment protocol included a series of treatments, performed twice a week for 6 weeks. Each treatment consisted of 500 pulses of low intensity shockwaves (0.09 mJ/〖mm〗^2 ) using the "Medispec ED-1000®" shock wave generator or sham.
Read the detailed description
The study was a single center, double-blinded, randomized, sham-controlled, prospective study. Study eligibility criteria were treatment at the Neuro-urology Unit in Rambam Medical Center, during January 2018 - January 2020 and a diagnosis of PVD. PVD diagnosis was based on description of the pain and on a positive cotton swab test15.
Women were randomized at a 2:1 ratio to treatment or sham groups. The treatment protocol included a series of treatments, performed twice a week for 6 weeks, for a total of 12 sessions. Each treatment consisted of 500 pulses of low intensity shockwaves (0.09 millijoul/〖mm〗^2 ) using the "Medispec ED-1000®" shock wave generator. The sham protocol included the same treatment protocol without shock wave generator activation. The patients were evaluated three times throughout the trial by an investigator blinded to the group allocation: before the first treatment, and one and three months after the twelfth treatment. Pain was assessed by both subjective and objective measures. The primary outcome measure was a change in dyspareunia, as assessed by scores on the 10-point visual analogue scale (VAS) (range 0-10 ).
Secondary outcome measures for evaluating pain were increases in pain threshold and tolerance, assessed by a quantitative validated algometer test16, 17, the Wong-Baker pain FACES scale (range 0-10)18, the Female Sexual Function Index (FSFI) (range 2-38)19 and the Patients' Global Impression of Change scale (PGIC) (first component range 0-7; 0=no change, 7=a great deal better; second component range 0-10; 0=much better and 10=much worse)20. The PGIC assessed the self-reported impression of a general change due to the intervention.
The algometer applied was a very basic and simple device that was assembled and used at our unit after validating its safety, accuracy, and adequacy in evaluating introitus pain vs control (doctorate dissertation). For assessing the pain threshold with the algometer, radial pressure (mmHg) was applied by progressively inflating a cylindrical balloon inserted in the introitus. The participant was required to report the first painful sensation, and this pressure, defined as the threshold pressure, was registered. The measurement was performed sequentially 4 times and the average of the measured pressures was considered the first pain threshold). Finally, for pain tolerance measurement, the participant was again asked to report when she had reached her pain limit (1-10 on the verbal scale ) upon continuous pressure
- Conditions
- Provoked Vestibulodynia
- Being tested
- Shockwave treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shockwave treatmentDevice
ED 1000 shockwave generator
| Study group | Role | What they receive |
|---|---|---|
| active | Active comparator | A shockwave device with a probe that conveys shockwave energy Receives: Device: Shockwave treatment |
| sham | Sham comparator | A shockwave device with specially designed probe which has the shockwave energy blocked Receives: Device: Shockwave treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
The primary outcome was a change in dyspareunia, as assessed by scores on the 10-point Visual Analogue Scale where 1 is the minimum score meaning painless and 10 is the maximum score meaning excruciating pain
Measured: 1 year
Secondary outcomes (4)
Algometer testing
measures threshold of pain in mmHg, where any threshold below 100 mmHg is considered pathological
Measured: 1 year
Wong-Baker pain FACES scale
from a scale of 1 to five showing sad face for score 1 and very happy face for score 5
Measured: 1 year
Female Sexual Function Index (FSFI)
A validated questionnaire assessing female sexual dysfunction, any score above 22.5 is pathological
Measured: 1 year
Patients' Global Impression of Change scale.
one question with a scale from -3 to+3 where 0 is not better nor worse, -3 is much worse and +3 is much better
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start21 Jun 2018
- Primary completion30 Oct 2019
- Study completion20 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Provoked VestibulodyniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A double-blinded, randomized, sham-controlled, prospective study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, i_gruenwald, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04545255
- Sponsor's protocol ID
- 0098-18-rmc
- Status last verified
- Sep 2020
- First submitted
- 20 Aug 2020
- Last updated
- 10 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Landry T, Bergeron S, Dupuis MJ, Desrochers G. The treatment of provoked vestibulodynia: a critical review. Clin J Pain. 2008 Feb;24(2):155-71. doi: 10.1097/AJP.0b013e31815aac4d.
PubMed 18209522Sutton KS, Pukall CF, Chamberlain S. Pain, psychosocial, sexual, and psychophysical characteristics of women with primary vs. secondary provoked vestibulodynia. J Sex Med. 2009 Jan;6(1):205-14. doi: 10.1111/j.1743-6109.2008.01038.x.
PubMed 19170850
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Low Intensity Shock Wave Therapy for the Treatment of Provoked Vestibulodynia Disorder (PVD)
- ClinicalTrials.gov ID
- NCT04545255
- Acronym / sponsor ID
- 0098-18-rmc
- Conditions
- Provoked Vestibulodynia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 21 Jun 2018 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 20 Jan 2020 (actual)
- First posted
- 10 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Provoked vestibulodynia (PVD) is an exhausting pain syndrome that immensely affects quality of sexual life, and consequently negatively affects quality of life. Low intensity shock wave therapy produces physical forces that lead to pain relief.
Aim: To evaluate the feasibility, safety and efficacy of low-intensity shockwave therapy in patients with provoked vestibulodynia.
Methods: A double-blinded, randomized, sham-controlled, prospective study of 32 women. The treatment protocol included a series of treatments, performed twice a week for 6 weeks. Each treatment consisted of 500 pulses of low intensity shockwaves (0.09 mJ/〖mm〗^2 ) using the "Medispec ED-1000®" shock wave generator or sham.
Detailed description
The study was a single center, double-blinded, randomized, sham-controlled, prospective study. Study eligibility criteria were treatment at the Neuro-urology Unit in Rambam Medical Center, during January 2018 - January 2020 and a diagnosis of PVD. PVD diagnosis was based on description of the pain and on a positive cotton swab test15.
Women were randomized at a 2:1 ratio to treatment or sham groups. The treatment protocol included a series of treatments, performed twice a week for 6 weeks, for a total of 12 sessions. Each treatment consisted of 500 pulses of low intensity shockwaves (0.09 millijoul/〖mm〗^2 ) using the "Medispec ED-1000®" shock wave generator. The sham protocol included the same treatment protocol without shock wave generator activation. The patients were evaluated three times throughout the trial by an investigator blinded to the group allocation: before the first treatment, and one and three months after the twelfth treatment. Pain was assessed by both subjective and objective measures. The primary outcome measure was a change in dyspareunia, as assessed by scores on the 10-point visual analogue scale (VAS) (range 0-10 ).
Secondary outcome measures for evaluating pain were increases in pain threshold and tolerance, assessed by a quantitative validated algometer test16, 17, the Wong-Baker pain FACES scale (range 0-10)18, the Female Sexual Function Index (FSFI) (range 2-38)19 and the Patients' Global Impression of Change scale (PGIC) (first component range 0-7; 0=no change, 7=a great deal better; second component range 0-10; 0=much better and 10=much worse)20. The PGIC assessed the self-reported impression of a general change due to the intervention.
The algometer applied was a very basic and simple device that was assembled and used at our unit after validating its safety, accuracy, and adequacy in evaluating introitus pain vs control (doctorate dissertation). For assessing the pain threshold with the algometer, radial pressure (mmHg) was applied by progressively inflating a cylindrical balloon inserted in the introitus. The participant was required to report the first painful sensation, and this pressure, defined as the threshold pressure, was registered. The measurement was performed sequentially 4 times and the average of the measured pressures was considered the first pain threshold). Finally, for pain tolerance measurement, the participant was again asked to report when she had reached her pain limit (1-10 on the verbal scale ) upon continuous pressure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A double-blinded, randomized, sham-controlled, prospective study
| Arm | Type | Receives |
|---|---|---|
| active | Active comparator | Device: Shockwave treatmentA shockwave device with a probe that conveys shockwave energy |
| sham | Sham comparator | Device: Shockwave treatmentA shockwave device with specially designed probe which has the shockwave energy blocked |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Above age 18 years
- Diagnosis of provoked vestibulodynia by a gynecologist at least 3 month prior to study date
- Positive cotton swab test
- Pain during intercourse/ tampon insertion, gynecologic examination
- Cognitively and physically adapted for undergoing treatment
Key exclusion criteria (6 listed)
- Pregnancy or lactating
- History of pelvic or external genitalia irradiation during the past year
- Any chronic neurological disorder causing local pain
- Any pelvic inflammatory process
- Any psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shockwave treatmentED 1000 shockwave generator | Device | active, sham |
Primary outcome
Visual Analog Scale (VAS)
Time frame: 1 year
The primary outcome was a change in dyspareunia, as assessed by scores on the 10-point Visual Analogue Scale where 1 is the minimum score meaning painless and 10 is the maximum score meaning excruciating pain
4 secondary outcomes
Algometer testing
Time frame: 1 year
Wong-Baker pain FACES scale
Time frame: 1 year
Female Sexual Function Index (FSFI)
Time frame: 1 year
Patients' Global Impression of Change scale.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
- Results publication: PubMed 18209522Landry T, Bergeron S, Dupuis MJ, Desrochers G. The treatment of provoked vestibulodynia: a critical review. Clin J Pain. 2008 Feb;24(2):155-71. doi: 10.1097/AJP.0b013e31815aac4d.
- Results publication: PubMed 19170850Sutton KS, Pukall CF, Chamberlain S. Pain, psychosocial, sexual, and psychophysical characteristics of women with primary vs. secondary provoked vestibulodynia. J Sex Med. 2009 Jan;6(1):205-14. doi: 10.1111/j.1743-6109.2008.01038.x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shockwave treatment in people with Provoked Vestibulodynia, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04545255, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2020.