The Use of Low Intensity Shock Wave Therapy for the Treatment of Provoked Vestibulodynia Disorder (PVD)

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.

Study Overview

• Status: Completed
• Conditions: Provoked Vestibulodynia
• Intervention / Treatment: Device: Shockwave treatment

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Northern Region
    • Haifa, Northern Region, Israel, 31096
      • Rambam Healthcare Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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..)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: active; A shockwave device with a probe that conveys shockwave energy	Device: Shockwave treatment; ED 1000 shockwave generator
Sham Comparator: sham; A shockwave device with specially designed probe which has the shockwave energy blocked	Device: Shockwave treatment; ED 1000 shockwave generator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Algometer testing	measures threshold of pain in mmHg, where any threshold below 100 mmHg is considered pathological	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	1 year
Female Sexual Function Index (FSFI)	A validated questionnaire assessing female sexual dysfunction, any score above 22.5 is pathological	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	1 year

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus

Publications and helpful links

General 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.
• Sutton 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2018
• Primary Completion (Actual): October 30, 2019
• Study Completion (Actual): January 20, 2020

Study Registration Dates

• First Submitted: August 20, 2020
• First Submitted That Met QC Criteria: September 3, 2020
• First Posted (Actual): September 10, 2020

Study Record Updates

• Last Update Posted (Actual): September 10, 2020
• Last Update Submitted That Met QC Criteria: September 3, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vulvar Diseases; Vulvitis; Vulvodynia; Vulvar Vestibulitis
• Other Study ID Numbers: 0098-18-rmc

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No