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

NCT04545255 | Completed

• 1 other identifier: 0098-18-rmc
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Provoked Vestibulodynia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Algometer testing

  1 year

• Wong-Baker pain FACES scale

  1 year

• Female Sexual Function Index (FSFI)

  1 year

• Patients' Global Impression of Change scale.

  1 year

Study Arms (2)

active

ACTIVE COMPARATOR

A shockwave device with a probe that conveys shockwave energy

Device: Shockwave treatment

sham

SHAM COMPARATOR

A shockwave device with specially designed probe which has the shockwave energy blocked

Device: Shockwave treatment

Interventions

Shockwave treatment DEVICE

ED 1000 shockwave generator

active; sham

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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..)

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Healthcare Campus

Haifa, Northern District, 31096, Israel

Location

Related Publications (2)

• 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.

  PMID: 18209522 RESULT

• 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.

  PMID: 19170850 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Shockwave probes were either active or sham (by blocking energy transfer from probe)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director of the Neuro- urology unit, Rambam healthcare campus

Model Details: A double-blinded, randomized, sham-controlled, prospective study

Study Record Dates

• First Submitted: August 20, 2020
• First Posted: September 10, 2020
• Study Start: June 21, 2018
• Primary Completion: October 30, 2019
• Study Completion: January 20, 2020
• Last Updated: September 10, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)