CompletedNot Applicable

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

Israel32 participantsStarted 2018-06-21

Plain-language 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.

Who can participate

Age range18 Years – 55 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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..)

What they're measuring

Visual Analog Scale (VAS)

Timeframe: 1 year

Trial details

NCT IDNCT04545255

SponsorRambam Health Care Campus

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-10-30

View on ClinicalTrials.gov More Provoked Vestibulodynia trials