A Study of Participants Ages 21-65 Diagnosed With Dyspareunia and the Effects of Low Intensity Shockwave Treatment
NCT ID: NCT05806203
Last Updated: 2023-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2023-08-15
2024-04-30
Brief Summary
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e purpose of this study is to determine the effectiveness of low intensity shockwave treatment for patients with dyspareunia and their ability to tolerate sexual activity, (i.e., penetration of vagina, self or partnered pleasure).
Participants will:
* Be given a preliminary physical therapy examination and evaluation.
* Be asked to attend weekly low intensity shockwave treatment visits.
* Be asked to complete 3 Month follow up questionnaires
Detailed Description
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This is a single blind, randomized controlled trial, with randomized placebo phase design.
A total of 60 participants enrolled at 4 clinical sites will be blinded to the group they are assigned to, (treatment or sham). Clinical investigators cannot be blinded to treatment or sham in order to deliver the treatment.
There are two arms of the study: the Intervention arm where subjects receive active low intensity shockwave treatment plus typical physical therapy. Intervention is the delivery of shockwaves to the pelvic floor region using Softwave Tissue RegenerationTechnologies OrthoGold 100 MTS OP155 unfocused parabolic probe electrohydraulic device.
The Control arm subjects receive sham shockwave treatment plus typical physical therapy.
Each clinical site will have an envelope with pre-determined even and odd numbers determining randomization. Upon enrollment a random number from the envelope will be drawn and assigned to the participant.
At 4-6 weeks participants in the control arm will be given the option of moving to the shockwave (intervention) arm. Participants will spend 4 to 4 1/2 months in the study receiving treatment once per week, 4-6 weeks duration for both treatment arms. Subjects will then be contacted for a 3-month follow-up by phone completing their study participation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Low Intensity plus PT
Participants receive active low intensity shockwave treatment from plus typical physical therapy.
Low intensity shockwave treatment to pelvic floor region plus typical physical therapy
Treatment dose: 1,000 - 1,500 shocks, 2.5-3.0 Hz, 0.06-0.10 mJ/mm2 (Intensity of 6-8), 8 to 12 minutes
Sham Shockwave Treatment plus PT
Participant receives sham shockwave treatment plus typical physical therapy.
Sham shockwave treatment plus typical physical therapy
Inactive dose of shockwave treatment
Interventions
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Low intensity shockwave treatment to pelvic floor region plus typical physical therapy
Treatment dose: 1,000 - 1,500 shocks, 2.5-3.0 Hz, 0.06-0.10 mJ/mm2 (Intensity of 6-8), 8 to 12 minutes
Sham shockwave treatment plus typical physical therapy
Inactive dose of shockwave treatment
Eligibility Criteria
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Inclusion Criteria
* Cisgender female or have natal vaginal tissu
* Has not started hormonal therapy within the past 2 weeks
* Has not received pelvic floor physical therapy within the past 2 weeks
* Is able to electronically access informed consent and outcomes measures forms
Exclusion Criteria
* Have an active infection (e.g. herpes)
* Are earlier than 12 weeks post-surgery
* Are earlier than 6 weeks postpartum
* Have a history of gynecological cancer
* Have a history of pelvic radiation
* Are actively undergoing cancer treatments
* Are currently pregnant
* Currently using lidocaine or cortisone
21 Years
65 Years
FEMALE
Yes
Sponsors
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SoftWave Tissue Regeneration Technologies
INDUSTRY
Responsible Party
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Principal Investigators
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Stacey Roberts
Role: PRINCIPAL_INVESTIGATOR
Locations
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New You Health and Wellness
Wauwatosa, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2018453-1
Identifier Type: -
Identifier Source: org_study_id