A Study of Participants Ages 21-65 Diagnosed With Dyspareunia and the Effects of Low Intensity Shockwave Treatment
Status unconfirmed · Not applicable · Has a placebo group
Conditions studied: Female Dyspareunia
In brief
Dyspareunia is defined as a complaint of persistent or recurring pain or discomfort associated with attempted or complete vaginal penetration 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
Key facts
- Study ID
- NCT05806203
- Run by
- SoftWave Tissue Regeneration Technologies
- People needed
- 60
- Starts
- 2023-08-15
- Expected to finish
- 2024-04-30
- Last updated by the study team
- 2023-11-28
Who can join
Age: 21 and older, up to 65. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Primary diagnosis of dyspareunia (pain with intercourse and/or vaginal penetration)
- 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
You may not qualify if…
- Have a diagnosis of lichen sclerosis
- 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
Where it is running
- New You Health and Wellness — Wauwatosa, Wisconsin, United States (enrolling)
Full record on ClinicalTrials.gov
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