Dyspareunia Shockwave Research Study

Now Enrolling!

Flow Rehab is one of 4 clinical sites engaging in a research study using shockwave and physical therapy to address pain with vaginal penetration.

If you have pain with vaginal penetration, you may be interested in learning more about participating in this research study. The purpose of our study is to determine the effectiveness of low intensity shockwave for patients with dyspareunia.

The study will include, but is not limited to: filling out online questionnaires; participating in a physical examination; completing the “Tampon test” (ability to insert and remove a regular sized Tampon); assessing size of dilator that can be inserted without pain; being assessed with biofeedback sensors on the outside of the pelvis; and receiving typical physical therapy for dyspareunia once/week over 4-6 weeks. If you are eligible to participate you would be enrolled in either the group receiving active shockwave, or the group receiving sham (inactive) shockwave.

Inclusion criteria for participation include:
Primary diagnosis of dyspareunia (pain with intercourse and/or vaginal penetration)
Cisgender female or have natal vaginal tissue
Must be between 21-65 years old
Has not started hormonal therapy within the past 4 weeks
Has not received pelvic floor physical therapy within the past 2 weeks
Is able to electronically access informed consent and outcomes measures forms
Able to participate consistently (1x/week for 4 weeks) to the best of one’s ability

Exclusion criteria includes:
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
Unable to participate in typical pelvic floor treatment
Has received cortisone injection in the past 4 weeks
Has received botox injection within the past 3 months
History of shockwave therapy (other than re-enrollment to this study)

The shockwave treatment, which typically costs $150 as a charge separate to physical therapy codes, will not be charged to any participant in the study as we are supported by the equipment manufacturer, Softwave Tissue Regeneration Technologies. The cost for participation in the clinical visit will be $150 per session. It is the clinic’s goal that finances do not limit a person’s ability to participate so if the cost of the physical therapy visit is a concern, please discuss this with Holly Tanner, the investigator.

The registered clinical trial number is NCT05806203 and this study has been approved by the Institutional Review Board at the College of St. Scholastica. More details about the research study are available on request and within the informed consent for participation. If you are interested in learning more, please contact holly@flowrehab.com.