Effects of low intensity shockwave treatment on dyspareunia in women
Randomized Controlled Trial for Use of Low Intensity Shockwave for Patients With Dyspareunia
NA · SoftWave Tissue Regeneration Technologies · NCT05806203
This study tests if low intensity shockwave treatment can help women aged 21-65 with pain during sex feel better and improve their quality of life.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 21 Years to 65 Years |
| Sex | Female |
| Sponsor | SoftWave Tissue Regeneration Technologies (industry) |
| Drugs / interventions | radiation |
| Locations | 1 site (Wauwatosa, Wisconsin) |
| Trial ID | NCT05806203 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of low intensity shockwave treatment for women aged 21-65 diagnosed with dyspareunia, which is characterized by pain during vaginal penetration. Participants will undergo a preliminary physical therapy evaluation and receive either active shockwave treatment or a sham treatment alongside typical physical therapy. The study is designed as a single blind, randomized controlled trial with a total of 60 participants across four clinical sites. Follow-up assessments will be conducted through questionnaires after three months to evaluate improvements in sexual activity tolerance and overall quality of life.
Who should consider this trial
Good fit: Ideal candidates are cisgender females aged 21-65 with a primary diagnosis of dyspareunia who meet specific inclusion criteria.
Not a fit: Patients with conditions such as lichen sclerosis, active infections, or those who are currently pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve sexual function and quality of life for women suffering from dyspareunia.
How similar studies have performed: While the use of shockwave therapy is gaining interest, this specific application for dyspareunia is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 this trial is running
Wauwatosa, Wisconsin
- New You Health and Wellness — Wauwatosa, Wisconsin, United States (RECRUITING)
Study contacts
- Principal investigator: Stacey Roberts
- Study coordinator: Stacey Roberts
- Email: staceyroberts22@gmail.com
- Phone: 414-299-8121
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Female Dyspareunia