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Shockwave Therapy

Shockwave Therapy for Painful Intercourse

N/A

Recruiting

Led By Stacey Roberts

Research Sponsored by SoftWave Tissue Regeneration Technologies

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Primary diagnosis of dyspareunia (pain with intercourse and/or vaginal penetration)

Cisgender female or have natal vaginal tissu

Timeline

Screening 3 weeks

Treatment Varies

Follow Up completed once per week for 4 to 6 weeks

Awards & highlights

Study Summary

This trial will test the ability of low intensity shockwave treatments to reduce pain associated with vaginal penetration & improve patient's ability to tolerate sexual activity.

Who is the study for?

This trial is for individuals aged 21-65 with dyspareunia, which means they experience pain during intercourse. Participants must be cisgender females or have natal vaginal tissue, not have started hormonal therapy or received pelvic floor physical therapy in the past two weeks, and must be able to access consent and outcome forms electronically.Check my eligibility

What is being tested?

The study tests low intensity shockwave treatment's effectiveness on dyspareunia when combined with standard physical therapy. Participants will undergo weekly treatments and complete follow-up questionnaires after three months to assess their tolerance of sexual activity.See study design

What are the potential side effects?

Potential side effects are not explicitly listed but may include discomfort or bruising at the treatment site due to shockwaves. As this is a non-invasive procedure, severe side effects are unlikely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I experience pain during intercourse.

Select...

I am a cisgender female or have vaginal tissue from birth.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ completed once per week for 4 to 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~completed once per week for 4 to 6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and completed once per week for 4 to 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Female Sexual Function Index, (FSFI)

Numerical pain rating scale for tampon test

Tampon Test

Secondary outcome measures

Beck Depression Scale

Numeric pain score for deep penetration.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Low Intensity plus PTActive Control1 Intervention

Participants receive active low intensity shockwave treatment from plus typical physical therapy.

Group II: Sham Shockwave Treatment plus PTPlacebo Group1 Intervention

Participant receives sham shockwave treatment plus typical physical therapy.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

SoftWave Tissue Regeneration TechnologiesLead Sponsor

Stacey RobertsPrincipal Investigator

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many volunteers will be accepted for this clinical trial?

"Affirmative. Clinicaltrials.gov hosts information that attests to this medical experiment being actively open for enrollment, with the initial posting date of August 15th 2023 and a recent update on November 21st 2023. Sixty patients are needed across one site to complete the trial."

Answered by AI

Is the current medical trial open to applicants younger than thirty-five?

"Enrollees for this medical trial must be aged between 21 and 65; however, there are 11 separate studies available to participants that are either too young or advanced in age."

Answered by AI

Could I qualify to participate in this scientific research?

"60 individuals aged 21 and 65 suffering from dyspareunia are being sought for this clinical trial. Cisgender females or those with natal vaginal tissue must meet the following criteria: not having received hormonal therapy in the past fortnight, no pelvic floor physical therapy during that same period, and access to informed consent documents as well as outcomes measures forms via electronic means."

Answered by AI

Is there still an opportunity for eligible participants to join this experiment?

"Affirmative. Evidence on clinicaltrials.gov suggests that this medical investigation, which was initially posted on August 15th 2023, is currently recruiting participants. Approximately 60 individuals need to be recruited from 1 centre location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Participants Ages 21-65 Diagnosed With Dyspareunia and the Effects of Low Intensity Shockwave Treatment

2023. "A Study of Participants Ages 21-65 Diagnosed With Dyspareunia and the Effects of Low Intensity Shockwave Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05806203.

All > Dyspareunia