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

NCT05806203 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-11-28

No results posted yet for this study

Summary

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

Conditions

  • Female Dyspareunia

Interventions

DEVICE

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

DEVICE

Sham shockwave treatment plus typical physical therapy

Inactive dose of shockwave treatment

Sponsors & Collaborators

  • SoftWave Tissue Regeneration Technologies

    lead INDUSTRY

Principal Investigators

  • Stacey Roberts

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-15
Primary Completion
2024-04-01
Completion
2024-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05806203 on ClinicalTrials.gov