RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Randomized Controlled Trial for Use of Low Intensity Shockwave for Patients With Dyspareunia

Quick Facts

Study Start:2023-08-15
Study Completion:2024-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05806203

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 65 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Primary diagnosis of dyspareunia (pain with intercourse and/or vaginal penetration)
  2. * Cisgender female or have natal vaginal tissu
  3. * Has not started hormonal therapy within the past 2 weeks
  4. * Has not received pelvic floor physical therapy within the past 2 weeks
  5. * Is able to electronically access informed consent and outcomes measures forms
  1. * Have a diagnosis of lichen sclerosis
  2. * Have an active infection (e.g. herpes)
  3. * Are earlier than 12 weeks post-surgery
  4. * Are earlier than 6 weeks postpartum
  5. * Have a history of gynecological cancer
  6. * Have a history of pelvic radiation
  7. * Are actively undergoing cancer treatments
  8. * Are currently pregnant
  9. * Currently using lidocaine or cortisone

Contacts and Locations

Study Contact

Stacey Roberts
CONTACT
414-299-8121
staceyroberts22@gmail.com
Christine Calbelka
CONTACT
218-723-6122
ccabelka@css.edu

Principal Investigator

Stacey Roberts
PRINCIPAL_INVESTIGATOR

Study Locations (Sites)

New You Health and Wellness
Wauwatosa, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: SoftWave Tissue Regeneration Technologies

  • Stacey Roberts, PRINCIPAL_INVESTIGATOR

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-15
Study Completion Date2024-04-30

Study Record Updates

Study Start Date2023-08-15
Study Completion Date2024-04-30

Terms related to this study

Additional Relevant MeSH Terms

  • Female Dyspareunia