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

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

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

Study Overview

• Status: Recruiting
• Conditions: Female Dyspareunia
• Intervention / Treatment: Device: Low intensity shockwave treatment to pelvic floor region plus typical physical therapy; Device: Sham shockwave treatment plus typical physical therapy

Detailed Description

This study seeks to determine the effectiveness of low intensity shockwave (LiSWT) for patients with dyspareunia, with the primary objective being the ability to tolerate penetration of the vagina and sexual activity, (self or partnered pleasure). A secondary objective of the study is an improved quality of life.

This is a single blind, randomized controlled trial, with randomized placebo phase design.

A total of 60 participants enrolled at 4 clinical sites will be blinded to the group they are assigned to, (treatment or sham). Clinical investigators cannot be blinded to treatment or sham in order to deliver the treatment.

There are two arms of the study: the Intervention arm where subjects receive active low intensity shockwave treatment plus typical physical therapy. Intervention is the delivery of shockwaves to the pelvic floor region using Softwave Tissue RegenerationTechnologies OrthoGold 100 MTS OP155 unfocused parabolic probe electrohydraulic device.

The Control arm subjects receive sham shockwave treatment plus typical physical therapy.

Each clinical site will have an envelope with pre-determined even and odd numbers determining randomization. Upon enrollment a random number from the envelope will be drawn and assigned to the participant.

At 4-6 weeks participants in the control arm will be given the option of moving to the shockwave (intervention) arm. Participants will spend 4 to 4 1/2 months in the study receiving treatment once per week, 4-6 weeks duration for both treatment arms. Subjects will then be contacted for a 3-month follow-up by phone completing their study participation.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stacey Roberts; Phone Number: 414-299-8121; Email: staceyroberts22@gmail.com
• Study Contact Backup: Name: Christine Calbelka; Phone Number: 218-723-6122; Email: ccabelka@css.edu

Study Locations

• United States
  • Wisconsin
    • Wauwatosa, Wisconsin, United States, 53226
      • Recruiting
      • New You Health and Wellness
      • Contact: Stacey Roberts; Phone Number: 414-299-8121; Email: staceyr@newyouhealthandwellness.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Low Intensity plus PT; Participants receive active low intensity shockwave treatment from plus typical physical therapy.	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
Sham Comparator: Sham Shockwave Treatment plus PT; Participant receives sham shockwave treatment plus typical physical therapy.	Device: Sham shockwave treatment plus typical physical therapy; Inactive dose of shockwave treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tampon Test	A self-reported measurement of pain on a numeric scale from 0 to 10, with 0 signifying no pain and 10 signifying extreme pain.	up to 6 weeks
Numerical pain rating scale for tampon test	A self-reported measurement of pain on a numeric scale from 1 to 10, with 0 signifying no pain and 10 signifying extreme pain.	up to 6 weeks
Female Sexual Function Index, (FSFI)	A validated, self-reported questionnaire assessing different domains of female sexual function including desire, arousal, lubrication, orgasm, satisfaction, and pain. Scores range from 2.0 to 36.0. Lower scores indicate greater risk of female sexual dysfunction, and higher scores indicate better outcomes in overall sexual function.	up to 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric pain score for deep penetration.	A self-reported measurement of pain on a numeric scale from 1 to 10, with 0 signifying no pain and 10 signifying extreme pain.	Completed once per week for 4 to 6 weeks
Beck Depression Scale	Sel-reported scale consisting of 21 items of emotional, behavioral, and somatic symptoms. Scoring ranges from 0, (no symptoms) to 27, (severe symptoms).	Completed once per week for 4 to 6 weeks

Collaborators and Investigators

• Sponsor: SoftWave Tissue Regeneration Technologies
• Investigators: Principal Investigator: Stacey Roberts

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: February 21, 2023
• First Submitted That Met QC Criteria: April 7, 2023
• First Posted (Actual): April 10, 2023

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Genital Diseases, Female; Dyspareunia
• Other Study ID Numbers: 2018453-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes