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

Primary Purpose

Female Dyspareunia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Low intensity shockwave treatment to pelvic floor region plus typical physical therapy
Sham shockwave treatment plus typical physical therapy
Sponsored by
SoftWave Tissue Regeneration Technologies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Female Dyspareunia

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Sham Comparator

    Arm Label

    Low Intensity plus PT

    Sham Shockwave Treatment plus PT

    Arm Description

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

    Participant receives sham shockwave treatment plus typical physical therapy.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.

    Secondary Outcome Measures

    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.
    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).

    Full Information

    First Posted
    February 21, 2023
    Last Updated
    April 7, 2023
    Sponsor
    SoftWave Tissue Regeneration Technologies
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05806203
    Brief Title
    A Study of Participants Ages 21-65 Diagnosed With Dyspareunia and the Effects of Low Intensity Shockwave Treatment
    Official Title
    Randomized Controlled Trial for Use of Low Intensity Shockwave for Patients With Dyspareunia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2023 (Anticipated)
    Primary Completion Date
    April 1, 2024 (Anticipated)
    Study Completion Date
    April 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    SoftWave Tissue Regeneration Technologies

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Female Dyspareunia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Low Intensity plus PT
    Arm Type
    Active Comparator
    Arm Description
    Participants receive active low intensity shockwave treatment from plus typical physical therapy.
    Arm Title
    Sham Shockwave Treatment plus PT
    Arm Type
    Sham Comparator
    Arm Description
    Participant receives sham shockwave treatment plus typical physical therapy.
    Intervention Type
    Device
    Intervention Name(s)
    Low intensity shockwave treatment to pelvic floor region plus typical physical therapy
    Intervention Description
    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
    Intervention Type
    Device
    Intervention Name(s)
    Sham shockwave treatment plus typical physical therapy
    Intervention Description
    Inactive dose of shockwave treatment
    Primary Outcome Measure Information:
    Title
    Tampon Test
    Description
    A self-reported measurement of pain on a numeric scale from 0 to 10, with 0 signifying no pain and 10 signifying extreme pain.
    Time Frame
    up to 6 weeks
    Title
    Numerical pain rating scale for tampon test
    Description
    A self-reported measurement of pain on a numeric scale from 1 to 10, with 0 signifying no pain and 10 signifying extreme pain.
    Time Frame
    up to 6 weeks
    Title
    Female Sexual Function Index, (FSFI)
    Description
    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.
    Time Frame
    up to 6 weeks
    Secondary Outcome Measure Information:
    Title
    Numeric pain score for deep penetration.
    Description
    A self-reported measurement of pain on a numeric scale from 1 to 10, with 0 signifying no pain and 10 signifying extreme pain.
    Time Frame
    Completed once per week for 4 to 6 weeks
    Title
    Beck Depression Scale
    Description
    Sel-reported scale consisting of 21 items of emotional, behavioral, and somatic symptoms. Scoring ranges from 0, (no symptoms) to 27, (severe symptoms).
    Time Frame
    Completed once per week for 4 to 6 weeks

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Cisgender female or have natal vaginal tissue
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Stacey Roberts
    Phone
    414-299-8121
    Email
    staceyroberts22@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Christine Calbelka
    Phone
    218-723-6122
    Email
    ccabelka@css.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Stacey Roberts
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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