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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Female Dyspareunia

Intervention / Treatment
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* Device: Low intensity shockwave treatment to pelvic floor region plus typical physical therapy
* Device: Sham shockwave treatment plus typical physical therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low Intensity plus PT<br>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<br>* 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<br>|
| Sham Comparator: Sham Shockwave Treatment plus PT<br>Participant receives sham shockwave treatment plus typical physical therapy. | Device: Sham shockwave treatment plus typical physical therapy<br>* Inactive dose of shockwave treatment<br>|

What is the study measuring?
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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 |