Clinical trial NCT05806203: 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
Overall status: RECRUITING
Phase: NA
Conditions: Female Dyspareunia
Lead sponsor: SoftWave Tissue Regeneration Technologies
Sponsor class: INDUSTRY
First posted: 2023-04-10
Enrollment: 60
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Tampon Test
timeFrame: up to 6 weeks
measure: Numerical pain rating scale for tampon test
timeFrame: up to 6 weeks
measure: Female Sexual Function Index, (FSFI)
timeFrame: up to 6 weeks
Secondary outcomes:
measure: Numeric pain score for deep penetration.
timeFrame: Completed once per week for 4 to 6 weeks
measure: Beck Depression Scale
timeFrame: Completed once per week for 4 to 6 weeks
Other outcomes:
Locations:
city: Wauwatosa
country: United States
facility: New You Health and Wellness
state: Wisconsin
Study officials:
name: Stacey Roberts
role: PRINCIPAL_INVESTIGATOR
References: