Female DyspareuniaNCT05806203
A Study of Participants Ages 21-65 Diagnosed With Dyspareunia and the Effects of Low Intensity Shockwave Treatment
A study testing Low intensity shockwave treatment to pelvic floor region plus typical physical therapy in people with Female Dyspareunia, run by SoftWave Tissue Regeneration Technologies at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Female Dyspareunia
- What is being tested?
- Low intensity shockwave treatment to pelvic floor region plus typical physical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2023to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Are actively undergoing cancer treatments
- Are currently pregnant
- Currently using lidocaine or cortisone
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
New You Health and Wellness
Wauwatosa, Wisconsin, 53226
Stacey Roberts, 414-299-8121, staceyr@newyouhealthandwellness.com
About this study
Official title: 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
Read the 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.
- Conditions
- Female Dyspareunia
- Being tested
- Low intensity shockwave treatment to pelvic floor region plus typical physical therapy, Sham shockwave treatment plus typical physical therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low intensity shockwave treatment to pelvic floor region plus typical physical therapyDevice
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 shockwave treatment plus typical physical therapyDevice
Inactive dose of shockwave treatment
| Study group | Role | What they receive |
|---|---|---|
| Low Intensity plus PT | Active comparator | Participants receive active low intensity shockwave treatment from plus typical physical therapy. Receives: Device: Low intensity shockwave treatment to pelvic floor region plus typical physical therapy |
| Sham Shockwave Treatment plus PT | Sham comparator | Participant receives sham shockwave treatment plus typical physical therapy. Receives: Device: Sham shockwave treatment plus typical physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: up to 6 weeks
Secondary outcomes (2)
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.
Measured: 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).
Measured: Completed once per week for 4 to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start15 Aug 2023
- Primary completion1 Apr 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female DyspareuniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SoftWave Tissue Regeneration Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stacey Roberts, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05806203
- Sponsor's protocol ID
- 2018453-1
- Status last verified
- Nov 2023
- First submitted
- 21 Feb 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial for Use of Low Intensity Shockwave for Patients With Dyspareunia
- ClinicalTrials.gov ID
- NCT05806203
- Acronym / sponsor ID
- 2018453-1
- Conditions
- Female Dyspareunia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- SoftWave Tissue Regeneration TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 10 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Intensity plus PT | Active comparator | Device: Low intensity shockwave treatment to pelvic floor region plus typical physical therapyParticipants receive active low intensity shockwave treatment from plus typical physical therapy. |
| Sham Shockwave Treatment plus PT | Sham comparator | Device: Sham shockwave treatment plus typical physical therapyParticipant receives sham shockwave treatment plus typical physical therapy. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low intensity shockwave treatment to pelvic floor region plus typical physical therapyTreatment 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 | Device | Low Intensity plus PT |
| Sham shockwave treatment plus typical physical therapyInactive dose of shockwave treatment | Device | Sham Shockwave Treatment plus PT |
Primary outcome
Tampon Test
Time frame: up to 6 weeks
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
Time frame: up to 6 weeks
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)
Time frame: up to 6 weeks
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.
2 secondary outcomes
Numeric pain score for deep penetration.
Time frame: Completed once per week for 4 to 6 weeks
Beck Depression Scale
Time frame: Completed once per week for 4 to 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stacey Roberts principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low intensity shockwave treatment to pelvic floor region plus typical physical therapy in people with Female Dyspareunia, run by SoftWave Tissue Regeneration Technologies at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stacey Roberts (414-299-8121, staceyroberts22@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tampon Test (time frame: up to 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.