An interventional study of Low intensity shockwave treatment to pelvic floor region plus typical physical therapy and Sham shockwave treatment plus typical physical therapy in Female Dyspareunia, sponsored by SoftWave Tissue Regeneration Technologies. Recruiting at 1 site in United States. Open to female participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-28.
Sponsored by SoftWave Tissue Regeneration Technologies · Not applicable, Interventional, and Treatment
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:
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.
158 studies on the registry are indexed under Dyspareunia; 40 are open to participants now.
This study's planned enrollment of 60 is close to the median of 63 across 126 interventional studies indexed under Dyspareunia.
Browse Dyspareunia studies →This is the only study on the registry with SoftWave Tissue Regeneration Technologies as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Participant receives sham shockwave treatment plus typical physical therapy.
Device: Sham shockwave treatment 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
Inactive dose of shockwave treatment
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.
Time frame: 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.
Time frame: 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.
Time frame: up to 6 weeks
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.
Time frame: 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).
Time frame: Completed once per week for 4 to 6 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2023 (actual). Primary completion is estimated for Apr 2024, 7 months after the start.
Of 59 interventional studies with no phase under Dyspareunia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 38. This study's planned 7 months is below that.
How these figures are worked out, and which studies are left out of them.
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