An interventional study of Pelvital probe and Placebo Probe in Incontinence, sponsored by Pelvital USA, Inc.. Completed at 4 sites in United States. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-04-14.
Sponsored by Pelvital USA, Inc. · Not applicable, Interventional, and Treatment
The purpose of this investigation is to compare the clinical benefits of using the Pelvital product, in comparison to a sham procedure as a noninvasive treatment for female incontinence
120 subjects with SUI will be recruited into a randomized, double-blind, sham-controlled crossover trial. Subjects will be allocated in a 1:1 ratio (60 per arm) to either the control arm (PFMT) or the treatment arm (PFMT in conjunction with the Pelvital therapy). Subjects will conduct their respective therapy five minutes a day over the course of six weeks. At weeks two, four and six, the subjects will conduct bi-weekly check-ups. After six weeks, all patients in the control arm will have the option to cross over into the treatment arm if no improvement in symptoms has been shown.
1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.
This study's enrollment of 120 is above the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →This is the only study on the registry with Pelvital USA, Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Probe to use for incontinence-Pevital is company name of product
Device: Pelvital probe
Placebo probe
Device: Placebo Probe
Pelvital probe
Placebo Probe
Improvement in severity of involuntary urine loss
Measured by pad testing
Time frame: Baseline, 6 weeks
incontinence episode frequency
Daily Diary
Time frame: Baseline, 6 weeks
health-related quality of life
Quality of Life questionarie
Time frame: Baseline, 6 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.