IncontinenceNCT02954042
Pelvital Stress Urinary Incontinence Training Device: P-SUIT
A study testing Pelvital probe in people with Incontinence, run by Pelvital USA, Inc. at 4 sites in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Incontinence
- What is being tested?
- Pelvital probe
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 4 sitesUnited States
- Study dates
- 10 Mar 2017to 30 Oct 2019
- 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 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female gender,
- Ages 18-75,
- Clinical diagnosis of stress urinary incontinence,
- Ability to contract the pelvic floor muscles,
- Able to document incontinence and voiding in a diary,
- Provision of written informed consent form,
- Minimum of 10 grams increase at initial 24-hour pad weight test
Who cannot join
- Diagnosed mixed or urge urinary incontinence,
- Impaired cognitive function or neurologic conditions
- Physical limitations that impede the patient's ability to participate (e.g., ability to stand),
- Acute infections or hematuria,
- Pregnant or actively trying to conceive,
- History of pelvic irradiation,
Show all 10Show fewer
- Concurrent medications with α-adrenergic antagonists or diuretics
- Pelvic organ prolapse stage III or IV,
- Severe urethral sphincter weakness and/or defect,
- Suspected urethral and/or vesical fistula
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Minnesota Medical Center
Maple Grove, Minnesota, 55369
Metro OBGYN
Maplewood, Minnesota, 55109
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
University of Washington Medical Center
Seattle, Washington, 98195
About this study
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
Read the detailed description
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.
- Conditions
- Incontinence
- Being tested
- Pelvital probe, Placebo Probe
- Keywords
- Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvital probeDevice
Pelvital probe
Placebo ProbeDevice
Placebo Probe
| Study group | Role | What they receive |
|---|---|---|
| Pelvital probe | Experimental | Probe to use for incontinence-Pevital is company name of product Receives: Device: Pelvital probe |
| Placebo Probe | Placebo comparator | Placebo probe Receives: Device: Placebo Probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in severity of involuntary urine loss
Measured by pad testing
Measured: Baseline, 6 weeks
Secondary outcomes (2)
incontinence episode frequency
Daily Diary
Measured: Baseline, 6 weeks
health-related quality of life
Quality of Life questionarie
Measured: Baseline, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2016 (estimated)
- Study start10 Mar 2017
- Primary completion30 Oct 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IncontinenceStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pelvital USA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nissrine Nakib, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02954042
- Sponsor's protocol ID
- URO-2016-25004
- Status last verified
- Apr 2021
- First submitted
- 28 Oct 2016
- Last updated
- 14 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Nakib N, Sutherland S, Hallman K, Mianulli M, R Boulware D. Randomized trial of mechanotherapy for the treatment of stress urinary incontinence in women. Ther Adv Urol. 2024 Feb 6;16:17562872241228023. doi: 10.1177/17562872241228023. eCollection 2024 Jan-Dec.
PubMed 38328552
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvital Stress Urinary Incontinence Training Device: P-SUIT
- ClinicalTrials.gov ID
- NCT02954042
- Acronym / sponsor ID
- URO-2016-25004
- Conditions
- Incontinence
- Keywords
- Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Pelvital USA, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Mar 2017 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 3 Nov 2016 (estimated)
- 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.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvital probe | Experimental | Device: Pelvital probeProbe to use for incontinence-Pevital is company name of product |
| Placebo Probe | Placebo comparator | Device: Placebo ProbePlacebo probe |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female gender,
- Ages 18-75,
- Clinical diagnosis of stress urinary incontinence,
- Ability to contract the pelvic floor muscles,
- Able to document incontinence and voiding in a diary,
Key exclusion criteria (10 listed)
- Diagnosed mixed or urge urinary incontinence,
- Impaired cognitive function or neurologic conditions
- Physical limitations that impede the patient's ability to participate (e.g., ability to stand),
- Acute infections or hematuria,
- Pregnant or actively trying to conceive,
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 |
|---|---|---|
| Pelvital probePelvital probe | Device | Pelvital probe |
| Placebo ProbePlacebo Probe | Device | Placebo Probe |
Primary outcome
Improvement in severity of involuntary urine loss
Time frame: Baseline, 6 weeks
Measured by pad testing
2 secondary outcomes
incontinence episode frequency
Time frame: Baseline, 6 weeks
health-related quality of life
Time frame: Baseline, 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
- Derived from this study: PubMed 38328552Nakib N, Sutherland S, Hallman K, Mianulli M, R Boulware D. Randomized trial of mechanotherapy for the treatment of stress urinary incontinence in women. Ther Adv Urol. 2024 Feb 6;16:17562872241228023. doi: 10.1177/17562872241228023. eCollection 2024 Jan-Dec.
- Individual participant dataSharing planned: Undecided
Related trials for Incontinence
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Recruiting
Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
Fecal Incontinence
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.
Nissrine Nakib, MD principal investigator
University of Minnesota
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvital probe in people with Incontinence, run by Pelvital USA, Inc. at 4 sites 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 7 inclusion and 10 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: finished, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in severity of involuntary urine loss (time frame: Baseline, 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02954042, which also lists 1 linked publication.
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 14 Apr 2021.