Urinary IncontinenceNCT05202717
the Effect of a New Type of Pelvic Floor Rehabilitation Device PHENIX U4+ on the Treatment of Urinary Incontinence
A study testing PHENIX U4+ and Traditional pelvic floor treatment instrument in people with Urinary Incontinence, run by Peking University People's Hospital at 1 site in China.
Trial summary
Enrolled patients with urinary incontinence in Peking University People's Hospital, Wuhan People's Hospital, Zhongshan People's Hospital, and Jiangsu Maternity and Child Health Hospital in the Department of Gynecology, and collected baseline data. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- PHENIX U4+ and Traditional pelvic floor treatment instrument
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteChina
- Study dates
- Jan 2022to Dec 2022
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Combined pelvic organ prolapse (with extrahymen bulging);
- Obesity (BMI>28kg/m2, BMI=weight (kg)/height square (m2));
- Uncontrolled asthma and chronic obstructive pulmonary disease (COPD);
- Combined connective tissue disease;
- Women with unclean lochia during pregnancy, within 6 weeks of postpartum and postpartum
- Malignant tumors;
- Combined neurological diseases (patients with epilepsy and dementia);
- Those with a synchronized pacemaker on their chest (biofeedback can be done).
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
About this study
Official title: Construction of the Early Warning and Prevention System for Urinary Incontinence in the Elderly--the Effect of a New Type of Pelvic Floor Rehabilitation Device PHENIX U4+ on the Treatment of Urinary Incontinence--a Multi-center Randomized Controlled Clinical Study
Enrolled patients with urinary incontinence in Peking University People's Hospital, Wuhan People's Hospital, Zhongshan People's Hospital, and Jiangsu Maternity and Child Health Hospital in the Department of Gynecology, and collected baseline data. The random number table was used to divide the period into observation group and control group. The observation group was treated with a new type of pelvic floor rehabilitation therapy device PHENIX U4+, and the control group was treated with a traditional pelvic floor electrical stimulation therapy device. Follow-up observations during the treatment period and at the end of the treatment, 3 months and 6 months, the main follow-up content includes 1h pad test, 72-hour urination diary, modified Oxford muscle strength classification diagnosis, urinary incontinence-related questionnaires, new equipment inspections, etc. , Track and compare the treatment effect.
Read the detailed description
Use two pelvic floor treatment devices to treat urinary incontinence, collect relevant questionnaires and pelvic floor muscle strength, and compare the two treatment devices.
- Conditions
- Urinary Incontinence
- Being tested
- PHENIX U4+, Traditional pelvic floor treatment instrument
- Keywords
- new type of pelvic floor rehabilitation device PHENIX U4+, Traditional pelvic floor electrical stimulation therapy instrument
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHENIX U4+Device
The newly developed domestic PHENIX U4+ is relatively small in size. In addition to the smooth muscle stimulation function of the traditional therapy device, its electrical stimulation waveform setting can also stimulate the striated muscle, and adds more than 10 A3 reflex treatment options, which can inhibit Urinary reflex, resulting in symptoms related to urinary incontinence in the patient.
Traditional pelvic floor treatment instrumentDevice
Traditional pelvic floor treatment instrument commonly used in clinical practice
| Study group | Role | What they receive |
|---|---|---|
| PHENIX U4+ | Experimental | Electrical stimulation treatment for patients with urinary incontinence using a new type of pelvic floor therapy instrument Receives: Device: PHENIX U4+ |
| Traditional pelvic floor electrical stimulation therapy instrument | Active comparator | Electrical stimulation treatment for patients with urinary incontinence using traditional pelvic floor therapy instrument Receives: Device: Traditional pelvic floor treatment instrument |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in the effective rate of urinary incontinence treatment between the two groups
The effective rate of urinary incontinence treatment is judged by whether it leaks urine or not
Measured: Before treatment, immediately after treatment, three months after treatment, and six months after treatment
Secondary outcomes (9)
Differences in pelvic floor electromyography between the two groups
Measured: Before treatment, immediately after treatment, three months after treatment, and six months after treatment
Differences in 72-hour urination diary
reflect urination of 72 hours
Measured: Before treatment, immediately after treatment, three months after treatment, and six months after treatment
Person coefficient of correlation between results of gynecological examination and new equipment examination
Measured: Before treatment, immediately after treatment, three months after treatment, and six months after treatment
Differences in questionnaire score： PFDI-20
Questionnaires reflecting pelvic floor function, lower urinary tract symptoms, and quality of life
Measured: Before treatment, immediately after treatment, three months after treatment, and six months after treatment
Differences in questionnaire score： ICI-Q-SF
Questionnaires reflecting lower urinary tract symptoms
Measured: Before treatment, immediately after treatment, three months after treatment, and six months after treatment
Differences in questionnaire score： OABSS
Questionnaires reflecting lower urinary tract symptoms
Measured: Before treatment, immediately after treatment, three months after treatment, and six months after treatment
Differences in questionnaire score： UDI-6
Questionnaires reflecting lower urinary tract symptoms, and quality of life
Measured: Before treatment, immediately after treatment, three months after treatment, and six months after treatment
Differences in pelvic floor pressure test between the two groups
Measured: Before treatment, immediately after treatment, three months after treatment, and six months after treatment
Differences in pelvic floor tension test between the two groups
Measured: Before treatment, immediately after treatment, three months after treatment, and six months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study startJan 2022 (estimated)
- Primary completionApr 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 202 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun Xiuli, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05202717
- Sponsor's protocol ID
- PkuH5
- Status last verified
- Oct 2021
- First submitted
- 23 Nov 2021
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of the Early Warning and Prevention System for Urinary Incontinence in the Elderly--the Effect of a New Type of Pelvic Floor Rehabilitation Device PHENIX U4+ on the Treatment of Urinary Incontinence--a Multi-center Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT05202717
- Acronym / sponsor ID
- PkuH5
- Conditions
- Urinary Incontinence
- Keywords
- new type of pelvic floor rehabilitation device PHENIX U4+, Traditional pelvic floor electrical stimulation therapy instrument
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 21 Jan 2022 (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.
Enrolled patients with urinary incontinence in Peking University People's Hospital, Wuhan People's Hospital, Zhongshan People's Hospital, and Jiangsu Maternity and Child Health Hospital in the Department of Gynecology, and collected baseline data. The random number table was used to divide the period into observation group and control group. The observation group was treated with a new type of pelvic floor rehabilitation therapy device PHENIX U4+, and the control group was treated with a traditional pelvic floor electrical stimulation therapy device. Follow-up observations during the treatment period and at the end of the treatment, 3 months and 6 months, the main follow-up content includes 1h pad test, 72-hour urination diary, modified Oxford muscle strength classification diagnosis, urinary incontinence-related questionnaires, new equipment inspections, etc. , Track and compare the treatment effect.
Detailed description
Use two pelvic floor treatment devices to treat urinary incontinence, collect relevant questionnaires and pelvic floor muscle strength, and compare the two treatment devices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PHENIX U4+ | Experimental | Device: PHENIX U4+Electrical stimulation treatment for patients with urinary incontinence using a new type of pelvic floor therapy instrument |
| Traditional pelvic floor electrical stimulation therapy instrument | Active comparator | Device: Traditional pelvic floor treatment instrumentElectrical stimulation treatment for patients with urinary incontinence using traditional pelvic floor therapy instrument |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- Combined pelvic organ prolapse (with extrahymen bulging);
- Obesity (BMI>28kg/m2, BMI=weight (kg)/height square (m2));
- Uncontrolled asthma and chronic obstructive pulmonary disease (COPD);
- Combined connective tissue disease;
- Women with unclean lochia during pregnancy, within 6 weeks of postpartum and postpartum
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 |
|---|---|---|
| PHENIX U4+The newly developed domestic PHENIX U4+ is relatively small in size. In addition to the smooth muscle stimulation function of the traditional therapy device, its electrical stimulation waveform setting can also stimulate the striated muscle, and adds more than 10 A3 reflex treatment options, which can inhibit Urinary reflex, resulting in symptoms related to urinary incontinence in the patient. | Device | PHENIX U4+ |
| Traditional pelvic floor treatment instrumentTraditional pelvic floor treatment instrument commonly used in clinical practice | Device | Traditional pelvic floor electrical stimulation therapy instrument |
Primary outcome
The difference in the effective rate of urinary incontinence treatment between the two groups
Time frame: Before treatment, immediately after treatment, three months after treatment, and six months after treatment
The effective rate of urinary incontinence treatment is judged by whether it leaks urine or not
9 secondary outcomes
Differences in pelvic floor electromyography between the two groups
Time frame: Before treatment, immediately after treatment, three months after treatment, and six months after treatment
Differences in 72-hour urination diary
Time frame: Before treatment, immediately after treatment, three months after treatment, and six months after treatment
Person coefficient of correlation between results of gynecological examination and new equipment examination
Time frame: Before treatment, immediately after treatment, three months after treatment, and six months after treatment
Differences in questionnaire score： PFDI-20
Time frame: Before treatment, immediately after treatment, three months after treatment, and six months after treatment
Differences in questionnaire score： ICI-Q-SF
Time frame: Before treatment, immediately after treatment, three months after treatment, and six months after treatment
Differences in questionnaire score： OABSS
Time frame: Before treatment, immediately after treatment, three months after treatment, and six months after treatment
Differences in questionnaire score： UDI-6
Time frame: Before treatment, immediately after treatment, three months after treatment, and six months after treatment
Differences in pelvic floor pressure test between the two groups
Time frame: Before treatment, immediately after treatment, three months after treatment, and six months after treatment
Differences in pelvic floor tension test between the two groups
Time frame: Before treatment, immediately after treatment, three months after treatment, and six months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PHENIX U4+ and Traditional pelvic floor treatment instrument in people with Urinary Incontinence, run by Peking University People's Hospital at 1 site in China.
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 0 inclusion and 8 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 21 Jan 2022. 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 China. 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. 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 xiuli P Sun, professor (18611661856, sunxiuli03351@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in the effective rate of urinary incontinence treatment between the two groups (time frame: Before treatment, immediately after treatment, three months after treatment, and six months after treatment). 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 21 Jan 2022.