Female Stress Urinary IncontinenceNCT04131387
The Safety and Efficacy of Micro-energy Ultrasound Therapy in the Treatment of Female Stress Urinary Incontinence
A study testing LIPUS-1 and LIPUS-2 in people with Female Stress Urinary Incontinence, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The Safety and Efficacy of Micro-energy Ultrasound Therapy in the Treatment of Female Stress Urinary Incontinence: A Multi-center Randomized Trail Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- Female Stress Urinary Incontinence
- What is being tested?
- LIPUS-1 and LIPUS-2
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 31 Dec 2021
- 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 30 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients diagnosed as mild to moderate female stress urinary incontinence in our hospital;
- other conservative treatments are ineffective or have poor results, and the operator is not considered for the time being;
- volunteer to participate in this clinical trial, complied with the requirements of this study and signed the informed consent form.
Who cannot join
- other types of urinary incontinence;
- blood routines indicate acute and chronic blood system diseases;
- B-ultrasound suggests other gynecological diseases;
- combine uncontrollable diseases such as diabetes, hypertension, and cardiovascular diseases;
- previous or current history of pelvic surgery and radiotherapy and chemotherapy;
- the investigator determined that it is not suitable for this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
Jiaming Wen, Dr., +86-571-87783550, wenjiaming@zju.edu.cn
About this study
Official title: The Safety and Efficacy of Micro-energy Ultrasound Therapy in the Treatment of Female Stress Urinary Incontinence: A Multi-center Randomized Clinical Trial
The Safety and Efficacy of Micro-energy Ultrasound Therapy in the Treatment of Female Stress Urinary Incontinence: A Multi-center Randomized Trail
Read the detailed description
- Study purpose: To evaluate the safety and efficacy of micro-energy ultrasound therapy in the treatment of female stress urinary incontinence
- Study design: This is a randomized, double-blind, controlled, multi-center clinical trial
- Study subjects: Females with mild to moderate stress urinary incontinence
- Number of subjects: 60
- Study center: The Second Affiliated Hospital, School of Medicine, Zhejiang University
- Treatment methods:
Test group: After installing the disposable treatment head coat, the pelvic floor muscles, ligaments, etc. were treated with an ultrasonic therapeutic apparatus; after the treatment, the disposable treatment head coat was removed. Patients were treated twice a week for 6 weeks.
Control group: The placebo was treated with an ultrasound therapy device and used in the same manner as the test group.
- Conditions
- Female Stress Urinary Incontinence
- Being tested
- LIPUS-1, LIPUS-2
- Keywords
- Female Stress Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIPUS-1Device
After installing the disposable treatment head coat, the pelvic floor muscles, ligaments, etc. were treated with an ultrasonic therapeutic apparatus; after the treatment, the disposable treatment head coat was removed. Treated twice a week for 6 weeks.
LIPUS-2Device
The placebo was treated with an ultrasound therapy device and used in the same manner as the test group.
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | After installing the disposable treatment head coat, the pelvic floor muscles, ligaments, etc. were treated with an ultrasonic therapeutic apparatus; after the treatment, the disposable treatment head coat was removed. Treated twice a week for 6 weeks. Receives: Device: LIPUS-1 |
| Control Group | Placebo comparator | The placebo was treated with an ultrasound therapy device and used in the same manner as the test group. Receives: Device: LIPUS-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The score of ICI-Q-SF
measure the international committee of incontinence brief list of urinary incontinence by a questionnaire
Measured: change from baseline level at 2 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 posted18 Oct 2019
- Study start1 Jan 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, First Affiliated Hospital of Wenzhou Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04131387
- Sponsor's protocol ID
- 2019-341
- Status last verified
- Oct 2019
- First submitted
- 14 Oct 2019
- Last updated
- 12 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Micro-energy Ultrasound Therapy in the Treatment of Female Stress Urinary Incontinence: A Multi-center Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04131387
- Acronym / sponsor ID
- 2019-341
- Conditions
- Female Stress Urinary Incontinence
- Keywords
- Female Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, First Affiliated Hospital of Wenzhou Medical University
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 18 Oct 2019 (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.
The Safety and Efficacy of Micro-energy Ultrasound Therapy in the Treatment of Female Stress Urinary Incontinence: A Multi-center Randomized Trail
Detailed description
- Study purpose: To evaluate the safety and efficacy of micro-energy ultrasound therapy in the treatment of female stress urinary incontinence
- Study design: This is a randomized, double-blind, controlled, multi-center clinical trial
- Study subjects: Females with mild to moderate stress urinary incontinence
- Number of subjects: 60
- Study center: The Second Affiliated Hospital, School of Medicine, Zhejiang University
- Treatment methods:
Test group: After installing the disposable treatment head coat, the pelvic floor muscles, ligaments, etc. were treated with an ultrasonic therapeutic apparatus; after the treatment, the disposable treatment head coat was removed. Patients were treated twice a week for 6 weeks.
Control group: The placebo was treated with an ultrasound therapy device and used in the same manner as the test group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Device: LIPUS-1After installing the disposable treatment head coat, the pelvic floor muscles, ligaments, etc. were treated with an ultrasonic therapeutic apparatus; after the treatment, the disposable treatment head coat was removed. Treated twice a week for 6 weeks. |
| Control Group | Placebo comparator | Device: LIPUS-2The placebo was treated with an ultrasound therapy device and used in the same manner as the test group. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients diagnosed as mild to moderate female stress urinary incontinence in our hospital;
- other conservative treatments are ineffective or have poor results, and the operator is not considered for the time being;
- volunteer to participate in this clinical trial, complied with the requirements of this study and signed the informed consent form.
Key exclusion criteria (6 listed)
- other types of urinary incontinence;
- blood routines indicate acute and chronic blood system diseases;
- B-ultrasound suggests other gynecological diseases;
- combine uncontrollable diseases such as diabetes, hypertension, and cardiovascular diseases;
- previous or current history of pelvic surgery and radiotherapy and chemotherapy;
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 |
|---|---|---|
| LIPUS-1After installing the disposable treatment head coat, the pelvic floor muscles, ligaments, etc. were treated with an ultrasonic therapeutic apparatus; after the treatment, the disposable treatment head coat was removed. Treated twice a week for 6 weeks. | Device | Test Group |
| LIPUS-2The placebo was treated with an ultrasound therapy device and used in the same manner as the test group. | Device | Control Group |
Primary outcome
The score of ICI-Q-SF
Time frame: change from baseline level at 2 months after treatment
measure the international committee of incontinence brief list of urinary incontinence by a questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
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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.
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LIPUS-1 and LIPUS-2 in people with Female Stress Urinary Incontinence, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 3 inclusion and 6 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 12 May 2020. 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. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The score of ICI-Q-SF (time frame: change from baseline level at 2 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 12 May 2020.