Back to resultsA Study of the Use of Vaginal Radiofrequency Therapy in Treatment of SUI.
Primary Purpose
Urinary Incontinence, Stress
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
physical therapy
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence, Stress
Eligibility Criteria
Inclusion Criteria:
18-75 years old women with a sexual history, and patients with mild to moderate stress urinary incontinence.
Exclusion Criteria:
Severe cardiopulmonary insufficiency, acute pelvic inflammatory disease or other infectious stage, non-steroidal anti-inflammatory drugs and steroid hormones affecting collagen production factors, POP-Q-2 and above prolapse.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
vaginal radiofrequency
electromyography biofeedback
Arm Description
vaginal radiofrequency therapy 4 times
electromyography combined with biofeedback therapy 15 times
Outcomes
Primary Outcome Measures
Urine leakage in 1-hour pad test
measure the urine leakage in 1-hour pad test
Change from urine leakage at 3 months
measure the urine leakage in 1-hour pad test at 3 months
Change from urine leakage at 12 months
measure the urine leakage in 1-hour pad test at 12 months
Secondary Outcome Measures
incontinence impact questionnaire short form,IIQ-7
Urinary incontinence may affect daily activities, interpersonal relationships or personal emotions.The minimum value is 0,and the maximum value is 21. Higher scores mean a worse outcome.
incontinence impact questionnaire short form,IIQ-7
Urinary incontinence may affect daily activities, interpersonal relationships or personal emotions.The minimum value is 0,and the maximum value is 21. Higher scores mean a worse outcome.
incontinence impact questionnaire short form,IIQ-7
Urinary incontinence may affect daily activities, interpersonal relationships or personal emotions.The minimum value is 0,and the maximum value is 21. Higher scores mean a worse outcome.
pelvic organ prolapsed-incontinence sexual questionnaire, PISQ-12
The sexual desire，orgasm，pain，urine leakage in sex of the participants.The minimum value is 0,and the maximum value is 48.Higher scores mean a better outcome.
pelvic organ prolapsed-incontinence sexual questionnaire, PISQ-12
The sexual desire，orgasm，pain，urine leakage in sex of the participants.The minimum value is 0,and the maximum value is 48.Higher scores mean a better outcome.
pelvic organ prolapsed-incontinence sexual questionnaire, PISQ-12
The sexual desire，orgasm，pain，urine leakage in sex of the participants.The minimum value is 0,and the maximum value is 48.Higher scores mean a better outcome.
Female Sexual index，FSFI
Sex frequency，sexual satisfaction, physiological factors, affective factor , sexual partner factor. The minimum value is 0,and the maximum value is 124.Higher scores mean a better outcome.
Female Sexual index，FSFI
Sex frequency，sexual satisfaction, physiological factors, affective factor , sexual partner factor. The minimum value is 0,and the maximum value is 124.Higher scores mean a better outcome.
Female Sexual index，FSFI
Sex frequency，sexual satisfaction, physiological factors, affective factor , sexual partner factor.The minimum value is 0,and the maximum value is 124. Higher scores mean a better outcome.
Full Information
NCT ID
NCT05570071
First Posted
September 26, 2022
Last Updated
October 11, 2022
Sponsor
Qianfoshan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05570071
Brief Title
A Study of the Use of Vaginal Radiofrequency Therapy in Treatment of SUI.
Official Title
A Randomized Controlled Clinical Study of the Use of Vaginal Radiofrequency Therapy in Treatment of Stress Urinary Incontinence.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 20, 2022 (Anticipated)
Primary Completion Date
March 31, 2025 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qianfoshan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To investigate the immediate, short-term and long-term efficacy of vaginal radiofrequency therapy in the treatment of stress urinary incontinence, and to compare the efficacy of pelvic floor electromyography combined with biofeedback therapy in stress urinary incontinence.
Detailed Description
Before treatment, patients with mild and moderate stress urinary incontinence were diagnosed according to the diagnostic criteria through medical history inquiry and gynecological physical examination, and patients were screened according to the inclusion and exclusion criteria. After informing two treatment plans and signing the informed consent, they were randomly divided into vaginal radiofrequency therapy group and electrical stimulation combined biofeedback group. After being included in the test, one hour urine pad test was conducted, and IIQ-7, PISQ-12 and FSFI questionnaires were completed. IIQ-7, PISQ-12 and FSFI questionnaires were followed up 1, 3, 6 and 12 months after treatment. After 3 months and 1 year of treatment, 1 hour urine pad test was given again.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Stress
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
vaginal radiofrequency
Arm Type
Experimental
Arm Description
vaginal radiofrequency therapy 4 times
Arm Title
electromyography biofeedback
Arm Type
Active Comparator
Arm Description
electromyography combined with biofeedback therapy 15 times
Intervention Type
Device
Intervention Name(s)
physical therapy
Intervention Description
medical treatment of pelvic floor
Primary Outcome Measure Information:
Title
Urine leakage in 1-hour pad test
Description
measure the urine leakage in 1-hour pad test
Time Frame
before therapy
Title
Change from urine leakage at 3 months
Description
measure the urine leakage in 1-hour pad test at 3 months
Time Frame
3months after therapy
Title
Change from urine leakage at 12 months
Description
measure the urine leakage in 1-hour pad test at 12 months
Time Frame
12months after therapy
Secondary Outcome Measure Information:
Title
incontinence impact questionnaire short form,IIQ-7
Description
Urinary incontinence may affect daily activities, interpersonal relationships or personal emotions.The minimum value is 0,and the maximum value is 21. Higher scores mean a worse outcome.
Time Frame
before therapy
Title
incontinence impact questionnaire short form,IIQ-7
Description
Urinary incontinence may affect daily activities, interpersonal relationships or personal emotions.The minimum value is 0,and the maximum value is 21. Higher scores mean a worse outcome.
Time Frame
3months after therapy
Title
incontinence impact questionnaire short form,IIQ-7
Description
Urinary incontinence may affect daily activities, interpersonal relationships or personal emotions.The minimum value is 0,and the maximum value is 21. Higher scores mean a worse outcome.
Time Frame
12months after therapy
Title
pelvic organ prolapsed-incontinence sexual questionnaire, PISQ-12
Description
The sexual desire，orgasm，pain，urine leakage in sex of the participants.The minimum value is 0,and the maximum value is 48.Higher scores mean a better outcome.
Time Frame
before therapy
Title
pelvic organ prolapsed-incontinence sexual questionnaire, PISQ-12
Description
The sexual desire，orgasm，pain，urine leakage in sex of the participants.The minimum value is 0,and the maximum value is 48.Higher scores mean a better outcome.
Time Frame
3months after therapy
Title
pelvic organ prolapsed-incontinence sexual questionnaire, PISQ-12
Description
The sexual desire，orgasm，pain，urine leakage in sex of the participants.The minimum value is 0,and the maximum value is 48.Higher scores mean a better outcome.
Time Frame
12months after therapy
Title
Female Sexual index，FSFI
Description
Sex frequency，sexual satisfaction, physiological factors, affective factor , sexual partner factor. The minimum value is 0,and the maximum value is 124.Higher scores mean a better outcome.
Time Frame
before therapy
Title
Female Sexual index，FSFI
Description
Sex frequency，sexual satisfaction, physiological factors, affective factor , sexual partner factor. The minimum value is 0,and the maximum value is 124.Higher scores mean a better outcome.
Time Frame
3months after therapy
Title
Female Sexual index，FSFI
Description
Sex frequency，sexual satisfaction, physiological factors, affective factor , sexual partner factor.The minimum value is 0,and the maximum value is 124. Higher scores mean a better outcome.
Time Frame
12months after therapy
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-75 years old women with a sexual history, and patients with mild to moderate stress urinary incontinence.
Exclusion Criteria:
Severe cardiopulmonary insufficiency, acute pelvic inflammatory disease or other infectious stage, non-steroidal anti-inflammatory drugs and steroid hormones affecting collagen production factors, POP-Q-2 and above prolapse.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Yan
Phone
+860531-89268917
Email
yanliqy@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Miao Yuan
Phone
+860531-89268917
Email
qyfckjys@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Yan
Organizational Affiliation
The First Affiliated Hospital of Shandong First Medical University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Miao Yuan
Organizational Affiliation
The First Affiliated Hospital of Shandong First Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fangfang Zhao
Organizational Affiliation
The First Affiliated Hospital of Shandong First Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Guangli Liu
Organizational Affiliation
The First Affiliated Hospital of Shandong First Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jing Li
Organizational Affiliation
The First Affiliated Hospital of Shandong First Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Min Lu
Organizational Affiliation
The First Affiliated Hospital of Shandong First Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hongyan Niu
Organizational Affiliation
The First Affiliated Hospital of Shandong First Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dongyue Wang
Organizational Affiliation
The First Affiliated Hospital of Shandong First Medical University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of the Use of Vaginal Radiofrequency Therapy in Treatment of SUI.
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