Clinical trial NCT05570071: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Incontinence, Stress
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2022-10-06
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Urine leakage in 1-hour pad test
timeFrame: before therapy
measure: Change from urine leakage at 3 months
timeFrame: 3months after therapy
measure: Change from urine leakage at 12 months
timeFrame: 12months after therapy
Secondary outcomes:
measure: incontinence impact questionnaire short form,IIQ-7
timeFrame: before therapy
measure: incontinence impact questionnaire short form,IIQ-7
timeFrame: 3months after therapy
measure: incontinence impact questionnaire short form,IIQ-7
timeFrame: 12months after therapy
measure: pelvic organ prolapsed-incontinence sexual questionnaire, PISQ-12
timeFrame: before therapy
measure: pelvic organ prolapsed-incontinence sexual questionnaire, PISQ-12
timeFrame: 3months after therapy
measure: pelvic organ prolapsed-incontinence sexual questionnaire, PISQ-12
timeFrame: 12months after therapy
measure: Female Sexual index，FSFI
timeFrame: before therapy
measure: Female Sexual index，FSFI
timeFrame: 3months after therapy
measure: Female Sexual index，FSFI
timeFrame: 12months after therapy
Other outcomes:
Locations:
Study officials:
affiliation: Shandong First Medical University
name: Li Yan
role: STUDY_DIRECTOR
affiliation: Shandong First Medical University
name: Miao Yuan
role: PRINCIPAL_INVESTIGATOR
affiliation: Shandong First Medical University
name: Fangfang Zhao
role: PRINCIPAL_INVESTIGATOR
affiliation: Shandong First Medical University
name: Guangli Liu
role: PRINCIPAL_INVESTIGATOR
affiliation: Shandong First Medical University
name: Jing Li
role: PRINCIPAL_INVESTIGATOR
affiliation: Shandong First Medical University
name: Min Lu
role: PRINCIPAL_INVESTIGATOR
affiliation: Shandong First Medical University
name: Hongyan Niu
role: PRINCIPAL_INVESTIGATOR
affiliation: Shandong First Medical University
name: Dongyue Wang
role: PRINCIPAL_INVESTIGATOR
References: