NCT05570071

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 6, 2022

Completed
14 days until next milestone

Study Start

First participant enrolled

October 20, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

October 12, 2022

Status Verified

October 1, 2022

Enrollment Period

2.4 years

First QC Date

September 26, 2022

Last Update Submit

October 11, 2022

Conditions

Urinary Incontinence, Stress

Outcome Measures

Primary Outcomes (3)

  • Urine leakage in 1-hour pad test

    measure the urine leakage in 1-hour pad test

    before therapy

  • Change from urine leakage at 3 months

    measure the urine leakage in 1-hour pad test at 3 months

    3months after therapy

  • Change from urine leakage at 12 months

    measure the urine leakage in 1-hour pad test at 12 months

    12months after therapy

Secondary Outcomes (9)

  • incontinence impact questionnaire short form,IIQ-7

    before therapy

  • incontinence impact questionnaire short form,IIQ-7

    3months after therapy

  • incontinence impact questionnaire short form,IIQ-7

    12months after therapy

  • pelvic organ prolapsed-incontinence sexual questionnaire, PISQ-12

    before therapy

  • pelvic organ prolapsed-incontinence sexual questionnaire, PISQ-12

    3months after therapy

  • +4 more secondary outcomes

Study Arms (2)

vaginal radiofrequency

EXPERIMENTAL

vaginal radiofrequency therapy 4 times

Device: physical therapy

electromyography biofeedback

ACTIVE COMPARATOR

electromyography combined with biofeedback therapy 15 times

Device: physical therapy

Interventions

physical therapyDEVICE

medical treatment of pelvic floor

electromyography biofeedbackvaginal radiofrequency

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old women with a sexual history, and patients with mild to moderate stress urinary incontinence.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Li Yan

    Shandong First Medical University

    STUDY DIRECTOR

  • Miao Yuan

    Shandong First Medical University

    PRINCIPAL INVESTIGATOR

  • Fangfang Zhao

    Shandong First Medical University

    PRINCIPAL INVESTIGATOR

  • Guangli Liu

    Shandong First Medical University

    PRINCIPAL INVESTIGATOR

  • Jing Li

    Shandong First Medical University

    PRINCIPAL INVESTIGATOR

  • Min Lu

    Shandong First Medical University

    PRINCIPAL INVESTIGATOR

  • Hongyan Niu

    Shandong First Medical University

    PRINCIPAL INVESTIGATOR

  • Dongyue Wang

    Shandong First Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Yan

CONTACT

+860531-89268917yanliqy@163.com

Miao Yuan

CONTACT

+860531-89268917qyfckjys@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
pfofessor

Study Record Dates

First Submitted

September 26, 2022

First Posted

October 6, 2022

Study Start

October 20, 2022

Primary Completion

March 31, 2025

Study Completion

March 31, 2025

Last Updated

October 12, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share