NCT07440927

Brief Summary

This study is a multicenter, prospective, randomized, double-blind, sham-controlled clinical trial conducted in female patients with stress urinary incontinence.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Dec 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Dec 2024Sep 2026

Study Start

First participant enrolled

December 13, 2024

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2026

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

1.8 years

First QC Date

February 2, 2026

Last Update Submit

February 25, 2026

Conditions

Stress Urinary Incontinence (SUI)

Keywords

Stress Urinary Incontinence (SUI)

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with urine leakage <1 g

    Proportion of patients with urine leakage \<1 g on the standardized pad test at Week 12 compared with baseline.

    at week 12 compared with baseline.

Secondary Outcomes (11)

  • Proportion of patients with urine leakage <1 g

    at Weeks 4, 8, and 12 from baseline

  • Proportion of patients with urine leakage ≥ 50%

    at Weeks 12.

  • Proportion of patients with urine leakage ≥ 75%

    at Weeks 12.

  • Change and percent change from baseline in the mean the standardized pad test

    at Weeks 4 and 12.

  • Change and percent change from baseline in the average number of urinary incontinence episodes

    at Weeks 12.

  • +6 more secondary outcomes

Study Arms (2)

Non-implantable neuromuscular electrical stimulation (NMES) group

EXPERIMENTAL

Non-implantable neuromuscular electrical stimulation (NMES) group for urinary incontinence

Device: Ceragem Innerfit medi-tech

Comparator device group

SHAM COMPARATOR

Non-implantable neuromuscular electrical stimulation (NMES) without electrical stimulation group for urinary incontinence

Device: Ceragem Innerfit medi-tech

Interventions

Ceragem Innerfit medi-techDEVICE

Stress Urinary Incontinence Device (Ceragem Innerfit medi-tech) The investigational device and control device were applied at least 5 days per week, twice daily (morning and evening), for 15 minutes per session, over a total period of 12 weeks.

Comparator device groupNon-implantable neuromuscular electrical stimulation (NMES) group

Eligibility Criteria

Age19 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale patient with stress urinary incontinence
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with urine leakage of ≥1 g on the standardized pad test

You may not qualify if:

  • Patients with mixed urinary incontinence with predominant urgency urinary incontinence
  • Patients with stress urinary incontinence
  • Patients with overflow urinary incontinence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Seoul Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Stress

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

Study Officials

  • Kyu Sung Lee, MD

    Samsung Seoul Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Myeongbae Shin, Researcher

CONTACT

82-10-4373-2808mbshin94@ceragem.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2026

First Posted

February 27, 2026

Study Start

December 13, 2024

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Locations

KR(1)