Health TrialsbyHealthPanel

Stress Urinary Incontinence for Female Patients (CGM MUIT-2301)

ConditionStress Urinary Incontinence (SUI)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age19+
SponsorCeragem Clinical Inc.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients with mixed urinary incontinence with predominant urgency urinary incontinence

Patients with stress urinary incontinence

Patients with overflow urinary incontinence

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ceragem Innerfit medi-tech

    Device

    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.

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: Non-implantable neuromuscular electrical stimulation (NMES) groupExperimental treatment 1 intervention
Group B: Comparator device groupSham comparator 1 intervention

Trial outcomes

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.

Time frame
at week 12 compared with baseline.

Secondary outcomes

1

Proportion of patients with urine leakage <1 g

Change from baseline and percent change in ICIQ-UI-SF(International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form) scores at Weeks 4, 8, and 12.

Time frame
at Weeks 4, 8, and 12 from baseline
2

Proportion of patients with urine leakage ≥ 50%

Proportion of patients with urine leakage ≥ 50% on the standardized pad test at Week 12 compared with baseline.

Time frame
at Weeks 12.
3

Proportion of patients with urine leakage ≥ 75%

Proportion of patients with urine leakage ≥ 75% on the standardized pad test at Week 12 compared with baseline.

Time frame
at Weeks 12.
4

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

Change and percent change from baseline in the mean the standardized pad test result (urine leakage amount) at Weeks 4 and 12

Time frame
at Weeks 4 and 12.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ceragem Clinical Inc.

Lead sponsor

Source ClinicalTrials.gov
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