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| ClinicalTrials.gov Identifier: NCT02452593 |
| Recruitment Status: Unknown
First Posted: June 21, 2019
Last Update Posted: June 21, 2019
|
Sponsor:
BladderCell a Leonhardt’s Launchpads company, Los Angeles, California www.bladdercell.com
Collaborator:
TBD
Study Details
Study Description
Brief Summary:
Urinary incontinence is defined as any involuntary loss of urine…
The study aims to evaluate sacral nerve electroacupuncture stimulation…
The study aims to evaluate sacral nerve electroacupuncture stimulation…
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Urge Incontinence | Sacral nerve S3 electro acupuncture stimulation and pelvic floor exercises | Not Applicable |
Detailed Description:
Goal: Development of home treatment instrumentation for overactive bladder…
Study Design
| Study Type | Interventional (Clinical Trial) |
| Enrollment | 30 participants |
| Allocation | Randomized |
| Intervention Model | Crossover Assignment |
| Masking | None (Open Label) |
| Primary Purpose | Treatment |
| Official Title | Randomized Trial of Sacral Nerve Electroacupuncture vs Pelvic Floor Exercises |
| Study Start Date | Summer 2019 |
| Primary Completion Date | Winter 2020 |
| Study Completion Date | March 2020 |
Outcome Measures
Primary Outcome: Number of participants with urinary incontinence (3 months)
Eligibility Criteria
Ages: 18+ Female. Inclusion: Urgency or mixed urinary incontinence.
Exclusion Criteria:
- Vaginal or urinary infection
- Pregnancy or postpartum period
- Use of Botox or implantable devices
- Other conditions affecting urinary function
Contacts and Locations: TBD