Trials / Completed
CompletedNCT03969368
rPMS Compared With Pelvic Floor Exercises for Treatment of Urinary Incontinence
Randomized Trial of rPMS Pelvic Floor Stimulation Device Compared With Pelvic Floor Exercises for Treatment of Urinary Incontinence
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- BTL Industries Ltd. · Industry
- Sex
- Female
- Age
- 25 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This study will compare the clinical efficacy and safety between rPMS device and pelvic floor exercises for the treatment of urinary incontinence. The subjects will be enrolled and assigned into two study groups - active and control group. Subjects will be required to complete six (6) treatment visits and five follow-up visits - 1, 3, 6, 9 and 12 months after the final treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | rPMS device | Pelvic floor muscle contractions will be induced by the rPMS device. |
| PROCEDURE | Pelvic floor muscle training | Control group will undergo a pelvic floor muscle training |
Timeline
- Start date
- 2019-06-01
- Primary completion
- 2021-07-23
- Completion
- 2022-06-23
- First posted
- 2019-05-31
- Last updated
- 2022-08-31
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03969368. Inclusion in this directory is not an endorsement.