Urinary Incontinence Clinical Trial
Official title:
The Effects of External Electrical Stimulation Added to Pelvic Floor Muscle Training in Women With Stress Incontinence
NCT number | NCT04792125 |
Other study ID # | 2019-55 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 29, 2019 |
Est. completion date | April 27, 2020 |
Verified date | March 2021 |
Source | Giresun University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In this study, the effects of the external electrical stimulation (EES) added to pelvic floor muscle training (PFMT) on stress urinary incontinence (SUI) were investigated.
Status | Completed |
Enrollment | 51 |
Est. completion date | April 27, 2020 |
Est. primary completion date | April 27, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - having symptoms of pure stress urinary incontinence and stress predominant UI - ability to contract pelvic floor muscle strength - Having a mild or moderate SUI symptom according to the 24-hour pad test results. Exclusion Criteria: - Pregnancy, - Having been treated for incontinence within a period of six months ago, - Not being able to cooperate, - Presence of urinary infection - Use of metal implants or cardiac pacemakers, - Epilepsy, - Presence of stage 3 or 4 pelvic organ prolapse, - Presence of accompanying neurological disease |
Country | Name | City | State |
---|---|---|---|
Turkey | Giresun University | Giresun |
Lead Sponsor | Collaborator |
---|---|
Giresun University |
Turkey,
Huebner M, Riegel K, Hinninghofen H, Wallwiener D, Tunn R, Reisenauer C. Pelvic floor muscle training for stress urinary incontinence: a randomized, controlled trial comparing different conservative therapies. Physiother Res Int. 2011 Sep;16(3):133-40. do — View Citation
Kaya S, Akbayrak T, Gursen C, Beksac S. Short-term effect of adding pelvic floor muscle training to bladder training for female urinary incontinence: a randomized controlled trial. Int Urogynecol J. 2015 Feb;26(2):285-93. doi: 10.1007/s00192-014-2517-4. E — View Citation
Turkan A, Inci Y, Fazli D. The short-term effects of physical therapy in different intensities of urodynamic stress incontinence. Gynecol Obstet Invest. 2005;59(1):43-8. Epub 2004 Sep 29. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Self-reported improvement | Perception of urinary incontinence improvement compared with baseline was assessed using four-item Likert-type scale (worse, same, better, cured). | 8 weeks | |
Secondary | 24 hour pad test | Urinary incontinence severity was assessed. | 8 weeks | |
Secondary | pelvic floor muscle strength and endurance | measured using noninvasive vaginal perineometer | 8 weeks |
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