Clinical trial NCT04792125: Effect of External Electrical Stimulation and Pelvic Floor Muscle Training
Official title: The Effects of External Electrical Stimulation Added to Pelvic Floor Muscle Training in Women With Stress Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence, Stress
Electrical Stimulation
Pelvic Floor Disorders
Urinary Incontinence
Lead sponsor: Giresun University
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Fifty one women with mild and moderate SUI symptoms were included in the study. The patients were divided into three groups of PFMT (n:17), EES (n:17) and PFMT+ EES (n:17) by block randomization. The PFMT was applied every day of the week, and EES was applied 3 days a week for 8 weeks. Pelvic floor muscle strength (PFMS), pelvic floor muscle endurance, subjective perception of improvement, severity of incontinence, quality of life, pelvic floor dysfunction (PTD) and urinary parameters were assessed as outcome variables. All measurements, except subjective perception of improvement were investigated before and after treatment.

Eligibility criteria: 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

Primary outcomes:
measure: Self-reported improvement
timeFrame: 8 weeks
Secondary outcomes:
measure: 24 hour pad test
timeFrame: 8 weeks
measure: pelvic floor muscle strength and endurance
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Giresun
country: Turkey
facility: Giresun University
Study officials:
affiliation: Giresun University
name: ULKU K SAHIN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. Epub 2014 Sep 30.
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. doi: 10.1159/000081133. Epub 2004 Sep 29.
citation: 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. doi: 10.1002/pri.489. Epub 2010 Sep 16.