Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date March 2021
Source Giresun University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Intervention

Behavioral:
External electrical stimulation (EES) added to pelvic floor muscle training (PFMT)
Patients will be treated with the Innovo device using eight external electrodes with a combined stimulator. Electrodes will be applied to the buttocks, outer hips and anterior and posterior proximal thighs 3 days a week for 30 minutes each session. While explaining the exercise to the patients, it was stated that 1 set of exercise consisted of 10 fast contractions and 10 slow contractions. For the first 2 weeks, they were asked to exercise 2 sets a day, every day. Thus, in the first 2 weeks, 20 fast contractions and 20 slow contractions were performed. Then, 2 sets were increased every two weeks and the exercise was ended as 8 sets (80 fast and 80 slow contractions) at the end of the 8th week.
External electrical stimulation
Patients will be treated with the Innovo device using eight external electrodes with a combined stimulator. Electrodes will be applied to the buttocks, outer hips and anterior and posterior proximal thighs 3 days a week for 30 minutes each session.
Pelvic floor muscle training (PFMT)
While explaining the exercise to the patients, it was stated that 1 set of exercise consisted of 10 fast contractions and 10 slow contractions. For the first 2 weeks, they were asked to exercise 2 sets a day, every day. Thus, in the first 2 weeks, 20 fast contractions and 20 slow contractions were performed. Then, 2 sets were increased every two weeks and the exercise was ended as 8 sets (80 fast and 80 slow contractions) at the end of the 8th week.

Locations

Country Name City State
Turkey Giresun University Giresun

Sponsors (1)

Lead Sponsor Collaborator
Giresun University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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

Outcome

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
See also
  Status Clinical Trial Phase
Recruiting NCT05534412 - A Practice-Based Intervention To Improve Care for a Diverse Population Of Women With Urinary Incontinence N/A
Recruiting NCT05515198 - Improving Care for Women With Urinary Incontinence (EMPOWER) N/A
Completed NCT04071301 - Collection of Real-life Measurement Data for TENA SmartCare Change Indicator in Subjects With Urinary Incontinence N/A
Completed NCT03623880 - Enhancing Behavioral Treatment for Women With Pelvic Floor Disorders N/A
Recruiting NCT05880862 - Comparative Effectiveness of Initial OAB Treatment Options Among Older Women at High Risk of Falls Early Phase 1
Recruiting NCT04159467 - Effect of Pelvic Floor Muscle Training on Urinary Incontinence Reports in Obese Women Undergoing a Low Calorie Diet N/A
Completed NCT05485922 - Performance of a Single-use Intermittent Micro-hole Zone Catheter N/A
Completed NCT06268782 - The Effectiveness of an Online Exercise Program on Well-being of Postpartum Women N/A
Not yet recruiting NCT03027986 - Evaluation of a Postural Rehabilitation Program Based on Sensory-motor Control in Men With Urinary Incontinence After Prostatectomy N/A
Recruiting NCT02490917 - ACT™ Balloons Versus Artificial Urinary Sphincter (AMS800™) for the Treatment of Female Stress Urinary Incontinence N/A
Enrolling by invitation NCT02530372 - Feasibility of the UriCap-F for Urine Collection in Hospitalized Women N/A
Enrolling by invitation NCT02529371 - Pre-Marketing Feasibility Evaluation of the UriCap-RM - Urine Collection in Hospitalized Male Patients N/A
Completed NCT02549729 - Effect of the Pelvic Floor Training in Postmenopausal Women With or Without Hormonal Therapy N/A
Completed NCT02600676 - Transcutaneous Electric Nerve Stimulation (TENS) in Children With Enuresis N/A
Completed NCT02338726 - Pelvic Floor Symptoms and Quality of Life in Elderly Women - a Population-based Pilot Study N/A
Completed NCT02239796 - Feasibility Controlled Trial of Tibial Nerve Stimulation for Stroke Related Urinary Incontinence N/A
Completed NCT02368262 - Prevalence of Incontinence and Risk Factors in Children With Cerebral Palsy N/A
Completed NCT01942681 - Female Patients With Signs of uRgE and Stress Urinary Incontinence Study of Propiverine Hydrochloride N/A
Recruiting NCT01804153 - Stem Cells Tratment for the Local Feminine Stress Urinary Incontinence Treatment (HULPURO) Phase 1/Phase 2
Completed NCT01520948 - Behavioral Therapy to Treat Urinary Symptoms in Parkinson Disease Phase 3