Clinical Trials Logo

Clinical Trial Summary

To reveal the effects of Neuromuscular Electrical Stimulation (NMES) applied over the thigh on incontinence symptoms, pelvic floor muscle function, bladder function, quality of life and sexual function in women with urge urinary incontinence (UUI) symptoms. Our goal is to contribute to the literature on electrical stimulation (ES) applications used in UUI treatment. Female patients aged 18-65 years with UUI symptoms will be included in the study. Patients will be divided into 2 groups randomly. The first group will be given Neuromuscular Electrical Stimulation (NMES) and lifestyle suggestions (LSS) (NMES group). The second group will be given sham NMES in addition to LSS (SHAM ES group). Information about bladder irritants, voiding posture and behavior, weight control and pelvic floor muscle training will be provided in the LSS. ES applications will be performed 3 days a week for 30 minutes per session for 8 weeks. All participants will be evaluated pretreatment, after the 4th week and posttreatment. Pelvic floor muscle function will evulate with the Modified Oxford Scale. In addition, women's bladder function with the urinary diary for 3 days, incontinence symptoms with the International Incontinence Consultation Questionnaire-Short Form (ICIQ-SF) and the Coital Incontinence Score (CIS), quality of life with the King Health Questionnaire (KHQ) and Sexual Function will be evaluated with Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). At the end of the 8th week, both the Subjective perception of improvement and treatment satisfaction of the patients will be questioned


Clinical Trial Description

Our study will be carried out with female patients between the ages of 18-65 who have Urge urinary Incontinence (UUI) symptoms and applied to the Recep Tayyip Erdogan University Training and Research Hospital, Gynecology and Obstetrics Policlinic. Inclusion criterias are; who do not want to use medication, who do not benefit from medication for a long time or who do not use any medication. Exclusion criterias are; Those with any malignant conditions, those with neurological disease, those with infection, pregnant women, those with pelvic organ prolapse above stage 2 according to the POP-Q staging, those with cardiac implants and pacemakers, those with cardiac arrhythmia, those with urinary retention, those with sensory loss, copper coil intrauterine those who wear a vehicle, patients with metal implants and patients with communication and cooperation problems. Before starting the study, all participants will be questioned about demographic and physical characteristics, medical, obstetric, gynecological and urological history and drug use. After these evaluations, sensory and reflex evaluations will be made. Sensory assessment will be performed with a light touch test to the hip circumference and pelvic floor muscles. In reflex evaluation, anal and bulbocavernous reflexes will be checked. All of the applications will be carried out by Specialist Physiotherapist Tuğba Birben under the supervision of Specialist Gynecologist Physician Beril Gürlek. Our study will be in 2 groups. It is estimated that the number of people will consist of 40 volunteers, with 20 patients for each group. The sample size will be determined after the pilot study. Patients who were diagnosed with UUI, met the study criteria and accepted to be included in the study, within a period of 9 months after the approval of the ethics committee, with the four-block randomization method, via the website https://www.sealedenvelope.com/simple-randomiser/v1/lists will be included in groups according to randomization. lifestyle suggestions (LSS)+ NMES (NMES group) will be applied to the first group and LSS + SHAM Electrical Stimulation (SHAM ES group) will be applied to the second group. Each group will be included in the 8-week treatment program for 30 minutes, 3 days a week. Pelvic floor muscle function of all participants will be evaluated with the Modified Oxford Scale before treatment, at the end of the 4th week and after treatment. In addition, women's bladder function with the urinary diary, incontinence symptoms with the International Incontinence Consultation Questionnaire-Short Form (ICIQ-SF) and the Coital Incontinence Score (CIS), quality of life with the King Health Questionnaire (KHQ) and Sexual Function will be evaluated with Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). At the end of the 8th week, both the Subjective perception of improvement and treatment satisfaction of the patients will be questioned. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04727983
Study type Interventional
Source Recep Tayyip Erdogan University Training and Research Hospital
Contact
Status Completed
Phase N/A
Start date July 1, 2021
Completion date November 30, 2022

See also
  Status Clinical Trial Phase
Active, not recruiting NCT03556891 - Pivotal Study of eCoin for Overactive Bladder With Urgency Urinary Incontinence N/A
Active, not recruiting NCT04936464 - Transcutaneous Tibial Nerve Stimulation for Urgency Urinary Incontinence N/A
Completed NCT04470765 - Transcutaneous Tibial Nerve Stimulation: the ZIDA Device Equivalence N/A
Recruiting NCT05415865 - The Effect of Local Anesthetic Solution in the Bladder Prior to Botox Injections in the Bladder Phase 3
Recruiting NCT05099419 - Repetitive Transcranial Magnetic Stimulation in Women With Overactive Bladder With Urgency Incontinence Early Phase 1
Recruiting NCT05874375 - UCon Treatment of Overactive Bladder (OAB) in Males N/A
Active, not recruiting NCT05241379 - AURA-2: Augmenting Urinary Reflex Activity N/A
Completed NCT02657057 - Effects of Transcutaneous and Percutaneous PTNS on Idiopathic OAB N/A
Withdrawn NCT00773552 - Solifenacin Succinate Versus Placebo in Inner City Women Ages 20-45 With Overactive Bladder Phase 4
Recruiting NCT04752709 - Efficacy of Surface Electrical Stimulation for Urge Urinary Incontinence in Women N/A
Recruiting NCT03755089 - Oral vs Intravesical Analgesia for Office Bladder Botox Injections Phase 4
Terminated NCT03687164 - Group Medical Visits for Latina Women With Urgency Urinary Incontinence N/A
Withdrawn NCT03697954 - Direct Full-stage Implantation of Sacral Neuromodulation
Completed NCT00337558 - A Study of Solifenacin With Bladder Training Versus Solifenacin Alone in Patients With Overactive Bladder (SOLAR) Phase 4
Completed NCT03180372 - Hybrid Fractional Laser Treatment for Symptoms of Urinary Incontinence N/A
Completed NCT05783219 - Lidocaine Patches Prior to Percutaneous Nerve Evaluation Phase 2
Active, not recruiting NCT05308979 - Intradetrusor Botulinum Toxin A for OAB Via 1 Versus 10 Injections: A Randomized Clinical Trial Phase 4
Completed NCT03672461 - A Group-Based Therapeutic Yoga Intervention for Urinary Incontinence in Ambulatory Older Women N/A
Completed NCT01391780 - Pelvic Floor Muscle Evaluation in Women With Stress Urinary and Urgency Urinary Incontinence N/A
Completed NCT03655054 - eCoin for OAB Feasibility Follow-on Study N/A