Effects of External Neuromuscular Electrical Stimulation in Women With Urgency Urinary Incontinence
Condition: Physiotherapy; Women's Health; Urge Incontinence; Electrical Stimulation
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Urge
Study type: Interventional

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
    

Detailed 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.
    

Intervention name(s): Electrotherapy; Sham Electrotherapy
Intervention type(s): Device; Device
Intervention description(s): 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)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be divided into 2 groups randomly.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Urge urinary incontinence; Electrical stimulation; Neuromuscular electrical stimulation (NMES); Physiotherapy