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Effects of External Neuromuscular Electrical Stimulation in Women With Urgency Urinary Incontinence

NCT04727983 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2023-02-24

No results posted yet for this study

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

Conditions

  • Physiotherapy
  • Women's Health
  • Urge Incontinence
  • Electrical Stimulation

Interventions

DEVICE

Electrotherapy

The first group will be given Neuromuscular Electrical Stimulation (NMES) and lifestyle suggestions (LSS) (NMES group)

DEVICE

Sham Electrotherapy

The second group will be given sham NMES in addition to LSS (SHAM ES group)

Sponsors & Collaborators

  • Recep Tayyip Erdogan University Training and Research Hospital

    lead OTHER

Principal Investigators

  • TUGBA BIRBEN, MSc · Recep Tayyıp Erdogan University Guneysu Vocational School of Physical Therapy and Rehabilitation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2022-06-30
Completion
2022-11-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04727983 on ClinicalTrials.gov