Effects of External Neuromuscular Electrical Stimulation in Women With Urgency Urinary Incontinence
NCT ID: NCT04727983
Last Updated: 2023-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
34 participants
INTERVENTIONAL
2021-07-01
2022-11-30
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Pelvic Floor Muscle Function
Pelvic floor muscle function will be evulated with the Modified Oxford Scale
No interventions assigned to this group
Bladder function
Bladder function will be evulated with the urinary diary for 3 days
No interventions assigned to this group
Incontinence Symptoms
Incontinence Symptoms will be evulated with The International Incontinence Consultation Questionnaire-Short Form (ICIQ-SF) and the Coital Incontinence Score (CIS)
No interventions assigned to this group
Quality of Life
Quality of life will be evulated with the King Health Questionnaire (KHQ)
No interventions assigned to this group
Sexual Function
Sexual Function will be evaluated with Pelvic Organ Prolapse / Urinary Incontinence Sexual Questionnaire (PISQ-12).
No interventions assigned to this group
NMES group
The first group will be given Neuromuscular Electrical Stimulation (NMES) and lifestyle suggestions (LSS)
Electrotherapy
The first group will be given Neuromuscular Electrical Stimulation (NMES) and lifestyle suggestions (LSS) (NMES group)
SHAM ES group
The second group will be given sham NMES in addition to LSS
Sham Electrotherapy
The second group will be given sham NMES in addition to LSS (SHAM ES group)
End of Treatment Special Evaluations
Subjective perception of improvement and treatment satisfaction of the patients will be questioned
No interventions assigned to this group
Interventions
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Electrotherapy
The first group will be given Neuromuscular Electrical Stimulation (NMES) and lifestyle suggestions (LSS) (NMES group)
Sham Electrotherapy
The second group will be given sham NMES in addition to LSS (SHAM ES group)
Eligibility Criteria
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Inclusion Criteria
* who do not benefit from medication for a long time
* who do not use any medication
Exclusion Criteria
* those with neurological disease,
* those with infection,
* pregnancy,
* 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
* patients with communication and cooperation problems
18 Years
65 Years
FEMALE
No
Sponsors
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Recep Tayyip Erdogan University Training and Research Hospital
OTHER
Responsible Party
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TUĞBA BİRBEN
Tugba Birben
Principal Investigators
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TUGBA BIRBEN, MSc
Role: STUDY_DIRECTOR
Recep Tayyıp Erdogan University Guneysu Vocational School of Physical Therapy and Rehabilitation
Locations
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Recep Tayyıp Erdogan University Guneysu Vocational School of Physical Therapy and Rehabilitation
Rize, Guneysu, Turkey (Türkiye)
Countries
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References
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Kurt TB, Yilmaz B, Celenay ST. Effects of external neuromuscular electrical stimulation in women with urgency urinary incontinence: a randomized sham-controlled study. World J Urol. 2024 Jul 21;42(1):423. doi: 10.1007/s00345-024-05126-7.
Other Identifiers
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2020/07 decision, 21 protocol
Identifier Type: -
Identifier Source: org_study_id
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