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

Primary Purpose

Physiotherapy, Women's Health, Urge Incontinence

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Electrotherapy
Sham Electrotherapy
Sponsored by
Recep Tayyip Erdogan University Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Physiotherapy focused on measuring Urge urinary incontinence, Electrical stimulation, Neuromuscular electrical stimulation (NMES), Physiotherapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • who do not want to use medication,
  • who do not benefit from medication for a long time
  • who do not use any medication

Exclusion Criteria:

  • Those with any malignant conditions,
  • 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

Sites / Locations

  • Recep Tayyıp Erdogan University Guneysu Vocational School of Physical Therapy and Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

No Intervention

No Intervention

No Intervention

No Intervention

No Intervention

Experimental

Sham Comparator

No Intervention

Arm Label

Pelvic Floor Muscle Function

Bladder function

Incontinence Symptoms

Quality of Life

Sexual Function

NMES group

SHAM ES group

End of Treatment Special Evaluations

Arm Description

Pelvic floor muscle function will be evulated with the Modified Oxford Scale

Bladder function will be evulated with the urinary diary for 3 days

Incontinence Symptoms will be evulated with The International Incontinence Consultation Questionnaire-Short Form (ICIQ-SF) and the Coital Incontinence Score (CIS)

Quality of life will be evulated with the King Health Questionnaire (KHQ)

Sexual Function will be evaluated with Pelvic Organ Prolapse / Urinary Incontinence Sexual Questionnaire (PISQ-12).

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

The second group will be given sham NMES in addition to LSS

Subjective perception of improvement and treatment satisfaction of the patients will be questioned

Outcomes

Primary Outcome Measures

Pelvic Floor Muscle Function
Pelvic Floor Muscle Function will be evulated with The Modified Oxford Scale (MOS). It rates the Pelvic floor muscle contraction on a scale of 0-5; 0 = no contraction; 1 = minor muscle 'flicker'; 2 = weak muscle contraction; 3 = moderate muscle contraction; 4 = good muscle contraction and 5 = strong muscle contraction.
Bladder Function
Bladder Function will be evulated with the bladder diary for 3 days
Incontinence Symptoms
Incontinence symptoms will be evulated with The International Consultation of Incontinence Questionnaire - Short Form (ICIQ-SF) it has 5 questions and total score ranges is 1 - 5 (slight), 6 - 12 (moderate), 13 - 18 (severe) and 19 - 21 (very severe).
Quality of Life Questionnaire
quality of life will be evulated with the King's Health Questionnaire (KHQ) It consists of 3 parts. In the first part; 2 questions evaluating General health perception, in the second part; 19 questions that divide the quality of life into different areas (Incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/ energy, general health status, symptom severity) and in the third part; It consists of 11 questions evaluating the severity of urinary symptoms. The individual items in the domains are scaled from 0 (best) to 100 worst. Another dimension is added which is called as Symptom severity scale; where in there are 10 different bladder symptoms, the score ranges from 0 to 30 and the values are not converted to percentages.
Sexual Function
Sexual Function will be evulated with the Pelvic Organ Prolapse Urinary Incontinence Sexual Questionnaire - 12 (Short Form) (PISQ-12-SF) The questionnaire is based on 12 items that allow investigation of three different domains of sexual life; behavior (items 1-4), physical (items 5-9) and partner-related (items 10-12). Scores are calculated by totaling the scores for each question with 0 = always to 4 = never. Reversed scoring is used for items 1, 2, 3 and 4. Higher PISQ-12-SF scores indicate a better sexual function. Maximum score is 48.
End of Treatment Special Evaluations
Subjective perception of improvement and treatment satisfaction of the patients will be questioned

Secondary Outcome Measures

Full Information

First Posted
January 23, 2021
Last Updated
February 22, 2023
Sponsor
Recep Tayyip Erdogan University Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04727983
Brief Title
Effects of External Neuromuscular Electrical Stimulation in Women With Urgency Urinary Incontinence
Official Title
Effects of External Neuromuscular Electrical Stimulation in Women With Urgency Urinary Incontinence: A Randomized Sham-Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Recep Tayyip Erdogan University Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physiotherapy, Women's Health, Urge Incontinence, Electrical Stimulation
Keywords
Urge urinary incontinence, Electrical stimulation, Neuromuscular electrical stimulation (NMES), Physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be divided into 2 groups randomly.
Masking
Participant
Masking Description
This study was planned single blinded randomized control.
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pelvic Floor Muscle Function
Arm Type
No Intervention
Arm Description
Pelvic floor muscle function will be evulated with the Modified Oxford Scale
Arm Title
Bladder function
Arm Type
No Intervention
Arm Description
Bladder function will be evulated with the urinary diary for 3 days
Arm Title
Incontinence Symptoms
Arm Type
No Intervention
Arm Description
Incontinence Symptoms will be evulated with The International Incontinence Consultation Questionnaire-Short Form (ICIQ-SF) and the Coital Incontinence Score (CIS)
Arm Title
Quality of Life
Arm Type
No Intervention
Arm Description
Quality of life will be evulated with the King Health Questionnaire (KHQ)
Arm Title
Sexual Function
Arm Type
No Intervention
Arm Description
Sexual Function will be evaluated with Pelvic Organ Prolapse / Urinary Incontinence Sexual Questionnaire (PISQ-12).
Arm Title
NMES group
Arm Type
Experimental
Arm Description
The first group will be given Neuromuscular Electrical Stimulation (NMES) and lifestyle suggestions (LSS)
Arm Title
SHAM ES group
Arm Type
Sham Comparator
Arm Description
The second group will be given sham NMES in addition to LSS
Arm Title
End of Treatment Special Evaluations
Arm Type
No Intervention
Arm Description
Subjective perception of improvement and treatment satisfaction of the patients will be questioned
Intervention Type
Device
Intervention Name(s)
Electrotherapy
Intervention Description
The first group will be given Neuromuscular Electrical Stimulation (NMES) and lifestyle suggestions (LSS) (NMES group)
Intervention Type
Device
Intervention Name(s)
Sham Electrotherapy
Intervention Description
The second group will be given sham NMES in addition to LSS (SHAM ES group)
Primary Outcome Measure Information:
Title
Pelvic Floor Muscle Function
Description
Pelvic Floor Muscle Function will be evulated with The Modified Oxford Scale (MOS). It rates the Pelvic floor muscle contraction on a scale of 0-5; 0 = no contraction; 1 = minor muscle 'flicker'; 2 = weak muscle contraction; 3 = moderate muscle contraction; 4 = good muscle contraction and 5 = strong muscle contraction.
Time Frame
8 weeks
Title
Bladder Function
Description
Bladder Function will be evulated with the bladder diary for 3 days
Time Frame
8 weeks
Title
Incontinence Symptoms
Description
Incontinence symptoms will be evulated with The International Consultation of Incontinence Questionnaire - Short Form (ICIQ-SF) it has 5 questions and total score ranges is 1 - 5 (slight), 6 - 12 (moderate), 13 - 18 (severe) and 19 - 21 (very severe).
Time Frame
8 weeks
Title
Quality of Life Questionnaire
Description
quality of life will be evulated with the King's Health Questionnaire (KHQ) It consists of 3 parts. In the first part; 2 questions evaluating General health perception, in the second part; 19 questions that divide the quality of life into different areas (Incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/ energy, general health status, symptom severity) and in the third part; It consists of 11 questions evaluating the severity of urinary symptoms. The individual items in the domains are scaled from 0 (best) to 100 worst. Another dimension is added which is called as Symptom severity scale; where in there are 10 different bladder symptoms, the score ranges from 0 to 30 and the values are not converted to percentages.
Time Frame
8 weeks
Title
Sexual Function
Description
Sexual Function will be evulated with the Pelvic Organ Prolapse Urinary Incontinence Sexual Questionnaire - 12 (Short Form) (PISQ-12-SF) The questionnaire is based on 12 items that allow investigation of three different domains of sexual life; behavior (items 1-4), physical (items 5-9) and partner-related (items 10-12). Scores are calculated by totaling the scores for each question with 0 = always to 4 = never. Reversed scoring is used for items 1, 2, 3 and 4. Higher PISQ-12-SF scores indicate a better sexual function. Maximum score is 48.
Time Frame
8 weeks
Title
End of Treatment Special Evaluations
Description
Subjective perception of improvement and treatment satisfaction of the patients will be questioned
Time Frame
8 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female patients aged 18-65 years with UUI symptoms will be included in the study.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: who do not want to use medication, who do not benefit from medication for a long time who do not use any medication Exclusion Criteria: Those with any malignant conditions, 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
TUGBA BIRBEN, MSc
Organizational Affiliation
Recep Tayyıp Erdogan University Guneysu Vocational School of Physical Therapy and Rehabilitation
Official's Role
Study Director
Facility Information:
Facility Name
Recep Tayyıp Erdogan University Guneysu Vocational School of Physical Therapy and Rehabilitation
City
Rize
State/Province
Guneysu
ZIP/Postal Code
53390
Country
Turkey

12. IPD Sharing Statement

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

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