NCT04727983

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 27, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

February 24, 2023

Status Verified

February 1, 2023

Enrollment Period

12 months

First QC Date

January 23, 2021

Last Update Submit

February 22, 2023

Conditions

PhysiotherapyWomen's HealthUrge IncontinenceElectrical Stimulation

Keywords

Urge urinary incontinenceElectrical stimulationNeuromuscular electrical stimulation (NMES)Physiotherapy

Outcome Measures

Primary Outcomes (6)

  • 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.

    8 weeks

  • Bladder Function

    Bladder Function will be evulated with the bladder diary for 3 days

    8 weeks

  • 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).

    8 weeks

  • 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.

    8 weeks

  • 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.

    8 weeks

  • End of Treatment Special Evaluations

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

    8 weeks

Study Arms (8)

Pelvic Floor Muscle Function

NO INTERVENTION

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

Bladder function

NO INTERVENTION

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

Incontinence Symptoms

NO INTERVENTION

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

Quality of Life

NO INTERVENTION

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

Sexual Function

NO INTERVENTION

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

NMES group

EXPERIMENTAL

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

Device: Electrotherapy

SHAM ES group

SHAM COMPARATOR

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

Device: Sham Electrotherapy

End of Treatment Special Evaluations

NO INTERVENTION

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

Interventions

ElectrotherapyDEVICE

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

NMES group
Sham ElectrotherapyDEVICE

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

SHAM ES group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale patients aged 18-65 years with UUI symptoms will be included in the study.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Rize, Guneysu, 53390, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 39033475DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Urge

Interventions

Electric Stimulation Therapy

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • TUGBA BIRBEN, MSc

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
This study was planned single blinded randomized control.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients will be divided into 2 groups randomly.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Tugba Birben

Study Record Dates

First Submitted

January 23, 2021

First Posted

January 27, 2021

Study Start

July 1, 2021

Primary Completion

June 30, 2022

Study Completion

November 30, 2022

Last Updated

February 24, 2023

Record last verified: 2023-02

Locations

TU(1)