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

Urge Incontinence Clinical Trial

Official title:

Effects of External Neuromuscular Electrical Stimulation in Women With Urgency Urinary Incontinence: A Randomized Sham-Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04727983
• Other study ID #: 2020/07 decision, 21 protocol
• Status: Completed
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: November 30, 2022

Study information

• Verified date: February 2023
• Source: Recep Tayyip Erdogan University Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: November 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Electrical Stimulation
• Enuresis
• Physiotherapy
• Urge Incontinence
• Urinary Incontinence
• Urinary Incontinence, Urge
• Women's Health

Intervention

Device:
• 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)

Locations

Country	Name	City	State
Turkey	Recep Tayyip Erdogan University Guneysu Vocational School of Physical Therapy and Rehabilitation	Rize	Guneysu

Sponsors (1)

Lead Sponsor	Collaborator
Recep Tayyip Erdogan University Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Bladder Function	Bladder Function will be evulated with the bladder diary for 3 days	8 weeks
Primary	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
Primary	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
Primary	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
Primary	End of Treatment Special Evaluations	Subjective perception of improvement and treatment satisfaction of the patients will be questioned	8 weeks