The Effectiveness of NMES Over the Thigh in Women With Urge Urinary Incontinence Symptoms

• ClinicalTrials.gov Identifier: NCT04727983
• Recruitment Status: Recruiting
• First Posted: January 27, 2021
• Last Update Posted: February 17, 2022
• Sponsor: Recep Tayyip Erdogan University Training and Research Hospital
• Information provided by (Responsible Party): TUĞBA BİRBEN, Recep Tayyip Erdogan University Training and Research Hospital

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

Condition or disease	Intervention/treatment	Phase
Physiotherapy; Women's Health; Urge Incontinence; Electrical Stimulation	Device: Electrotherapy; Device: Sham Electrotherapy	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Patients will be divided into 2 groups randomly.
• Masking: Double (Participant, Investigator)
• Masking Description: This study was planned as a double-blind (participant and investigator) randomized control.
• Primary Purpose: Treatment
• Official Title: The Effectiveness of Neuromuscular Electrical Stimulation Over the Thigh in Women With Urge Urinary Incontinence Symptoms
• Actual Study Start Date: July 1, 2021
• Estimated Primary Completion Date: June 30, 2022
• Estimated Study Completion Date: December 31, 2022

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Pelvic Floor Muscle Function; Pelvic floor muscle function will be evulated with the Modified Oxford Scale
No Intervention: Bladder function; Bladder function will be evulated with the urinary diary for 3 days
No Intervention: Incontinence Symptoms; Incontinence Symptoms will be evulated with The International Incontinence Consultation Questionnaire-Short Form (ICIQ-SF) and the Coital Incontinence Score (CIS)
No Intervention: Quality of Life; Quality of life will be evulated with the King Health Questionnaire (KHQ)
No Intervention: Sexual Function; Sexual Function will be evaluated with Pelvic Organ Prolapse / Urinary Incontinence Sexual Questionnaire (PISQ-12).
Experimental: NMES group; The first group will be given Neuromuscular Electrical Stimulation (NMES) and lifestyle suggestions (LSS)	Device: Electrotherapy; The first group will be given Neuromuscular Electrical Stimulation (NMES) and lifestyle suggestions (LSS) (NMES group)
Sham Comparator: SHAM ES group; The second group will be given sham NMES in addition to LSS	Device: Sham Electrotherapy; The second group will be given sham NMES in addition to LSS (SHAM ES group)
No Intervention: End of Treatment Special Evaluations; Subjective perception of improvement and treatment satisfaction of the patients will be questioned

Outcome Measures

Primary Outcome Measures :

1. Pelvic Floor Muscle Function [ Time Frame: 8 weeks ]

   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.

2. Bladder Function [ Time Frame: 8 weeks ]
   Bladder Function will be evulated with the bladder diary for 3 days
3. Incontinence Symptoms [ Time Frame: 8 weeks ]
   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).
4. Quality of Life Questionnaire [ Time Frame: 8 weeks ]

   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.

5. Sexual Function [ Time Frame: 8 weeks ]
   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.
6. End of Treatment Special Evaluations [ Time Frame: 8 weeks ]
   Subjective perception of improvement and treatment satisfaction of the patients will be questioned

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Female patients aged 18-65 years with UUI symptoms will be included in the study.
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: TUGBA BİRBEN, MSc; +905523929253; birbentugba@gmail.com

Locations

Turkey

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

Rize, Guneysu, Turkey, 53390

Contact: TUĞBA BİRBEN, MSc +905523929253 birbentugba@gmail.com

Sponsors and Collaborators

Recep Tayyip Erdogan University Training and Research Hospital

Investigators

• Study Director: TUGBA BIRBEN, MSc; Recep Tayyıp Erdogan University Guneysu Vocational School of Physical Therapy and Rehabilitation

More Information

• Responsible Party: TUĞBA BİRBEN, Tugba Birben, Recep Tayyip Erdogan University Training and Research Hospital
• ClinicalTrials.gov Identifier: NCT04727983
• Other Study ID Numbers: 2020/07 decision, 21 protocol
• First Posted: January 27, 2021
• Last Update Posted: February 17, 2022
• Last Verified: February 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by TUĞBA BİRBEN, Recep Tayyip Erdogan University Training and Research Hospital:

Urge urinary incontinence; Electrical stimulation; Neuromuscular electrical stimulation (NMES); Physiotherapy

Additional relevant MeSH terms:

Urinary Incontinence; Enuresis; Urinary Incontinence, Urge; Urination Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Mental Disorders