PhysiotherapyNCT04727983
Effects of External Neuromuscular Electrical Stimulation in Women With Urgency Urinary Incontinence
A study testing Electrotherapy in people with Physiotherapy and Women's Health, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Physiotherapy, Women's Health, Urge Incontinence
- What is being tested?
- Electrotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2021to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- who do not want to use medication,
- who do not benefit from medication for a long time
- who do not use any medication
Who cannot join
- 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,
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Recep Tayyıp Erdogan University Guneysu Vocational School of Physical Therapy and Rehabilitation
Rize, Guneysu, 53390
About this study
Official title: Effects of External Neuromuscular Electrical Stimulation in Women With Urgency Urinary Incontinence: A Randomized Sham-Controlled Study
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
Read the 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.
- Being tested
- Electrotherapy, Sham Electrotherapy
- Keywords
- Urge urinary incontinence, Electrical stimulation, Neuromuscular electrical stimulation (NMES), Physiotherapy
- Medical subject headings
- Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectrotherapyDevice
The first group will be given Neuromuscular Electrical Stimulation (NMES) and lifestyle suggestions (LSS) (NMES group)
Sham ElectrotherapyDevice
The second group will be given sham NMES in addition to LSS (SHAM ES group)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: Electrotherapy |
| SHAM ES group | Sham comparator | The second group will be given sham NMES in addition to LSS Receives: Device: Sham Electrotherapy |
| End of Treatment Special Evaluations | No intervention | Subjective perception of improvement and treatment satisfaction of the patients will be questioned |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Bladder Function
Bladder Function will be evulated with the bladder diary for 3 days
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 8 weeks
End of Treatment Special Evaluations
Subjective perception of improvement and treatment satisfaction of the patients will be questioned
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start1 Jul 2021
- Primary completion30 Jun 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PhysiotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be divided into 2 groups randomly.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TUĞBA BİRBEN, Recep Tayyip Erdogan University Training and Research Hospital
- Investigators
- TUGBA BIRBEN, MSc, Study director, Recep Tayyıp Erdogan University Guneysu Vocational School of Physical Therapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04727983
- Sponsor's protocol ID
- 2020/07 decision, 21 protocol
- Status last verified
- Feb 2023
- First submitted
- 23 Jan 2021
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39033475
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of External Neuromuscular Electrical Stimulation in Women With Urgency Urinary Incontinence: A Randomized Sham-Controlled Study
- ClinicalTrials.gov ID
- NCT04727983
- Acronym / sponsor ID
- 2020/07 decision, 21 protocol
- Keywords
- Urge urinary incontinence, Electrical stimulation, Neuromuscular electrical stimulation (NMES), Physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 8
- Model description
- Patients will be divided into 2 groups randomly.
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: ElectrotherapyThe first group will be given Neuromuscular Electrical Stimulation (NMES) and lifestyle suggestions (LSS) |
| SHAM ES group | Sham comparator | Device: Sham ElectrotherapyThe second group will be given sham NMES in addition to LSS |
| End of Treatment Special Evaluations | No intervention | –Subjective perception of improvement and treatment satisfaction of the patients will be questioned |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- who do not want to use medication,
- who do not benefit from medication for a long time
- who do not use any medication
Key exclusion criteria (12 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectrotherapyThe first group will be given Neuromuscular Electrical Stimulation (NMES) and lifestyle suggestions (LSS) (NMES group) | Device | NMES group |
| Sham ElectrotherapyThe second group will be given sham NMES in addition to LSS (SHAM ES group) | Device | SHAM ES group |
Primary outcome
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.
Bladder Function
Time frame: 8 weeks
Bladder Function will be evulated with the bladder diary for 3 days
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).
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.
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.
End of Treatment Special Evaluations
Time frame: 8 weeks
Subjective perception of improvement and treatment satisfaction of the patients will be questioned
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
- Derived from this study: PubMed 39033475Kurt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TUGBA BIRBEN, MSc study director
Recep Tayyıp Erdogan University Guneysu Vocational School of Physical Therapy and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrotherapy in people with Physiotherapy and Women's Health, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic Floor Muscle Function (time frame: 8 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04727983, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2023.