Urinary Incontinence, StressNCT04792125
Effect of External Electrical Stimulation and Pelvic Floor Muscle Training
A study testing External electrical stimulation (EES) added to pelvic floor muscle training (PFMT), External electrical stimulation and Pelvic floor muscle training (PFMT) in people with Urinary Incontinence, Stress and Electrical Stimulation, run by Giresun University at 1 site in Turkey (Türkiye).
Trial summary
In this study, the effects of the external electrical stimulation (EES) added to pelvic floor muscle training (PFMT) on stress urinary incontinence (SUI) were investigated. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Urinary Incontinence, Stress, Electrical Stimulation, Pelvic Floor Disorders
- What is being tested?
- External electrical stimulation (EES) added to pelvic floor muscle training (PFMT), External electrical stimulation and Pelvic floor muscle training (PFMT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Apr 2019to 27 Apr 2020
- 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
- having symptoms of pure stress urinary incontinence and stress predominant UI
- ability to contract pelvic floor muscle strength
- Having a mild or moderate SUI symptom according to the 24-hour pad test results.
Who cannot join
- Pregnancy,
- Having been treated for incontinence within a period of six months ago,
- Not being able to cooperate,
- Presence of urinary infection
- Use of metal implants or cardiac pacemakers,
- Epilepsy,
- Presence of stage 3 or 4 pelvic organ prolapse,
- Presence of accompanying neurological disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of External Electrical Stimulation Added to Pelvic Floor Muscle Training in Women With Stress Incontinence
In this study, the effects of the external electrical stimulation (EES) added to pelvic floor muscle training (PFMT) on stress urinary incontinence (SUI) were investigated.
Read the detailed description
Fifty one women with mild and moderate SUI symptoms were included in the study. The patients were divided into three groups of PFMT (n:17), EES (n:17) and PFMT+ EES (n:17) by block randomization. The PFMT was applied every day of the week, and EES was applied 3 days a week for 8 weeks. Pelvic floor muscle strength (PFMS), pelvic floor muscle endurance, subjective perception of improvement, severity of incontinence, quality of life, pelvic floor dysfunction (PTD) and urinary parameters were assessed as outcome variables. All measurements, except subjective perception of improvement were investigated before and after treatment.
- Conditions
- Urinary Incontinence, Stress, Electrical Stimulation, Pelvic Floor Disorders, Urinary Incontinence
- Being tested
- External electrical stimulation (EES) added to pelvic floor muscle training (PFMT), External electrical stimulation, Pelvic floor muscle training (PFMT)
- Medical subject headings
- Urinary Incontinence, Stress, Pelvic Floor Disorders, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External electrical stimulation (EES) added to pelvic floor muscle training (PFMT)Behavioural
Patients will be treated with the Innovo device using eight external electrodes with a combined stimulator. Electrodes will be applied to the buttocks, outer hips and anterior and posterior proximal thighs 3 days a week for 30 minutes each session.
While explaining the exercise to the patients, it was stated that 1 set of exercise consisted of 10 fast contractions and 10 slow contractions. For the first 2 weeks, they were asked to exercise 2 sets a day, every day. Thus, in the first 2 weeks, 20 fast contractions and 20 slow contractions were performed. Then, 2 sets were increased every two weeks and the exercise was ended as 8 sets (80 fast and 80 slow contractions) at the end of the 8th week.
External electrical stimulationBehavioural
Patients will be treated with the Innovo device using eight external electrodes with a combined stimulator. Electrodes will be applied to the buttocks, outer hips and anterior and posterior proximal thighs 3 days a week for 30 minutes each session.
Pelvic floor muscle training (PFMT)Behavioural
While explaining the exercise to the patients, it was stated that 1 set of exercise consisted of 10 fast contractions and 10 slow contractions. For the first 2 weeks, they were asked to exercise 2 sets a day, every day. Thus, in the first 2 weeks, 20 fast contractions and 20 slow contractions were performed. Then, 2 sets were increased every two weeks and the exercise was ended as 8 sets (80 fast and 80 slow contractions) at the end of the 8th week.
| Study group | Role | What they receive |
|---|---|---|
| External electrical stimulation (EES) added to pelvic floor muscle training (PFMT) group | Experimental | This arm is going to include the patients who are performed external electrical stimulation (EES) added to pelvic floor muscle training (PFMT). Receives: Behavioral: External electrical stimulation (EES) added to pelvic floor muscle training (PFMT) |
| External electrical stimulation (EES) group | Other | This arm is going to include the patients who are performed external electrical stimulation (EES). Receives: Behavioral: External electrical stimulation |
| Pelvic floor muscle training (PFMT) group | Active comparator | This arm is going to include the patients who are performed pelvic floor muscle training (PFMT). Receives: Behavioral: Pelvic floor muscle training (PFMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported improvement
Perception of urinary incontinence improvement compared with baseline was assessed using four-item Likert-type scale (worse, same, better, cured).
Measured: 8 weeks
Secondary outcomes (2)
24 hour pad test
Urinary incontinence severity was assessed.
Measured: 8 weeks
pelvic floor muscle strength and endurance
measured using noninvasive vaginal perineometer
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 posted10 Mar 2021
- Study start29 Apr 2019
- Primary completion27 Apr 2020
- Study completion27 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Urinary Incontinence, StressStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Giresun University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulkukezbansahin, Giresun University
- Investigators
- ULKU K SAHIN, PhD, Principal investigator, Giresun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04792125
- Sponsor's protocol ID
- 2019-55
- Status last verified
- Mar 2021
- First submitted
- 28 Feb 2021
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets generated during and analyzed during the current study are available from the corresponding author on reasonable request.
Publications
Kaya S, Akbayrak T, Gursen C, Beksac S. Short-term effect of adding pelvic floor muscle training to bladder training for female urinary incontinence: a randomized controlled trial. Int Urogynecol J. 2015 Feb;26(2):285-93. doi: 10.1007/s00192-014-2517-4. Epub 2014 Sep 30.
PubMed 25266357Turkan A, Inci Y, Fazli D. The short-term effects of physical therapy in different intensities of urodynamic stress incontinence. Gynecol Obstet Invest. 2005;59(1):43-8. doi: 10.1159/000081133. Epub 2004 Sep 29.
PubMed 15459518Huebner M, Riegel K, Hinninghofen H, Wallwiener D, Tunn R, Reisenauer C. Pelvic floor muscle training for stress urinary incontinence: a randomized, controlled trial comparing different conservative therapies. Physiother Res Int. 2011 Sep;16(3):133-40. doi: 10.1002/pri.489. Epub 2010 Sep 16.
PubMed 20848671
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of External Electrical Stimulation Added to Pelvic Floor Muscle Training in Women With Stress Incontinence
- ClinicalTrials.gov ID
- NCT04792125
- Acronym / sponsor ID
- 2019-55
- Conditions
- Urinary Incontinence, Stress, Electrical Stimulation, Pelvic Floor Disorders, Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Giresun UniversityUniversity, hospital or other
- Study start
- 29 Apr 2019 (actual)
- Primary completion
- 27 Apr 2020 (actual)
- Study completion
- 27 Apr 2020 (actual)
- First posted
- 10 Mar 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.
In this study, the effects of the external electrical stimulation (EES) added to pelvic floor muscle training (PFMT) on stress urinary incontinence (SUI) were investigated.
Detailed description
Fifty one women with mild and moderate SUI symptoms were included in the study. The patients were divided into three groups of PFMT (n:17), EES (n:17) and PFMT+ EES (n:17) by block randomization. The PFMT was applied every day of the week, and EES was applied 3 days a week for 8 weeks. Pelvic floor muscle strength (PFMS), pelvic floor muscle endurance, subjective perception of improvement, severity of incontinence, quality of life, pelvic floor dysfunction (PTD) and urinary parameters were assessed as outcome variables. All measurements, except subjective perception of improvement were investigated before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| External electrical stimulation (EES) added to pelvic floor muscle training (PFMT) group | Experimental | Behavioral: External electrical stimulation (EES) added to pelvic floor muscle training (PFMT)This arm is going to include the patients who are performed external electrical stimulation (EES) added to pelvic floor muscle training (PFMT). |
| External electrical stimulation (EES) group | Other | Behavioral: External electrical stimulationThis arm is going to include the patients who are performed external electrical stimulation (EES). |
| Pelvic floor muscle training (PFMT) group | Active comparator | Behavioral: Pelvic floor muscle training (PFMT)This arm is going to include the patients who are performed pelvic floor muscle training (PFMT). |
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)
- having symptoms of pure stress urinary incontinence and stress predominant UI
- ability to contract pelvic floor muscle strength
- Having a mild or moderate SUI symptom according to the 24-hour pad test results.
Key exclusion criteria (8 listed)
- Pregnancy,
- Having been treated for incontinence within a period of six months ago,
- Not being able to cooperate,
- Presence of urinary infection
- Use of metal implants or cardiac pacemakers,
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 |
|---|---|---|
| External electrical stimulation (EES) added to pelvic floor muscle training (PFMT)Patients will be treated with the Innovo device using eight external electrodes with a combined stimulator. Electrodes will be applied to the buttocks, outer hips and anterior and posterior proximal thighs 3 days a week for 30 minutes each session. While explaining the exercise to the patients, it was stated that 1 set of exercise consisted of 10 fast contractions and 10 slow contractions. For the first 2 weeks, they were asked to exercise 2 sets a day, every day. Thus, in the first 2 weeks, 20 fast contractions and 20 slow contractions were performed. Then, 2 sets were increased every two weeks and the exercise was ended as 8 sets (80 fast and 80 slow contractions) at the end of the 8th week. | Behavioural | External electrical stimulation (EES) added to pelvic floor muscle training (PFMT) group |
| External electrical stimulationPatients will be treated with the Innovo device using eight external electrodes with a combined stimulator. Electrodes will be applied to the buttocks, outer hips and anterior and posterior proximal thighs 3 days a week for 30 minutes each session. | Behavioural | External electrical stimulation (EES) group |
| Pelvic floor muscle training (PFMT)While explaining the exercise to the patients, it was stated that 1 set of exercise consisted of 10 fast contractions and 10 slow contractions. For the first 2 weeks, they were asked to exercise 2 sets a day, every day. Thus, in the first 2 weeks, 20 fast contractions and 20 slow contractions were performed. Then, 2 sets were increased every two weeks and the exercise was ended as 8 sets (80 fast and 80 slow contractions) at the end of the 8th week. | Behavioural | Pelvic floor muscle training (PFMT) group |
Primary outcome
Self-reported improvement
Time frame: 8 weeks
Perception of urinary incontinence improvement compared with baseline was assessed using four-item Likert-type scale (worse, same, better, cured).
2 secondary outcomes
24 hour pad test
Time frame: 8 weeks
pelvic floor muscle strength and endurance
Time frame: 8 weeks
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 10 Mar 2021.
- Results publication: PubMed 25266357Kaya S, Akbayrak T, Gursen C, Beksac S. Short-term effect of adding pelvic floor muscle training to bladder training for female urinary incontinence: a randomized controlled trial. Int Urogynecol J. 2015 Feb;26(2):285-93. doi: 10.1007/s00192-014-2517-4. Epub 2014 Sep 30.
- Results publication: PubMed 15459518Turkan A, Inci Y, Fazli D. The short-term effects of physical therapy in different intensities of urodynamic stress incontinence. Gynecol Obstet Invest. 2005;59(1):43-8. doi: 10.1159/000081133. Epub 2004 Sep 29.
- Results publication: PubMed 20848671Huebner M, Riegel K, Hinninghofen H, Wallwiener D, Tunn R, Reisenauer C. Pelvic floor muscle training for stress urinary incontinence: a randomized, controlled trial comparing different conservative therapies. Physiother Res Int. 2011 Sep;16(3):133-40. doi: 10.1002/pri.489. Epub 2010 Sep 16.
- Individual participant dataSharing planned: No. The datasets generated during and analyzed during the current study are available from the corresponding author on reasonable request.
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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.
ULKU K SAHIN, PhD principal investigator
Giresun University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External electrical stimulation (EES) added to pelvic floor muscle training (PFMT), External electrical stimulation and Pelvic floor muscle training (PFMT) in people with Urinary Incontinence, Stress and Electrical Stimulation, run by Giresun University 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 8 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 10 Mar 2021. 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. 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?
Self-reported improvement (time frame: 8 weeks). 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 NCT04792125, which also lists 3 linked publications.
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 10 Mar 2021.