Stress Urinary IncontinenceNCT05272644
Efficacy of Biofeedback-Assisted Pelvic Muscle Floor Training and Electrical Stimulation on Women With Stress Urinary Incontinence
A study testing surface electromyographic biofeedback assisted pelvic floor muscle training and surface electromyographic biofeedback and electrical stimulation in people with Stress Urinary Incontinence and Urethral Hypermobility, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
The pathophysiological mechanism of stress urinary incontinence divides stress urinary incontinence into urethral hypermobility and intrinsic sphincter deficiency. Pelvic floor muscle exercise as first line therapy has been found to be extremely helpful in patients with mild to moderate forms of incontinence. Read more about this study
- Who is it for?
- Ages 20 to 85 years, women only
- Conditions the study is for
- Stress Urinary Incontinence, Urethral Hypermobility, Intrinsic Sphincter Deficiency
- What is being tested?
- surface electromyographic biofeedback assisted pelvic floor muscle training and surface electromyographic biofeedback and electrical stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Sep 2022to 31 Dec 2023
- 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 20 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- overactivity bladder for more than 3 months
- more then 20 year old,less then 85 year old and acceptable to receive vaginal examination
- need to match schedule with the investigator's clinic for 45 times,followed by individual therapy, each takes about 30 to 60 minutes, a total of 8 weeks of pelvic floor muscle exercises
Who cannot join
- Suffering from systemic neuromuscular diseases, such as stroke, spinal cord injury, peripheral neuropathy, etc.
- Kidney disease
- Liver disease
- Patients with cardiac rhythm devices.
- Insufficient cognitive function, unable to cooperate with pelvic floor muscle exercises.
- Women during pregnancy.
- Maternity within six weeks after delivery
Trial locations and contacts
1 site in 1 country.
Far Eastern Memorial Hospital contact
Taiwan1 site, 1 recruiting
- Recruiting
Far Eastern Memorial Hospital
New Taipei City, 220
About this study
Official title: Efficacy of Biofeedback-Assisted Pelvic Muscle Floor Training and Electrical Stimulation on Women With Different Pathophysiological Classifications of Stress Urinary Incontinence
The pathophysiological mechanism of stress urinary incontinence divides stress urinary incontinence into urethral hypermobility and intrinsic sphincter deficiency. Pelvic floor muscle exercise as first line therapy has been found to be extremely helpful in patients with mild to moderate forms of incontinence. Biofeedback uses an instrument to record the biological signals ( electrical activity) during a voluntary pelvic floor muscle contraction and present this information back to the woman in auditory or visual form. Electrical stimulation can aid in detecting pelvic floor muscles, and also promote the contraction of the pelvic floor muscles and strengthen the muscles. This study assumes that urinary incontinence women with different pathophysiological classifications receiving a pelvic floor muscle training with surface electromyographic biofeedback and electrical stimulation show differences in the strength of pelvic muscle and degree of symptoms improvement.
Read the detailed description
Participant will be assigned randomly to biofeedback-assisted pelvic floor muscle training (PFMT) group and biofeedback-assisted pelvic floor muscle training (PFMT) combined with electrical stimulation group. Each of the participant will receive the therapy for two months.The investigators expected that combination therapy will improve the compliance and severity of symptoms in women with stress urinary incontinence.
- Being tested
- surface electromyographic biofeedback assisted pelvic floor muscle training, surface electromyographic biofeedback and electrical stimulation
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surface electromyographic biofeedback assisted pelvic floor muscle trainingBehavioural
participants will be doing surface electromyographic biofeedback assisted pelvic floor muscle training for 2 months
surface electromyographic biofeedback and electrical stimulationBehavioural
participants will be doing surface electromyographic biofeedback and electrical stimulation assisted pelvic floor muscle training for 2 months
| Study group | Role | What they receive |
|---|---|---|
| urethral hypermobility-surface electromyographic biofeedback only | Active comparator | Participant will be doing surface electromyographic biofeedback assisted pelvic floor muscle training for 2 months Receives: Behavioral: surface electromyographic biofeedback assisted pelvic floor muscle training |
| urethral hypermobility-surface electromyographic biofeedback and electrical stimulation | Experimental | Participant will be doing surface electromyographic biofeedback and electrical stimulation assisted pelvic floor muscle training for 2 months Receives: Behavioral: surface electromyographic biofeedback and electrical stimulation |
| intrinsic sphincter deficiency-surface electromyographic biofeedback only | Active comparator | Participant will be doing surface electromyographic biofeedback assisted pelvic floor muscle training for 2 months Receives: Behavioral: surface electromyographic biofeedback assisted pelvic floor muscle training |
| intrinsic sphincter deficiency-surface electromyographic biofeedback and electrical stimulation | Experimental | Participant will be doing surface electromyographic biofeedback and electrical stimulation assisted pelvic floor muscle training for 2 months Receives: Behavioral: surface electromyographic biofeedback and electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
King's Health Questionnaire (KHQ)
KHQ has 3 parts consisting of 21 items. Part 1 contains general health perception and incontinence impact (one item each). Part 2 contains role limitations, physical limitations, social limitations (two items each), personal relationships, emotions (three items each) and sleep/energy (two items), severity measures (four items).Part 3 is considered as a single item and contains ten responses in relation to frequency, nocturia, urgency,urge, stress, intercourse incontinence, nocturnal enuresis,infections, pain, and difficulty in voiding. The 4 subscales scored between 1 (best) and 4 (worst) in part 1 and 2. The Symptom Severity scale is scored from 0 (best) to 3 (worst) in part 3 .
Measured: Time Frame: through study completion, an average of 8 weeks
A five-item Self-Assessment of Treatment (SAT)
to assess improvement and satisfaction with treatment, consists of 1 item. The scale scored between 1 (worst) and 5 (best ) .
Measured: Time Frame: through study completion, an average of 8 weeks.
Sandvik urinary incontinence severity test
The Sandvik test was developed by Sandvik et al to be used as a simple way to calculate severity of urinary incontinence in women. Answer the two questions below and your result will be displayed (Severity Index Score).
Measured: Time Frame: through study completion, an average of 8 weeks
Symptom Indexes for Stress Incontinence
assigning a grade based on a clinical history of incontinence: grade 1-only on Severe coughing, sneezing, lifting heavy objects, lifting heavy objects, jumping; grade 2-on walking or running; grade 3-on walking, doing housework (eg washing dishes, sweeping the floor), changing posture (eg from standing to squatting or sitting...);grade 4-on Resting state, such as turning over in bed
Measured: Time Frame: through study completion, an average of 8 weeks
Secondary outcomes (3)
Introital and transvaginal ultrasound in the assessment of urogenital and pelvic floor dysfunction
the transducer is placed over the external urethral orifice with the transducer axis corresponding to the body axis Ultrasound assessment of the bladder and urethra starts in the midsagittal plane.
From this position, the transducer can be moved to the left or to the right for additional assessment of the periurethral tissue. The distance between bladder neck and line through the lower edge of the pubic symphysis, and the posterior urethrovesical angle β (angle between urethral axis and bladder floor) are determined at rest and during contraction, coughing, and pressing. Changes in these parameters during contraction and pressing and in particular visual real-time ultrasound assessment serve to evaluate the reactivity of the pelvic floor muscles and the adequacy of the connective tissue supportive structures of the urogenital organs.
Measured: Time Frame: through study completion, an average of 8 weeks
one-hour pad test
The test is carried out according to the recommendations of the International Continence Society and lasts for one hour and fifteen minutes. It consists in weighing the amount of urine retained in a sanitary napkin after the patient has completed a set of standard exercises, distributed over an hour.
Measured: Time Frame: through study completion, an average of 8 weeks
change of electromyographic activity
Electromyographic activity of the pelvic floor muscles (PFMs) and the synergistic abdominal muscles (SAMs) during each session of PFMT(µV)
Measured: Time Frame: through study completion, an average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start16 Sep 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies 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
- A total of 128 women with stress urinary incontinence will be divided into two groups: urethral hypermobility and intrinsic sphincter deficiency; and they will be further randomized to 2 arms: surface electromyographic biofeedback arm, surface electromyographic biofeedback and electrical stimulation arm
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05272644
- Sponsor's protocol ID
- 109184-F
- Status last verified
- Mar 2023
- First submitted
- 28 Feb 2022
- Last updated
- 22 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Biofeedback-Assisted Pelvic Muscle Floor Training and Electrical Stimulation on Women With Different Pathophysiological Classifications of Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT05272644
- Acronym / sponsor ID
- 109184-F
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 16 Sep 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 9 Mar 2022 (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.
The pathophysiological mechanism of stress urinary incontinence divides stress urinary incontinence into urethral hypermobility and intrinsic sphincter deficiency. Pelvic floor muscle exercise as first line therapy has been found to be extremely helpful in patients with mild to moderate forms of incontinence. Biofeedback uses an instrument to record the biological signals ( electrical activity) during a voluntary pelvic floor muscle contraction and present this information back to the woman in auditory or visual form. Electrical stimulation can aid in detecting pelvic floor muscles, and also promote the contraction of the pelvic floor muscles and strengthen the muscles. This study assumes that urinary incontinence women with different pathophysiological classifications receiving a pelvic floor muscle training with surface electromyographic biofeedback and electrical stimulation show differences in the strength of pelvic muscle and degree of symptoms improvement.
Detailed description
Participant will be assigned randomly to biofeedback-assisted pelvic floor muscle training (PFMT) group and biofeedback-assisted pelvic floor muscle training (PFMT) combined with electrical stimulation group. Each of the participant will receive the therapy for two months.The investigators expected that combination therapy will improve the compliance and severity of symptoms in women with stress urinary incontinence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- A total of 128 women with stress urinary incontinence will be divided into two groups: urethral hypermobility and intrinsic sphincter deficiency; and they will be further randomized to 2 arms: surface electromyographic biofeedback arm, surface electromyographic biofeedback and electrical stimulation arm
| Arm | Type | Receives |
|---|---|---|
| urethral hypermobility-surface electromyographic biofeedback only | Active comparator | Behavioral: surface electromyographic biofeedback assisted pelvic floor muscle trainingParticipant will be doing surface electromyographic biofeedback assisted pelvic floor muscle training for 2 months |
| urethral hypermobility-surface electromyographic biofeedback and electrical stimulation | Experimental | Behavioral: surface electromyographic biofeedback and electrical stimulationParticipant will be doing surface electromyographic biofeedback and electrical stimulation assisted pelvic floor muscle training for 2 months |
| intrinsic sphincter deficiency-surface electromyographic biofeedback only | Active comparator | Behavioral: surface electromyographic biofeedback assisted pelvic floor muscle trainingParticipant will be doing surface electromyographic biofeedback assisted pelvic floor muscle training for 2 months |
| intrinsic sphincter deficiency-surface electromyographic biofeedback and electrical stimulation | Experimental | Behavioral: surface electromyographic biofeedback and electrical stimulationParticipant will be doing surface electromyographic biofeedback and electrical stimulation assisted pelvic floor muscle training for 2 months |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- overactivity bladder for more than 3 months
- more then 20 year old,less then 85 year old and acceptable to receive vaginal examination
- need to match schedule with the investigator's clinic for 45 times,followed by individual therapy, each takes about 30 to 60 minutes, a total of 8 weeks of pelvic floor muscle exercises
Key exclusion criteria (7 listed)
- Suffering from systemic neuromuscular diseases, such as stroke, spinal cord injury, peripheral neuropathy, etc.
- Kidney disease
- Liver disease
- Patients with cardiac rhythm devices.
- Insufficient cognitive function, unable to cooperate with pelvic floor muscle exercises.
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 |
|---|---|---|
| surface electromyographic biofeedback assisted pelvic floor muscle trainingparticipants will be doing surface electromyographic biofeedback assisted pelvic floor muscle training for 2 months | Behavioural | intrinsic sphincter deficiency-surface electromyographic biofeedback only, urethral hypermobility-surface electromyographic biofeedback only |
| surface electromyographic biofeedback and electrical stimulationparticipants will be doing surface electromyographic biofeedback and electrical stimulation assisted pelvic floor muscle training for 2 months | Behavioural | intrinsic sphincter deficiency-surface electromyographic biofeedback and electrical stimulation, urethral hypermobility-surface electromyographic biofeedback and electrical stimulation |
Primary outcome
King's Health Questionnaire (KHQ)
Time frame: Time Frame: through study completion, an average of 8 weeks
KHQ has 3 parts consisting of 21 items. Part 1 contains general health perception and incontinence impact (one item each). Part 2 contains role limitations, physical limitations, social limitations (two items each), personal relationships, emotions (three items each) and sleep/energy (two items), severity measures (four items).Part 3 is considered as a single item and contains ten responses in relation to frequency, nocturia, urgency,urge, stress, intercourse incontinence, nocturnal enuresis,infections, pain, and difficulty in voiding. The 4 subscales scored between 1 (best) and 4 (worst) in part 1 and 2. The Symptom Severity scale is scored from 0 (best) to 3 (worst) in part 3 .
A five-item Self-Assessment of Treatment (SAT)
Time frame: Time Frame: through study completion, an average of 8 weeks.
to assess improvement and satisfaction with treatment, consists of 1 item. The scale scored between 1 (worst) and 5 (best ) .
Sandvik urinary incontinence severity test
Time frame: Time Frame: through study completion, an average of 8 weeks
The Sandvik test was developed by Sandvik et al to be used as a simple way to calculate severity of urinary incontinence in women. Answer the two questions below and your result will be displayed (Severity Index Score).
Symptom Indexes for Stress Incontinence
Time frame: Time Frame: through study completion, an average of 8 weeks
assigning a grade based on a clinical history of incontinence: grade 1-only on Severe coughing, sneezing, lifting heavy objects, lifting heavy objects, jumping; grade 2-on walking or running; grade 3-on walking, doing housework (eg washing dishes, sweeping the floor), changing posture (eg from standing to squatting or sitting...);grade 4-on Resting state, such as turning over in bed
3 secondary outcomes
Introital and transvaginal ultrasound in the assessment of urogenital and pelvic floor dysfunction
Time frame: Time Frame: through study completion, an average of 8 weeks
one-hour pad test
Time frame: Time Frame: through study completion, an average of 8 weeks
change of electromyographic activity
Time frame: Time Frame: through study completion, an average of 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
Related trials for Stress Urinary Incontinence
RecruitingPhase 3
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
Urinary Incontinence,Stress
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
RecruitingPhase 1
Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
Urinary Incontinence Stress
Recruiting
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Prostate Cancer (Post Prostatectomy)
RecruitingObservational study
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
Urinary Incontinence , Stress, Laser Therapy
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.
Far Eastern Memorial Hospital contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surface electromyographic biofeedback assisted pelvic floor muscle training and surface electromyographic biofeedback and electrical stimulation in people with Stress Urinary Incontinence and Urethral Hypermobility, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
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 7 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: status not confirmed, as of the sponsor's last update on 22 Mar 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wen-Yih Wu (88689667000 ext. 1424, wenyih@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
King's Health Questionnaire (KHQ) (time frame: Time Frame: through study completion, an average of 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Mar 2023.