Overactive BladderPFMTNCT04477265
Efficacy of Biofeedback PFMT and Medication in Women With Overactive Bladder
A study testing Solifenacin Succinate 5mg/tab daily and biofeedback-assisted pelvic floor muscle training in people with Overactive Bladder, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
Medical treatment for overactive bladder is acceptable widely. However, the effect of drug treatment is different due to compliance and side effect of the drug. Biofeedback-assisted pelvic floor muscle training (PFMT) is the first line recommendation for overactive bladder. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Solifenacin Succinate 5mg/tab daily and biofeedback-assisted pelvic floor muscle training
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Jun 2016to 24 Dec 2021
- 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 80 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 5 times,followed by individual therapy, each takes about 30 to 60 minutes, a total of 12 weeks of pelvic floor muscle exercises
Who cannot join
- Suffering from systemic neuromuscular diseases, such as stroke, spinal cord injury, peripheral neuropathy, etc.
- Glaucoma
- 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.
About this study
Official title: Efficacy of of Pelvic Floor Muscle Training( PFMT ) With Surface Electromyographic Biofeedback and Medication in Women With Overactive Bladder
Medical treatment for overactive bladder is acceptable widely. However, the effect of drug treatment is different due to compliance and side effect of the drug. Biofeedback-assisted pelvic floor muscle training (PFMT) is the first line recommendation for overactive bladder. The slow effect of biofeedback-assisted pelvic floor muscle training leads to low motivation for continuous treatment and results in compliance difference. This slow effect also changes the degree of improvement in the treatment of overactive bladder. This study is designed to evaluate the efficacy of combination therapy for treatment of female overactive bladder.
Read the detailed description
Participant will be prescribed with oral medication in combination with biofeedback-assisted pelvic floor muscle training (PFMT) for the first month. Participant will continue to have biofeedback assisted PFMT for another two months without oral medication. The investigators expected that combination therapy will improve the compliance and severity of symptoms in women with overactive bladder.
- Conditions
- Overactive Bladder
- Being tested
- Solifenacin Succinate 5mg/tab daily, biofeedback-assisted pelvic floor muscle training
- Keywords
- Overactive, drug only, exercise only, combination of drug and exercise
- Medical subject headings
- Urinary Bladder, Overactive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solifenacin Succinate 5mg/tab dailyDrug
Also called Vesicare 5mg/tab daily
participants will be taking oral medication for 3 months
biofeedback-assisted pelvic floor muscle trainingBehavioural
participants will be doing biofeedback-assisted pelvic floor muscle training for 3 months
| Study group | Role | What they receive |
|---|---|---|
| combination of drug and exercise | Experimental | Participant will be prescribed with oral medication in combination with biofeedback-assisted pelvic floor muscle training (PFMT) during the first month, participant will continue to have biofeedback assisted PFMT for another 2 months Receives: Drug: Solifenacin Succinate 5mg/tab daily; Behavioral: biofeedback-assisted pelvic floor muscle training |
| drug only | Active comparator | Participant will be prescribed with oral medication for 3 months Receives: Drug: Solifenacin Succinate 5mg/tab daily |
| exercise only | Active comparator | Participant will be doing biofeedback-assisted pelvic floor muscle training for 3 months Receives: Behavioral: biofeedback-assisted pelvic floor muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-Day Voiding Diary
to record urinary output, fluid consumed, and urinary leakage (if applicable) for 3 complete 24-hour periods (they do not have to be consecutive days).
Measured: Baseline through study completion, an average of 12 weeks.
Symptom Distress scale(SDS)
the degree of discomfort from the specific symptoms being experienced, as perceived by the participants, consists of 23 items.The scale scored between 1 (best) and 5 (worst) .
Measured: through study completion, an average of 12 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: through study completion, an average of 12 weeks.
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: through study completion, an average of 12 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: through study completion, an average of 12 weeks.
A five-item Self-Assessment of Self-efficacy
to assess motivation with PFMT, consists of 14 items.The scale scored between 1 (worst) and 6(best) .
Measured: through study completion, an average of 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start16 Jun 2016
- Primary completion24 Dec 2021
- Study completion24 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies 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 210 women with overactive bladder will be recruited and randomized to 3 arms: drug only, exercise only and combination arm.
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wen-Yih Wu, Principal investigator, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04477265
- Sponsor's protocol ID
- 105019 - F
- Acronym
- PFMT
- Status last verified
- May 2020
- First submitted
- 15 Jun 2020
- Last updated
- 28 Jan 2022
- 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 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of of Pelvic Floor Muscle Training( PFMT ) With Surface Electromyographic Biofeedback and Medication in Women With Overactive Bladder
- ClinicalTrials.gov ID
- NCT04477265
- Acronym / sponsor ID
- PFMT / 105019 - F
- Conditions
- Overactive Bladder
- Keywords
- Overactive, drug only, exercise only, combination of drug and exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 16 Jun 2016 (actual)
- Primary completion
- 24 Dec 2021 (actual)
- Study completion
- 24 Dec 2021 (actual)
- First posted
- 20 Jul 2020 (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.
Medical treatment for overactive bladder is acceptable widely. However, the effect of drug treatment is different due to compliance and side effect of the drug. Biofeedback-assisted pelvic floor muscle training (PFMT) is the first line recommendation for overactive bladder. The slow effect of biofeedback-assisted pelvic floor muscle training leads to low motivation for continuous treatment and results in compliance difference. This slow effect also changes the degree of improvement in the treatment of overactive bladder. This study is designed to evaluate the efficacy of combination therapy for treatment of female overactive bladder.
Detailed description
Participant will be prescribed with oral medication in combination with biofeedback-assisted pelvic floor muscle training (PFMT) for the first month. Participant will continue to have biofeedback assisted PFMT for another two months without oral medication. The investigators expected that combination therapy will improve the compliance and severity of symptoms in women with overactive bladder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A total of 210 women with overactive bladder will be recruited and randomized to 3 arms: drug only, exercise only and combination arm.
| Arm | Type | Receives |
|---|---|---|
| combination of drug and exercise | Experimental | Drug: Solifenacin Succinate 5mg/tab daily, Behavioral: biofeedback-assisted pelvic floor muscle trainingParticipant will be prescribed with oral medication in combination with biofeedback-assisted pelvic floor muscle training (PFMT) during the first month, participant will continue to have biofeedback assisted PFMT for another 2 months |
| drug only | Active comparator | Drug: Solifenacin Succinate 5mg/tab dailyParticipant will be prescribed with oral medication for 3 months |
| exercise only | Active comparator | Behavioral: biofeedback-assisted pelvic floor muscle trainingParticipant will be doing biofeedback-assisted pelvic floor muscle training for 3 months |
Who may qualify
- Ages
- 20 to 80 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 5 times,followed by individual therapy, each takes about 30 to 60 minutes, a total of 12 weeks of pelvic floor muscle exercises
Key exclusion criteria (8 listed)
- Suffering from systemic neuromuscular diseases, such as stroke, spinal cord injury, peripheral neuropathy, etc.
- Glaucoma
- Kidney disease
- Liver disease
- Patients with cardiac rhythm devices.
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 |
|---|---|---|
| Solifenacin Succinate 5mg/tab dailyAlso: Vesicare 5mg/tab dailyparticipants will be taking oral medication for 3 months | Drug | combination of drug and exercise, drug only |
| biofeedback-assisted pelvic floor muscle trainingparticipants will be doing biofeedback-assisted pelvic floor muscle training for 3 months | Behavioural | combination of drug and exercise, exercise only |
Primary outcome
3-Day Voiding Diary
Time frame: Baseline through study completion, an average of 12 weeks.
to record urinary output, fluid consumed, and urinary leakage (if applicable) for 3 complete 24-hour periods (they do not have to be consecutive days).
Symptom Distress scale(SDS)
Time frame: through study completion, an average of 12 weeks.
the degree of discomfort from the specific symptoms being experienced, as perceived by the participants, consists of 23 items.The scale scored between 1 (best) and 5 (worst) .
change of electromyographic activity
Time frame: through study completion, an average of 12 weeks.
Electromyographic activity of the pelvic floor muscles (PFMs) and the synergistic abdominal muscles (SAMs) during each session of PFMT(µV)
King's Health Questionnaire (KHQ)
Time frame: through study completion, an average of 12 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: through study completion, an average of 12 weeks.
to assess improvement and satisfaction with treatment, consists of 1 item. The scale scored between 1 (worst) and 5 (best ) .
A five-item Self-Assessment of Self-efficacy
Time frame: through study completion, an average of 12 weeks.
to assess motivation with PFMT, consists of 14 items.The scale scored between 1 (worst) and 6(best) .
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 28 Jan 2022.
Related trials for Overactive Bladder
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
RecruitingObservational study
Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder
Overactive Bladder (OAB)
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.
Wen-Yih Wu principal investigator
Far Eastern Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Solifenacin Succinate 5mg/tab daily and biofeedback-assisted pelvic floor muscle training in people with Overactive Bladder, 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 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 28 Jan 2022. 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?
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?
3-Day Voiding Diary (time frame: Baseline through study completion, an average of 12 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?
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 28 Jan 2022.