Urinary IncontinenceNCT05977231
Efficacy of Conservative Treatments for Urinary Incontinence in Women
An observational study of Urinary Incontinence, run by Mackay Medical College at 1 site in Taiwan.
Trial summary
To conduct a retrospective study to examine the effect of these conservative treatments to the symptoms and quality of life of patients with urinary incontinence. The investigators will use both subjective and objective assessment parameters, such as self-report symptoms, bladder diary, pad test and urodynamic study… Read more about this study
- Who is it for?
- Ages 20 to 100 years, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- BT, bPFMT and iVES
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2023to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Diagnosed at Mackay Memorial Hospital, the adult female patient was clinically assessed and diagnosed with urinary incontinence. Non-surgical treatments were administered, followed by subsequent monitoring and follow-up.
Who may be able to join
- Adult female patient diagnosed with urinary incontinence through clinical assessment
- Diagnosed at Mackay Memorial Hospital and underwent non-surgical treatment and subsequent follow-up.
Who cannot join
- Choosing invasive or surgical treatment options (such as bladder botulinum toxin injection, urethral sling surgery).
- Unable to comply with regular follow-up for at least one year.
- Pregnant women
- Patients with a history of neuromuscular disorders.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynecology
New Taipei City
Hui-Hsuan Lau, PhD, +886 975-835928, huihsuan1220@gmail.com
About this study
Official title: Evaluation of Efficacy of Conservative Treatments in Women With Urinary Incontinence
To conduct a retrospective study to examine the effect of these conservative treatments to the symptoms and quality of life of patients with urinary incontinence. The investigators will use both subjective and objective assessment parameters, such as self-report symptoms, bladder diary, pad test and urodynamic study to access the improvement.
Read the detailed description
Urinary incontinence is a common problem among women. The main types include stress incontinence, urge incontinence, and overflow incontinence. Other underlying pathology, such as cancer or neurologic disease can also cause urinary incontinence. To limit the medical expenses and possible complications of surgical treatment, the current treatment guidelines recommend conservative treatment as the first choice. According to American Urological Association (AUA)/Society of Urodynamics, Female Pelvic Medicine \& Urogenital Reconstruction (SUFU) guidelines, the first-line treatment for non-neurologic overactive bladder should be behavioral therapy, such as bladder training, water restriction, and pelvic floor muscle training, physiological feedback, pessary, etc. Bladder training aims to increase the time interval between voids, and to increase the bladder capacity by self-adjusted schedules. Pelvic floor muscle training strengthens the pelvic floor muscles to provide urethral support to prevent urine leakage and suppress urgency. There is strong evidence that pelvic floor muscle training is beneficial for stress urinary incontinence.
The second-line treatment is medication, including anticholinergic drugs and ß3 adrenoceptor-acting agents. Anticholinergic drugs can reduce bladder detrusor contraction, and ß3 adrenoceptor-acting agents can relax the detrusor and increase bladder capacity.
- Conditions
- Urinary Incontinence
- Being tested
- BT, bPFMT, iVES, BT + bPFMT, BT + iVES
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTProcedure or surgery
A program of BT (including exercise and muscle training)
bPFMTProcedure or surgery
A bPFMT program at home
iVESProcedure or surgery
An iVES program at home
BT + bPFMTProcedure or surgery
Combination of BT and bPFMT
BT + iVESProcedure or surgery
Combination of BT and iVES
bPFMT + iVESProcedure or surgery
Combination of bPFMT and iVES
| Study group | Role | What they receive |
|---|---|---|
| Bladder training (BT) | Data obtained before and after the training. Receives: Procedure: BT | |
| biofeedback-assisted pelvic floor muscle training (bPFMT) | Data obtained before and after the training. Receives: Procedure: bPFMT | |
| intra-vaginal electric stimulation (iVES) | Data obtained before and after the training. Receives: Procedure: iVES | |
| BT+bPFMT | Data obtained before and after the training. Receives: Procedure: BT + bPFMT | |
| BT+iVES | Data obtained before and after the training. Receives: Procedure: BT + iVES | |
| bPFMT+iVES | Data obtained before and after the training. Receives: Procedure: bPFMT + iVES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urodynamic study (intravesical pressure)
intravesical pressure (cmH2O)
Measured: form the baseline to the post-treatment measurement (about 6 month post)
Urodynamic study (abdominal pressure)
abdominal pressure (cmH2O)
Measured: form the baseline to the post-treatment measurement (about 6 month post)
Urodynamic study (detrusor pressure)
detrusor pressure (cmH2O)
Measured: from the baseline to the post-treatment measurement (about 6 month post)
Urodynamic study (Infused volume)
infused volume (ml)
Measured: from the baseline to the post-treatment measurement (about 6 month post)
Urodynamic study (voided volume)
voided volume (ml)
Measured: from the baseline to the post-treatment measurement (about 6 month post)
Pad test
The weight of Pad (g) before and after testing
Measured: from the baseline to the post-treatment measurement (about 6 month post)
Bladder diary (voiding frequency)
the daily voiding frequency (times)
Measured: from the baseline to the post-treatment measurement (about 6 month post)
Bladder diary (voiding volume)
the daily voiding volume (ml)
Measured: from the baseline to the post-treatment measurement (about 6 month post)
Questionaire (UDI-6)
The urogenital distress inventory-6 (UDI-6)
Measured: from the baseline to the post-treatment measurement (about 6 month post)
Questionaire (IIQ-7)
incontinence impact questionnaire-7 (IIQ-7)
Measured: from the baseline to the post-treatment measurement (about 6 month post)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start1 Jan 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mackay Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chin-Tsung Shen, Mackay Medical College
- Investigators
- Hui-Hsuan Lau, M.D., Study chair, Department of Ear, Nose, and Throat, MacKay Memorial Hospital, Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05977231
- Sponsor's protocol ID
- 23MMHIS058e
- Status last verified
- Jul 2023
- First submitted
- 13 Jul 2023
- Last updated
- 4 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For we uncertain if this might violate personal information laws in our country.
Publications
Denisenko AA, Clark CB, D'Amico M, Murphy AM. Evaluation and management of female urinary incontinence. Can J Urol. 2021 Aug;28(S2):27-32.
PubMed 34453426Wallace SL, Miller LD, Mishra K. Pelvic floor physical therapy in the treatment of pelvic floor dysfunction in women. Curr Opin Obstet Gynecol. 2019 Dec;31(6):485-493. doi: 10.1097/GCO.0000000000000584.
PubMed 31609735Aoki Y, Brown HW, Brubaker L, Cornu JN, Daly JO, Cartwright R. Urinary incontinence in women. Nat Rev Dis Primers. 2017 Jul 6;3:17042. doi: 10.1038/nrdp.2017.42.
PubMed 28681849Lin HY, Tsai HW, Tsui KH, An YF, Lo CC, Lin ZH, Liou WS, Wang PH. The short-term outcome of laser in the management of female pelvic floor disorders: Focus on stress urine incontinence and sexual dysfunction. Taiwan J Obstet Gynecol. 2018 Dec;57(6):825-829. doi: 10.1016/j.tjog.2018.10.010.
PubMed 30545535Lau HH, Lai CY, Hsieh MC, Peng HY, Chou D, Su TH, Lee JJ, Lin TB. Effect of intra-vaginal electric stimulation on bladder compliance in stress urinary incontinence patients: the involvement of autonomic tone. Front Neurosci. 2024 Aug 7;18:1432616. doi: 10.3389/fnins.2024.1432616. eCollection 2024.
PubMed 39170685
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy of Conservative Treatments in Women With Urinary Incontinence
- ClinicalTrials.gov ID
- NCT05977231
- Acronym / sponsor ID
- 23MMHIS058e
- Conditions
- Urinary Incontinence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mackay Medical CollegeUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 4 Aug 2023 (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 conduct a retrospective study to examine the effect of these conservative treatments to the symptoms and quality of life of patients with urinary incontinence. The investigators will use both subjective and objective assessment parameters, such as self-report symptoms, bladder diary, pad test and urodynamic study to access the improvement.
Detailed description
Urinary incontinence is a common problem among women. The main types include stress incontinence, urge incontinence, and overflow incontinence. Other underlying pathology, such as cancer or neurologic disease can also cause urinary incontinence. To limit the medical expenses and possible complications of surgical treatment, the current treatment guidelines recommend conservative treatment as the first choice. According to American Urological Association (AUA)/Society of Urodynamics, Female Pelvic Medicine \& Urogenital Reconstruction (SUFU) guidelines, the first-line treatment for non-neurologic overactive bladder should be behavioral therapy, such as bladder training, water restriction, and pelvic floor muscle training, physiological feedback, pessary, etc. Bladder training aims to increase the time interval between voids, and to increase the bladder capacity by self-adjusted schedules. Pelvic floor muscle training strengthens the pelvic floor muscles to provide urethral support to prevent urine leakage and suppress urgency. There is strong evidence that pelvic floor muscle training is beneficial for stress urinary incontinence.
The second-line treatment is medication, including anticholinergic drugs and ß3 adrenoceptor-acting agents. Anticholinergic drugs can reduce bladder detrusor contraction, and ß3 adrenoceptor-acting agents can relax the detrusor and increase bladder capacity.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Bladder training (BT) | – | Procedure: BTData obtained before and after the training. |
| biofeedback-assisted pelvic floor muscle training (bPFMT) | – | Procedure: bPFMTData obtained before and after the training. |
| intra-vaginal electric stimulation (iVES) | – | Procedure: iVESData obtained before and after the training. |
| BT+bPFMT | – | Procedure: BT + bPFMTData obtained before and after the training. |
| BT+iVES | – | Procedure: BT + iVESData obtained before and after the training. |
| bPFMT+iVES | – | Procedure: bPFMT + iVESData obtained before and after the training. |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diagnosed at Mackay Memorial Hospital, the adult female patient was clinically assessed and diagnosed with urinary incontinence. Non-surgical treatments were administered, followed by subsequent monitoring and follow-up.
Key inclusion criteria (2 listed)
- Adult female patient diagnosed with urinary incontinence through clinical assessment
- Diagnosed at Mackay Memorial Hospital and underwent non-surgical treatment and subsequent follow-up.
Key exclusion criteria (4 listed)
- Choosing invasive or surgical treatment options (such as bladder botulinum toxin injection, urethral sling surgery).
- Unable to comply with regular follow-up for at least one year.
- Pregnant women
- Patients with a history of neuromuscular disorders.
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 |
|---|---|---|
| BTA program of BT (including exercise and muscle training) | Procedure or surgery | Bladder training (BT) |
| bPFMTA bPFMT program at home | Procedure or surgery | biofeedback-assisted pelvic floor muscle training (bPFMT) |
| iVESAn iVES program at home | Procedure or surgery | intra-vaginal electric stimulation (iVES) |
| BT + bPFMTCombination of BT and bPFMT | Procedure or surgery | BT+bPFMT |
| BT + iVESCombination of BT and iVES | Procedure or surgery | BT+iVES |
| bPFMT + iVESCombination of bPFMT and iVES | Procedure or surgery | bPFMT+iVES |
Primary outcome
Urodynamic study (intravesical pressure)
Time frame: form the baseline to the post-treatment measurement (about 6 month post)
intravesical pressure (cmH2O)
Urodynamic study (abdominal pressure)
Time frame: form the baseline to the post-treatment measurement (about 6 month post)
abdominal pressure (cmH2O)
Urodynamic study (detrusor pressure)
Time frame: from the baseline to the post-treatment measurement (about 6 month post)
detrusor pressure (cmH2O)
Urodynamic study (Infused volume)
Time frame: from the baseline to the post-treatment measurement (about 6 month post)
infused volume (ml)
Urodynamic study (voided volume)
Time frame: from the baseline to the post-treatment measurement (about 6 month post)
voided volume (ml)
Pad test
Time frame: from the baseline to the post-treatment measurement (about 6 month post)
The weight of Pad (g) before and after testing
Bladder diary (voiding frequency)
Time frame: from the baseline to the post-treatment measurement (about 6 month post)
the daily voiding frequency (times)
Bladder diary (voiding volume)
Time frame: from the baseline to the post-treatment measurement (about 6 month post)
the daily voiding volume (ml)
Questionaire (UDI-6)
Time frame: from the baseline to the post-treatment measurement (about 6 month post)
The urogenital distress inventory-6 (UDI-6)
Questionaire (IIQ-7)
Time frame: from the baseline to the post-treatment measurement (about 6 month post)
incontinence impact questionnaire-7 (IIQ-7)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- Background: PubMed 34453426Denisenko AA, Clark CB, D'Amico M, Murphy AM. Evaluation and management of female urinary incontinence. Can J Urol. 2021 Aug;28(S2):27-32.
- Background: PubMed 31609735Wallace SL, Miller LD, Mishra K. Pelvic floor physical therapy in the treatment of pelvic floor dysfunction in women. Curr Opin Obstet Gynecol. 2019 Dec;31(6):485-493. doi: 10.1097/GCO.0000000000000584.
- Background: PubMed 28681849Aoki Y, Brown HW, Brubaker L, Cornu JN, Daly JO, Cartwright R. Urinary incontinence in women. Nat Rev Dis Primers. 2017 Jul 6;3:17042. doi: 10.1038/nrdp.2017.42.
- Background: PubMed 30545535Lin HY, Tsai HW, Tsui KH, An YF, Lo CC, Lin ZH, Liou WS, Wang PH. The short-term outcome of laser in the management of female pelvic floor disorders: Focus on stress urine incontinence and sexual dysfunction. Taiwan J Obstet Gynecol. 2018 Dec;57(6):825-829. doi: 10.1016/j.tjog.2018.10.010.
- Derived from this study: PubMed 39170685Lau HH, Lai CY, Hsieh MC, Peng HY, Chou D, Su TH, Lee JJ, Lin TB. Effect of intra-vaginal electric stimulation on bladder compliance in stress urinary incontinence patients: the involvement of autonomic tone. Front Neurosci. 2024 Aug 7;18:1432616. doi: 10.3389/fnins.2024.1432616. eCollection 2024.
- Individual participant dataSharing planned: No. For we uncertain if this might violate personal information laws in our country.
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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.
Hui-Hsuan Lau, M.D. study chair
Department of Ear, Nose, and Throat, MacKay Memorial Hospital, Taipei, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence, run by Mackay Medical College 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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 4 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hui-Hsuan Lau, M.D. (+886-975-835928, huihsuan1220@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urodynamic study (intravesical pressure) (time frame: form the baseline to the post-treatment measurement (about 6 month post)). The study lists 10 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 NCT05977231, which also lists 5 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 4 Aug 2023.