Urinary IncontinenceNCT02047032
Effect of Electroacupuncture Versus PFMT Plus Solifenacin for Mixed Urinary Incontinence
A study testing acupuncture, solifenacin and PFMT in people with Urinary Incontinence, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
A noninferiority randomized controlled trial aimed at comparing the effect and safety of electroacupuncture versus the pelvic floor muscle training (PFMT) plus solifenacin for mixed urinary incontinence (MUI). Read more about this study
- Who is it for?
- Ages 35 to 75 years, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- acupuncture, solifenacin and PFMT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Apr 2014to Oct 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- females meet the meet the diagnostic criteria of mixed urinary incontinence
- aged 35-75 years
- moderate and severe urinary incontinence with the urinary incontinence severity index between 3 and 9
- suffering from urinary incontinence at least for 3 months with the 72-h incontinence episode frequency≥2 in the baseline assessment
- voluntarily join the research and sign the informed consent
Who cannot join
- pure stress urinary incontinence, pure urgency urinary incontinence, overflow incontinence and neurogenic bladder
- medicine use for urinary incontinence or may affect the bladder function, or taking any non-drug therapy (such as electric stimulation, bladder training and pelvic floor muscle training) in the last month
- symptomatic urinary tract infection and non-functional urologic disease
- having ever undergone an operation for urinary incontinence or on the pelvic floor (including hysterectomy)
- pelvic organ prolapse degree ≥2
- residual urinary volume (RUV) >30 mL
Show all 16Show fewer
- maximum flow rate (Qmax) <20 mL/s;
- be allergic to solifenacin or having contradictions for muscarine antagonist (such as urinary retention, gastric retention, myasthenia gravis, ulcerative colitis and angle closure glaucoma)
- diseases affect function of lower urinary tract, such as uncontrolled diabetes, multiple sclerosis, Alzheimer's disease, Parkinson's disease, spinal injury, cauda equina injury and multiple system atrophy.
- serious cardiovascular, pulmonary, cerebral, liver, kidney, hematopoietic system or psychiatric disease and cognitive impairment
- patients with severe renal dysfunction or moderate hepatic dysfunction who are using strong Cyp3a4 Inhibitor like ketoconazole
- unable or limited to walking, up and down stairs and running
- poor compliance with electroacupuncture, pelvic floor muscle training or drug
- pregnancy, lactation or within the 12 months after birth
- having a cardiac pacemaker, a metal allergy, or a severe needle phobia.
- volunteer of other trials
Trial locations and contacts
1 site in 1 country.
China1 site
Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences
Beijing, 100053
About this study
Official title: Effect of Electroacupuncture Versus PFMT Plus Solifenacin for Moderate and Severe Mixed Urinary Incontinence in Female: a Multicenter, Noninferiority, Randomized Controlled Trial
A noninferiority randomized controlled trial aimed at comparing the effect and safety of electroacupuncture versus the pelvic floor muscle training (PFMT) plus solifenacin for mixed urinary incontinence (MUI).
Read the detailed description
Participants experiencing mixed urinary incontinence will be recruited from 10 centers. A gynecologist or urologist will make the diagnosis. Central randomization will be performed by the Clinical Evaluation Center of the China Academy of Chinese Medical Sciences in Beijing.
Sample size: Sample size is based on the primary outcome. According to literature, the investigators predict that MUI patient's average 72-h incontinence episode frequency of the week 1-12 will decrease by 60% from the baseline after treatment of PFMT plus solifenacin. The number of the acupuncture group is 57%. For the assessment of noninferiority, 250 participants will be needed for each group allowing for a 15% dropout (α=0.05，β=0.2，δ=15%).
Quality control: A 3-level monitoring system (monitors responsible for one center, monitors responsible for all centers and monitors responsible for the whole trial) will be established to check the performance of the trial in time. Outcome assessment, completion of case report forms and data management will be under strict supervision.
Data management: The Remote Dara Capture (RDC) system will be used for data entering. Both paper and electronic case report form will be reserved. A data verification plan is made.
- Conditions
- Urinary Incontinence
- Being tested
- acupuncture, solifenacin, PFMT
- Keywords
- electroacupuncture, urinary incontinence, PFMT, Solifenacin
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureProcedure or surgery
Also called electroacupuncture
For BL33, the needle (75mm) will be inserted at the point upper and outside of BL33. Insert the needle with a 30-45°angle to a depth of 50-60 mm. The needle will be manipulated with an even lifting, thrusting and twisting method and the sense of soreness and distention will radiate to the perineal region or the anus. For BL35, the needle will be inserted upward and outward slightly with an even lifting, thrusting and twisting method. The sense of soreness and distention will radiate to the perineal region or the anus. The electric stimulator will be put on the two pair of points with a spare-dense wave, 10/50 Hz, 0.1-5.0 mA. The current intensity will be increased until the participant can not stand.
solifenacinDrug
Also called competitive cholinergic receptor antagonist
Solifenacin used in this trial is produced by Astellas Pharma Europe B.V.(Country medicine accurate character No. J20090109 )
PFMTProcedure or surgery
Also called pelvic floor muscle training
Intensity of the PFMT exercises will conform to the guideline of National Institute for Health and Clinical Excellence (NICE).
| Study group | Role | What they receive |
|---|---|---|
| acupuncture | Experimental | BL33 and BL35 of both sides are used. Every session will last for 30 minuets and will be given every other day. There are 36 sessions for each participant in all (3 session per week, 12 weeks). Receives: Procedure: acupuncture |
| Solifenacin plus PFMT | Active comparator | Both PFMT and solifenacin will be given for 36 weeks. Solifenacin will be taken 5mg once daily, before or after meal. PFMT includes intensive exercises conducted in hospital and home exercises. Intensive exercises will be done once every week for the first 12 weeks and once every four weeks for the 13th to 36th week. Home exercises will be done three times daily for 36 weeks. Receives: Drug: solifenacin; Procedure: PFMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Change From Baseline in 72-hour Incontinence Episode Frequency (IEF) Over Weeks 1-12
The average 72-h IEF is calculated based on a 72-h bladder diary. All relevant time points used in the calculation in the Time Frame (baseline, weeks 1-12)
Measured: baseline, weeks 1-12
Secondary outcomes (11)
Percentage of Change From Baseline in Mean 72-hour IEF During Weeks 13-24 and Weeks 25-36
Calculated as the same way as the primary outcome. But this outcome will be assessed at different time point.
Measured: baseline, weeks 13-24, week 25-36
Percentage of Participants With ≥50% Decrease in Average 72-h Incontinence Episode Frequency
Count the number of cases with the reduction of average 72-h incontinence episode frequency ≥50% and divide it by the number of participants at baseline.
Measured: Weeks 1-12, 13-24, 25-36
Change of Episodes From Baseline in Average 72-hour Urgencies/Urination/Nocturia Episodes
The average 72-h IEF (urinary incontinence, stress urinary incontinence and urgency urinary incontinence respectively) is calculated based on a 72-h bladder diary. For example, the average 72-h incontinence episodes from the 13th to 36th week equal to the sum of 72-h incontinence episodes of the 16th, 20th, 24th, 28th, 32nd, 36th weeks divided by 6.
Measured: Baseline, weeks 1-12, 13-24, 25-36
Change From Baseline in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Score
The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF (range, 0 [best]-21 [worst] outcomes, and 2.52 as minimal clinically important differences (MCID)) scores.
Measured: baseline, weeks 12, 24 and 36
Weekly Median Number of Urine Pads Used During Weeks 1-12, 13-24, and 25-36
Measured: Baseline, weeks 1-12, 13-24, 25-36
the Amount of Urine Leakage (Grams) Measured by the 1-hour Pad Test at Weeks 4 and 12
The performance of 1-hour pad test according to the International Incontinence Society:
Participants were instructed to void 2 hours before the pad test. On arrival, they received a pre-weighed pad and were asked to sit and drink 500 ml sodium-free water in 15 minutes. Next, they were instructed to walk for 30 minutes, including going up and down 24 stairs. On returning to the clinic, the participants were instructed to perform several activities, including standing and sitting 10 times, coughing vigorously 10 times, running for 1 minute, picking up a coin from the floor 5 times, and putting their hands under water for 1 minute. After the activities were completed, the pad was reweighed to measure the amount of urinary leakage using a gram sensitive weight scale (Xiangshan, EK3820).
Measured: Weeks 4 and 12
Patient's Treatment Satisfaction Degree
The self-assessing satisfaction degree on a 5-point Likert scale (range, 1 [unsatisfied strongly] to 5 [satisfied strongly]) will be finished by participants to evaluate their satisfaction for the treatment.
Measured: Weeks 12, 36
Patient Global Impression Improvement
Participants will be asked to finish one item evaluating their present condition.
Measured: Weeks 12, 36
Electroacupuncture Acceptance Assessment
The acceptance of electroacupuncture will be tested within 5 minute with a 5-point scale ('0' means very difficult to accept and '4' means accept easily). Median of scores of the three times will be calculated.
Measured: Weeks 2, 6 and 12
The Number of Participants Using Urine Pads
Measured: Weeks 1-12, 13-24, 25-36
Change of Episodes From Baseline in Mean 72-h Incontinence Episodes
Measured: Weeks 1-12, 13-24, 25-36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startApr 2014
- Primary completionAug 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Zhishun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Zhishun Liu, doctor, Study director, Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02047032
- Sponsor's protocol ID
- 2012BAI24B01-MUI
- Status last verified
- Mar 2019
- First submitted
- 23 Jan 2014
- Last updated
- 6 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Hargreaves E, Baker K, Barry G, Harding C, Zhang Y, Kandala NB, Zhang X, Kernohan A, Clarkson CE. Acupuncture for treating overactive bladder in adults. Cochrane Database Syst Rev. 2022 Sep 23;9(9):CD013519. doi: 10.1002/14651858.CD013519.pub2.
PubMed 36148895Sun B, Liu Y, Su T, Sun Y, Liu Z. Electroacupuncture for stress-related urinary incontinence in elderly women: data analysis from two randomised controlled studies. BMJ Support Palliat Care. 2022 May;12(e1):e164-e170. doi: 10.1136/bmjspcare-2019-002034. Epub 2020 Jan 9.
PubMed 31919102Liu B, Liu Y, Qin Z, Zhou K, Xu H, He L, Li N, Su T, Sun J, Yue Z, Zang Z, Zhang W, Zhao J, Zhou Z, Liu L, Wu D, Wu J, Zhou J, Pang R, Wang Y, Liu J, Yu J, Liu Z. Electroacupuncture Versus Pelvic Floor Muscle Training Plus Solifenacin for Women With Mixed Urinary Incontinence: A Randomized Noninferiority Trial. Mayo Clin Proc. 2019 Jan;94(1):54-65. doi: 10.1016/j.mayocp.2018.07.021.
PubMed 30611454Liu B, Wang Y, Xu H, Chen Y, Wu J, Mo Q, Liu Z. Effect of electroacupuncture versus pelvic floor muscle training plus solifenacin for moderate and severe mixed urinary incontinence in women: a study protocol. BMC Complement Altern Med. 2014 Aug 15;14:301. doi: 10.1186/1472-6882-14-301.
PubMed 25128002
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Electroacupuncture Versus PFMT Plus Solifenacin for Moderate and Severe Mixed Urinary Incontinence in Female: a Multicenter, Noninferiority, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02047032
- Acronym / sponsor ID
- 2012BAI24B01-MUI
- Conditions
- Urinary Incontinence
- Keywords
- electroacupuncture, urinary incontinence, PFMT, Solifenacin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 28 Jan 2014 (estimated)
- Results
- Posted 6 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A noninferiority randomized controlled trial aimed at comparing the effect and safety of electroacupuncture versus the pelvic floor muscle training (PFMT) plus solifenacin for mixed urinary incontinence (MUI).
Detailed description
Participants experiencing mixed urinary incontinence will be recruited from 10 centers. A gynecologist or urologist will make the diagnosis. Central randomization will be performed by the Clinical Evaluation Center of the China Academy of Chinese Medical Sciences in Beijing.
Sample size: Sample size is based on the primary outcome. According to literature, the investigators predict that MUI patient's average 72-h incontinence episode frequency of the week 1-12 will decrease by 60% from the baseline after treatment of PFMT plus solifenacin. The number of the acupuncture group is 57%. For the assessment of noninferiority, 250 participants will be needed for each group allowing for a 15% dropout (α=0.05，β=0.2，δ=15%).
Quality control: A 3-level monitoring system (monitors responsible for one center, monitors responsible for all centers and monitors responsible for the whole trial) will be established to check the performance of the trial in time. Outcome assessment, completion of case report forms and data management will be under strict supervision.
Data management: The Remote Dara Capture (RDC) system will be used for data entering. Both paper and electronic case report form will be reserved. A data verification plan is made.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acupuncture | Experimental | Procedure: acupunctureBL33 and BL35 of both sides are used. Every session will last for 30 minuets and will be given every other day. There are 36 sessions for each participant in all (3 session per week, 12 weeks). |
| Solifenacin plus PFMT | Active comparator | Drug: solifenacin, Procedure: PFMTBoth PFMT and solifenacin will be given for 36 weeks. Solifenacin will be taken 5mg once daily, before or after meal. PFMT includes intensive exercises conducted in hospital and home exercises. Intensive exercises will be done once every week for the first 12 weeks and once every four weeks for the 13th to 36th week. Home exercises will be done three times daily for 36 weeks. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- females meet the meet the diagnostic criteria of mixed urinary incontinence
- aged 35-75 years
- moderate and severe urinary incontinence with the urinary incontinence severity index between 3 and 9
- suffering from urinary incontinence at least for 3 months with the 72-h incontinence episode frequency≥2 in the baseline assessment
- voluntarily join the research and sign the informed consent
Key exclusion criteria (16 listed)
- pure stress urinary incontinence, pure urgency urinary incontinence, overflow incontinence and neurogenic bladder
- medicine use for urinary incontinence or may affect the bladder function, or taking any non-drug therapy (such as electric stimulation, bladder training and pelvic floor muscle training) in the last month
- symptomatic urinary tract infection and non-functional urologic disease
- having ever undergone an operation for urinary incontinence or on the pelvic floor (including hysterectomy)
- pelvic organ prolapse degree ≥2
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 |
|---|---|---|
| acupunctureAlso: electroacupunctureFor BL33, the needle (75mm) will be inserted at the point upper and outside of BL33. Insert the needle with a 30-45°angle to a depth of 50-60 mm. The needle will be manipulated with an even lifting, thrusting and twisting method and the sense of soreness and distention will radiate to the perineal region or the anus. For BL35, the needle will be inserted upward and outward slightly with an even lifting, thrusting and twisting method. The sense of soreness and distention will radiate to the perineal region or the anus. The electric stimulator will be put on the two pair of points with a spare-dense wave, 10/50 Hz, 0.1-5.0 mA. The current intensity will be increased until the participant can not stand. | Procedure or surgery | acupuncture |
| solifenacinAlso: competitive cholinergic receptor antagonistSolifenacin used in this trial is produced by Astellas Pharma Europe B.V.(Country medicine accurate character No. J20090109 ) | Drug | Solifenacin plus PFMT |
| PFMTAlso: pelvic floor muscle trainingIntensity of the PFMT exercises will conform to the guideline of National Institute for Health and Clinical Excellence (NICE). | Procedure or surgery | Solifenacin plus PFMT |
Primary outcome
Percentage of Change From Baseline in 72-hour Incontinence Episode Frequency (IEF) Over Weeks 1-12
Time frame: baseline, weeks 1-12
The average 72-h IEF is calculated based on a 72-h bladder diary. All relevant time points used in the calculation in the Time Frame (baseline, weeks 1-12)
11 secondary outcomes
Percentage of Change From Baseline in Mean 72-hour IEF During Weeks 13-24 and Weeks 25-36
Time frame: baseline, weeks 13-24, week 25-36
Percentage of Participants With ≥50% Decrease in Average 72-h Incontinence Episode Frequency
Time frame: Weeks 1-12, 13-24, 25-36
Change of Episodes From Baseline in Average 72-hour Urgencies/Urination/Nocturia Episodes
Time frame: Baseline, weeks 1-12, 13-24, 25-36
Change From Baseline in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Score
Time frame: baseline, weeks 12, 24 and 36
Weekly Median Number of Urine Pads Used During Weeks 1-12, 13-24, and 25-36
Time frame: Baseline, weeks 1-12, 13-24, 25-36
the Amount of Urine Leakage (Grams) Measured by the 1-hour Pad Test at Weeks 4 and 12
Time frame: Weeks 4 and 12
Patient's Treatment Satisfaction Degree
Time frame: Weeks 12, 36
Patient Global Impression Improvement
Time frame: Weeks 12, 36
Electroacupuncture Acceptance Assessment
Time frame: Weeks 2, 6 and 12
The Number of Participants Using Urine Pads
Time frame: Weeks 1-12, 13-24, 25-36
Change of Episodes From Baseline in Mean 72-h Incontinence Episodes
Time frame: Weeks 1-12, 13-24, 25-36
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36148895Hargreaves E, Baker K, Barry G, Harding C, Zhang Y, Kandala NB, Zhang X, Kernohan A, Clarkson CE. Acupuncture for treating overactive bladder in adults. Cochrane Database Syst Rev. 2022 Sep 23;9(9):CD013519. doi: 10.1002/14651858.CD013519.pub2.
- Derived from this study: PubMed 31919102Sun B, Liu Y, Su T, Sun Y, Liu Z. Electroacupuncture for stress-related urinary incontinence in elderly women: data analysis from two randomised controlled studies. BMJ Support Palliat Care. 2022 May;12(e1):e164-e170. doi: 10.1136/bmjspcare-2019-002034. Epub 2020 Jan 9.
- Derived from this study: PubMed 30611454Liu B, Liu Y, Qin Z, Zhou K, Xu H, He L, Li N, Su T, Sun J, Yue Z, Zang Z, Zhang W, Zhao J, Zhou Z, Liu L, Wu D, Wu J, Zhou J, Pang R, Wang Y, Liu J, Yu J, Liu Z. Electroacupuncture Versus Pelvic Floor Muscle Training Plus Solifenacin for Women With Mixed Urinary Incontinence: A Randomized Noninferiority Trial. Mayo Clin Proc. 2019 Jan;94(1):54-65. doi: 10.1016/j.mayocp.2018.07.021.
- Derived from this study: PubMed 25128002Liu B, Wang Y, Xu H, Chen Y, Wu J, Mo Q, Liu Z. Effect of electroacupuncture versus pelvic floor muscle training plus solifenacin for moderate and severe mixed urinary incontinence in women: a study protocol. BMC Complement Altern Med. 2014 Aug 15;14:301. doi: 10.1186/1472-6882-14-301.
- Individual participant dataSharing planned: No
Related trials for Urinary Incontinence
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
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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)
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.
Zhishun Liu, doctor study director
Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture, solifenacin and PFMT in people with Urinary Incontinence, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
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 5 inclusion and 16 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 6 Jun 2019. 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 China. 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?
Yes. Results are posted in the registry (first posted 6 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Change From Baseline in 72-hour Incontinence Episode Frequency (IEF) Over Weeks 1-12 (time frame: baseline, weeks 1-12). 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 NCT02047032, which also lists 4 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 6 Jun 2019.