Urinary IncontinenceNCT02819336

Effectiveness and Safety of Electroacupuncture on Poststroke Urinary Incontinence

A study testing Electroacupuncture (EA) in people with Urinary Incontinence and Stroke, Complication, run by Kyunghee University at 2 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This pilot protocol is aimed to evaluate the effectiveness and safety of electroacupuncture therapy for the post-stroke patients with urinary incontinence. Read more about this study

Who is it for?: Ages 19 years and older
Conditions the study is for: Urinary Incontinence, Stroke, Complication
What is being tested?: Electroacupuncture (EA)
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 56 participants
Where: 2 sitesSouth Korea
Study dates: Jun 2016to 1 Jun 2017
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 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female aged over 19 years old
Patients diagnosed with stroke (cerebral hemorrhage or infarction) by the examination of computed tomography or magnetic resonance imaging methods within 2 years
Twice or more of urination with 3 to 4 points of PPIUS* at baseline OR 13 points or more of K-IPSS*
Any volunteers who signed the informed consent forms

Who cannot join

Once or more of post-voiding residual > 200 ml per day
Clinically significant stress urinary incontinence diagnosed based on cough induction test or investigator's decision
Recurrent urinary tract infection defined as 4 or more treatments for urinary tract infection for the recent 1 year
Cognitive impairment with less than 23 points of MMSE-K* examination
Acute or chronic lower urinary tract infection examined by urine culture
Urinary incontinence diagnosed before the stroke occurred and the symptoms have continued until now based on medical history

Show all 14Show fewer

Any severe diseases in lower urinary tract based on medical history and screening examination
Coagulation disorders based on medical history
Peripheral arterial diseases, which resulted in taking medical or surgical procedures to treat them based on medical history
Psychiatric diseases based on medical history
Fear of acupuncture based on questionnaire test
Pregnancy based on urine test
Any other inappropriate reasons on which the primary or sub investigators do not let the patients participate in the trial
Abbreviations PPIUS; Patient Perception of Intensity of Urgency Scale K-IPSS; The Korean version of International Prostate Symptom Scale MMSE-K; The Korean version of Mini-Mental State Examination

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

Wonkwang University Gwangju Medical Center
Gwangju, 61729
Kyung Hee University Korean Medicine Hospital
Seoul, 156-853

Other trials in South Korea

About this study

Official title: Effectiveness and Safety of Electroacupuncture on Poststroke Urinary Incontinence: a Pilot Multicentered, Randomized, Parallel, Sham-controlled Trial

This pilot protocol is aimed to evaluate the effectiveness and safety of electroacupuncture therapy for the post-stroke patients with urinary incontinence.

Conditions: Urinary Incontinence, Stroke, Complication
Being tested: Electroacupuncture (EA), Sham electroacupuncture
Keywords: urinary incontinence, electroacupuncture, stroke, complications, randomized controlled trial, pilot projects
Medical subject headings: Urinary Incontinence, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Electroacupuncture (EA)Device
Also called STN-111, Stratek, Republic of Korea
The EA group will receive the verum therapies using the following procedures.
1. Let the patient lie down on lateral decubitus.
2. The practitioners install the same guide-tubes as Park sham needle on CV2, CV3, CV4, CV6 and bilateral points of SP11 and SP6.
3. The verum acupunctures are inserted on each acupoint inside the installed guide-tube. (stainless steel, 0.25 mm in diameter and 4.0 mm in length, Dong Bang Acupuncture Inc., Republic of Korea)
4. After de qi response is elicited, the electrical stimulation is presented for 20 minutes by middle frequency (30 Hz). (STN-111, Stratek, Republic of Korea)
5. The practitioner should have at least 1-year clinical experiences.
The procedure will be repeated 10 times (once a session) within 21 days.
Sham electroacupunctureDevice
Also called Park sham device
1. Let the patient lie down on lateral decubitus.
2. The practitioners install the same guide-tubes as Park sham needle on CV2, CV3, CV4, and CV6 unilaterally \& SP11 and SP6 bilaterally.
3. The non-penetrating sham acupunctures are implemented on each acupoint inside the installed guide-tube.
4. The electrical stimulation is presented for 20 minutes by middle frequency (30 Hz), (STN-111, Stratek, Republic of Korea) even though the electrical stimulation is not delivered through the skin because the needles are not penetrated through the skin.
5. The practitioner should have at least 1-year clinical experiences.
The procedure will be repeated 10 times (once a session) within 21 days.

Study groups in NCT02819336
Study group	Role	What they receive
Electroacupuncture (EA) group	Experimental	1. Electroacupuncture therapy (10 sessions within 21 days) 2. CV2, CV3, CV4, CV6, and bilateral points of SP11, SP6 (8 acupoints in total) 3. 20 minutes duration with middle frequency (30 Hz) of electrical stimulation 4. Conventional treatments (drugs, traditional herbal medications, rehabilitation therapies, or acupuncture therapies without electrostimulation for stroke and urinary incontinence / electroacupuncture therapies other than the acupoints (CV2, CV3, CV4, CV6, SP1 and SP6) for stroke and urinary incontinence) are permitted. Receives: Device: Electroacupuncture (EA)
Park sham (PS) group	Sham comparator	1. Non-penetrating Park sham electroacupuncture treatment (10 sessions within 21 days) 2. CV2, CV3, CV4, CV6, and bilateral points of SP11, SP6 (8 acupoints in total) 3. 20 minutes duration with undelivered electrostimulation of middle frequency (30 Hz) 4. Conventional treatments (drugs, traditional herbal medications, rehabilitation therapies, or acupuncture therapies without electrostimulation for stroke and urinary incontinence / electroacupuncture therapies other than the acupoints (CV2, CV3, CV4, CV6, SP1 and SP6) for stroke and urinary incontinence) are permitted. Receives: Device: Sham electroacupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

Total Urgency and Frequency Score (TUFS)
The patients will be asked to fill the scale about their perception of urgency intensity (24 hours before the 1st session and after the last session, respectively) by themselves. They have to record every time of urination and select one of the 5 levels in perception of urgency intensity (0=No urgency, 1=Mild urgency, 2=Moderate urgency, 3=Severe urgency, 4= urgency incontinence) for 24 hours at baseline and the end of the treatment, respectively.
Measured: at least 15 days (at most 21 days) (at baseline and the end of the treatment)

Secondary outcomes (4)

International Consultation on Incontinence Questionnaire for Urinary Incontinence Short Form (ICIQ-UI-SF)
Measured: at least 15 days (at most 21 days) (at baseline and the end of the treatment)
The Korean version of International Prostate Symptom Scale (K-IPSS)
Measured: at least 15 days (at most 21 days) (at baseline and the end of the treatment)
The Lower urinary track system Outcome Score (LOS)
Measured: at least 15 days (at most 21 days) (at baseline and the end of the treatment)
Adverse events report
Measured: intraoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 20161 Jun 2017

First posted30 Jun 2016 (estimated)
Study startJun 2016
Primary completionApr 2017
Study completion1 Jun 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (17)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: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02819336
Sponsor's protocol ID: 2016006
Other IDs: KOMCIRB-160215-HR-006
Status last verified: Jun 2017
First submitted: 28 Jun 2016
Last updated: 27 Jun 2017
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

Currie CT. Urinary incontinence after stroke. Br Med J (Clin Res Ed). 1986 Nov 22;293(6558):1322-3. doi: 10.1136/bmj.293.6558.1322-a. No abstract available.
PubMed 3790967
Gelber DA, Good DC, Laven LJ, Verhulst SJ. Causes of urinary incontinence after acute hemispheric stroke. Stroke. 1993 Mar;24(3):378-82. doi: 10.1161/01.str.24.3.378.
PubMed 8446973
Brittain KR, Perry SI, Peet SM, Shaw C, Dallosso H, Assassa RP, Williams K, Jagger C, Potter JF, Castleden CM. Prevalence and impact of urinary symptoms among community-dwelling stroke survivors. Stroke. 2000 Apr;31(4):886-91. doi: 10.1161/01.str.31.4.886.
PubMed 10753993
Garrett VE, Scott JA, Costich J, Aubrey DL, Gross J. Bladder emptying assessment in stroke patients. Arch Phys Med Rehabil. 1989 Jan;70(1):41-3.
PubMed 2916918
Mizrahi EH, Waitzman A, Arad M, Blumstein T, Adunksy A. Bladder management and the functional outcome of elderly ischemic stroke patients. Arch Gerontol Geriatr. 2011 Sep-Oct;53(2):e125-8. doi: 10.1016/j.archger.2010.07.007. Epub 2010 Aug 12.
PubMed 20708280
Mustonen S, Ala-Houhala IO, Tammela TL. Long-term renal dysfunction in patients with acute urinary retention. Scand J Urol Nephrol. 2001 Feb;35(1):44-8. doi: 10.1080/00365590151030804.
PubMed 11291687
Curtis LA, Dolan TS, Cespedes RD. Acute urinary retention and urinary incontinence. Emerg Med Clin North Am. 2001 Aug;19(3):591-619. doi: 10.1016/s0733-8627(05)70205-4.
PubMed 11554277
Tibaek S, Gard G, Jensen R. Pelvic floor muscle training is effective in women with urinary incontinence after stroke: a randomised, controlled and blinded study. Neurourol Urodyn. 2005;24(4):348-57. doi: 10.1002/nau.20134.
PubMed 15791633
Herr-Wilbert IS, Imhof L, Hund-Georgiadis M, Wilbert DM. Assessment-guided therapy of urinary incontinence after stroke. Rehabil Nurs. 2010 Nov-Dec;35(6):248-53. doi: 10.1002/j.2048-7940.2010.tb00055.x.
PubMed 21140719
Tong Y, Jia Q, Sun Y, Hou Z, Wang Y. Acupuncture in the treatment of diabetic bladder dysfunction. J Altern Complement Med. 2009 Aug;15(8):905-9. doi: 10.1089/acm.2009.0062.
PubMed 19678782
Mehdi Z, Birns J, Bhalla A. Post-stroke urinary incontinence. Int J Clin Pract. 2013 Nov;67(11):1128-37. doi: 10.1111/ijcp.12183. Epub 2013 Jul 8.
PubMed 23834208
van Kerrebroeck P, Chapple C, Drogendijk T, Klaver M, Sokol R, Speakman M, Traudtner K, Drake MJ; NEPTUNE Study Group. Combination therapy with solifenacin and tamsulosin oral controlled absorption system in a single tablet for lower urinary tract symptoms in men: efficacy and safety results from the randomised controlled NEPTUNE trial. Eur Urol. 2013 Dec;64(6):1003-12. doi: 10.1016/j.eururo.2013.07.034. Epub 2013 Aug 3.
PubMed 23932438
Chapple CR, Drake MJ, Van Kerrebroeck P, Cardozo L, Drogendijk T, Klaver M, Van Charldorp K, Hakimi Z, Compion G. Total urgency and frequency score as a measure of urgency and frequency in overactive bladder and storage lower urinary tract symptoms. BJU Int. 2014 May;113(5):696-703. doi: 10.1111/bju.12555. Epub 2014 Feb 20.
PubMed 24712917
Abrams P, Avery K, Gardener N, Donovan J; ICIQ Advisory Board. The International Consultation on Incontinence Modular Questionnaire: www.iciq.net. J Urol. 2006 Mar;175(3 Pt 1):1063-6; discussion 1066. doi: 10.1016/S0022-5347(05)00348-4.
PubMed 16469618
Hajebrahimi S, Nourizadeh D, Hamedani R, Pezeshki MZ. Validity and reliability of the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form and its correlation with urodynamic findings. Urol J. 2012 Fall;9(4):685-90.
PubMed 23235974

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Urinary Incontinence trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness and Safety of Electroacupuncture on Poststroke Urinary Incontinence: a Pilot Multicentered, Randomized, Parallel, Sham-controlled Trial
ClinicalTrials.gov ID: NCT02819336
Acronym / sponsor ID: 2016006
Conditions: Urinary Incontinence, Stroke, Complication
Keywords: urinary incontinence, electroacupuncture, stroke, complications, randomized controlled trial, pilot projects
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: Kyunghee UniversityUniversity, hospital or other
Collaborators: Wonkwang University
Study start: Jun 2016 (actual)
Primary completion: Apr 2017 (actual)
Study completion: 1 Jun 2017 (actual)
First posted: 30 Jun 2016 (estimated)
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.

This pilot protocol is aimed to evaluate the effectiveness and safety of electroacupuncture therapy for the post-stroke patients with urinary incontinence.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Electroacupuncture (EA) group	Experimental	Device: Electroacupuncture (EA)1. Electroacupuncture therapy (10 sessions within 21 days) 2. CV2, CV3, CV4, CV6, and bilateral points of SP11, SP6 (8 acupoints in total) 3. 20 minutes duration with middle frequency (30 Hz) of electrical stimulation 4. Conventional treatments (drugs, traditional herbal medications, rehabilitation therapies, or acupuncture therapies without electrostimulation for stroke and urinary incontinence / electroacupuncture therapies other than the acupoints (CV2, CV3, CV4, CV6, SP1 and SP6) for stroke and urinary incontinence) are permitted.
Park sham (PS) group	Sham comparator	Device: Sham electroacupuncture1. Non-penetrating Park sham electroacupuncture treatment (10 sessions within 21 days) 2. CV2, CV3, CV4, CV6, and bilateral points of SP11, SP6 (8 acupoints in total) 3. 20 minutes duration with undelivered electrostimulation of middle frequency (30 Hz) 4. Conventional treatments (drugs, traditional herbal medications, rehabilitation therapies, or acupuncture therapies without electrostimulation for stroke and urinary incontinence / electroacupuncture therapies other than the acupoints (CV2, CV3, CV4, CV6, SP1 and SP6) for stroke and urinary incontinence) are permitted.

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Male or female aged over 19 years old
Patients diagnosed with stroke (cerebral hemorrhage or infarction) by the examination of computed tomography or magnetic resonance imaging methods within 2 years
Twice or more of urination with 3 to 4 points of PPIUS* at baseline OR 13 points or more of K-IPSS*
Any volunteers who signed the informed consent forms

Key exclusion criteria (14 listed)

Once or more of post-voiding residual > 200 ml per day
Clinically significant stress urinary incontinence diagnosed based on cough induction test or investigator's decision
Recurrent urinary tract infection defined as 4 or more treatments for urinary tract infection for the recent 1 year
Cognitive impairment with less than 23 points of MMSE-K* examination
Acute or chronic lower urinary tract infection examined by urine culture

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
Electroacupuncture (EA)Also: STN-111, Stratek, Republic of KoreaThe EA group will receive the verum therapies using the following procedures. 1. Let the patient lie down on lateral decubitus. 2. The practitioners install the same guide-tubes as Park sham needle on CV2, CV3, CV4, CV6 and bilateral points of SP11 and SP6. 3. The verum acupunctures are inserted on each acupoint inside the installed guide-tube. (stainless steel, 0.25 mm in diameter and 4.0 mm in length, Dong Bang Acupuncture Inc., Republic of Korea) 4. After de qi response is elicited, the electrical stimulation is presented for 20 minutes by middle frequency (30 Hz). (STN-111, Stratek, Republic of Korea) 5. The practitioner should have at least 1-year clinical experiences. The procedure will be repeated 10 times (once a session) within 21 days.	Device	Electroacupuncture (EA) group
Sham electroacupunctureAlso: Park sham device1. Let the patient lie down on lateral decubitus. 2. The practitioners install the same guide-tubes as Park sham needle on CV2, CV3, CV4, and CV6 unilaterally \& SP11 and SP6 bilaterally. 3. The non-penetrating sham acupunctures are implemented on each acupoint inside the installed guide-tube. 4. The electrical stimulation is presented for 20 minutes by middle frequency (30 Hz), (STN-111, Stratek, Republic of Korea) even though the electrical stimulation is not delivered through the skin because the needles are not penetrated through the skin. 5. The practitioner should have at least 1-year clinical experiences. The procedure will be repeated 10 times (once a session) within 21 days.	Device	Park sham (PS) group

Primary outcome

Total Urgency and Frequency Score (TUFS)
Time frame: at least 15 days (at most 21 days) (at baseline and the end of the treatment)
The patients will be asked to fill the scale about their perception of urgency intensity (24 hours before the 1st session and after the last session, respectively) by themselves. They have to record every time of urination and select one of the 5 levels in perception of urgency intensity (0=No urgency, 1=Mild urgency, 2=Moderate urgency, 3=Severe urgency, 4= urgency incontinence) for 24 hours at baseline and the end of the treatment, respectively.

4 secondary outcomes

International Consultation on Incontinence Questionnaire for Urinary Incontinence Short Form (ICIQ-UI-SF)
Time frame: at least 15 days (at most 21 days) (at baseline and the end of the treatment)
The Korean version of International Prostate Symptom Scale (K-IPSS)
Time frame: at least 15 days (at most 21 days) (at baseline and the end of the treatment)
The Lower urinary track system Outcome Score (LOS)
Time frame: at least 15 days (at most 21 days) (at baseline and the end of the treatment)
Adverse events report
Time frame: intraoperative

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 27 Jun 2017.
Background: PubMed 3790967Currie CT. Urinary incontinence after stroke. Br Med J (Clin Res Ed). 1986 Nov 22;293(6558):1322-3. doi: 10.1136/bmj.293.6558.1322-a. No abstract available.
Background: PubMed 8446973Gelber DA, Good DC, Laven LJ, Verhulst SJ. Causes of urinary incontinence after acute hemispheric stroke. Stroke. 1993 Mar;24(3):378-82. doi: 10.1161/01.str.24.3.378.
Background: PubMed 10753993Brittain KR, Perry SI, Peet SM, Shaw C, Dallosso H, Assassa RP, Williams K, Jagger C, Potter JF, Castleden CM. Prevalence and impact of urinary symptoms among community-dwelling stroke survivors. Stroke. 2000 Apr;31(4):886-91. doi: 10.1161/01.str.31.4.886.
Background: PubMed 2916918Garrett VE, Scott JA, Costich J, Aubrey DL, Gross J. Bladder emptying assessment in stroke patients. Arch Phys Med Rehabil. 1989 Jan;70(1):41-3.
Background: PubMed 20708280Mizrahi EH, Waitzman A, Arad M, Blumstein T, Adunksy A. Bladder management and the functional outcome of elderly ischemic stroke patients. Arch Gerontol Geriatr. 2011 Sep-Oct;53(2):e125-8. doi: 10.1016/j.archger.2010.07.007. Epub 2010 Aug 12.
Background: PubMed 11291687Mustonen S, Ala-Houhala IO, Tammela TL. Long-term renal dysfunction in patients with acute urinary retention. Scand J Urol Nephrol. 2001 Feb;35(1):44-8. doi: 10.1080/00365590151030804.
Background: PubMed 11554277Curtis LA, Dolan TS, Cespedes RD. Acute urinary retention and urinary incontinence. Emerg Med Clin North Am. 2001 Aug;19(3):591-619. doi: 10.1016/s0733-8627(05)70205-4.
Background: PubMed 15791633Tibaek S, Gard G, Jensen R. Pelvic floor muscle training is effective in women with urinary incontinence after stroke: a randomised, controlled and blinded study. Neurourol Urodyn. 2005;24(4):348-57. doi: 10.1002/nau.20134.
Background: PubMed 21140719Herr-Wilbert IS, Imhof L, Hund-Georgiadis M, Wilbert DM. Assessment-guided therapy of urinary incontinence after stroke. Rehabil Nurs. 2010 Nov-Dec;35(6):248-53. doi: 10.1002/j.2048-7940.2010.tb00055.x.
Background: PubMed 19678782Tong Y, Jia Q, Sun Y, Hou Z, Wang Y. Acupuncture in the treatment of diabetic bladder dysfunction. J Altern Complement Med. 2009 Aug;15(8):905-9. doi: 10.1089/acm.2009.0062.
Background: PubMed 23834208Mehdi Z, Birns J, Bhalla A. Post-stroke urinary incontinence. Int J Clin Pract. 2013 Nov;67(11):1128-37. doi: 10.1111/ijcp.12183. Epub 2013 Jul 8.
Background: PubMed 23932438van Kerrebroeck P, Chapple C, Drogendijk T, Klaver M, Sokol R, Speakman M, Traudtner K, Drake MJ; NEPTUNE Study Group. Combination therapy with solifenacin and tamsulosin oral controlled absorption system in a single tablet for lower urinary tract symptoms in men: efficacy and safety results from the randomised controlled NEPTUNE trial. Eur Urol. 2013 Dec;64(6):1003-12. doi: 10.1016/j.eururo.2013.07.034. Epub 2013 Aug 3.
Individual participant dataSharing planned: No

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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.

Euiju Lee, Ph.D. principal investigator

Kyunghee University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Electroacupuncture (EA) in people with Urinary Incontinence and Stroke, Complication, run by Kyunghee University at 2 sites in South Korea.

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 4 inclusion and 14 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 27 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Korea. 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. Some participants in this study may receive a placebo. 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?

Total Urgency and Frequency Score (TUFS) (time frame: at least 15 days (at most 21 days) (at baseline and the end of the treatment)). 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 NCT02819336, which also lists 17 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 27 Jun 2017.