Overactive BladderTEST-ONNCT04957524
TEST-ON - Does iStim Reduce Urinary Urgency?
A study testing iStim TENS unit and Transvaginal Probe in people with Overactive Bladder and Urgency-frequency Syndrome, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Overactive bladder (OAB) is a chronic disorder with an overall prevalence in the adult population of over 10%, but that may exceed 40% in elderly groups. Most overactive bladder treatments are aimed at decreasing urgency incontinence episodes. Read more about this study
- Who is it for?
- Ages 18 to 120 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overactive Bladder, Urgency-frequency Syndrome, Urinary Frequency More Than Once at Night
- What is being tested?
- iStim TENS unit and Transvaginal Probe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2021to 11 Feb 2025
- 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 18 to 120 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female
- Age > 18 years old
- English speaking
- OAB symptoms for greater than 3 months duration defined as:
- Urgency: Answer to OAB-q3 > 4]
- Frequency: greater than 8 voids on bladder diary during waking hours and OAB-q1 > 3
- No urinary urge incontinence: OAB-q8 < 2 and OAB-q4 < 2
- No significant pelvic pain: fGUPI4 < 4
Who cannot join
- Age less than 18
- Pregnancy
- Vaginal infection or lesion
- Neurogenic bladder
- Immunocompromised state (hx of transplant, on immunosuppressing drugs)
- PVR >150cc
Show all 11Show fewer
- Urinary tract infections
- Neurogenic bladder
- Reduced perception of vaginal sensation
- Metallic implants
- Implanted electrical devices (i.e. pace maker)
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Center for Women's Pelvic Health
Los Angeles, California, 90095
About this study
Official title: Transvaginal Electrical Stimulation for the Treatment of OAB-dry
Overactive bladder (OAB) is a chronic disorder with an overall prevalence in the adult population of over 10%, but that may exceed 40% in elderly groups. Most overactive bladder treatments are aimed at decreasing urgency incontinence episodes. The purpose of this study is to determine whether an at-home transvaginal electrical stimulation (TES) program works to alleviate symptoms of urgency in patients with urinary urgency and frequency without incontinence. This is a cross-over trial. Women >18 yo presenting with OAB-dry will be randomized to receive one of two TES at home programs for 4 weeks. After completion of the program, the participant's symptoms will be assessed with standardized patient questionnaires. There will then be a 3 week washout period followed by the second at-home TES program. At the completion of the second program, the participant's symptoms will be assessed with the same standardized questionnaires. The participants will be followed for 6 months following the completion of the TES program.
Read the detailed description
This will be a prospective randomized cross over trial. We will recruit women who present to clinic to see a Female Pelvic Medicine and Reconstructive Surgery, fellowship-trained provider within the UCLA Health System with the symptoms of OAB-dry and have failed or decline anti-cholinergic therapy.
Screening: Patients will be made aware of the study by their physician. Interested subjects will interact with study staff in person or by telephone for a complete description of the study. If they wish to continue, they will be screened for eligibility by study staff. If eligible, they will be given as much time as they wish to complete the process of informed consent and have their questions answered. Consent will be obtained electronically using the RedCap system.
After informed consent, subjects will be asked to complete intake questionnaires, sent through the RedCap site. These questionnaires include the International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS), female GenitoUrinary Pain Index (fGUPI), Pelvic Organ Prolapse Distress Inventory (POPDI-6) portion of the Pelvic Floor Disability Index (PFDI), the first 8 questions of the OverActive Bladder questionnaire (OAB-q), the last question of the AUA symptom score, and the Urgency Perception Scale: UPC.
After informed consent, study staff will access subjects' medical records to obtain the results of standard care procedures that are regularly performed for patients with this symptomatology, specifically, pelvic exam and urodynamics.
Participants will be asked to make a research visit for training and to obtain materials. They will be issued the iStim device. Both groups will be oriented to the vaginal stimulation device which includes the iStim TENS unit and Transvaginal Probe. The iStim TENS unit delivers a bipolar square wave that can be delivered over a range of 0 to 100 mA. On the TENS unit the patient can set frequency, duration of stimulation, pulse duration, and amplitude. During each participant's in-person visit they will be instructed by trained study staff on how to use the electrical stimulation.
Patients will be randomized to treatment A followed by treatment B (Group 1) or treatment B followed by treatment A (Group 2). The patients will be blinded to which treatment they are receiving first.
Each treatment phase will be 4 weeks in duration. The washout period between phases will be three weeks. Patients will be given a log to record each session completed at home in order to determine compliance. They will also be asked to record the amplitude achieved for each session in the treatment phase. Patients will be able to report adverse events electronically through RedCap or by contacting study staff directly.
At the end of each 4-week treatment patients will be asked to complete the same intake questionnaires again with the addition of the select questions from the modified version of the Overactive Bladder Patient Satisfaction with Treatment Questionnaire (OAB-PSTQ) and Patient Global Assessment (PGA) which assesses their perception of the intervention.
At the end of the intervention, participants will be asked to complete a bladder diary again using the same IUGA bladder diary.
Participants will be followed through their medical record for 6 months after completion of study activities. Further OAB therapies tried will be recorded as well as pelvic exams and/or urodynamics done as part of their standard care. They will be asked to complete the set of intake questionnaires once more at the end of 6 months.
- Being tested
- iStim TENS unit and Transvaginal Probe
- Medical subject headings
- Urinary Bladder, Overactive, Nocturia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iStim TENS unit and Transvaginal ProbeDevice
iStim TENS unit and Transvaginal Probe are both commercially available products. TENS units work by delivering small electrical impulses through electrodes either attached to the skin or through a transvaginal probe.
iStim transvaginal probe will be inserted vaginally to provide transvaginal electrical stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Set Amplitude | Active comparator | This arm is to test a specific amplitude. Participants will be instructed to set the amplitude to 20 mA, frequency to 20 Hz, and pulse duration to 5 mS. The parameters will stay the same for the entire session. This stimulation will last 15 minutes and patients will be instructed to perform the at-home therapy once per day. Receives: Device: iStim TENS unit and Transvaginal Probe |
| Customizable Amplitude | Experimental | In this arm, the participant will set the frequency to 12 Hz and pulse duration to 1 millisecond. The participant will be instructed to increase the amplitude gradually and set it at the maximal tolerable amplitude. This stimulation will last 15 minutes and patients will be instructed to perform the at-home therapy once per day. Receives: Device: iStim TENS unit and Transvaginal Probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary urgency
The primary outcome is the change in participant's reported urgency as measured by the composite score of the first 8 questions of the OAB-q questionnaire. The questionnaire is out of 8 with higher scores corresponding with more bother from urinary urgency. The primary outcome is the difference between the pre-treament and post-treatment scores. The range is 0 to 48 with a larger difference corresponding to more improvement in patient's urgency over the study period.
Measured: This will be the difference in score from the date of enrollment to the end of both treatment arms. This will range from 11 weeks to 20 weeks.
Secondary outcomes (3)
Percentage of assigned treatment sessions that were successfully completed
Number of home programs completed compared to planned treatments based on paper treatment log completed by patient. Range is 0 to 100% completion.
Measured: 4 weeks
Change in Urinary Urgency Episodes
Change in number of urgency episodes (per 24 hours) as measured on the voiding diaries. This will be the difference in number of urgency episodes pretreatment compared to posttreatment. The range is 0 to 10 urgency episodes.
Measured: This will be the difference in score from the date of enrollment to the end of both treatment arms. This will range from 11 weeks to 20 weeks.
Change in number of micturitions per 24 hours
Change in number of micturition episodes (per 24 hours) as measured on the voiding diaries. This will be the difference in number of micturition episodes pretreatment compared to post-treatment. The range is 0 to 20 micturition episodes.
Measured: This will be the difference in score from the date of enrollment to the end of both treatment arms. This will range from 11 weeks to 20 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start20 Dec 2021
- Primary completion15 May 2023
- Study completion11 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Crossover
- Model description
- Patient will then be randomized to treatment A followed by treamtent B (Group 1) or treatment B followed by treatment A (Group 2).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Lenore Ackerman, University of California, Los Angeles
- Investigators
- Anne L Ackerman, MD, PhD, Principal investigator, UCLA, Department of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04957524
- Sponsor's protocol ID
- 21-005834
- Acronym
- TEST-ON
- Status last verified
- May 2025
- First submitted
- 23 Jun 2021
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Publications
Soomro NA, Khadra MH, Robson W, Neal DE. A crossover randomized trial of transcutaneous electrical nerve stimulation and oxybutynin in patients with detrusor instability. J Urol. 2001 Jul;166(1):146-9.
PubMed 11435843Primus G, Kramer G. Maximal external electrical stimulation for treatment of neurogenic or non-neurogenic urgency and/or urge incontinence. Neurourol Urodyn. 1996;15(3):187-94. doi: 10.1002/(SICI)1520-6777(1996)15:33.0.CO;2-B.
PubMed 8732985Messelink EJ. The overactive bladder and the role of the pelvic floor muscles. BJU Int. 1999 Mar;83 Suppl 2:31-5. doi: 10.1046/j.1464-410x.83.s2.7.x. No abstract available.
PubMed 10210602Hoffman D. Understanding multisymptom presentations in chronic pelvic pain: the inter-relationships between the viscera and myofascial pelvic floor dysfunction. Curr Pain Headache Rep. 2011 Oct;15(5):343-6. doi: 10.1007/s11916-011-0215-1.
PubMed 21739128Guralnick ML, Kelly H, Engelke H, Koduri S, O'Connor RC. InTone: a novel pelvic floor rehabilitation device for urinary incontinence. Int Urogynecol J. 2015 Jan;26(1):99-106. doi: 10.1007/s00192-014-2476-9. Epub 2014 Jul 30.
PubMed 25074260Brubaker L, Benson JT, Bent A, Clark A, Shott S. Transvaginal electrical stimulation for female urinary incontinence. Am J Obstet Gynecol. 1997 Sep;177(3):536-40. doi: 10.1016/s0002-9378(97)70142-x.
PubMed 9322620Amaro JL, Gameiro MO, Kawano PR, Padovani CR. Intravaginal electrical stimulation: a randomized, double-blind study on the treatment of mixed urinary incontinence. Acta Obstet Gynecol Scand. 2006;85(5):619-22. doi: 10.1080/00016340500495058.
PubMed 16752244Yamanishi T, Yasuda K, Sakakibara R, Hattori T, Suda S. Randomized, double-blind study of electrical stimulation for urinary incontinence due to detrusor overactivity. Urology. 2000 Mar;55(3):353-7. doi: 10.1016/s0090-4295(99)00476-8.
PubMed 10699609Torosis M, Stothers L, Cisneros C, Dominique G, Lenore Ackerman A. Transvaginal Electrical Stimulation for Treatment of Overactive Bladder Without Incontinence: A Pilot Cross-Over Clinical Trial. Neurourol Urodyn. 2025 Jun;44(5):977-986. doi: 10.1002/nau.70034. Epub 2025 Mar 26.
PubMed 40135809
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transvaginal Electrical Stimulation for the Treatment of OAB-dry
- ClinicalTrials.gov ID
- NCT04957524
- Acronym / sponsor ID
- TEST-ON / 21-005834
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 11 Feb 2025 (actual)
- First posted
- 12 Jul 2021 (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.
Overactive bladder (OAB) is a chronic disorder with an overall prevalence in the adult population of over 10%, but that may exceed 40% in elderly groups. Most overactive bladder treatments are aimed at decreasing urgency incontinence episodes. The purpose of this study is to determine whether an at-home transvaginal electrical stimulation (TES) program works to alleviate symptoms of urgency in patients with urinary urgency and frequency without incontinence. This is a cross-over trial. Women >18 yo presenting with OAB-dry will be randomized to receive one of two TES at home programs for 4 weeks. After completion of the program, the participant's symptoms will be assessed with standardized patient questionnaires. There will then be a 3 week washout period followed by the second at-home TES program. At the completion of the second program, the participant's symptoms will be assessed with the same standardized questionnaires. The participants will be followed for 6 months following the completion of the TES program.
Detailed description
This will be a prospective randomized cross over trial. We will recruit women who present to clinic to see a Female Pelvic Medicine and Reconstructive Surgery, fellowship-trained provider within the UCLA Health System with the symptoms of OAB-dry and have failed or decline anti-cholinergic therapy.
Screening: Patients will be made aware of the study by their physician. Interested subjects will interact with study staff in person or by telephone for a complete description of the study. If they wish to continue, they will be screened for eligibility by study staff. If eligible, they will be given as much time as they wish to complete the process of informed consent and have their questions answered. Consent will be obtained electronically using the RedCap system.
After informed consent, subjects will be asked to complete intake questionnaires, sent through the RedCap site. These questionnaires include the International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS), female GenitoUrinary Pain Index (fGUPI), Pelvic Organ Prolapse Distress Inventory (POPDI-6) portion of the Pelvic Floor Disability Index (PFDI), the first 8 questions of the OverActive Bladder questionnaire (OAB-q), the last question of the AUA symptom score, and the Urgency Perception Scale: UPC.
After informed consent, study staff will access subjects' medical records to obtain the results of standard care procedures that are regularly performed for patients with this symptomatology, specifically, pelvic exam and urodynamics.
Participants will be asked to make a research visit for training and to obtain materials. They will be issued the iStim device. Both groups will be oriented to the vaginal stimulation device which includes the iStim TENS unit and Transvaginal Probe. The iStim TENS unit delivers a bipolar square wave that can be delivered over a range of 0 to 100 mA. On the TENS unit the patient can set frequency, duration of stimulation, pulse duration, and amplitude. During each participant's in-person visit they will be instructed by trained study staff on how to use the electrical stimulation.
Patients will be randomized to treatment A followed by treatment B (Group 1) or treatment B followed by treatment A (Group 2). The patients will be blinded to which treatment they are receiving first.
Each treatment phase will be 4 weeks in duration. The washout period between phases will be three weeks. Patients will be given a log to record each session completed at home in order to determine compliance. They will also be asked to record the amplitude achieved for each session in the treatment phase. Patients will be able to report adverse events electronically through RedCap or by contacting study staff directly.
At the end of each 4-week treatment patients will be asked to complete the same intake questionnaires again with the addition of the select questions from the modified version of the Overactive Bladder Patient Satisfaction with Treatment Questionnaire (OAB-PSTQ) and Patient Global Assessment (PGA) which assesses their perception of the intervention.
At the end of the intervention, participants will be asked to complete a bladder diary again using the same IUGA bladder diary.
Participants will be followed through their medical record for 6 months after completion of study activities. Further OAB therapies tried will be recorded as well as pelvic exams and/or urodynamics done as part of their standard care. They will be asked to complete the set of intake questionnaires once more at the end of 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Patient will then be randomized to treatment A followed by treamtent B (Group 1) or treatment B followed by treatment A (Group 2).
| Arm | Type | Receives |
|---|---|---|
| Set Amplitude | Active comparator | Device: iStim TENS unit and Transvaginal ProbeThis arm is to test a specific amplitude. Participants will be instructed to set the amplitude to 20 mA, frequency to 20 Hz, and pulse duration to 5 mS. The parameters will stay the same for the entire session. This stimulation will last 15 minutes and patients will be instructed to perform the at-home therapy once per day. |
| Customizable Amplitude | Experimental | Device: iStim TENS unit and Transvaginal ProbeIn this arm, the participant will set the frequency to 12 Hz and pulse duration to 1 millisecond. The participant will be instructed to increase the amplitude gradually and set it at the maximal tolerable amplitude. This stimulation will last 15 minutes and patients will be instructed to perform the at-home therapy once per day. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female
- Age > 18 years old
- English speaking
- OAB symptoms for greater than 3 months duration defined as:
- Urgency: Answer to OAB-q3 > 4]
Key exclusion criteria (11 listed)
- Age less than 18
- Pregnancy
- Vaginal infection or lesion
- Neurogenic bladder
- Immunocompromised state (hx of transplant, on immunosuppressing drugs)
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 |
|---|---|---|
| iStim TENS unit and Transvaginal ProbeiStim TENS unit and Transvaginal Probe are both commercially available products. TENS units work by delivering small electrical impulses through electrodes either attached to the skin or through a transvaginal probe. iStim transvaginal probe will be inserted vaginally to provide transvaginal electrical stimulation. | Device | Customizable Amplitude, Set Amplitude |
Primary outcome
Urinary urgency
Time frame: This will be the difference in score from the date of enrollment to the end of both treatment arms. This will range from 11 weeks to 20 weeks.
The primary outcome is the change in participant's reported urgency as measured by the composite score of the first 8 questions of the OAB-q questionnaire. The questionnaire is out of 8 with higher scores corresponding with more bother from urinary urgency. The primary outcome is the difference between the pre-treament and post-treatment scores. The range is 0 to 48 with a larger difference corresponding to more improvement in patient's urgency over the study period.
3 secondary outcomes
Percentage of assigned treatment sessions that were successfully completed
Time frame: 4 weeks
Change in Urinary Urgency Episodes
Time frame: This will be the difference in score from the date of enrollment to the end of both treatment arms. This will range from 11 weeks to 20 weeks.
Change in number of micturitions per 24 hours
Time frame: This will be the difference in score from the date of enrollment to the end of both treatment arms. This will range from 11 weeks to 20 weeks.
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 6 May 2025.
- Background: PubMed 11435843Soomro NA, Khadra MH, Robson W, Neal DE. A crossover randomized trial of transcutaneous electrical nerve stimulation and oxybutynin in patients with detrusor instability. J Urol. 2001 Jul;166(1):146-9.
- Background: PubMed 8732985Primus G, Kramer G. Maximal external electrical stimulation for treatment of neurogenic or non-neurogenic urgency and/or urge incontinence. Neurourol Urodyn. 1996;15(3):187-94. doi: 10.1002/(SICI)1520-6777(1996)15:33.0.CO;2-B.
- Background: PubMed 10210602Messelink EJ. The overactive bladder and the role of the pelvic floor muscles. BJU Int. 1999 Mar;83 Suppl 2:31-5. doi: 10.1046/j.1464-410x.83.s2.7.x. No abstract available.
- Background: PubMed 21739128Hoffman D. Understanding multisymptom presentations in chronic pelvic pain: the inter-relationships between the viscera and myofascial pelvic floor dysfunction. Curr Pain Headache Rep. 2011 Oct;15(5):343-6. doi: 10.1007/s11916-011-0215-1.
- Background: PubMed 25074260Guralnick ML, Kelly H, Engelke H, Koduri S, O'Connor RC. InTone: a novel pelvic floor rehabilitation device for urinary incontinence. Int Urogynecol J. 2015 Jan;26(1):99-106. doi: 10.1007/s00192-014-2476-9. Epub 2014 Jul 30.
- Background: PubMed 9322620Brubaker L, Benson JT, Bent A, Clark A, Shott S. Transvaginal electrical stimulation for female urinary incontinence. Am J Obstet Gynecol. 1997 Sep;177(3):536-40. doi: 10.1016/s0002-9378(97)70142-x.
- Background: PubMed 16752244Amaro JL, Gameiro MO, Kawano PR, Padovani CR. Intravaginal electrical stimulation: a randomized, double-blind study on the treatment of mixed urinary incontinence. Acta Obstet Gynecol Scand. 2006;85(5):619-22. doi: 10.1080/00016340500495058.
- Results publication: PubMed 10699609Yamanishi T, Yasuda K, Sakakibara R, Hattori T, Suda S. Randomized, double-blind study of electrical stimulation for urinary incontinence due to detrusor overactivity. Urology. 2000 Mar;55(3):353-7. doi: 10.1016/s0090-4295(99)00476-8.
- Derived from this study: PubMed 40135809Torosis M, Stothers L, Cisneros C, Dominique G, Lenore Ackerman A. Transvaginal Electrical Stimulation for Treatment of Overactive Bladder Without Incontinence: A Pilot Cross-Over Clinical Trial. Neurourol Urodyn. 2025 Jun;44(5):977-986. doi: 10.1002/nau.70034. Epub 2025 Mar 26.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
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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.
Anne L Ackerman, MD, PhD principal investigator
UCLA, Department of Urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iStim TENS unit and Transvaginal Probe in people with Overactive Bladder and Urgency-frequency Syndrome, run by University of California, Los Angeles at 1 site in United States.
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 8 inclusion and 11 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 May 2025. 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 United States. 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?
Urinary urgency (time frame: This will be the difference in score from the date of enrollment to the end of both treatment arms. This will range from 11 weeks to 20 weeks.). 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 NCT04957524, which also lists 9 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 May 2025.