Urgency Urinary IncontinenceNI-UUI-2025NCT07259148
Behavioral Interventions Versus Pelvic Floor Muscle Therapy as Adjuncts to Anticholinergic Pharmacotherapy for Urgency Urinary Incontinence: A Non-Inferiority Trial
A study testing Pelvic Floor Muscle Training (PFMT), Behavioral Bladder Training Program and Oxybutynin / Mirabegron (Standardized Pharmacotherapy) in people with Urgency Urinary Incontinence, run by Emilio José Dávila Álvarez at 1 site in Nicaragua.
Trial summary
Urgency urinary incontinence (UUI) is a common condition that significantly affects women's quality of life. Pharmacotherapy is often used as first-line treatment, but its effectiveness can be limited unless combined with non-pharmacological interventions. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urgency Urinary Incontinence
- What is being tested?
- Pelvic Floor Muscle Training (PFMT), Behavioral Bladder Training Program and Oxybutynin / Mirabegron (Standardized Pharmacotherapy)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteNicaragua
- Study dates
- 22 Nov 2025to Apr 2026
- Phase
- Interventional
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged ≥18 years.
- Symptoms of urgency urinary incontinence (UUI) or mixed urinary incontinence with predominance of urgency, with duration ≥3 months.
- Clinical diagnosis of UUI based on history, physical examination, and a 3-day bladder diary.
- Predominance of urgency defined as: at least 50% of total recorded episodes in the bladder diary correspond to urgency (with or without leakage).
- Baseline ICIQ-SF score ≥6.
- Ability to attend scheduled visits and comply with assigned intervention.
- Signed informed consent.
Who cannot join
- Pure stress urinary incontinence.
- Mixed urinary incontinence with predominance of stress defined as: more than 70% of episodes in the 3-day bladder diary are triggered by physical effort.
- Symptomatic advanced pelvic organ prolapse (POP-Q stage ≥III).
- Active or recent urinary tract infection (within the last 7 days).
- Prior use of anticholinergics or β3-agonists that cannot be discontinued for a 14-day washout period.
- Pregnancy or breastfeeding.
- Neurological or psychiatric disorders affecting bladder function, record-keeping, or adherence.
- Cognitive or functional difficulty preventing understanding or completion of study procedures.
Trial locations and contacts
1 site in 1 country.
Nicaragua1 site
Hospital Militar Escuela Dr. Alejandro Dávila Bolaños
Managua, Managua Department
About this study
Official title: Non-Inferiority Randomized Clinical Trial Comparing Behavioral Therapy Plus Pharmacotherapy Versus Pelvic Floor Muscle Training Plus Pharmacotherapy in Women With Urgency Urinary Incontinence
Urgency urinary incontinence (UUI) is a common condition that significantly affects women's quality of life. Pharmacotherapy is often used as first-line treatment, but its effectiveness can be limited unless combined with non-pharmacological interventions. Pelvic floor muscle therapy (PFMT) is widely recommended; however, access to specialized physiotherapy services is limited in many low-resource settings such as Nicaragua. Behavioral interventions-including bladder training, fluid control, avoidance of bladder irritants, and sleep-hygiene strategies-represent a low-cost alternative, but direct comparative evidence against PFMT is limited.
This randomized, controlled, non-inferiority clinical trial will compare two adjuvant strategies combined with standard anticholinergic pharmacotherapy (oxibutinine):
Read more
- Pelvic floor muscle therapy (PFMT), and
- Behavioral interventions (bladder training and lifestyle modification).
Eighty adult women with urgency urinary incontinence or mixed incontinence with urgency-predominance will be randomized 1:1. The intervention period is 8 weeks, with assessments at baseline, week 4, week 8, and an exploratory follow-up at week 12.
The primary outcome is the change in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) score from baseline to week 8. A non-inferiority margin of 3 points will be applied. Secondary outcomes include episodes of urgency/incontinence per 24 h, ICIQ-LUTSqol scores, patient-reported global improvement (PGI-I), adherence, and adverse events.
This study aims to determine whether behavioral interventions are not inferior to PFMT as adjuncts to pharmacotherapy, potentially offering a feasible and more accessible therapeutic alternative for women with UUI in resource-limited healthcare environments.
Read the detailed description
Urgency urinary incontinence (UUI) is highly prevalent among women and is associated with substantial psychosocial, functional, and economic consequences. Although anticholinergic medications are commonly used, their effectiveness is often improved when combined with adjunctive non-pharmacological interventions. Pelvic floor muscle therapy (PFMT) has strong evidence supporting its use; however, its implementation requires trained personnel, scheduled sessions, and specialized infrastructure, which may not be accessible in low-resource settings.
Behavioral interventions-including bladder training, fluid management, avoidance of bladder irritants, dietary modifications, bowel regulation, and sleep-hygiene measures-represent a practical and low-cost alternative. Despite their clinical utility, there is limited evidence from randomized trials directly comparing behavioral interventions to PFMT when used as adjuncts to pharmacotherapy.
This study is a randomized, controlled, non-inferiority trial conducted at a national reference hospital in Nicaragua. The trial will enroll 80 adult women (≥18 years) diagnosed with UUI or mixed urinary incontinence with urgency predominance. Participants will be randomized in a 1:1 ratio to receive either (1) PFMT plus pharmacotherapy or (2) behavioral interventions plus pharmacotherapy. Oxibutinine (5 mg every 12 hours) will be used as the standard pharmacological agent, with mirabegron available as second-line therapy when intolerance occurs.
The intervention period lasts 8 weeks. PFMT includes supervised sessions twice per week plus a structured home-exercise program. Behavioral interventions include individualized bladder-training schedules, fluid-intake monitoring, avoidance of irritants, lifestyle counseling, and sleep-hygiene strategies. Adherence will be monitored at weeks 4 and 8.
The primary outcome is the change in ICIQ-SF score from baseline to week 8, with non-inferiority defined as an upper bound of the 95% confidence interval below 3 points. Secondary outcomes include ICIQ-LUTSqol, episodes of urgency and incontinence (3-day bladder diary), PGI-I, adherence to interventions, and adverse events. Week 12 assessments will explore persistence of clinical benefit.
This study is designed to generate locally applicable evidence to inform clinical practice in settings where PFMT availability is limited. Demonstrating non-inferiority of behavioral interventions could support more accessible and cost-effective management strategies for women with UUI.
- Conditions
- Urgency Urinary Incontinence
- Being tested
- Pelvic Floor Muscle Training (PFMT), Behavioral Bladder Training Program, Oxybutynin / Mirabegron (Standardized Pharmacotherapy)
- Keywords
- Urgency urinary incontinence, Overactive bladder, Pelvic floor muscle therapy, Behavioral therapy, Bladder training, Anticholinergic pharmacotherapy, Oxibutinine, Mirabegron, Non-inferiority trial, Women's health
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic Floor Muscle Training (PFMT)Behavioural
Supervised pelvic floor muscle training twice weekly for 8 weeks, including 3 sets of slow contractions (6-8 seconds) and 3 sets of fast contractions, posture education, breathing training, and daily home exercises.
Behavioral Bladder Training ProgramBehavioural
Structured behavioral program including timed voiding every 2 hours with weekly interval increases, suppression of urgency techniques, fluid optimization, reduction of bladder irritants, sleep hygiene measures, and lifestyle recommendations.
Oxybutynin / Mirabegron (Standardized Pharmacotherapy)Drug
Oxybutynin 5 mg every 12 hours as first-line therapy. Mirabegron 25-50 mg daily will be used in cases of intolerance or inadequate response. Medication use will be monitored and recorded.
| Study group | Role | What they receive |
|---|---|---|
| Pelvic Floor Muscle Therapy + Pharmacotherapy | Active comparator | Supervised pelvic floor muscle training (PFMT) twice weekly for 8 weeks, including slow and fast contractions, posture education, and home exercises. Combined with standardized pharmacotherapy: oxybutynin 5 mg every 12 hours; switch to mirabegron 25-50 mg daily if adverse effects or insufficient response occur. Receives: Behavioral: Pelvic Floor Muscle Training (PFMT); Drug: Oxybutynin / Mirabegron (Standardized Pharmacotherapy) |
| Behavioral Therapy + Pharmacotherapy | Active comparator | Behavioral intervention consisting of bladder training, fluid management, reduction of bladder irritants, sleep hygiene, and healthy lifestyle counseling. Combined with standardized pharmacotherapy: oxybutynin 5 mg every 12 hours; switch to mirabegron 25-50 mg daily if adverse effects or insufficient response occur. Receives: Behavioral: Behavioral Bladder Training Program; Drug: Oxybutynin / Mirabegron (Standardized Pharmacotherapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ICIQ-SF Total Score from Baseline to Week 8
This measure evaluates the change in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) total score between baseline and week 8. The ICIQ-SF assesses frequency, severity, and impact of urinary incontinence on quality of life. Scores range from 0 to 21, with higher scores indicating greater severity.
Measured: Baseline and Week 8
Secondary outcomes (8)
Change in ICIQ-LUTSqol Score from Baseline to Week 8
This measure evaluates the change in the International Consultation on Incontinence Questionnaire-Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol) score between baseline and week 8. The questionnaire assesses the impact of urinary incontinence on daily activities, psychological well-being, and social functioning. Total scores range from 19 to 76, with higher scores indicating greater impairment.
Measured: Baseline and Week 8
Change in Number of Urgency Urinary Incontinence Episodes per 24 Hours
Change in the frequency of urgency urinary incontinence episodes per 24 hours, based on a 3-day bladder diary completed at baseline and week 8.
Measured: Baseline and Week 8
Patient Global Impression of Improvement (PGI-I) at Week 8
The PGI-I is a validated single-item global rating scale in which participants rate their improvement on a 7-point scale ranging from "very much better" to "very much worse." Lower scores indicate greater subjective improvement.
Measured: Week 8
Change in Number of Micturitions per 24 Hours
Change in the total number of micturitions per 24 hours, based on a 3-day bladder diary completed at baseline and week 8.
Measured: Baseline and Week 8
Change in Number of Urgency Urinary Incontinence Episodes per 24 Hours
Change in the frequency of urgency urinary incontinence episodes per 24 hours, recorded in a 3-day bladder diary at baseline and week 8.
Measured: Baseline and Week 8
Change in Number of Urgency Episodes per 24 Hours
Change in the number of urgency episodes per 24 hours, obtained from a 3-day bladder diary at baseline and week 8.
Measured: Baseline and Week 8
Change in Number of Absorbent Pads Used per 24 Hours
Change in the total number of absorbent pads used per 24 hours, as documented in a 3-day bladder diary at baseline and week 8.
Measured: Baseline and Week 8
Adherence to Assigned Intervention
Proportion of participants achieving ≥80% adherence to the assigned intervention protocol, monitored through weekly checklists and session attendance logs.
Measured: Throughout the 8-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start22 Nov 2025
- Primary completion23 Jan 2026
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urgency 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
- Model description
- Two-arm, parallel-group, randomized controlled trial comparing pelvic floor muscle therapy versus behavioral therapy, both as adjuncts to standardized anticholinergic pharmacotherapy.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emilio José Dávila Álvarez
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Militar Escuela "Dr. Alejandro Dávila Bolaños"
- Responsible party
- Sponsor-investigator, Emilio José Dávila Álvarez, Hospital Militar Escuela "Dr. Alejandro Dávila Bolaños"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07259148
- Sponsor's protocol ID
- HMEADB-IUU-2025
- Acronym
- NI-UUI-2025
- Status last verified
- Dec 2025
- First submitted
- 21 Nov 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect participant privacy and based on institutional policy. Summary aggregated results will be reported in ClinicalTrials.gov according to regulatory requirements.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Inferiority Randomized Clinical Trial Comparing Behavioral Therapy Plus Pharmacotherapy Versus Pelvic Floor Muscle Training Plus Pharmacotherapy in Women With Urgency Urinary Incontinence
- ClinicalTrials.gov ID
- NCT07259148
- Acronym / sponsor ID
- NI-UUI-2025 / HMEADB-IUU-2025
- Conditions
- Urgency Urinary Incontinence
- Keywords
- Urgency urinary incontinence, Overactive bladder, Pelvic floor muscle therapy, Behavioral therapy, Bladder training, Anticholinergic pharmacotherapy, Oxibutinine, Mirabegron
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Emilio José Dávila ÁlvarezUniversity, hospital or other
- Collaborators
- Hospital Militar Escuela "Dr. Alejandro Dávila Bolaños"
- Study start
- 22 Nov 2025 (actual)
- Primary completion
- 23 Jan 2026 (actual)
- Study completion
- Apr 2026 (estimated)
- First posted
- 2 Dec 2025 (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.
Urgency urinary incontinence (UUI) is a common condition that significantly affects women's quality of life. Pharmacotherapy is often used as first-line treatment, but its effectiveness can be limited unless combined with non-pharmacological interventions. Pelvic floor muscle therapy (PFMT) is widely recommended; however, access to specialized physiotherapy services is limited in many low-resource settings such as Nicaragua. Behavioral interventions-including bladder training, fluid control, avoidance of bladder irritants, and sleep-hygiene strategies-represent a low-cost alternative, but direct comparative evidence against PFMT is limited.
This randomized, controlled, non-inferiority clinical trial will compare two adjuvant strategies combined with standard anticholinergic pharmacotherapy (oxibutinine):
- Pelvic floor muscle therapy (PFMT), and
- Behavioral interventions (bladder training and lifestyle modification).
Eighty adult women with urgency urinary incontinence or mixed incontinence with urgency-predominance will be randomized 1:1. The intervention period is 8 weeks, with assessments at baseline, week 4, week 8, and an exploratory follow-up at week 12.
The primary outcome is the change in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) score from baseline to week 8. A non-inferiority margin of 3 points will be applied. Secondary outcomes include episodes of urgency/incontinence per 24 h, ICIQ-LUTSqol scores, patient-reported global improvement (PGI-I), adherence, and adverse events.
This study aims to determine whether behavioral interventions are not inferior to PFMT as adjuncts to pharmacotherapy, potentially offering a feasible and more accessible therapeutic alternative for women with UUI in resource-limited healthcare environments.
Detailed description
Urgency urinary incontinence (UUI) is highly prevalent among women and is associated with substantial psychosocial, functional, and economic consequences. Although anticholinergic medications are commonly used, their effectiveness is often improved when combined with adjunctive non-pharmacological interventions. Pelvic floor muscle therapy (PFMT) has strong evidence supporting its use; however, its implementation requires trained personnel, scheduled sessions, and specialized infrastructure, which may not be accessible in low-resource settings.
Behavioral interventions-including bladder training, fluid management, avoidance of bladder irritants, dietary modifications, bowel regulation, and sleep-hygiene measures-represent a practical and low-cost alternative. Despite their clinical utility, there is limited evidence from randomized trials directly comparing behavioral interventions to PFMT when used as adjuncts to pharmacotherapy.
This study is a randomized, controlled, non-inferiority trial conducted at a national reference hospital in Nicaragua. The trial will enroll 80 adult women (≥18 years) diagnosed with UUI or mixed urinary incontinence with urgency predominance. Participants will be randomized in a 1:1 ratio to receive either (1) PFMT plus pharmacotherapy or (2) behavioral interventions plus pharmacotherapy. Oxibutinine (5 mg every 12 hours) will be used as the standard pharmacological agent, with mirabegron available as second-line therapy when intolerance occurs.
The intervention period lasts 8 weeks. PFMT includes supervised sessions twice per week plus a structured home-exercise program. Behavioral interventions include individualized bladder-training schedules, fluid-intake monitoring, avoidance of irritants, lifestyle counseling, and sleep-hygiene strategies. Adherence will be monitored at weeks 4 and 8.
The primary outcome is the change in ICIQ-SF score from baseline to week 8, with non-inferiority defined as an upper bound of the 95% confidence interval below 3 points. Secondary outcomes include ICIQ-LUTSqol, episodes of urgency and incontinence (3-day bladder diary), PGI-I, adherence to interventions, and adverse events. Week 12 assessments will explore persistence of clinical benefit.
This study is designed to generate locally applicable evidence to inform clinical practice in settings where PFMT availability is limited. Demonstrating non-inferiority of behavioral interventions could support more accessible and cost-effective management strategies for women with UUI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm, parallel-group, randomized controlled trial comparing pelvic floor muscle therapy versus behavioral therapy, both as adjuncts to standardized anticholinergic pharmacotherapy.
| Arm | Type | Receives |
|---|---|---|
| Pelvic Floor Muscle Therapy + Pharmacotherapy | Active comparator | Behavioral: Pelvic Floor Muscle Training (PFMT), Drug: Oxybutynin / Mirabegron (Standardized Pharmacotherapy)Supervised pelvic floor muscle training (PFMT) twice weekly for 8 weeks, including slow and fast contractions, posture education, and home exercises. Combined with standardized pharmacotherapy: oxybutynin 5 mg every 12 hours; switch to mirabegron 25-50 mg daily if adverse effects or insufficient response occur. |
| Behavioral Therapy + Pharmacotherapy | Active comparator | Behavioral: Behavioral Bladder Training Program, Drug: Oxybutynin / Mirabegron (Standardized Pharmacotherapy)Behavioral intervention consisting of bladder training, fluid management, reduction of bladder irritants, sleep hygiene, and healthy lifestyle counseling. Combined with standardized pharmacotherapy: oxybutynin 5 mg every 12 hours; switch to mirabegron 25-50 mg daily if adverse effects or insufficient response occur. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women aged ≥18 years.
- Symptoms of urgency urinary incontinence (UUI) or mixed urinary incontinence with predominance of urgency, with duration ≥3 months.
- Clinical diagnosis of UUI based on history, physical examination, and a 3-day bladder diary.
- Predominance of urgency defined as: at least 50% of total recorded episodes in the bladder diary correspond to urgency (with or without leakage).
- Baseline ICIQ-SF score ≥6.
Key exclusion criteria (8 listed)
- Pure stress urinary incontinence.
- Mixed urinary incontinence with predominance of stress defined as: more than 70% of episodes in the 3-day bladder diary are triggered by physical effort.
- Symptomatic advanced pelvic organ prolapse (POP-Q stage ≥III).
- Active or recent urinary tract infection (within the last 7 days).
- Prior use of anticholinergics or β3-agonists that cannot be discontinued for a 14-day washout period.
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 |
|---|---|---|
| Pelvic Floor Muscle Training (PFMT)Supervised pelvic floor muscle training twice weekly for 8 weeks, including 3 sets of slow contractions (6-8 seconds) and 3 sets of fast contractions, posture education, breathing training, and daily home exercises. | Behavioural | Pelvic Floor Muscle Therapy + Pharmacotherapy |
| Behavioral Bladder Training ProgramStructured behavioral program including timed voiding every 2 hours with weekly interval increases, suppression of urgency techniques, fluid optimization, reduction of bladder irritants, sleep hygiene measures, and lifestyle recommendations. | Behavioural | Behavioral Therapy + Pharmacotherapy |
| Oxybutynin / Mirabegron (Standardized Pharmacotherapy)Oxybutynin 5 mg every 12 hours as first-line therapy. Mirabegron 25-50 mg daily will be used in cases of intolerance or inadequate response. Medication use will be monitored and recorded. | Drug | Behavioral Therapy + Pharmacotherapy, Pelvic Floor Muscle Therapy + Pharmacotherapy |
Primary outcome
Change in ICIQ-SF Total Score from Baseline to Week 8
Time frame: Baseline and Week 8
This measure evaluates the change in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) total score between baseline and week 8. The ICIQ-SF assesses frequency, severity, and impact of urinary incontinence on quality of life. Scores range from 0 to 21, with higher scores indicating greater severity.
8 secondary outcomes
Change in ICIQ-LUTSqol Score from Baseline to Week 8
Time frame: Baseline and Week 8
Change in Number of Urgency Urinary Incontinence Episodes per 24 Hours
Time frame: Baseline and Week 8
Patient Global Impression of Improvement (PGI-I) at Week 8
Time frame: Week 8
Change in Number of Micturitions per 24 Hours
Time frame: Baseline and Week 8
Change in Number of Urgency Urinary Incontinence Episodes per 24 Hours
Time frame: Baseline and Week 8
Change in Number of Urgency Episodes per 24 Hours
Time frame: Baseline and Week 8
Change in Number of Absorbent Pads Used per 24 Hours
Time frame: Baseline and Week 8
Adherence to Assigned Intervention
Time frame: Throughout the 8-week intervention period
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 26 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect participant privacy and based on institutional policy. Summary aggregated results will be reported in ClinicalTrials.gov according to regulatory requirements.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic Floor Muscle Training (PFMT), Behavioral Bladder Training Program and Oxybutynin / Mirabegron (Standardized Pharmacotherapy) in people with Urgency Urinary Incontinence, run by Emilio José Dávila Álvarez at 1 site in Nicaragua.
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 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Jan 2026. 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 Nicaragua. 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?
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?
Change in ICIQ-SF Total Score from Baseline to Week 8 (time frame: Baseline and Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.