A Phase 4 interventional study of Urgent PC in Overactive Bladder and Overactive Bladder Syndrome, sponsored by Chi Dang Hornik. Not yet recruiting. Open to participants aged 5 Years to 21 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-17.
Sponsored by Chi Dang Hornik · Phase 4, Interventional, and Treatment
The purpose of this study is to find out if overactive bladder (OAB) can be safely treated by stimulating a nerve near the ankle. This procedure is called percutaneous tibial nerve stimulation (PTNS). It will be done by a device called the Urgent PC. The Urgent PC works by sending weak electrical signals through a thin needle to the nerve near the ankle. Stimulating this nerve may change bladder control.
This study is a single-arm, open label, prospective, multicenter study of 50 participants aged 5-21 years with OAB. Participants will undergo outpatient PTNS sessions per routine clinical care using Urgent PC once weekly for 12 weeks. Patients, parents and clinicians will not be blinded to treatment or assessments during the study.
858 studies on the registry are indexed under Urinary Bladder, Overactive; 127 are open to participants now.
This study's planned enrollment of 50 is below the median of 70 across 649 interventional studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →Chi Dang Hornik is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single Arm Cohort: (n=50) PTNS treatment weekly over 30 minutes for a total of 12 weekly sessions.
Device: Urgent PC
PTNS is a technique of electrical neuromodulation used primarily for treating OAB. The procedure for PTNS consists of the insertion of a fine needle above the medial malleolus near the posterior tibial nerve followed by the application of low-voltage electrical stimulation that produces sensory and motor responses.
Also known as: Non-drug, non-surgical treatment for overactive bladder, PRC 26348 - V1.00
The frequency of select safety Events of Special Interest.
1. Electrode site reaction (bruising, bleeding, hematoma, or persistent erythema at the electrode site) 2. Electrode site infection 3. Repeated post-void residual \>60 mL (at ≥ 2 consecutive visits) 4. Urinary tract infection 5. Urinary retention/obstruction 6. Toe numbness 7. Stomach and leg cramps
Time frame: Weekly, Week 1 through Week 16
Change in maximum voided volume on the Bladder Diary
The Bladder Diary is a paper diary recommended by the International Children's Continence Society that will be completed by the parent/guardian/LAR or participant. The Bladder Diary includes the following variables: fluid intake, number of voids, volume of voids, degree of urgency, number of incontinent episodes.
Time frame: Week 1, Week 12
Proportion of children who experienced complete response, no response, or partial response on the Vancouver Dysfunctional Elimination Survey (VDES)
The VDES is a validated questionnaire that was developed for diagnosing dysfunctional elimination syndrome. The survey uses a five-point Likert scale to score symptoms of bladder dysfunction. Each question is scored on a scale of 0-4, with 0 indicating no complaints and 4 indicating severe symptoms. The total score ranges from 0-52, with higher scores indicating more severe symptoms. The question about voiding frequency is scored differently from the other questions. A neutral choice of five to six urination per day is scored as 0. A urinary frequency of one to two times or more than eight times a day is scored as 4. A urinary frequency of three or four and seven or eight times a day is scored as 2. A cutoff score of 11 is used for patients and 9 for parents to diagnose dysfunctional voiding. The VDES is completed by the parent/legal guardian if participants are \< 9 years old and by participants if they are ≥ 9 years old.
Time frame: Screening, Weekly (Week 1 through Week 12)
Change in OAB symptoms (Urgency, Frequency and Daytime Incontinence) reported on the VDES
Change in OAB symptoms will be evaluated from the symptom questions on the VDES survey assessing Urgency, Frequency and Daytime Incontinence. The survey uses a five-point Likert scale to score symptoms of bladder dysfunction. Each question is scored on a scale of 0-4, with 0 indicating no complaints and 4 indicating severe symptoms. The total score ranges from 0-52, with higher scores indicating more severe symptoms. The question about voiding frequency is scored differently from the other questions. A neutral choice of five to six urination per day is scored as 0. A urinary frequency of one to two times or more than eight times a day is scored as 4. A urinary frequency of three or four and seven or eight times a day is scored as 2. A cutoff score of 11 is used for patients and 9 for parents to diagnose dysfunctional voiding. The VDES is completed by the parent/legal guardian if participants are \< 9 years old and by participants if they are ≥ 9 years old.
Time frame: Screening, Weekly (Week 1 through Week 12), Week 16, Week 36
Proportion of children who develop a febrile UTI
Febrile UTI occurrence, defined as: • Fever \> 101.5°F (\> 38.6°C); and \>50,000 colony forming units (CFU)/mL of 1 or more speciated organisms; and 10 white blood cells per higher power field (WBC/HPF) on urine microscopy and/or leucocyte esterase \> 2+ on dipstick; and At least 1 of the following symptoms: Gross hematuria (defined as pink or red urine, not a spot of blood on a catheter) OR Abdominal, suprapubic, or flank pain or tenderness OR New or worsening incontinence OR New or worsening urinary urgency, frequency, or hesitancy OR Nausea/vomiting OR Pain with urination OR Malodorous/cloudy urine.
Time frame: Weekly, Week 1 through Week 12
The change of Pediatric Incontinence Quality of Life (PINQ) score
The Pediatric Incontinence Quality of Life (PINQ) is a 20-item, self-reported questionnaire that evaluates the QoL of children who have urinary incontinence. Each item is scored on a 5-point Likert scale, with 1 being "no" and 5 being "always". The total score ranges from 20 to 100 points. A higher score indicates a better QoL that is less affected by urinary symptoms. The PINQ is validated for use in children 6-17 years old and has been used in studies of participants up to 30 years old.21,25 The PINQ will be completed by the parent/legal guardian/LAR if participants are \< 9 years old and by participants if they are ≥ 9 years old.
Time frame: Week 1, Week 6, Week 12, Week 16, and Week 36
The percent of study visits attended within the protocol specified window from baseline through Week 12
The percent of study visits attended within the protocol specified window from baseline through Week 12
Time frame: Screening, Weekly (week 1 through week 12)
No study locations are listed for this record.
Plan to share: Yes — All data collected is uploaded into the National Institute of Health Data Repository (DASH) at the end of the study (de-identified).
Supporting information: Study protocol, Informed consent form
Time frame: Data will be uploaded to the repository within 2 years of study completion. It will be maintained in the repository indefinitely.
Access criteria: In order to have access, researchers have to complete a Data access request. NICHD will review the request and either approve or deny it. IRB approval must be obtained by the researcher to access the data. https://dash.nichd.nih.gov/Resource/DataRequestChecklist
Data sharing details ↗ · dash.nichd.nih.gov
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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