BOTOXNCT05911594
IDB Injection Combined With PTNS for Managing Children With OAB Not Responding to Monotherapy
A study testing Solifenacin group, Percutaneous tibial nerve stimulation group and Intradetrusor BOTOX group in people with BOTOX and Percutaneous Tibial Nerve Stimulation, run by Benha University at 1 site in Egypt.
Trial summary
This study aimed to evaluate the outcome of simultaneous intradetrusor BOTOX (IDB) injection and Percutaneous tibial nerve stimulation (PTNS) for management of children with recurrent wetness since at least 6 months. Read more about this study
- Who is it for?
- Ages 7 to 16 years
- Conditions the study is for
- BOTOX, Percutaneous Tibial Nerve Stimulation
- What is being tested?
- Solifenacin group, Percutaneous tibial nerve stimulation group and Intradetrusor BOTOX group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Feb 2022to 14 Feb 2023
- 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 7 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with non-neurogenic overactive bladder defined after exclusion of neurogenic causes not responding to medical treatment for 6 months, and
- aged of 7-16 years
- presenting with recurrent night-time with occasional day-time wetness for overactive bladder.
Who cannot join
- recurrent OAB manifestations within less than 6 months after the previous monotherapy
- obstructive urinary tract diseases
- a history of pelvic surgery
- anatomical abnormalities
- neurogenic bladder
- syndromes that affect the bladder functions
- either current infection that was evidenced by urinalysis and culture or within the last two months
- systemic diseases inducing liability for wetness
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Pediatric Urology departments Benha University Hospitals
Banhā, Qalyubiyya, 13511
About this study
Official title: Efficacy and Safety of Intradetrusor BOTOX Injection Combined With Percutaneous Tibial Nerve Stimulation for Managing Children With Overactive Bladder Not Responding to Monotherapy
This study aimed to evaluate the outcome of simultaneous intradetrusor BOTOX (IDB) injection and Percutaneous tibial nerve stimulation (PTNS) for management of children with recurrent wetness since at least 6 months.
Read the detailed description
Overactive bladder is a syndrome characterized by symptoms of urgency, with or without urgency incontinence, usually with increased daytime frequency and nocturia. The Neurogenic or myogenic bladder dysfunction can lead to the symptoms that characterize Overactive bladder. Normal bladder contraction occurs when the muscarinic receptors in the detrusor muscle are stimulated with acetylcholine. Although the pathogenesis of Overactive bladder is not fully explained; sensitization of afferent nerves, deactivation of inhibitory mechanisms, and the emergence of contractions similar to primitive voiding reflexes are shown as pathogenetic mechanisms. Another hypothesis is that the number of intercellular connections among detrusor myocytes increase, and these cells are spontaneously stimulated.
In addition to the fact that the etiopathogenesis cannot be explained clearly and due to the intense relationship with the autonomic nervous system, undesirable systemic side effects are common in treatments applied.
- Conditions
- BOTOX, Percutaneous Tibial Nerve Stimulation
- Being tested
- Solifenacin group, Percutaneous tibial nerve stimulation group, Intradetrusor BOTOX group, Intradetrusor BOTOX combined with Percutaneous tibial nerve stimulation group
- Keywords
- Overactive Bladder
- 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.
Solifenacin groupDrug
Patients in this group will receive medical treatment (Solifenacin 5 mg once or twice daily) without any second line of treatment
Percutaneous tibial nerve stimulation groupProcedure or surgery
Patients in this group will receive Percutaneous tibial nerve stimulation after failure of medical therapy
Intradetrusor BOTOX groupDrug
Patients in this group will receive Intradetrusor BOTOX after failure of medical
Intradetrusor BOTOX combined with Percutaneous tibial nerve stimulation groupCombination product
Patients in this group will receive Intradetrusor BOTOX combined with Percutaneous tibial nerve stimulation after failure of medical
| Study group | Role | What they receive |
|---|---|---|
| Solifenacin group | Experimental | Patients in this group will receive medical treatment (Solifenacin 5 mg once or twice daily) without any second line of treatment Receives: Drug: Solifenacin group |
| Percutaneous tibial nerve stimulation group | Experimental | Patients in this group will receive Percutaneous tibial nerve stimulation after failure of medical therapy Receives: Procedure: Percutaneous tibial nerve stimulation group |
| Intradetrusor BOTOX group | Experimental | Patients in this group will receive Intradetrusor BOTOX after the failure of medical therapy Receives: Drug: Intradetrusor BOTOX group |
| Intradetrusor BOTOX combined with Percutaneous tibial nerve stimulation group | Experimental | Patients in this group will receive Intradetrusor BOTOX combined with Percutaneous tibial nerve stimulation after the failure of medical therapy Receives: Combination Product: Intradetrusor BOTOX combined with Percutaneous tibial nerve stimulation group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overactive bladder symptom score
the Overactive bladder symptom score (OABSS) questionnaire will be calculated which consists of four items; namely, daytime frequency (score: 0-2), night-time frequency (score: 0-3), urgency (score: 0-5), and urgency incontinence (score: 0-5). The results scores were summed and a score of>8 suggesting an overactive bladder
Measured: Baseline, 3, 6, 9 and 12 months after the intervention
Secondary outcomes (2)
Patient Perception of Bladder Condition (PPBC) scale
The Patient Perception of Bladder Condition (PPBC) scale will be calculated which includes 6-point describing patient's comment of his/her bladder problems and ranging from 1: Not at all, 2: Some very minor, 3: Some minor, 4: some moderate, 5: severe, 6: many severe problems.
Measured: Baseline, 3, 6, 9 and 12 months after the intervention
Patients' satisfaction
The Patients' satisfaction will be assessed by the Likert scale (self-report scale where 0 = strong dissatisfaction, 1 = dissatisfaction, 2 = neutral, 3 = satisfaction, and 4 = strong satisfaction)
Measured: Up to the 12-month follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start14 Feb 2022
- Primary completion14 Feb 2023
- Study completion14 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BOTOXStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamer Abd El-Wahab Diab, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05911594
- Sponsor's protocol ID
- Rc 14-2-2022
- Status last verified
- Aug 2023
- First submitted
- 14 May 2023
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study will be available under a reasonable request from the corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Intradetrusor BOTOX Injection Combined With Percutaneous Tibial Nerve Stimulation for Managing Children With Overactive Bladder Not Responding to Monotherapy
- ClinicalTrials.gov ID
- NCT05911594
- Acronym / sponsor ID
- Rc 14-2-2022
- Conditions
- BOTOX, Percutaneous Tibial Nerve Stimulation
- Keywords
- Overactive Bladder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 14 Feb 2023 (actual)
- Study completion
- 14 Feb 2023 (actual)
- First posted
- 22 Jun 2023 (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.
This study aimed to evaluate the outcome of simultaneous intradetrusor BOTOX (IDB) injection and Percutaneous tibial nerve stimulation (PTNS) for management of children with recurrent wetness since at least 6 months.
Detailed description
Overactive bladder is a syndrome characterized by symptoms of urgency, with or without urgency incontinence, usually with increased daytime frequency and nocturia. The Neurogenic or myogenic bladder dysfunction can lead to the symptoms that characterize Overactive bladder. Normal bladder contraction occurs when the muscarinic receptors in the detrusor muscle are stimulated with acetylcholine. Although the pathogenesis of Overactive bladder is not fully explained; sensitization of afferent nerves, deactivation of inhibitory mechanisms, and the emergence of contractions similar to primitive voiding reflexes are shown as pathogenetic mechanisms. Another hypothesis is that the number of intercellular connections among detrusor myocytes increase, and these cells are spontaneously stimulated.
In addition to the fact that the etiopathogenesis cannot be explained clearly and due to the intense relationship with the autonomic nervous system, undesirable systemic side effects are common in treatments applied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Solifenacin group | Experimental | Drug: Solifenacin groupPatients in this group will receive medical treatment (Solifenacin 5 mg once or twice daily) without any second line of treatment |
| Percutaneous tibial nerve stimulation group | Experimental | Procedure: Percutaneous tibial nerve stimulation groupPatients in this group will receive Percutaneous tibial nerve stimulation after failure of medical therapy |
| Intradetrusor BOTOX group | Experimental | Drug: Intradetrusor BOTOX groupPatients in this group will receive Intradetrusor BOTOX after the failure of medical therapy |
| Intradetrusor BOTOX combined with Percutaneous tibial nerve stimulation group | Experimental | Combination Product: Intradetrusor BOTOX combined with Percutaneous tibial nerve stimulation groupPatients in this group will receive Intradetrusor BOTOX combined with Percutaneous tibial nerve stimulation after the failure of medical therapy |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children with non-neurogenic overactive bladder defined after exclusion of neurogenic causes not responding to medical treatment for 6 months, and
- aged of 7-16 years
- presenting with recurrent night-time with occasional day-time wetness for overactive bladder.
Key exclusion criteria (8 listed)
- recurrent OAB manifestations within less than 6 months after the previous monotherapy
- obstructive urinary tract diseases
- a history of pelvic surgery
- anatomical abnormalities
- neurogenic bladder
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 |
|---|---|---|
| Solifenacin groupPatients in this group will receive medical treatment (Solifenacin 5 mg once or twice daily) without any second line of treatment | Drug | Solifenacin group |
| Percutaneous tibial nerve stimulation groupPatients in this group will receive Percutaneous tibial nerve stimulation after failure of medical therapy | Procedure or surgery | Percutaneous tibial nerve stimulation group |
| Intradetrusor BOTOX groupPatients in this group will receive Intradetrusor BOTOX after failure of medical | Drug | Intradetrusor BOTOX group |
| Intradetrusor BOTOX combined with Percutaneous tibial nerve stimulation groupPatients in this group will receive Intradetrusor BOTOX combined with Percutaneous tibial nerve stimulation after failure of medical | Combination product | Intradetrusor BOTOX combined with Percutaneous tibial nerve stimulation group |
Primary outcome
Overactive bladder symptom score
Time frame: Baseline, 3, 6, 9 and 12 months after the intervention
the Overactive bladder symptom score (OABSS) questionnaire will be calculated which consists of four items; namely, daytime frequency (score: 0-2), night-time frequency (score: 0-3), urgency (score: 0-5), and urgency incontinence (score: 0-5). The results scores were summed and a score of>8 suggesting an overactive bladder
2 secondary outcomes
Patient Perception of Bladder Condition (PPBC) scale
Time frame: Baseline, 3, 6, 9 and 12 months after the intervention
Patients' satisfaction
Time frame: Up to the 12-month follow-up period
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 15 Aug 2023.
- Individual participant dataSharing planned: Yes. The study will be available under a reasonable request from the corresponding author
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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 Solifenacin group, Percutaneous tibial nerve stimulation group and Intradetrusor BOTOX group in people with BOTOX and Percutaneous Tibial Nerve Stimulation, run by Benha University at 1 site in Egypt.
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 3 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: finished, as of the sponsor's last update on 15 Aug 2023. 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 Egypt. 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?
Overactive bladder symptom score (time frame: Baseline, 3, 6, 9 and 12 months after the intervention). 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 15 Aug 2023.