Overactive Bladder SyndromePhase 4SBD-BOT-OABNCT06796855
Comparing Treatments for Refractory Overactive Bladder: Bladder Denervation vs Botulinum Toxin Injections
A Phase 4 study testing Selective Bladder Denervation via Radiofrequency Ablation and Intravesical Onabotulinum Toxin A Injection in people with Overactive Bladder Syndrome and Refractory Overactive Bladder, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to compare the effectiveness and safety of two treatments for refractory overactive bladder in adult women. The main questions it aims to answer are: Does selective bladder denervation using radiofrequency ablation improve overactive bladder symptoms more effectively than… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overactive Bladder Syndrome, Refractory Overactive Bladder
- What is being tested?
- Selective Bladder Denervation via Radiofrequency Ablation and Intravesical Onabotulinum Toxin A Injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2023to 1 Feb 2024
- Phase
- Phase 4
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biological females aged 18 years or older.
- Diagnosis of refractory overactive bladder syndrome, defined as:
- Persistent symptoms despite having completed behavioral therapy and at least two different oral pharmacotherapies (e.g., anticholinergics or beta-3 adrenergic agonists) for a minimum of 3 months each; or
- Inability to tolerate oral pharmacotherapy for overactive bladder syndrome. Willingness and ability to provide written informed consent. Ability to comply with the study protocol, including attendance at scheduled follow-up visits and completion of validated symptom assessment questionnaires (e.g., Overactive Bladder Symptom Score - OAB-V8, International Consultation on Incontinence Questionnaire - Female Lower Urinary Tract Symptoms - ICIQ-FLUTS).
Who cannot join
- Pregnancy or intention to become pregnant within 12 months of enrollment. History of stress urinary incontinence as the predominant symptom.
- Recent interventions prior to enrollment:
- Oral medication for overactive bladder within the past 2 weeks.
- Intravesical Onabotulinum toxin A injection within the past 9 months.
- Pelvic electrical stimulation within the past 2 weeks. Active or chronic urinary tract infection or a history of urinary retention within the past 6 months.
- Active hematuria or known bleeding disorders.
Show all 14Show fewer
- History or current diagnosis of:
- Bladder cancer or ongoing bladder cancer treatment.
- Bladder outlet obstruction, ureteral dysfunction, ureteral stricture, or vesicoureteral reflux.
- Elevated serum creatinine level (≥2 times the upper limit of normal) within the past 6 months.
- Neurological conditions affecting bladder function, including but not limited to:
- Multiple sclerosis.
- Myasthenia gravis.
- Spinal cord injury or disease. Any condition deemed by the investigator to interfere with study participation or accurate evaluation of outcomes.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences, Istanbul Bagcilar Hospital
Istanbul, 34200
About this study
Official title: Selective Bladder Denervation vs Intramuscular Onabotulinum Toxin A for Refractory Overactive Bladder: A Randomized Comparative Study
The goal of this clinical trial is to compare the effectiveness and safety of two treatments for refractory overactive bladder in adult women.
The main questions it aims to answer are:
Read more
- Does selective bladder denervation using radiofrequency ablation improve overactive bladder symptoms more effectively than intravesical Onabotulinum toxin A injections?
- What are the safety profiles of each treatment?
Researchers will compare selective bladder denervation using radiofrequency ablation to intravesical Onabotulinum toxin A injections to determine which treatment is more effective and tolerable for patients whose symptoms persist despite behavioral and medical therapies.
Participants will:
- Be women aged 18 and older diagnosed with overactive bladder who did not benefit from at least two prior medical treatments for 3 months or were unable to tolerate those treatments.
- Be randomly assigned to receive either radiofrequency ablation or Onabotulinum toxin A treatment.
- Attend follow-up visits at weeks 2, 4, and 12 over a 3-month period, during which symptom improvement will be assessed using validated questionnaires and side effects will be monitored through imaging, blood, and urine tests.
Read the detailed description
This randomized clinical trial aims to evaluate the effectiveness and safety of two third-line treatment options for women with refractory overactive bladder syndrome: selective bladder denervation using radiofrequency ablation and intravesical Onabotulinum toxin A injection.
The study includes 60 symptomatic female patients aged 18 years and older who met the eligibility criteria and had either failed to achieve adequate symptom control with at least two different oral pharmacological treatments or were unable to tolerate such therapies. Participants were randomly assigned into two equal groups, with 30 patients in each group, using the "Research Randomizer" tool.
Participant Assessments:
At the initial assessment, all participants underwent the following evaluations:
- A detailed medical history, including past surgeries and prior medication use.
- Urinary tests, including urinalysis and urine culture, as well as blood biochemical evaluations.
- Imaging with urinary system ultrasonography to evaluate both the upper and lower urinary tract and measure post-void residual urine volume.
- Symptom assessment using the following validated patient-reported outcome questionnaires:
International Consultation on Incontinence Questionnaire - Female Lower Urinary Tract Symptoms (ICIQ-FLUTS).
Overactive Bladder Symptom Score Questionnaire (OAB-V8). Incontinence Quality of Life Questionnaire (I-QOL).
Additionally, participants were asked to maintain a three-day bladder diary to document:
- The number of daily urinations.
- Episodes of waking up at night to urinate (nocturia).
- Urgency episodes.
- Instances of urge urinary incontinence.
Treatment Groups:
- Selective Bladder Denervation with Radiofrequency Ablation: This procedure was performed under general anesthesia using the Apro Korea AK-F200 radiofrequency system, which operates with temperature and impedance control along with a cooling mechanism. Radiofrequency energy was applied to four specific submucosal points in the bladder's trigone region. The target tissue temperature was 100 degrees Celsius, with energy delivery set to 25 watts for 60 seconds at each point. Post-procedure imaging and post-void residual urine measurements were performed to ensure patient safety.
- Intravesical Onabotulinum Toxin A Injection:
This treatment was administered under local anesthesia using a rigid cystoscope.
A total dose of 100 units of Onabotulinum toxin A was injected into ten separate points across the bladder wall.
Follow-Up Protocol:
Patients were scheduled for follow-up visits at 2, 4, and 12 weeks after the intervention. At each visit, the following evaluations were conducted:
- Ultrasonographic imaging of the urinary system to assess for any upper tract dilation (hydronephrosis) and to measure post-void residual urine volume.
- Laboratory assessments, including urinalysis and serum creatinine level evaluation.
- Reassessment of urinary symptoms through a repeat three-day bladder diary and completion of the same validated patient-reported outcome questionnaires.
Study Objective:
This clinical trial aims to compare the two treatment modalities concerning their effectiveness in relieving symptoms of overactive bladder, improving patients' quality of life, and assessing their safety profiles. The results of this study are expected to provide valuable insights into the optimal third-line treatment approach for patients with refractory overactive bladder who have not responded to conventional behavioral and pharmacological therapies.
- Being tested
- Selective Bladder Denervation via Radiofrequency Ablation, Intravesical Onabotulinum Toxin A Injection
- Keywords
- Onabotulinum Toxin A, Selective Bladder Denervation, RF Ablation, Overactive Bladder, Intravesical Botox
- 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.
Selective Bladder Denervation via Radiofrequency AblationDevice
Participants in this arm will undergo a single session of selective bladder denervation using radiofrequency ablation (RFA). The procedure is performed under general anesthesia using the Apro Korea AK-F200 system, which delivers radiofrequency energy at four submucosal points in the bladder trigone area. The energy is applied at 25 watts per site for 60 seconds, targeting nerve pathways involved in overactive bladder symptoms. The procedure is conducted using a 19 Fr. rigid cystoscope in lithotomy position, ensuring precise electrode placement. Patients are discharged on postoperative day 1 following urinary ultrasound and post-void residual (PVR) assessment. Follow-up visits are scheduled at 2, 4, and 12 weeks to evaluate symptom improvement and safety.
Intravesical Onabotulinum Toxin A InjectionDrug
Participants in this arm will receive a single dose of 100 units of Onabotulinum Toxin A injected into 10 sites on the bladder wall using a 4mm injection needle and 19 Fr. rigid cystoscope. The injection is administered under local anesthesia in an outpatient setting. The Onabotulinum Toxin A is diluted in sterile saline and delivered into the detrusor muscle, aiming to reduce detrusor overactivity and urgency symptoms. Patients undergo urinary ultrasound and post-void residual volume (PVR) assessment on postoperative day 1 before discharge. No additional doses are administered, and follow-up visits are scheduled at 2, 4, and 12 weeks to evaluate symptom improvement and safety.
| Study group | Role | What they receive |
|---|---|---|
| Selective Bladder Denervation via Radiofrequency Ablation | Experimental | Participants in this arm will undergo selective bladder denervation using a radiofrequency ablation procedure. This minimally invasive treatment involves applying controlled radiofrequency energy at four submucosal points in the bladder trigone area under general anesthesia. The procedure aims to reduce nerve overactivity and improve symptoms of refractory overactive bladder. Follow-up assessments will evaluate symptom improvement, safety, and quality of life over a 3-month period. Receives: Device: Selective Bladder Denervation via Radiofrequency Ablation |
| Intravesical Onabotulinum Toxin A Injection | Active comparator | Participants in this arm will receive intravesical injections of Onabotulinum toxin A. A total of 100 units will be injected into 10 sites on the bladder wall under local anesthesia. This intervention is an established third-line treatment for refractory overactive bladder, aimed at reducing bladder overactivity. Symptom improvement, safety, and quality of life will be assessed during follow-up visits over a 3-month period. Receives: Drug: Intravesical Onabotulinum Toxin A Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Overactive Bladder Assessment Tool (OAB-V8) Total Score at 12 Weeks
The Overactive Bladder Assessment Tool (OAB-V8) is an 8-item validated questionnaire used to assess the severity of overactive bladder (OAB) symptoms, including urinary urgency, frequency, nocturia, and urge urinary incontinence.
Each item is rated on a 6-point Likert scale from 0 (not at all) to 5 (a very severe problem), resulting in a total score ranging from 0 to 40, with higher scores indicating greater symptom severity.
The primary outcome of this study is the change from baseline in OAB-V8 total score at 12 weeks. A clinically significant response is defined as a ≥50% reduction in total OAB-V8 score compared to baseline.
Measured: From baseline to 12 weeks post-treatment
Secondary outcomes (4)
Change from Baseline in International Consultation on Incontinence Questionnaire - Female Lower Urinary Tract Symptoms (ICQ-FLUTS) Score at 12 Weeks
The International Consultation on Incontinence Questionnaire - Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) is a validated tool used to assess lower urinary tract symptoms and their impact on quality of life in female patients. It consists of three domains:
Filling symptoms (e.g., urgency, frequency) Voiding symptoms (e.g., hesitancy, weak stream) Incontinence symptoms (e.g., stress or urgency incontinence)
Each item is scored on a 4-point Likert scale (0 to 3), with higher scores indicating greater symptom severity. The total score ranges from 0 to 48.
The secondary outcome is the change in ICIQ-FLUTS total score from baseline to 12 weeks. Improvement is defined as a reduction of 30% or more in the total score.
Measured: From baseline to 12 weeks post-treatment
Change from Baseline in Incontinence Quality of Life (I-QOL) Score at 12 Weeks
The Incontinence Quality of Life (I-QOL) questionnaire is a 26-item validated tool assessing the impact of urinary incontinence on daily activities, emotional well-being, and social interactions.
Each item is rated on a 5-point Likert scale (1 = extremely, 5 = not at all). The total score ranges from 0 to 100, with higher scores indicating better quality of life.
The secondary outcome is the change in I-QOL score from baseline to 12 weeks. A clinically significant improvement is defined as an increase of 10 points or more.
Measured: From baseline to 12 weeks post-treatment
Change from Baseline in Urgency and Urgency Urinary Incontinence (UUI) Episodes at 12 Weeks
The number of urgency episodes and urgency incontinence episodes per 24-hour period will be recorded using a patient-reported bladder diary.
A clinically significant improvement is defined as a ≥50% reduction in urgency or urge urinary incontinence episodes from baseline.
Measured: From baseline to 12 weeks post-treatment
Incidence of Treatment-Related Adverse Events at 12 Weeks
The incidence and severity of treatment-related adverse events (AEs) will be documented at each follow-up visit. AEs will be classified according to Common Terminology Criteria for Adverse Events (CTCAE v5.0) and may include:
Urinary retention Hematuria (gross or microscopic) Dysuria or pain during urination Pelvic pain or discomfort Hydronephrosis
Measured: From baseline to 12 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start1 Feb 2023
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Overactive Bladder SyndromeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a parallel design, where participants are randomly assigned to one of two groups for the duration of the study. The two groups are: The Selective Bladder Denervation group, which undergoes treatment with radiofrequency ablation (RFA). The Intravesical Onabotulinum Toxin A group, which receives onabotulinum toxin A injections into the bladder wall. Each group receives its respective intervention without crossover between treatments. Randomization was performed using the "Research Randomizer" tool to ensure an unbiased allocation of participants.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bagcilar Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Muhammet M Dinçer, MD, Study director, University of Health Sciences, Istanbul Bagcilar Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06796855
- Sponsor's protocol ID
- Bagcilar Training and Research
- Acronym
- SBD-BOT-OAB
- Status last verified
- Dec 2024
- First submitted
- 22 Jan 2025
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Baseline demographic data. Outcome measures (e.g., Overactive Bladder Symptom Score (OAB-V8), International Consultation on Incontinence Questionnaire - Female Lower Urinary Tract Symptoms (ICQ-FLUTS), Incontinence Quality of Life Scale (I-QOL), and Post-Void Residual (PVR) urine volume values). Adverse event data.
Publications
Rovner ES, Versi E, Le Mai T, Dmochowski RR, De Wachter S. One-year results with selective bladder denervation in women with refractory overactive bladder. Neurourol Urodyn. 2019 Nov;38(8):2178-2184. doi: 10.1002/nau.24110. Epub 2019 Jul 29.
PubMed 31359508Fugett J 2nd, Phillips L, Tobin E, Whitbrook E, Bennett H, Shrout J, Coad JE. Selective bladder denervation for overactive bladder (OAB) syndrome: From concept to healing outcomes using the ovine model. Neurourol Urodyn. 2018 Sep;37(7):2097-2105. doi: 10.1002/nau.23560. Epub 2018 Mar 31.
PubMed 29603776Tu LM, De Wachter S, Robert M, Dmochowski RR, Miller LE, Everaert K. Initial clinical experience with selective bladder denervation for refractory overactive bladder. Neurourol Urodyn. 2019 Feb;38(2):644-652. doi: 10.1002/nau.23881. Epub 2018 Nov 29.
PubMed 30499155
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Bladder Denervation vs Intramuscular Onabotulinum Toxin A for Refractory Overactive Bladder: A Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT06796855
- Acronym / sponsor ID
- SBD-BOT-OAB / Bagcilar Training and Research
- Keywords
- Onabotulinum Toxin A, Selective Bladder Denervation, RF Ablation, Overactive Bladder, Intravesical Botox
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bagcilar Training and Research HospitalOther government
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 28 Jan 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.
The goal of this clinical trial is to compare the effectiveness and safety of two treatments for refractory overactive bladder in adult women.
The main questions it aims to answer are:
- Does selective bladder denervation using radiofrequency ablation improve overactive bladder symptoms more effectively than intravesical Onabotulinum toxin A injections?
- What are the safety profiles of each treatment?
Researchers will compare selective bladder denervation using radiofrequency ablation to intravesical Onabotulinum toxin A injections to determine which treatment is more effective and tolerable for patients whose symptoms persist despite behavioral and medical therapies.
Participants will:
- Be women aged 18 and older diagnosed with overactive bladder who did not benefit from at least two prior medical treatments for 3 months or were unable to tolerate those treatments.
- Be randomly assigned to receive either radiofrequency ablation or Onabotulinum toxin A treatment.
- Attend follow-up visits at weeks 2, 4, and 12 over a 3-month period, during which symptom improvement will be assessed using validated questionnaires and side effects will be monitored through imaging, blood, and urine tests.
Detailed description
This randomized clinical trial aims to evaluate the effectiveness and safety of two third-line treatment options for women with refractory overactive bladder syndrome: selective bladder denervation using radiofrequency ablation and intravesical Onabotulinum toxin A injection.
The study includes 60 symptomatic female patients aged 18 years and older who met the eligibility criteria and had either failed to achieve adequate symptom control with at least two different oral pharmacological treatments or were unable to tolerate such therapies. Participants were randomly assigned into two equal groups, with 30 patients in each group, using the "Research Randomizer" tool.
Participant Assessments:
At the initial assessment, all participants underwent the following evaluations:
- A detailed medical history, including past surgeries and prior medication use.
- Urinary tests, including urinalysis and urine culture, as well as blood biochemical evaluations.
- Imaging with urinary system ultrasonography to evaluate both the upper and lower urinary tract and measure post-void residual urine volume.
- Symptom assessment using the following validated patient-reported outcome questionnaires:
International Consultation on Incontinence Questionnaire - Female Lower Urinary Tract Symptoms (ICIQ-FLUTS).
Overactive Bladder Symptom Score Questionnaire (OAB-V8). Incontinence Quality of Life Questionnaire (I-QOL).
Additionally, participants were asked to maintain a three-day bladder diary to document:
- The number of daily urinations.
- Episodes of waking up at night to urinate (nocturia).
- Urgency episodes.
- Instances of urge urinary incontinence.
Treatment Groups:
- Selective Bladder Denervation with Radiofrequency Ablation: This procedure was performed under general anesthesia using the Apro Korea AK-F200 radiofrequency system, which operates with temperature and impedance control along with a cooling mechanism. Radiofrequency energy was applied to four specific submucosal points in the bladder's trigone region. The target tissue temperature was 100 degrees Celsius, with energy delivery set to 25 watts for 60 seconds at each point. Post-procedure imaging and post-void residual urine measurements were performed to ensure patient safety.
- Intravesical Onabotulinum Toxin A Injection:
This treatment was administered under local anesthesia using a rigid cystoscope.
A total dose of 100 units of Onabotulinum toxin A was injected into ten separate points across the bladder wall.
Follow-Up Protocol:
Patients were scheduled for follow-up visits at 2, 4, and 12 weeks after the intervention. At each visit, the following evaluations were conducted:
- Ultrasonographic imaging of the urinary system to assess for any upper tract dilation (hydronephrosis) and to measure post-void residual urine volume.
- Laboratory assessments, including urinalysis and serum creatinine level evaluation.
- Reassessment of urinary symptoms through a repeat three-day bladder diary and completion of the same validated patient-reported outcome questionnaires.
Study Objective:
This clinical trial aims to compare the two treatment modalities concerning their effectiveness in relieving symptoms of overactive bladder, improving patients' quality of life, and assessing their safety profiles. The results of this study are expected to provide valuable insights into the optimal third-line treatment approach for patients with refractory overactive bladder who have not responded to conventional behavioral and pharmacological therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study uses a parallel design, where participants are randomly assigned to one of two groups for the duration of the study. The two groups are: The Selective Bladder Denervation group, which undergoes treatment with radiofrequency ablation (RFA). The Intravesical Onabotulinum Toxin A group, which receives onabotulinum toxin A injections into the bladder wall. Each group receives its respective intervention without crossover between treatments. Randomization was performed using the "Research Randomizer" tool to ensure an unbiased allocation of participants.
| Arm | Type | Receives |
|---|---|---|
| Selective Bladder Denervation via Radiofrequency Ablation | Experimental | Device: Selective Bladder Denervation via Radiofrequency AblationParticipants in this arm will undergo selective bladder denervation using a radiofrequency ablation procedure. This minimally invasive treatment involves applying controlled radiofrequency energy at four submucosal points in the bladder trigone area under general anesthesia. The procedure aims to reduce nerve overactivity and improve symptoms of refractory overactive bladder. Follow-up assessments will evaluate symptom improvement, safety, and quality of life over a 3-month period. |
| Intravesical Onabotulinum Toxin A Injection | Active comparator | Drug: Intravesical Onabotulinum Toxin A InjectionParticipants in this arm will receive intravesical injections of Onabotulinum toxin A. A total of 100 units will be injected into 10 sites on the bladder wall under local anesthesia. This intervention is an established third-line treatment for refractory overactive bladder, aimed at reducing bladder overactivity. Symptom improvement, safety, and quality of life will be assessed during follow-up visits over a 3-month period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Biological females aged 18 years or older.
- Persistent symptoms despite having completed behavioral therapy and at least two different oral pharmacotherapies (e.g., anticholinergics or beta-3 adrenergic agonists) for a minimum of 3 months each; or
- Inability to tolerate oral pharmacotherapy for overactive bladder syndrome. Willingness and ability to provide written informed consent. Ability to comply with the study protocol, including attendance at scheduled follow-up visits and completion of validated symptom assessment questionnaires (e.g., Overactive Bladder Symptom Score - OAB-V8, International Consultation on Incontinence Questionnaire - Female Lower Urinary Tract Symptoms - ICIQ-FLUTS).
Key exclusion criteria (14 listed)
- Pregnancy or intention to become pregnant within 12 months of enrollment. History of stress urinary incontinence as the predominant symptom.
- Oral medication for overactive bladder within the past 2 weeks.
- Intravesical Onabotulinum toxin A injection within the past 9 months.
- Pelvic electrical stimulation within the past 2 weeks. Active or chronic urinary tract infection or a history of urinary retention within the past 6 months.
- Active hematuria or known bleeding disorders.
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 |
|---|---|---|
| Selective Bladder Denervation via Radiofrequency AblationParticipants in this arm will undergo a single session of selective bladder denervation using radiofrequency ablation (RFA). The procedure is performed under general anesthesia using the Apro Korea AK-F200 system, which delivers radiofrequency energy at four submucosal points in the bladder trigone area. The energy is applied at 25 watts per site for 60 seconds, targeting nerve pathways involved in overactive bladder symptoms. The procedure is conducted using a 19 Fr. rigid cystoscope in lithotomy position, ensuring precise electrode placement. Patients are discharged on postoperative day 1 following urinary ultrasound and post-void residual (PVR) assessment. Follow-up visits are scheduled at 2, 4, and 12 weeks to evaluate symptom improvement and safety. | Device | Selective Bladder Denervation via Radiofrequency Ablation |
| Intravesical Onabotulinum Toxin A InjectionParticipants in this arm will receive a single dose of 100 units of Onabotulinum Toxin A injected into 10 sites on the bladder wall using a 4mm injection needle and 19 Fr. rigid cystoscope. The injection is administered under local anesthesia in an outpatient setting. The Onabotulinum Toxin A is diluted in sterile saline and delivered into the detrusor muscle, aiming to reduce detrusor overactivity and urgency symptoms. Patients undergo urinary ultrasound and post-void residual volume (PVR) assessment on postoperative day 1 before discharge. No additional doses are administered, and follow-up visits are scheduled at 2, 4, and 12 weeks to evaluate symptom improvement and safety. | Drug | Intravesical Onabotulinum Toxin A Injection |
Primary outcome
Change from Baseline in Overactive Bladder Assessment Tool (OAB-V8) Total Score at 12 Weeks
Time frame: From baseline to 12 weeks post-treatment
The Overactive Bladder Assessment Tool (OAB-V8) is an 8-item validated questionnaire used to assess the severity of overactive bladder (OAB) symptoms, including urinary urgency, frequency, nocturia, and urge urinary incontinence. Each item is rated on a 6-point Likert scale from 0 (not at all) to 5 (a very severe problem), resulting in a total score ranging from 0 to 40, with higher scores indicating greater symptom severity. The primary outcome of this study is the change from baseline in OAB-V8 total score at 12 weeks. A clinically significant response is defined as a ≥50% reduction in total OAB-V8 score compared to baseline.
4 secondary outcomes
Change from Baseline in International Consultation on Incontinence Questionnaire - Female Lower Urinary Tract Symptoms (ICQ-FLUTS) Score at 12 Weeks
Time frame: From baseline to 12 weeks post-treatment
Change from Baseline in Incontinence Quality of Life (I-QOL) Score at 12 Weeks
Time frame: From baseline to 12 weeks post-treatment
Change from Baseline in Urgency and Urgency Urinary Incontinence (UUI) Episodes at 12 Weeks
Time frame: From baseline to 12 weeks post-treatment
Incidence of Treatment-Related Adverse Events at 12 Weeks
Time frame: From baseline to 12 weeks post-treatment
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 19 Feb 2025.
- Background: PubMed 31359508Rovner ES, Versi E, Le Mai T, Dmochowski RR, De Wachter S. One-year results with selective bladder denervation in women with refractory overactive bladder. Neurourol Urodyn. 2019 Nov;38(8):2178-2184. doi: 10.1002/nau.24110. Epub 2019 Jul 29.
- Background: PubMed 29603776Fugett J 2nd, Phillips L, Tobin E, Whitbrook E, Bennett H, Shrout J, Coad JE. Selective bladder denervation for overactive bladder (OAB) syndrome: From concept to healing outcomes using the ovine model. Neurourol Urodyn. 2018 Sep;37(7):2097-2105. doi: 10.1002/nau.23560. Epub 2018 Mar 31.
- Background: PubMed 30499155Tu LM, De Wachter S, Robert M, Dmochowski RR, Miller LE, Everaert K. Initial clinical experience with selective bladder denervation for refractory overactive bladder. Neurourol Urodyn. 2019 Feb;38(2):644-652. doi: 10.1002/nau.23881. Epub 2018 Nov 29.
- Individual participant dataSharing planned: Yes. Baseline demographic data. Outcome measures (e.g., Overactive Bladder Symptom Score (OAB-V8), International Consultation on Incontinence Questionnaire - Female Lower Urinary Tract Symptoms (ICQ-FLUTS), Incontinence Quality of Life Scale (I-QOL), and Post-Void Residual (PVR) urine volume values). Adverse event data.
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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.
Muhammet M Dinçer, MD study director
University of Health Sciences, Istanbul Bagcilar Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Selective Bladder Denervation via Radiofrequency Ablation and Intravesical Onabotulinum Toxin A Injection in people with Overactive Bladder Syndrome and Refractory Overactive Bladder, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
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 19 Feb 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 Turkey (Türkiye). 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change from Baseline in Overactive Bladder Assessment Tool (OAB-V8) Total Score at 12 Weeks (time frame: From baseline to 12 weeks post-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 NCT06796855, which also lists 3 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 19 Feb 2025.