Overactive Bladder Clinical Trial
— BPH BotoxOfficial title:
Prostate Enucleation With Intravesical Botox Injections in Treating Benign Prostatic Hyperplasia and Bladder Overactivity : A Randomized Controlled Trial
The aim of this study is to evaluate the effect of intravesical Botox injections on lower urinary tract symptoms (LUTS) when administered during Bipolar prostate enucleation surgery in patients with bladder outlet obstruction (BOO) and overactive bladder symptoms (OAB).
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | December 1, 2025 |
Est. primary completion date | November 1, 2025 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 40 Years and older |
Eligibility | Inclusion Criteria: - Males age > 40 - Patients diagnosed with Benign Prostatic Hyperplasia (BPH) and referred for Bipolar enucleation of the prostate ( BipolEP ) surgery - Lower urinary tract symptoms (LUTS) of Overactive Bladder Syndrome (OABS) frequency - urgency - urge incontinence episodes - dysuria - nocturia and eligible for bladder botox injections - International Prostate Symptom Score (IPSS) = 17 - Overactive Bladder Symptom Score (OABSS) = 7 - Participants have failed, are intolerant, or bad candidates for anticholinergic medication treatment for OAB Exclusion Criteria: - History of bladder/prostate cancer - History of pelvic radiotherapy - History of neurological diseases - Presence of active Urinary Tract Infection (UTI) - Previous Bladder Outlet Procedure (Transurethral resection of prostate (TURP) Transurethral Incision of Prostate (TUIP) - UroLift, etc..) - History of adverse reaction to Botox injections - Post-void residual (PVR) greater than 300 ml - History of clean intermittent catheterization - Patients unable to stop anticoagulation of antiplatelet inhibitors 3 days prior to procedure |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Menoufia University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in International Prostate Symptom Score (IPSS) | Comparing the change in IPSS score between the two arms across time | IPSS scores will be recorded before the surgery and at 4 checkpoints after the surgery during every clinical visit: 2 weeks -1 month - 3 months - 6 months postoperatively | |
Primary | Change in Overactive Bladder Symptoms Score (OABSS) | Comparing the change in OABSS score between the two arms across time | OABSS scores will be recorded before the surgery and at 4 checkpoints after the surgery during every clinical visit: 2 weeks -1 month - 3 months - 6 months postoperatively | |
Primary | Change in Maximum Urinary Flow rate | Comparing the change in maximum urinary flow rate(mL/sec) between the two arms across time | Uroflowmetry will be performed before the surgery and at 4 checkpoints after the surgery during every clinical visit: 2 weeks -1 month - 3 months - 6 months postoperatively | |
Primary | Change in Post-Void Residual (PVR) Volume | Comparing the change in postvoid residual volume (mL) between the two arms across time | Postvoid residual volume (mL) will be performed before the surgery and at 4 checkpoints after the surgery during every clinical visit: 2 weeks -1 month - 3 months - 6 months postoperatively | |
Secondary | Adverse events | Any adverse events in the context of readmissions, emergency department visits, and clinical visits will be recorded | Adverse events will be monitored throughout the entire study duration (6 months after the surgery) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04578899 -
"The Effectiveness of Transvertebral Magnetic Neuromodulation in Patients With Detrusor Overactivity"
|
N/A | |
Active, not recruiting |
NCT03556891 -
Pivotal Study of eCoin for Overactive Bladder With Urgency Urinary Incontinence
|
N/A | |
Not yet recruiting |
NCT05977634 -
Transcutaneous Tibial Nerve Stimulation for Idiopathic Overactive Bladder
|
N/A | |
Completed |
NCT01955408 -
Severity of Overactive Bladder Symptoms in Patients After Synergo Treatment
|
N/A | |
Recruiting |
NCT06201013 -
Efficacy and Safety of Vitamin D in the Treatment of OAB-wet in Children
|
N/A | |
Recruiting |
NCT03727711 -
TPTNS: Home vs Hospital Treatment for Overactive Bladder
|
N/A | |
Completed |
NCT00768521 -
A Study to Test the Effects of Tolterodine Tartrate in Patients With Overactive Bladder (0000-107)
|
Phase 1 | |
Completed |
NCT03625843 -
Mindfulness Exercises to Reduce Anxiety and Pain During Urodynamic Testing
|
N/A | |
Completed |
NCT02211846 -
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron OCAS (Oral Controlled Absorption System) in Pediatric Subjects With Neurogenic Detrusor Overactivity or Overactive Bladder
|
Phase 1 | |
Completed |
NCT02835846 -
Investigation of the Effect of the Female Urinary Microbiome on Incontinence
|
Phase 4 | |
Completed |
NCT02857816 -
PRospective Study to Evaluate EffectivenesS With the NURO™ PErcutaneous Tibial Neuromodulation System in Patients With OAB
|
N/A | |
Completed |
NCT02202031 -
Controlling Urgency Through Relaxation Exercises
|
N/A | |
Withdrawn |
NCT02320201 -
Foot Neuromodulation for Overactive Bladder in Children
|
N/A | |
Completed |
NCT01458197 -
A Phase 2 Study to Compare the Efficacy and Tolerability of Tarafenacin 0.2 mg and Tarafenacin 0.4 mg to Placebo in Patients Suffering From Overactive Bladder.
|
Phase 2 | |
Not yet recruiting |
NCT01409512 -
Evaluation of Autonomic System Before and After Anticholinergic Treatment in Women With Overactive Bladder
|
N/A | |
Completed |
NCT01437670 -
Observational Study to Estimate the Dry Mouth in OAB Patients With Solifenacin
|
N/A | |
Not yet recruiting |
NCT01423838 -
Comparison of Solifenacin and Oxybutynin in the Treatment of Overactive Bladder
|
Phase 4 | |
Terminated |
NCT01758848 -
Physical Therapy for Overactive Bladder
|
N/A | |
Withdrawn |
NCT01210859 -
Effects of Antimuscarinic Drugs on Overactive Bladder (OAB) Symptoms After Insertion of Ureteral Stents
|
N/A | |
Completed |
NCT01122563 -
A Study to Evaluate Response of Overactive Bladder Symptom Score (OABSS) to Treatment
|
N/A |