Overactive Bladder Clinical Trial
Official title:
Minimizing Pain During Office Intradetrussor Botox Injection: A Prospective Randomized Controlled Trial Comparing Two Protocols
Verified date | July 2023 |
Source | Boston Urogynecology Associates |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This will be a prospective double-blinded randomized controlled trial comparing two pre-treatment protocols for patients undergoing intradetrussor botox injections to determine if a buffered lidocaine solution offers superior pain control.
Status | Completed |
Enrollment | 72 |
Est. completion date | June 30, 2023 |
Est. primary completion date | June 30, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Female patient - Primary diagnosis of overactive bladder - Failed first and second line therapy for overactive bladder - Planning to undergo bladder botox injections Exclusion Criteria: - Neurogenic bladder - Urinary retention |
Country | Name | City | State |
---|---|---|---|
United States | Boston Urogynecology Associates | Cambridge | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston Urogynecology Associates |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain: VAS | Pain on VAS | Immediately after the procedure | |
Secondary | Satisfaction: Likert scale | Likert scale questions assessing overall satisfaction with the procedure with responses from very dissatisfied to very satisfied | Immediately after the procedure | |
Secondary | Willingness to undergo repeat procedure | Likert scale questions assessing the patient's willingness to undergo a repeat procedure from very likely to very unlikely | Immediately after the procedure | |
Secondary | Adverse events | Urinary retention, defined as a post-void residual of greater than 100cc, will be assessed with a bladder scan at the two week post-procedure appointment | Immediately after the procedure, 2 weeks post treatment | |
Secondary | Pelvic Floor Distress Inventory (PFDI-20) Scores | baseline Pelvic Floor Distress Inventory (PFDI-20), scores range from 0-300 with higher scores representing higher symptom burden | Baseline, pre-procedure |
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 | |
Not yet recruiting |
NCT01423838 -
Comparison of Solifenacin and Oxybutynin in the Treatment of Overactive Bladder
|
Phase 4 | |
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 | |
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 | |
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 |
NCT01122550 -
Reproducibility Study of Overactive Bladder Symptom Score [OABSS]
|
N/A |