Overactive Bladder
Conditions
Brief summary
The specific aim of this trial is to determine if hydrodistention at the time of intradetrusor injection of botulinum toxin A has additional benefit in patients with refractory overactive bladder (OAB) and urgency symptoms compared to intradetrusor injection of botulinum toxin A alone. Consented patients will be randomized to hydrodistention at a pressure of 80 cm H2O for 5 minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A (hydrodistention group) or intradetrusor injection of 100 units of botulinum toxin A alone (botulinum toxin A alone group). The primary aim will be subjective improvement measured as change from baseline at 12 weeks using the OAB-q bother subscale.
Interventions
PROCEDUREHydrodistention
The hydrodistention will then be performed with the bladder filled at a pressure of 80 cm H2O and noted to be full as evidenced by no further influx of water into the bladder. This volume will be held in the bladder for 5 minutes.
Intradetrusor injection of 100 units of botulinum toxin a
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Women with refractory overactive bladder symptoms, failing a credible behavioral therapy intervention and medical therapy or not tolerating medical therapy. Patients who are on medical therapy will stop the medical therapy for at least 2 weeks prior to botulinum toxin A treatment in the study * Female ≥ 18 years old * Desires further treatment for OAB symptoms. * Express understanding and ability to perform clean intermittent self-catheterization (CISC) if required. * Ability to consent * Ability to complete all study related items and interviews
Exclusion criteria
* Post void residual urine volume \> 150 mL as assessed by catheter or ultrasound * History of intradetrusor botulinum toxin A injection * History of or current cancer of the genitourinary or gynecology tract * Neurogenic bladder * Interstitial cystitis * Current urinary tract infection (can be treated and re-considered for study) * Current active sacral neuromodulation device * Non-English speaking * History of chronic pelvic pain * Hematuria not previously evaluated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptom Bother | 12 weeks | The primary outcome will be measured as change from baseline at 12 weeks using the OAB-q bother subscale which consists of eight questions assessing symptom bother with a possible score from 0 to 100 with a higher score indicating greater symptom bother. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Voids | 12 weeks | Total number of voids reported in the 3-day bladder diary at 12 weeks as measured in change from baseline. |
| Subjects Requiring Clean Intermittent Self-catheterization | 2 weeks | Proportion of subjects requiring clean intermittent self-catheterization (CISC) post-operatively as reported at 2 week post-operative visit. CISC will be initiated at post-void residual volumes of \> 300 mL or \> 150 mL in the presence of bothersome retention symptoms. |
| Post Void Residual Volume | 2 weeks | Post-void residual volume (PVR) at the 2 week follow-up visit measured with catheter or bladder scan. |
| Urge Urinary Incontinence Episodes | 12 weeks | Number of UUI episodes as reported in a 3-day bladder diary at 12 weeks as measured in change from baseline. |
| Quality of Life Measures | 12 weeks | Health related quality of life (HRQL) will be measured as a change from baseline at 12 weeks using the OAB-q HRQL subscale part which consists of 25 questions that assess HRQL addressing coping, concern, sleep, and social interaction where the scoring scale is from 0 to 100 with a higher score indicating a better quality of life. |
| Patient Impression of Improvement | 12 weeks | Patient global impression of improvement at 12 weeks as measured using the Patient Global Impression of Improvement Questionnaire (PGI-I). |
| Patient Satisfaction | 12 weeks | Patient satisfaction at 12 weeks as measured using Patient Satisfaction Questionnaire (PSQ). |
| Rate of UTI | 2 weeks | Rate of urinary tract infection (UTI) as assessed by positive urine culture in patients having symptoms (dysuria, urgency, frequency, temperature ≥ 38 degrees Celcius, and/or suprapubic pain) at the 2 weeks post-operative visit. Subjects who call throughout the study complaining of symptoms but are unable to give a urine culture in clinic will also be treated and reported as having had a UTI. |
Countries
United States
Participant flow
Pre-assignment details
Although 3 participants completed the study, no analysis done due to study being stopped for poor enrollment.
Participants by arm
| Arm | Count |
|---|---|
| Botulinum Toxin A Alone Group Intradetrusor injection of 100 units of botulinum toxin A alone
Botulinum toxin-A: Intradetrusor injection of 100 units of botulinum toxin a | 1 |
| Hydrodistention Group Hydrodistention at a pressure of 80 cm H2O for 5 minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A
Hydrodistention: The hydrodistention will then be performed with the bladder filled at a pressure of 80 cm H2O and noted to be full as evidenced by no further influx of water into the bladder. This volume will be held in the bladder for 5 minutes. | 2 |
| Total | 3 |
Baseline characteristics
| Characteristic | Botulinum Toxin A Alone Group | Hydrodistention Group | Total |
|---|---|---|---|
| Age, Customized age over 50 yrs | 1 Participants | 2 Participants | 3 Participants |
| Age, Customized age uner 50 yrs | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or AlaskaNative | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 2 |
| other Total, other adverse events | 0 / 1 | 0 / 2 |
| serious Total, serious adverse events | 0 / 1 | 0 / 2 |
Outcome results
Primary
Symptom Bother
The primary outcome will be measured as change from baseline at 12 weeks using the OAB-q bother subscale which consists of eight questions assessing symptom bother with a possible score from 0 to 100 with a higher score indicating greater symptom bother.
Time frame: 12 weeks
Population: No analysis done due to study being stopped for poor enrollment
Secondary
Patient Impression of Improvement
Patient global impression of improvement at 12 weeks as measured using the Patient Global Impression of Improvement Questionnaire (PGI-I).
Time frame: 12 weeks
Population: No analysis done due to study being stopped for poor enrollment
Secondary
Patient Satisfaction
Patient satisfaction at 12 weeks as measured using Patient Satisfaction Questionnaire (PSQ).
Time frame: 12 weeks
Population: No analysis done due to study being stopped for poor enrollment
Secondary
Post Void Residual Volume
Post-void residual volume (PVR) at the 2 week follow-up visit measured with catheter or bladder scan.
Time frame: 2 weeks
Population: No analysis done due to study being stopped for poor enrollment
Secondary
Quality of Life Measures
Subjective outcome at 24 weeks using the OAB-q
Time frame: 24 weeks
Population: No analysis done due to study being stopped for poor enrollment
Secondary
Quality of Life Measures
Health related quality of life (HRQL) will be measured as a change from baseline at 12 weeks using the OAB-q HRQL subscale part which consists of 25 questions that assess HRQL addressing coping, concern, sleep, and social interaction where the scoring scale is from 0 to 100 with a higher score indicating a better quality of life.
Time frame: 12 weeks
Population: No analysis done due to study being stopped for poor enrollment
Secondary
Rate of UTI
Rate of urinary tract infection (UTI) as assessed by positive urine culture in patients having symptoms (dysuria, urgency, frequency, temperature ≥ 38 degrees Celcius, and/or suprapubic pain) at the 2 weeks post-operative visit. Subjects who call throughout the study complaining of symptoms but are unable to give a urine culture in clinic will also be treated and reported as having had a UTI.
Time frame: 2 weeks
Population: No analysis done due to study being stopped for poor enrollment
Secondary
Subjects Requiring Clean Intermittent Self-catheterization
Proportion of subjects requiring clean intermittent self-catheterization (CISC) post-operatively as reported at 2 week post-operative visit. CISC will be initiated at post-void residual volumes of \> 300 mL or \> 150 mL in the presence of bothersome retention symptoms.
Time frame: 2 weeks
Population: No analysis done due to study being stopped for poor enrollment
Secondary
Total Number of Voids
Total number of voids reported in the 3-day bladder diary at 12 weeks as measured in change from baseline.
Time frame: 12 weeks
Population: No analysis done due to study being stopped for poor enrollment
Secondary
Urge Urinary Incontinence Episodes
Number of UUI episodes as reported in a 3-day bladder diary at 12 weeks as measured in change from baseline.
Time frame: 12 weeks
Population: No analysis done due to study being stopped for poor enrollment