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Poor enrollment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botulinum toxin A alone group | Active Comparator | Just the intradetrusor injection of 100 units of botulinum toxin A alone |
|
| Hydrodistention group | Experimental | Hydrodistention at a pressure of 80 cm H2O for 5 minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrodistention | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| Total Number of Voids | Total number of voids reported in the 3-day bladder diary at 12 weeks as measured in change from baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Birmingham Hospital | Birmingham | Alabama | 35233 | United States |
Although 3 participants completed the study, no analysis done due to study being stopped for poor enrollment.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Hydrodistention Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | No analysis done due to study being stopped for poor enrollment | Posted | 12 weeks |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph Malek | UAB | 2059965466 | jmalek@uabmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 9, 2016 | Aug 14, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| Botulinum toxin-A | Drug | Intradetrusor injection of 100 units of botulinum toxin a |
|
| 12 weeks |
| 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. | 2 weeks |
| Post Void Residual Volume | Post-void residual volume (PVR) at the 2 week follow-up visit measured with catheter or bladder scan. | 2 weeks |
| 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. | 2 weeks |
| 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. | 12 weeks |
| Patient Impression of Improvement | Patient global impression of improvement at 12 weeks as measured using the Patient Global Impression of Improvement Questionnaire (PGI-I). | 12 weeks |
| Patient Satisfaction | Patient satisfaction at 12 weeks as measured using Patient Satisfaction Questionnaire (PSQ). | 12 weeks |
| Quality of Life Measures | Subjective outcome at 24 weeks using the OAB-q | 24 weeks |
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.
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
|
| 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. | No analysis done due to study being stopped for poor enrollment | Posted | 12 weeks |
|
|
| 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. | No analysis done due to study being stopped for poor enrollment | Posted | 12 weeks |
|
|
| 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. | No analysis done due to study being stopped for poor enrollment | Posted | 2 weeks |
|
|
| Secondary | Post Void Residual Volume | Post-void residual volume (PVR) at the 2 week follow-up visit measured with catheter or bladder scan. | No analysis done due to study being stopped for poor enrollment | Posted | 2 weeks |
|
|
| 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. | No analysis done due to study being stopped for poor enrollment | Posted | 2 weeks |
|
|
| 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. | No analysis done due to study being stopped for poor enrollment | Posted | 12 weeks |
|
|
| 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). | No analysis done due to study being stopped for poor enrollment | Posted | 12 weeks |
|
|
| Secondary | Patient Satisfaction | Patient satisfaction at 12 weeks as measured using Patient Satisfaction Questionnaire (PSQ). | No analysis done due to study being stopped for poor enrollment | Posted | 12 weeks |
|
|
| Secondary | Quality of Life Measures | Subjective outcome at 24 weeks using the OAB-q | No analysis done due to study being stopped for poor enrollment | Posted | 24 weeks |
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | 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. | 0 | 2 | 0 | 2 | 0 | 2 |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |