Back to resultsEvaluation of Botulinum Toxin A Alone Versus Botulinum Toxin A With Hydrodistension for Treatment of Overactive Bladder (HydrA)
Primary Purpose
Overactive Bladder
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hydrodistention
Botulinum toxin-A
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder
Eligibility Criteria
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
Sites / Locations
- University of Alabama Birmingham Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Botulinum toxin A alone group
Hydrodistention group
Arm Description
Just the intradetrusor injection of 100 units of botulinum toxin A alone
Hydrodistention at a pressure of 80 cm H2O for 5 minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Total Number of Voids
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
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
Post-void residual volume (PVR) at the 2 week follow-up visit measured with catheter or bladder scan.
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.
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.
Patient Impression of Improvement
Patient global impression of improvement at 12 weeks as measured using the Patient Global Impression of Improvement Questionnaire (PGI-I).
Patient Satisfaction
Patient satisfaction at 12 weeks as measured using Patient Satisfaction Questionnaire (PSQ).
Quality of Life Measures
Subjective outcome at 24 weeks using the OAB-q
Full Information
NCT ID
NCT02995967
First Posted
December 9, 2016
Last Updated
February 15, 2019
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT02995967
Brief Title
Evaluation of Botulinum Toxin A Alone Versus Botulinum Toxin A With Hydrodistension for Treatment of Overactive Bladder
Acronym
HydrA
Official Title
Evaluation of Botulinum Toxin A Alone Versus Botulinum Toxin A With Hydrodistension for Treatment of Overactive Bladder
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
Poor enrollment
Study Start Date
November 2016 (undefined)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Botulinum toxin A alone group
Arm Type
Active Comparator
Arm Description
Just the intradetrusor injection of 100 units of botulinum toxin A alone
Arm Title
Hydrodistention group
Arm Type
Experimental
Arm Description
Hydrodistention at a pressure of 80 cm H2O for 5 minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A
Intervention Type
Procedure
Intervention Name(s)
Hydrodistention
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin-A
Intervention Description
Intradetrusor injection of 100 units of botulinum toxin a
Primary Outcome Measure Information:
Title
Symptom Bother
Description
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
Secondary Outcome Measure Information:
Title
Urge Urinary Incontinence Episodes
Description
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
Title
Total Number of Voids
Description
Total number of voids reported in the 3-day bladder diary at 12 weeks as measured in change from baseline.
Time Frame
12 weeks
Title
Subjects Requiring Clean Intermittent Self-catheterization
Description
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
Title
Post Void Residual Volume
Description
Post-void residual volume (PVR) at the 2 week follow-up visit measured with catheter or bladder scan.
Time Frame
2 weeks
Title
Rate of UTI
Description
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
Title
Quality of Life Measures
Description
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
Title
Patient Impression of Improvement
Description
Patient global impression of improvement at 12 weeks as measured using the Patient Global Impression of Improvement Questionnaire (PGI-I).
Time Frame
12 weeks
Title
Patient Satisfaction
Description
Patient satisfaction at 12 weeks as measured using Patient Satisfaction Questionnaire (PSQ).
Time Frame
12 weeks
Title
Quality of Life Measures
Description
Subjective outcome at 24 weeks using the OAB-q
Time Frame
24 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University of Alabama Birmingham Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Botulinum Toxin A Alone Versus Botulinum Toxin A With Hydrodistension for Treatment of Overactive Bladder
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