Overactive BladderHydrANCT02995967
Evaluation of Botulinum Toxin A Alone Versus Botulinum Toxin A With Hydrodistension for Treatment of Overactive Bladder
A study testing Hydrodistention and Botulinum toxin-A in people with Overactive Bladder, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Hydrodistention and Botulinum toxin-A
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- Current active sacral neuromodulation device
- Non-English speaking
- History of chronic pelvic pain
- Hematuria not previously evaluated
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama Birmingham Hospital
Birmingham, Alabama, 35233
About this study
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.
- Conditions
- Overactive Bladder
- Being tested
- Hydrodistention, Botulinum toxin-A
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrodistentionProcedure or surgery
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.
Botulinum toxin-ADrug
Intradetrusor injection of 100 units of botulinum toxin a
| Study group | Role | What they receive |
|---|---|---|
| Botulinum toxin A alone group | Active comparator | Just the intradetrusor injection of 100 units of botulinum toxin A alone Receives: Drug: Botulinum toxin-A |
| 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 Receives: Procedure: Hydrodistention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 2 weeks
Post Void Residual Volume
Post-void residual volume (PVR) at the 2 week follow-up visit measured with catheter or bladder scan.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 12 weeks
Patient Satisfaction
Patient satisfaction at 12 weeks as measured using Patient Satisfaction Questionnaire (PSQ).
Measured: 12 weeks
Quality of Life Measures
Subjective outcome at 24 weeks using the OAB-q
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study startNov 2016
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Why it stopped: Poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Malek, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02995967
- Sponsor's protocol ID
- F160629005
- Acronym
- HydrA
- Status last verified
- Feb 2019
- First submitted
- 9 Dec 2016
- Last updated
- 13 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Botulinum Toxin A Alone Versus Botulinum Toxin A With Hydrodistension for Treatment of Overactive Bladder
- ClinicalTrials.gov ID
- NCT02995967
- Acronym / sponsor ID
- HydrA / F160629005
- Conditions
- Overactive Bladder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor enrollment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 19 Dec 2016 (estimated)
- Results
- Posted 12 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botulinum toxin A alone group | Active comparator | Drug: Botulinum toxin-AJust the intradetrusor injection of 100 units of botulinum toxin A alone |
| Hydrodistention group | Experimental | Procedure: HydrodistentionHydrodistention at a pressure of 80 cm H2O for 5 minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydrodistentionThe 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. | Procedure or surgery | Hydrodistention group |
| Botulinum toxin-AIntradetrusor injection of 100 units of botulinum toxin a | Drug | Botulinum toxin A alone group |
Primary outcome
Symptom Bother
Time frame: 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.
9 secondary outcomes
Urge Urinary Incontinence Episodes
Time frame: 12 weeks
Total Number of Voids
Time frame: 12 weeks
Subjects Requiring Clean Intermittent Self-catheterization
Time frame: 2 weeks
Post Void Residual Volume
Time frame: 2 weeks
Rate of UTI
Time frame: 2 weeks
Quality of Life Measures
Time frame: 12 weeks
Patient Impression of Improvement
Time frame: 12 weeks
Patient Satisfaction
Time frame: 12 weeks
Quality of Life Measures
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrodistention and Botulinum toxin-A in people with Overactive Bladder, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom Bother (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2019.