Overactive BladderPhase 4ROBINNCT02600715
Reduction of Bladder Injection Pain With Belladonna Opiate Suppository
A Phase 4 study testing Onabotulinumtoxin A (BoNT), belladonna and Morphine in people with Overactive Bladder and Urinary Urge Incontinence, run by Edgar LeClaire, MD at 2 sites in United States.
Trial summary
The purpose of this study is to test whether using belladonna \& opiate suppositories (B\&Os) can improve patient discomfort during Onabotulinumtoxin A (BoNT) injection into the bladder for treatment of overactive bladder, neurogenic detrusor overactivity, or interstitial cystitis. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overactive Bladder, Urinary Urge Incontinence, Urinary Bladder, Neurogenic
- What is being tested?
- Onabotulinumtoxin A (BoNT), belladonna and Morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2015to 26 Jun 2017
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Met clinical criteria under outside care or during the Principal Investigator's routine standard of care for BoNT injection therapy
- No contraindication to BoNT therapy as outlined by drug manufacturer guidelines
- Participants have elected to have the BoNT injection therapy prior to being offered enrollment into the study for either overactive bladder (OAB), neurogenic detrusor overactivity (NDO), or refractory interstitial cystitis (IC)
Who cannot join
- Currently pregnant
- Currently nursing a baby
- Anticipated geographic relocation within the first 3 months following treatment
- Allergy to morphine, belladonna, or opiates
- Patients will be excluded if participating in another research study
- Individuals unable to provide informed consent or to complete two-week follow-up bladder testing (post-void residual) or data collection will also be excluded
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Wichita Women's Pelvic Surgery Center at Associates in Women's Health
Wichita, Kansas, 67208
University of Kansas School of Medicine - Wichita
Wichita, Kansas, 67214
About this study
Official title: Reduction of Bladder Injection Pain With Belladonna Opiate Suppository: A Randomized, Double-Blind, Placebo-Controlled Trial (ROBIN Trial)
The purpose of this study is to test whether using belladonna \& opiate suppositories (B\&Os) can improve patient discomfort during Onabotulinumtoxin A (BoNT) injection into the bladder for treatment of overactive bladder, neurogenic detrusor overactivity, or interstitial cystitis.
- Conditions
- Overactive Bladder, Urinary Urge Incontinence, Urinary Bladder, Neurogenic, Painful Bladder Syndrome
- Being tested
- Onabotulinumtoxin A (BoNT), belladonna, Morphine, Placebo, Active B&O suppository of belladonna
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Urge, Urinary Bladder, Neurogenic, Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Onabotulinumtoxin A (BoNT)Drug
Also called Botox, Allergan
belladonnaDrug
Part of dosage of the compounded active B\&O suppository of belladonna 16.2mg and morphine 7.5mg.
MorphineDrug
Part of dosage of the compounded active B\&O suppository of belladonna 16.2mg and morphine 7.5mg.
PlaceboDrug
matching placebo to B\&O suppository
Active B&O suppository of belladonnaDrug
belladonna 16.2mg and morphine 7.5mg
| Study group | Role | What they receive |
|---|---|---|
| Active B&O suppository of belladonna | Experimental | Receive the B\&O suppository (belladonna/morphine) 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia. Receives: Drug: Onabotulinumtoxin A (BoNT); Drug: belladonna; Drug: Morphine; Drug: Active B&O suppository of belladonna |
| Placebo suppository | Placebo comparator | Receive a placebo suppository 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia. Receives: Drug: Onabotulinumtoxin A (BoNT); Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Bladder Injection Pain
The primary outcome will be calculated difference in numeric rating scale (NRS) pain score prior to procedure and midway through procedure. Scale is one question and has a range from a score of 0 (no pain) to 10 (worst possible pain). Measure will be reported as the intraoperative pain score minus the preoperative pain score.
Measured: Baseline and intraoperative
Secondary outcomes (7)
Pre-analgesia Pain Score
Measured using NRS. Scale is one question and has a range from a score of 0 (no pain) to 10 (worst possible pain).
Measured: Baseline
Post-operative Pain Score
Measured using NRS. Scale is one question and has a range from a score of 0 (no pain) to 10 (worst possible pain).
Measured: Postoperative (within 10 minutes of the end of the BoNT procedure)
Number of Participants Declining to Complete Procedure Due to Pain Intolerance
Number of patients that decline to proceed with entire procedure (20 injections) due to pain or discomfort.
Measured: Intraoperative
Postoperative Voiding Trial Results
Distribution of patients with postoperative volume in ml of post-void residual urine obtained via catheter greater than 200ml.
Measured: Postoperative (before leaving the clinic, within 3 hours of the end of the BoNT procedure)
Post Void Residual (PVR)
Distribution of patients with volume in ml of post-void residual urine obtained via catheter greater than 200 ml at 2-week follow-up appointment.
Measured: 2 Weeks
Number of Participants With Evidence of Infection or Positive Urine Culture
Urinalysis results showing evidence of infection or positive urine culture at 2-week follow-up appointment.
Measured: 2 Weeks
Participant Satisfaction With Pain Control
Measured using one question Likert scale. This will be a 4-level scale ranging from 'not at all satisfied,' 'slightly satisfied,' 'mostly satisfied,' and 'very much satisfied.'
Measured: Postoperative (within 10 minutes of the end of the BoNT procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2015 (estimated)
- Study startNov 2015
- Primary completion26 Jun 2017
- Study completion26 Jun 2017
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.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edgar LeClaire, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Edgar LeClaire, MD, University of Kansas Medical Center
- Investigators
- Edgar LeClaire, MD, FACOG, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02600715
- Sponsor's protocol ID
- STUDY00003056
- Other IDs
- 15-051
- Acronym
- ROBIN
- Status last verified
- Jun 2018
- First submitted
- 29 Oct 2015
- Last updated
- 20 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Bladder Injection Pain With Belladonna Opiate Suppository: A Randomized, Double-Blind, Placebo-Controlled Trial (ROBIN Trial)
- ClinicalTrials.gov ID
- NCT02600715
- Acronym / sponsor ID
- ROBIN / STUDY00003056
- Conditions
- Overactive Bladder, Urinary Urge Incontinence, Urinary Bladder, Neurogenic, Painful Bladder Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Edgar LeClaire, MDUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- 26 Jun 2017 (actual)
- Study completion
- 26 Jun 2017 (actual)
- First posted
- 9 Nov 2015 (estimated)
- Results
- Posted 20 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test whether using belladonna \& opiate suppositories (B\&Os) can improve patient discomfort during Onabotulinumtoxin A (BoNT) injection into the bladder for treatment of overactive bladder, neurogenic detrusor overactivity, or interstitial cystitis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active B&O suppository of belladonna | Experimental | Drug: Onabotulinumtoxin A (BoNT), Drug: belladonna, Drug: Morphine, Drug: Active B&O suppository of belladonnaReceive the B\&O suppository (belladonna/morphine) 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia. |
| Placebo suppository | Placebo comparator | Drug: Onabotulinumtoxin A (BoNT), Drug: PlaceboReceive a placebo suppository 40 minutes prior to Onabotulinumtoxin A (BoNT) injection procedure in conjunction with local analgesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Met clinical criteria under outside care or during the Principal Investigator's routine standard of care for BoNT injection therapy
- No contraindication to BoNT therapy as outlined by drug manufacturer guidelines
- Participants have elected to have the BoNT injection therapy prior to being offered enrollment into the study for either overactive bladder (OAB), neurogenic detrusor overactivity (NDO), or refractory interstitial cystitis (IC)
Key exclusion criteria (6 listed)
- Currently pregnant
- Currently nursing a baby
- Anticipated geographic relocation within the first 3 months following treatment
- Allergy to morphine, belladonna, or opiates
- Patients will be excluded if participating in another research study
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 |
|---|---|---|
| Onabotulinumtoxin A (BoNT)Also: Botox, Allergan | Drug | Active B&O suppository of belladonna, Placebo suppository |
| belladonnaPart of dosage of the compounded active B\&O suppository of belladonna 16.2mg and morphine 7.5mg. | Drug | Active B&O suppository of belladonna |
| MorphinePart of dosage of the compounded active B\&O suppository of belladonna 16.2mg and morphine 7.5mg. | Drug | Active B&O suppository of belladonna |
| Placebomatching placebo to B\&O suppository | Drug | Placebo suppository |
| Active B&O suppository of belladonnabelladonna 16.2mg and morphine 7.5mg | Drug | Active B&O suppository of belladonna |
Primary outcome
Change in Bladder Injection Pain
Time frame: Baseline and intraoperative
The primary outcome will be calculated difference in numeric rating scale (NRS) pain score prior to procedure and midway through procedure. Scale is one question and has a range from a score of 0 (no pain) to 10 (worst possible pain). Measure will be reported as the intraoperative pain score minus the preoperative pain score.
7 secondary outcomes
Pre-analgesia Pain Score
Time frame: Baseline
Post-operative Pain Score
Time frame: Postoperative (within 10 minutes of the end of the BoNT procedure)
Number of Participants Declining to Complete Procedure Due to Pain Intolerance
Time frame: Intraoperative
Postoperative Voiding Trial Results
Time frame: Postoperative (before leaving the clinic, within 3 hours of the end of the BoNT procedure)
Post Void Residual (PVR)
Time frame: 2 Weeks
Number of Participants With Evidence of Infection or Positive Urine Culture
Time frame: 2 Weeks
Participant Satisfaction With Pain Control
Time frame: Postoperative (within 10 minutes of the end of the BoNT procedure)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Edgar LeClaire, MD, FACOG principal investigator
University of Kansas Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Onabotulinumtoxin A (BoNT), belladonna and Morphine in people with Overactive Bladder and Urinary Urge Incontinence, run by Edgar LeClaire, MD at 2 sites 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 20 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Sep 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?
Change in Bladder Injection Pain (time frame: Baseline and intraoperative). 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 20 Sep 2018.