Overactive BladderPhase 4NCT02865395
Timing of B and O Suppositories to Help Relieve Post-operative Bladder Spasms
A Phase 4 study testing Belladonna and Opium Suppository and Rectal Exam in people with Overactive Bladder, run by Campbell Grant at 1 site in United States.
Trial summary
Ureteroscopy is a common procedure in Urology that patients undergo daily to deal with a variety of ailments. These procedures often require that the bladder be filled and emptied with sterile water or saline several times during the procedure, and often result in the patient receiving a catheter at the end of the… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Belladonna and Opium Suppository and Rectal Exam
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing lithotripsy procedure at GW Hospital
Who cannot join
- The criteria for exclusion for those patients who agree to participate in the study will be patients with glaucoma, severe hepatic or renal disease, bronchial asthma, respiratory depression at the time of administration, convulsive disorders, allergy to anti-muscarinics or opiates, history of anorectal surgery, pre-operative use of antimuscarinics, chronic pain, chronic use of analgesics, or a history of alcohol or opioid dependency.
Trial locations and contacts
1 site in 1 country.
United States1 site
George Washington University
Washington D.C., District of Columbia, 20037
About this study
Official title: Timing of B and O Suppositories to Help Relieve Post-operative Bladder Spasms and Urinary Discomfort in Patients Undergoing Lithotripsy
Ureteroscopy is a common procedure in Urology that patients undergo daily to deal with a variety of ailments. These procedures often require that the bladder be filled and emptied with sterile water or saline several times during the procedure, and often result in the patient receiving a catheter at the end of the procedure. One common side effect is that patients experience bladder spasm or discomfort for a period of time after these procedures. Belladonna and Opium (B and O) suppositories and PO Oxybutynin are often given in the post-operative setting to relieve these symptoms.
The principle objectives of this study are:
- To determine if the addition of a B and O supprette suppository at the end of cystoscopic/ureteroscopic procedures reduces the incidence of bladder spasms and urinary discomfort that patients experience in the post-operative setting.
- To determine if using peri-operative B and O supprette suppositories reduces the need for pos-operative oral Ditropan and use of narcotic pain medications.
Read the detailed description
The patients will be divided into three research arms. Patients will be randomly selected for one of the groups using a random number generator between 1 and 3. There will be a "Control Group" which will receive a rectal exam while still in the operating room in the lithotomy position after the procedure. There will be a "Postoperative OR" group which will receive a B and O suppository while still in the operating room in the lithotomy position after the procedure. Finally, there will be a "Preoperative OR" group which will receive a B and O suppository after the induction of anesthesia prior to beginning the urologic procedure in the lithotomy position. The "Control Group" will receive a rectal exam in the operating room after the procedure but before extubation to simulate the effects of suppository administration so that the investigators know that any effects are due to the medication and not to the placement of the suppository itself. Those patients in the "control group" may receive a B and O suppository as part of standard procedure in the post-operative period if these individuals experience any bladder spasms and wish to have this as a treatment. This administration will be at the discretion of the operating surgeon as it is in standard cases. Patients may also receive Ditropan in the post-operative setting, which is part of the standard procedure for treating bladder spasms following urologic procedures. Patients in the postoperative and preoperative OR groups will be offered Ditropan for any bladder spasms in the post-operative setting to control symptoms, which is part of the normal standard of care for anyone who has already received a B and O suppository with inadequate control of symptoms. All patients will be treated with a normal post-operative pain regimen which may include narcotics. This will be at the discretion of the treating physician.
- Conditions
- Overactive Bladder
- Being tested
- Belladonna and Opium Suppository, Rectal Exam
- Keywords
- Belladonna and Opium Suppositories
- 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.
Belladonna and Opium SuppositoryDrug
Rectal ExamProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Pre-operative Suppository | Experimental | A B\&O Suppository will be placed in the patient's rectum after the induction of anesthesia, but before the surgery. Receives: Drug: Belladonna and Opium Suppository |
| Post-operative Suppository | Active comparator | A B\&O Suppository will be placed in the patient's rectum while still under anesthesia, but after the surgery. Receives: Drug: Belladonna and Opium Suppository |
| Rectal Exam | Placebo comparator | Patient's will be given a rectal exam after the procedure but while still under anesthesia to serve as a placebo. Receives: Procedure: Rectal Exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Morphine Equivalent Dose
No results collected on the post-operative morphine equivalent dose
Measured: 24 hours
Secondary outcomes (1)
Post-Operative Pain
Patients will be asked to fill out a short questionnaire with the faces scale to grade their pain on a scale of 1-10
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study startMar 2016
- Primary completionJun 2017
- Study completionJun 2017
Why it stopped: Another study published with similar results
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Campbell Grant
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Campbell Grant, George Washington University
- Investigators
- Patrick Mufarrij, Principal investigator, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02865395
- Sponsor's protocol ID
- GW051534
- Status last verified
- Feb 2019
- First submitted
- 17 Feb 2016
- Last updated
- 20 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of B and O Suppositories to Help Relieve Post-operative Bladder Spasms and Urinary Discomfort in Patients Undergoing Lithotripsy
- ClinicalTrials.gov ID
- NCT02865395
- Acronym / sponsor ID
- GW051534
- Conditions
- Overactive Bladder
- Keywords
- Belladonna and Opium Suppositories
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Another study published with similar results
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Campbell GrantUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 12 Aug 2016 (estimated)
- Results
- Posted 20 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ureteroscopy is a common procedure in Urology that patients undergo daily to deal with a variety of ailments. These procedures often require that the bladder be filled and emptied with sterile water or saline several times during the procedure, and often result in the patient receiving a catheter at the end of the procedure. One common side effect is that patients experience bladder spasm or discomfort for a period of time after these procedures. Belladonna and Opium (B and O) suppositories and PO Oxybutynin are often given in the post-operative setting to relieve these symptoms.
The principle objectives of this study are:
- To determine if the addition of a B and O supprette suppository at the end of cystoscopic/ureteroscopic procedures reduces the incidence of bladder spasms and urinary discomfort that patients experience in the post-operative setting.
- To determine if using peri-operative B and O supprette suppositories reduces the need for pos-operative oral Ditropan and use of narcotic pain medications.
Detailed description
The patients will be divided into three research arms. Patients will be randomly selected for one of the groups using a random number generator between 1 and 3. There will be a "Control Group" which will receive a rectal exam while still in the operating room in the lithotomy position after the procedure. There will be a "Postoperative OR" group which will receive a B and O suppository while still in the operating room in the lithotomy position after the procedure. Finally, there will be a "Preoperative OR" group which will receive a B and O suppository after the induction of anesthesia prior to beginning the urologic procedure in the lithotomy position. The "Control Group" will receive a rectal exam in the operating room after the procedure but before extubation to simulate the effects of suppository administration so that the investigators know that any effects are due to the medication and not to the placement of the suppository itself. Those patients in the "control group" may receive a B and O suppository as part of standard procedure in the post-operative period if these individuals experience any bladder spasms and wish to have this as a treatment. This administration will be at the discretion of the operating surgeon as it is in standard cases. Patients may also receive Ditropan in the post-operative setting, which is part of the standard procedure for treating bladder spasms following urologic procedures. Patients in the postoperative and preoperative OR groups will be offered Ditropan for any bladder spasms in the post-operative setting to control symptoms, which is part of the normal standard of care for anyone who has already received a B and O suppository with inadequate control of symptoms. All patients will be treated with a normal post-operative pain regimen which may include narcotics. This will be at the discretion of the treating physician.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pre-operative Suppository | Experimental | Drug: Belladonna and Opium SuppositoryA B\&O Suppository will be placed in the patient's rectum after the induction of anesthesia, but before the surgery. |
| Post-operative Suppository | Active comparator | Drug: Belladonna and Opium SuppositoryA B\&O Suppository will be placed in the patient's rectum while still under anesthesia, but after the surgery. |
| Rectal Exam | Placebo comparator | Procedure: Rectal ExamPatient's will be given a rectal exam after the procedure but while still under anesthesia to serve as a placebo. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing lithotripsy procedure at GW Hospital
Key exclusion criteria (1 listed)
- The criteria for exclusion for those patients who agree to participate in the study will be patients with glaucoma, severe hepatic or renal disease, bronchial asthma, respiratory depression at the time of administration, convulsive disorders, allergy to anti-muscarinics or opiates, history of anorectal surgery, pre-operative use of antimuscarinics, chronic pain, chronic use of analgesics, or a history of alcohol or opioid dependency.
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 |
|---|---|---|
| Belladonna and Opium Suppository | Drug | Post-operative Suppository, Pre-operative Suppository |
| Rectal Exam | Procedure or surgery | Rectal Exam |
Primary outcome
Post-operative Morphine Equivalent Dose
Time frame: 24 hours
No results collected on the post-operative morphine equivalent dose
1 secondary outcome
Post-Operative Pain
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2019.
- 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.
Patrick Mufarrij principal investigator
George Washington University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Belladonna and Opium Suppository and Rectal Exam in people with Overactive Bladder, run by Campbell Grant 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 1 inclusion and 1 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 20 Feb 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. 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 Feb 2019). 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?
Post-operative Morphine Equivalent Dose (time frame: 24 hours). 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 Feb 2019.