A Phase 4 interventional study of Belladonna and Opium Suppository and Rectal Exam in Overactive Bladder, sponsored by Campbell Grant. Terminated at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2019-02-20.
Sponsored by Campbell Grant · Phase 4, Interventional, and Treatment
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:
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.
855 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.
This study's enrollment of 23 is below the median of 72 across 652 interventional studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →This is the only study on the registry with Campbell Grant as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A B\&O Suppository will be placed in the patient's rectum after the induction of anesthesia, but before the surgery.
Drug: Belladonna and Opium Suppository
A B\&O Suppository will be placed in the patient's rectum while still under anesthesia, but after the surgery.
Drug: Belladonna and Opium Suppository
Patient's will be given a rectal exam after the procedure but while still under anesthesia to serve as a placebo.
Procedure: Rectal Exam
Post-operative Morphine Equivalent Dose
No results collected on the post-operative morphine equivalent dose
Time frame: 24 hours
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
Time frame: 24 hours
| Milestone | Pre-operative Suppository | Post-operative Suppository | Rectal Exam |
|---|---|---|---|
| Started | 6 | 10 | 7 |
| Completed | 0 | 0 | 0 |
| Not completed | 6 | 10 | 7 |
| Withdrew: Physician decision | 6 | 10 | 7 |
No results collected on the post-operative morphine equivalent dose
No measurements were reported for this outcome.
Patients will be asked to fill out a short questionnaire with the faces scale to grade their pain on a scale of 1-10
No measurements were reported for this outcome.
Collected over Adverse Data collected over 2 months while study was recruiting patients. No adverse events recorded.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pre-operative Suppository | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Post-operative Suppository | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Rectal Exam | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
We did not collect the data on any of these patients. Therefore there is no data on ethnicity, age, or sex.
| Age, Categorical | Pre-operative Suppository | Post-operative Suppository | Rectal Exam | Total |
|---|---|---|---|---|
| <=18 years | — | — | — | — |
| Between 18 and 65 years | — | — | — | — |
| >=65 years | — | — | — | — |
| Sex: Female, Male | Pre-operative Suppository | Post-operative Suppository | Rectal Exam | Total |
|---|---|---|---|---|
| Female | — | — | — | — |
| Male | — | — | — | — |
| Race and Ethnicity Not Collected | Pre-operative Suppository | Post-operative Suppository | Rectal Exam | Total |
|---|
| Participants | Pre-operative Suppository | Post-operative Suppository | Rectal Exam | Total |
|---|
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Plan to share: No
This study is terminated, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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