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Timing of B and O Suppositories to Help Relieve Post-operative Bladder Spasms

Primary Purpose

Overactive Bladder

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Belladonna and Opium Suppository
Rectal Exam
Sponsored by
Campbell Grant
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring Belladonna and Opium Suppositories

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing lithotripsy procedure at GW Hospital

Exclusion Criteria:

  • 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.

Sites / Locations

  • George Washington University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Pre-operative Suppository

Post-operative Suppository

Rectal Exam

Arm Description

A B&O Suppository will be placed in the patient's rectum after the induction of anesthesia, but before the surgery.

A B&O Suppository will be placed in the patient's rectum while still under anesthesia, but after the surgery.

Patient's will be given a rectal exam after the procedure but while still under anesthesia to serve as a placebo.

Outcomes

Primary Outcome Measures

Post-operative Morphine Equivalent Dose
No results collected on the post-operative morphine equivalent dose

Secondary Outcome Measures

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

Full Information

First Posted
February 17, 2016
Last Updated
February 19, 2019
Sponsor
Campbell Grant
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1. Study Identification

Unique Protocol Identification Number
NCT02865395
Brief Title
Timing of B and O Suppositories to Help Relieve Post-operative Bladder Spasms
Official Title
Timing of B and O Suppositories to Help Relieve Post-operative Bladder Spasms and Urinary Discomfort in Patients Undergoing Lithotripsy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
Another study published with similar results
Study Start Date
March 2016 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Campbell Grant

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
Belladonna and Opium Suppositories

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pre-operative Suppository
Arm Type
Experimental
Arm Description
A B&O Suppository will be placed in the patient's rectum after the induction of anesthesia, but before the surgery.
Arm Title
Post-operative Suppository
Arm Type
Active Comparator
Arm Description
A B&O Suppository will be placed in the patient's rectum while still under anesthesia, but after the surgery.
Arm Title
Rectal Exam
Arm Type
Placebo Comparator
Arm Description
Patient's will be given a rectal exam after the procedure but while still under anesthesia to serve as a placebo.
Intervention Type
Drug
Intervention Name(s)
Belladonna and Opium Suppository
Intervention Type
Procedure
Intervention Name(s)
Rectal Exam
Primary Outcome Measure Information:
Title
Post-operative Morphine Equivalent Dose
Description
No results collected on the post-operative morphine equivalent dose
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Post-Operative Pain
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing lithotripsy procedure at GW Hospital Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Mufarrij
Organizational Affiliation
George Washington University
Official's Role
Principal Investigator
Facility Information:
Facility Name
George Washington University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Timing of B and O Suppositories to Help Relieve Post-operative Bladder Spasms

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