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

NCT ID: NCT02865395

Last Updated: 2019-02-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2017-06-30

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:

1. 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.

2. 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.

Conditions

Overactive Bladder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Pre-operative Suppository

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

Group Type: EXPERIMENTAL

Belladonna and Opium Suppository

Intervention Type: DRUG

Post-operative Suppository

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

Group Type: ACTIVE_COMPARATOR

Belladonna and Opium Suppository

Intervention Type: DRUG

Rectal Exam

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

Group Type: PLACEBO_COMPARATOR

Rectal Exam

Intervention Type: PROCEDURE

Interventions

Belladonna and Opium Suppository

Intervention Type: DRUG

Rectal Exam

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Campbell Grant

OTHER

Sponsor Role: lead

Responsible Party

Campbell Grant

Urology Resident

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Patrick Mufarrij

Role: PRINCIPAL_INVESTIGATOR

George Washington University

Locations

George Washington University

Washington D.C., District of Columbia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

GW051534

Identifier Type: -

Identifier Source: org_study_id