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

Overactive Bladder Clinical Trial

Official title:

Timing of B and O Suppositories to Help Relieve Post-operative Bladder Spasms and Urinary Discomfort in Patients Undergoing Lithotripsy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02865395
• Other study ID #: GW051534
• Status: Terminated
• Phase: Phase 4
• Start date: March 2016
• Est. completion date: June 2017

Study information

• Verified date: February 2019
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• Belladonna and Opium Suppository

Procedure:
• Rectal Exam

Locations

Country	Name	City	State
United States	George Washington University	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Campbell Grant

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative Morphine Equivalent Dose	No results collected on the post-operative morphine equivalent dose	24 hours
Secondary	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	24 hours