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

NCT02865395 | Terminated Phase 4 Results DMC

• 1 other identifier: GW051534
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Overactive Bladder

Keywords

Belladonna and Opium Suppositories

Outcome Measures

Primary Outcomes (1)

• Post-operative Morphine Equivalent Dose

  No results collected on the post-operative morphine equivalent dose

  24 hours

Secondary Outcomes (1)

• Post-Operative Pain

  24 hours

Study Arms (3)

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.

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.

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.

Procedure: Rectal Exam

Interventions

Belladonna and Opium Suppository DRUG

Post-operative Suppository; Pre-operative Suppository

Rectal Exam PROCEDURE

Rectal Exam

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing lithotripsy procedure at GW Hospital

Sponsors & Collaborators

• Campbell Grant: lead

Study Sites (1)

George Washington University

Washington D.C., District of Columbia, 20037, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Patrick Mufarrij
• Organization: George Washington University

pmufarrij@gmail.com

2027154000

Study Officials

• Patrick Mufarrij

  George Washington University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Urology Resident

Study Record Dates

• First Submitted: February 17, 2016
• First Posted: August 12, 2016
• Study Start: March 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: February 20, 2019
• Results First Posted: February 20, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)