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Effect of an Anti-spasmodic Suppository to Improve Comfort After Urologic Surgery

Pre-operative Administration of a Muscarinic Antagonist for Elective Cystoscopy Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02291042
Acronym
SPASMS
Enrollment
50
Registered
2014-11-14
Start date
2015-10-31
Completion date
2016-03-31
Last updated
2017-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery

Keywords

Bladder, Surgery

Brief summary

This study evaluates the ability of a belladonna and opium suppository given prior to surgery to improve bladder comfort after surgery for patients who are having elective ureteroscopy surgery.

Detailed description

Belladonna and opium suppositories are administered postoperatively to relieve bladder discomfort usually caused by bladder spasms. The onset of action of the suppository is 30-60 minutes. Bladder spasms are more likely to occur following uteroscopy procedures. The spasms result in a felt desire to void, even when there is no urine in the bladder. The spasms can produce pain or a sense of severe urgency. By administering a belladonna and opium suppository at the beginning of surgery, it is hoped that there will be a decrease in the incidence of bladder spasms, increased comfort and less need for additional medications.

Interventions

DRUGB+O Suppository

Sponsors

Southern New Hampshire Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients from one urology practice schedule for elective uteroscopy.

Exclusion criteria

* Patients with pre-operative indwelling catheter or urinary stent. * Patients who report any allergy to belladonna or opium.

Design outcomes

Primary

MeasureTime frameDescription
Difference in mean bladder comfort (baseline at PACU admission to PACU discharge) between experimental and control groupsLength of postoperative stay from admission to PACU to discharge from PACU an expected average of 2 hoursBladder comfort is defined as bladder pain and bladder urgency. Bladder pain is measured on a 0-10 verbal analog scale with 0 = no pain and 10 = most pain possible. Bladder urgency is measured by a 0 - 4 scale with 0 = no desire to void, 1 = awarenes of need to void which can be delayed at least 30 minutes, 2 = moderate urgency than can be delayed for no more than 15 minutes, 3 = severe urgency that can be delayed for no more than 5 minutes, 4 = must void now. Pain and urgency are reported by the patient with or without questioning by the nurse.

Secondary

MeasureTime frameDescription
Duration of PACU length of stayTime from admission to PACU to discharge from PACU an expected average of 2 hoursThe time in minutes of the PACU length of stay

Other

MeasureTime frameDescription
Requirements for rescue therapy for pain and urgencyFrom PACU admission to PACU discharge an expected average of 2 hoursAdditional interventions for rescue pharmacology administered postoperatively to relieve pain or urgency

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026