Clinical trial NCT03513250: Efﬁcacy of Hyoscine-n-butylbromide in Catheter-related Bladder Discomfort After Elective Cesarean Section.
Official title: Efﬁcacy and Safety of Hyoscine-n-butylbromide for the Alleviation of Early Catheter-related Bladder Discomfort After Elective Cesarean Delivery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catheter Related Bladder Discomfort
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-05-01
Enrollment: 92
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective randomized clinical trial
Primary purpose: PREVENTION

Brief summary: a prospective, randomized, placebo-controlled study will be conducted to investigate whether hyoscine-n-butylbromide has preventive effects on early postoperative CRBD in patients with urinary catheters who will undergo elective cesarean sections.

Detailed description: The insertion of a urinary catheter in a patient undergoing a surgical procedure as cesarean section may lead to catheter-related bladder discomfort with varying degrees of severity during the postoperative period. Catheter-related bladder discomfort (CRBD) symptoms associated with an indwelling urinary catheter are similar to overactive bladder symptoms such as discomfort in the suprapubic region, urinary urgency, frequency, burning sensation with or without urge incontinence. Hyoscine N-butyl bromide also known as scopolamine is a drug with anticholinergic effects which exerts its effects by inhibiting the acetylcholine effects in parasympathetic receptors of smooth muscle cells, secretory glands, and central nervous system. Hyoscine-n-butylbromide was reported to be effective for treatment of CRBD.

More preventive than therapeutic drugs for CRBD should be investigated to improve patient comfort in all surgery patients with a urinary catheter.

A prospective, randomized, placebo-controlled study will be conducted to investigate whether hyoscine-n-butylbromide has preventive effects on early postoperative CRBD in patients with urinary catheters who will undergo elective cesarean sections.

Eligibility criteria: Inclusion Criteria:

* Elective primary or repeat cesarean section at or more than 38 weeks of gestation scheduled to insert a Foley catheter in the operation site.

Exclusion Criteria:

* • Urinary infection (assessed clinically and by urinalysis of midstream sample of urine (MSSU) with chemical indicator strips or dipsticks).

  * Contraindications for general anesthesia.
  * Maternal bladder, urethral and renal disorders causing irritating voiding problems such as dysuria, urge and stress incontinence.
  * Obstructive voiding symptoms like incomplete emptying, straining and voiding difﬁculty before surgery.
  * Overactive bladder (frequency: more than three times during the night or more than eight times in 24 h).
  * Morbid obesity.
  * Disturbances of the central nervous system (epilepsy, patients receiving MAO inhibitor).
  * Hypertensive disorders and/ or systemic disease requiring particular patient care (for example, cardiac disease, nephritic disorders).
  * Chronic analgesic abuse.
  * Hepatic or psychiatric disease will be excluded from the study.
  * A history of hypersensitivity or contraindication to hyoscine-n-butylbromide.

Primary outcomes:
measure: catheter related bladder discomfort(CRBD) measured by numerical rating scale(NRS).
timeFrame: one hour post-operatively.
Secondary outcomes:
measure: catheter related bladder discomfort(CRBD) measured by numerical rating scale(NRS).
timeFrame: two hours postopeatively.
measure: catheter related bladder discomfort(CRBD) measured by numerical rating scale(NRS).
timeFrame: six hours postoperatively.
measure: Postoperative nausea and vomiting
timeFrame: 6 hours postoperative
measure: dry mouth
timeFrame: 6 hours postoperative
measure: facial flushing
timeFrame: 6 hours postoperative
measure: painkiller
timeFrame: Up to 6 hours after study drug administration
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Ahmed Ashour
Study officials:
affiliation: Cairo University
name: AHMED SAMY, MD
role: PRINCIPAL_INVESTIGATOR
References: