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Effect of modified XiaoZhuosheng Decoction on ureteral catheter-related bladder irritation after ureteral calculi operation: a single-center, prospective, randomized, double-blind, controlled study

Effect of modified XiaoZhuosheng Decoction on ureteral catheter-related bladder irritation after ureteral calculi operation: a single-center, prospective, randomized, double-blind, controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083997
Enrollment
Unknown
Registered
2024-05-08
Start date
2024-05-13
Completion date
Unknown
Last updated
2024-05-13

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

Conditions

catheter-related bladder discomfort

Interventions

control group:Warm compress with hot water bag

Sponsors

Shanghai Fourth People's Hospital affiliated to Tongji University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1 Male; 2 Age 18-45 years old; 3 BMI less than 24kg/m2; 4 ASA Grade I-II; 5 Transurethral ureteral laser lithotripsy was performed under quasi-general anesthesia. The anesthesia time was 15-30 minutes. An 18-gauge catheter was indwelled after the operation. 6 With normal understanding ability, I or my family members can cooperate with CRBD evaluation or questionnaire filling; 7 Sign informed consent voluntarily.

Exclusion criteria

Exclusion criteria: 1 Serious heart, liver, kidney and other diseases; 2 Skin injury, ulceration, sensory disturbance, acute closed injury, and suppuration in the hot compress area Infection or acute inflammation and other infectious diseases, skin diseases, severe diabetes, high fever accompanied by excessive product materials, not suitable for hot compress; 3 Patients with prostatic hypertrophy and urethral stenosis have a history of indwelling catheter for one year.

Design outcomes

Primary

MeasureTime frame
Incidence of moderate to severe CRBD 30 minutes after surgery;

Secondary

MeasureTime frame
Incidence of moderate-to-severe CRBD 1 hour, 6 hours, and 24 hours after surgery;NRS scores of patients 30 minutes, 1 hour, 6 hours, and 24 hours after surgery;Incidence of skin discomfort above symphysis pubis (burns, redness, itching, allergies, etc.);Blood pressure, heart rate and oxygen saturation were measured 30 minutes, 1 hour, 6 hours and 24 hours after surgery;Patient satisfaction [24 hours after surgery, patient satisfaction using a 5-point scale, ranging from 1(" very dissatisfied ") to 5(" very satisfied ")];

Countries

China

Contacts

Public ContactHuixing Zhang

Shanghai Fourth People's Hospital affiliated to Tongji University

zhanghx_165@163.com+86 181 1627 6340

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026