Moxibustion in the Treatment of Hemorrhagic Cystitis After Allo-HSCT

Not Applicable

Recruiting

• Conditions: Hematopoietic Stem Cell Transplantation; Hemorrhagic Cystitis; Treatment; Moxibustion
• Interventions: Other: Moxibustion; Other: Symptomatic supportive treatment

• Registration Number: NCT06241274
• Lead Sponsor: Wuhan Union Hospital, China

Brief Summary

This study was a prospective, multicenter, single-arm clinical study planned to enroll 60 patients who developed hemorrhagic cystitis after sexually allogeneic hematopoietic stem cell transplantation Patients with hemorrhagic cystitis after allogeneic hematopoietic stem cell transplantation were given symptomatic supportive treatment combined with moxibustion covering Shenque, Zhongguo, Guanyuan, and Qihai for 30 minutes every day for 14 days and urine routine was collected every day for 14 days to assess the severity of hemorrhagic cystitis and pain scores to evaluate the effectiveness of moxibustion in treating hemorrhagic cystitis after allogeneic hematopoietic stem cell transplantation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-07
• Study First Submitted QC: 2024-01-27
• Study First Posted: 2024-02-05
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-23
• Last Update Posted: 2024-07-24
• Study Start: 2024-08-15
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. patients were fully aware of the study, participated voluntarily, and signed the informed consent form;
2. Age: 18-55 years old;
3. patients with hemorrhagic cystitis after allogeneic hematopoietic stem cell transplantation;

Exclusion Criteria

1. refusal to participate in this clinical study;
2. broken or sensitized skin corresponding to the moxibustion site;
3. allogeneic hematopoietic stem cell transplantationpatients pretreated with the Reduced-intensity conditioning.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Moxibustion	Moxibustion	Subjects received symptomatic supportive treatment combined with moxibustion covering Shenque, Zhonggong, Guanyuan, and Qihai for 30 minutes every day for 14 days.
Moxibustion	Symptomatic supportive treatment	Subjects received symptomatic supportive treatment combined with moxibustion covering Shenque, Zhonggong, Guanyuan, and Qihai for 30 minutes every day for 14 days.

Primary Outcome Measures

Name	Time	Method
Core Lower Urinary Tract Symptom Score	14 days	The Core Lower Urinary Tract Symptom Score consists of 10 questions. Frequent daytime urination---0 points:\<7 times;1 point:8\~9 times;2 points:10\~14 times;3 points:\> 14 times. Nocturia---0 points:0 times/night;1 point:1 time/night;2 points: 2\~3 times/night;3 points:\> 3 times/night. The other 8 problems were urgency, dysuria, hesitancy, thin urine line, urge incontinence, stress incontinence, bladder pain, and urethral pain, which were rated as 0, 1, 2, and 3 according to their frequency (never, rarely, sometimes, and often).

Trial Locations

Locations (1)

Yi Zhang; 🇨🇳 Wuhan, Hubei, China