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An intervention study of nazifa moxibustion in ischemic stroke patients with urinary incontinence of renal qi insufficiency type

Registration number：

ITMCTR2025000069

Date of Last Refreshed on：

2025-01-10

Date of Registration：

2025-01-10

Registration Status：

Retrospective registration

Public title：

An intervention study of nazifa moxibustion in ischemic stroke patients with urinary incontinence of renal qi insufficiency type

English Acronym：

Scientific title：

An intervention study of nazifa moxibustion in ischemic stroke patients with urinary incontinence of renal qi insufficiency type

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

HaiDi Wang

Study leader：

ZuKun Chen

Applicant telephone：

18812369100

Study leader's telephone：

18183859330

Applicant Fax：

Study leader's fax：

Applicant E-mail：

1915907793@qq.com

Study leader's E-mail：

535362396@qq.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

Yunnan University of Traditional Chinese Medicine No. 1076 Yuhua Road Chenggong District Kunming Yunnan Province China

Study leader's address：

No. 161 Dongjiao Road Guandu District Kunming Yunnan Province China

Applicant postcode：

650500

Study leader's postcode：

650032

Applicant's institution：

Yunnan University of Traditional Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

2024-048

Approved file of Ethical Committee：

View

Name of the ethic committee：

Medical Ethics Committee of the Second Affiliated Hospital of Yunnan University of Traditional Chinese Medicine

Date of approved by ethic committee：

2024/10/18 0:00:00

Contact Name of the ethic committee：

YuLian Wang

Contact Address of the ethic committee：

No. 161 Dongjiao Road Guandu District Kunming Yunnan Province China

Contact phone of the ethic committee：

18288953308

Contact email of the ethic committee：

chenbojunyn@163.com

Primary sponsor：

The Second Affiliated Hospital of Yunnan University of Traditional Chinese Medicine

Primary sponsor's address：

No. 161 Dongjiao Road Guandu District Kunming Yunnan Province China

Secondary sponsor：

Country：

China

Province：

Yunnan Province

City：

Kunming

Institution
hospital：

The Second Affiliated Hospital of Yunnan University of Traditional Chinese Medicine

Address：

No. 161 Dongjiao Road Guandu District Kunming Yunnan Province China

Source(s) of funding：

Yunnan Provincial Science and Technology Department of Chinese Medicine Joint Special Project

Target disease：

Urinary incontinence after ischemic stroke

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

Exploring the therapeutic effect of nazifa moxibustion on patients with urinary incontinence of renal qi insufficiency type in ischemic stroke

Description for medicine or protocol of treatment in detail：

Inclusion criteria

(1) Patients who met the above diagnostic criteria of Chinese and Western medicine regarding ischemic stroke and urinary incontinence and who met the diagnostic criteria of the urinary incontinence pattern of renal qi insufficiency; (2) Age 60-85 years old; (3) Patients with urinary incontinence without catheterization after ischemic stroke and without urinary tract infection; (4) The patients were conscious cognitive function was basically normal and they were able to cooperate with medical care to inquire about their condition and complete the questionnaire (5) Patients were informed and voluntarily signed an informed consent form.

Exclusion criteria：

(1) Combined with severe visceral insufficiency coagulation mechanism disorders urinary tumors or stones and infections or cognitive impairment can not properly express the will to cooperate with the treatment; (2) Patients who have participated in other incontinence-related clinical trials and treatments within 1 month which may have an impact on this clinical study; (3) Those with severe allergy to moxa and its products or those with skin breakdown at the moxa site.

Study execute time：

From 2024-08-10

To      2025-12-10

Recruiting time：

From 2024-10-18

To      2025-08-18

Interventions：

33

Group：

test group

Sample size：

Intervention：

Basic nursing + pelvic floor muscle therapy +nazi method of moxibustion

Intervention code：

33

Group：

control subjects

Sample size：

Intervention：

Basic nursing + pelvic floor muscle therapy +moxibustion

Intervention code：

Total sample size ： 66

Countries of recruitment
and research settings：

Country：

China

Province：

Yunnan Province

City：

Kunming

Institution/hospital：

The Second Affiliated Hospital of Yunnan University of Traditional Chinese Medicine

Level of the institution：

three-tier

Outcomes：

Outcome：

Average number of urinary incontinence per day

Type：

Primary indicator

Measure time point of outcome：

Pre-intervention 1 week of intervention 2 weeks of intervention

Measure method：

Outcome：

International Consultation on Incontinence questionnaireshort form

Type：

Primary indicator

Measure time point of outcome：

Pre-intervention 1 week of intervention 2 weeks of intervention

Measure method：

Outcome：

Chinese Medicine Symptom Score

Type：

Secondary indicator

Measure time point of outcome：

Pre-intervention 1 week of intervention 2 weeks of intervention

Measure method：

Outcome：

Therapeutic effect index

Type：

Secondary indicator

Measure time point of outcome：

Pre-intervention 2 weeks of intervention

Measure method：

Collecting sample(s)
from participants：

Sample Name：

faeces

Tissue：

Fate of sample 

Destruction after use

Note：

Sample Name：

hematology

Tissue：

Fate of sample 

Destruction after use

Note：

Sample Name：

urine

Tissue：

Fate of sample 

Destruction after use

Note：

Recruiting

60
Min age years
85
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

The 66 patients with urinary incontinence after ischemic stroke included were numbered according to the order of consultation from small to large and 66 numbers of different sizes were randomly generated using the SPSS29.0 statistical system which corresponded the patient numbers to the different numbers and after completion the patients were sorted and grouped according to the size of the numbers.

Blinding：

It is not possible to blind the researchers for this trial; it is possible to blind the subjects the collectors of trial data and the statistical analyzers.

IPD sharing：

Yes

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Available from the researcher on request

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

The data collection is recorded by a specialized Case Record Form (CRF) and data management mainly relies on Excel and SPSS 29.0 software.

Data Managemen Committee：

No

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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