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Acupuncture in the treatment of early postpartum stress urinary incontinence: A pilot randomised controlled trial

Registration number：

ITMCTR2024000290

Date of Last Refreshed on：

2024-08-24

Date of Registration：

2024-08-24

Registration Status：

Prospective registration

Public title：

Acupuncture in the treatment of early postpartum stress urinary incontinence: A pilot randomised controlled trial

English Acronym：

Scientific title：

Acupuncture in the treatment of early postpartum stress urinary incontinence: A pilot randomised controlled trial

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Xu Meng

Study leader：

Shi Shufeng

Applicant telephone：

18810383185

Study leader's telephone：

18810383185

Applicant Fax：

Study leader's fax：

Applicant E-mail：

chilli.xu@163.com

Study leader's E-mail：

17860506395@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

No.51 Xiaoguan Street, Andingmenwai, Chaoyang District, Beijing, China

Study leader's address：

No.51 Xiaoguan Street, Andingmenwai, Chaoyang District, Beijing, China

Applicant postcode：

Study leader's postcode：

Applicant's institution：

BEIJING UNIVERSITY OF CHINESE MEDICINE THIRD AFFILIATED HOSPITAL

Approved by ethic committee：

Approved No. of ethic committee：

BZYSY-2024KYKTPJ-23

Approved file of Ethical Committee：

View

Name of the ethic committee：

IRB of The third Hospital affiliated to Beijing University of Chinese Medicine

Date of approved by ethic committee：

2024/7/23 0:00:00

Contact Name of the ethic committee：

Zhao Ying

Contact Address of the ethic committee：

No.51 Xiaoguan Street, Andingmenwai, Chaoyang District, Beijing, China

Contact phone of the ethic committee：

010-84985602

Contact email of the ethic committee：

zydsyec2023@126.com

Primary sponsor：

BEIJING UNIVERSITY OF CHINESE MEDICINE THIRD AFFILIATED HOSPITAL

Primary sponsor's address：

BEIJING UNIVERSITY OF CHINESE MEDICINE THIRD AFFILIATED HOSPITAL

Secondary sponsor：

Country：

CHINA

Province：

Beijing

City：

Institution
hospital：

BEIJING UNIVERSITY OF CHINESE MEDICINE THIRD AFFILIATED HOSPITAL

Address：

No.51 Xiaoguan Street, Andingmenwai, Chaoyang District, Beijing, China

Source(s) of funding：

Section self-financed

Target disease：

Postpartum stress urinary incontinence

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

Postpartum stress urinary incontinence is one of the most common pelvic floor dysfunction disorders in women. In China, acupuncture is widely used to treat female stress urinary incontinence, but there is a lack of high-quality evidence-based medical evidence on acupuncture for postpartum stress urinary incontinence. The purpose of this pre-trial is to initially assess the effectiveness and safety of acupuncture for postpartum stress urinary incontinence, and to provide a reference basis for sample size estimation and feasibility of the study protocol for the formal trial.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

(1) Age 20-40 years; (2) Within 42 days-1 year postpartum; (3) Leakage of urine during coughing, sneezing, laughing or physical activity that stops at the end of stress, with ≥1 episode in three months; (4) Increase in pad weight greater than 1g less than 50g in a 1-hour pad test; (5) Mild and moderate SUI consistent with the Ingelman-Sundberg scale; (6) Voluntary participation in the study and signing the informed consent form. If any of the above items is "No", the participant cannot participate in the trial.

Exclusion criteria：

(1) Multiple pregnancies; (2) Symptoms of urinary incontinence before pregnancy; (3) Having symptoms of urinary frequency and urgency; (4) Having symptoms of urinary tract infection; (5) With unclean postnatal discharge, or with uterine residue after delivery; (6) With uterine or other gynaecological diseases; (7) Having had severe comorbidities, such as combined macrosomia, prolonged second stage of labour, placenta praevia, preterm labour or gestational hypertension; (8) Previous indication for caesarean section or contraindication to vaginal delivery; (9) Previous incontinence surgery or pelvic floor surgery; (10) Have pelvic organ prolapse greater than 2nd degree; (11) Has overactive bladder or urinary tumour; (12) Have diminished contractility of the forced urinary muscles; (13) Receiving specific treatment for continuous or regular SUI within the last month, or taking medications that may affect bladder function; (14) Severe cardiovascular, cerebral, hepatic, renal, or psychiatric disease, diabetes mellitus, multiple system atrophy, cauda equina injury, or spinal cord injury; (15) Have a pacemaker, metal allergy or severe needle phobia; (16) Participation in another clinical study within the last 3 months.

Study execute time：

From 2024-09-01

To      2025-07-22

Recruiting time：

From 2024-09-01

To      2025-07-22

Interventions：

36

Group：

Control group

Sample size：

Intervention：

pelvic floor muscle training + sham acupuncture

Intervention code：

36

Group：

Treatment group

Sample size：

Intervention：

pelvic floor muscle training + acupuncture

Intervention code：

Total sample size ： 72

Countries of recruitment
and research settings：

Country：

China

Province：

Beijing

City：

Institution/hospital：

BEIJING UNIVERSITY OF CHINESE MEDICINE THIRD AFFILIATED HOSPITAL

Level of the institution：

grade A class three hospital

Outcomes：

Outcome：

Pelvic floor muscle strength assessment

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

International Consultation on Incontinence Questionnaire - Short Form

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

One hour urine pad test

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Incontinence Quality of Life Questionnaire

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

72-hour bladder diary

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

not have

Tissue：

Fate of sample 

Others

Note：

Not yet recruiting

20
Min age years
40
Max age years

Recruiting status：

Participant age：

Gender：

Female

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

Eligible subjects will be randomised into 2 groups of 36 patients each, treatment and control, in a 1:1 ratio of 72 patients with early postpartum stress urinary incontinence, using a random number table method, with a random number administrator, who is not involved in this study, being responsible for the random number allocation. Participants, outcome assessors, and statistical analysts were unaware of treatment allocation. For patients who met the inclusion criteria, the random number administrator was called by the recruiter to ask the random number administrator about the patient's random number and grouping and recorded it on the patient's CRF form, while the random number administrator backed up to record the patient's random number and grouping.

Blinding：

The trial was blinded for subjects efficacy evaluators and statistical analysts. For the above persons groups are represented by A and B only. The statistical analysts were blinded to the groups represented by A and B only during the statistical analyses and the blinding was done after the statistical analyses were completed. Due to the characteristics of acupuncture itself this trial was not blinded to acupuncturists. Acupuncturists efficacy evaluators and statisticians were undertaken by separate personnel to achieve separation of the three. To help maximise blinding of subjects placebo needles will be used in the control group and adhesive pads will be used in both groups in the trial to control trial bias as maximally as possible. To evaluate the success of the blinding all subjects will be asked to guess whether the treatment they received was a pinprick or a sham within 5 minutes after the first treatment and 5 minutes after the last treatment.

IPD sharing：

Yes

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

https://pubmed.ncbi.nlm.nih.gov/

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

Data management using CRF tables

Data Managemen Committee：

Yes

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

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