Evaluation of Integrated Optimization Schemes for Female Stress Incontinence

NCT05053373 | Completed DMC

• 2 other identifiers: ChiCTR-IPR-150067112012BAI24B01
• Study Type: interventional
• Target: 358
• Locations: 1 country
• Sites: 4

Brief Summary

The aim of this study is to determine the effectiveness of PFMT added to EA vs PFMT added sham EA for SUI in women.

Conditions

Stress Urinary Incontinence in Women

Keywords

Stress Urinary Incontinence; Acupuncture

Outcome Measures

Primary Outcomes (1)

• The change of urine loss

  The change of urine loss is measured by the 1-hour urine pad test. The 1-hour pad test will be performed as follows: 1) Empty the bladder and wear a preweighted pad. 2) Drink 500 ml of sodium-free liquid in 15 minutes; 3) walk for half hours, including going up and down stairs; 4) perform the following activity in the remaining 30 minutes: squat and stand up 10 times; cough hard 10 times; run in place for 1 minute; bend down to pick up a small object on the ground 5 times; wash hands for 1 minute with running water. 5) Weigh the pad again to calculate the urine leakage (1 gram equivalent to 1 ml of urine).

  The evaluation will be performed when the participants are first distributed into the groups as a baseline, and then at weeks 2, 4, 6 and 8 of treatment.

Secondary Outcomes (6)

• The average 24-hour urinary incontinence episodes and reduction of more than 50%

  The average 24-hour urinary incontinence episodes and reduction of more than 50% at weeks 2, 4, 6, and 8 of treatment measured by a urinary diary. Reduction more than 50% in urine leakage at week 8 from baseline measured by the 1-hour pad test.

• The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) scores

  The evaluation will be performed at baseline, weeks 4, 6, 8 of treatment, and weeks 20 and 32 of follow-up.

• Participants using urine pads

  week 2-8, week 17-20, week 29-32

• severity of urinary incontinence

  weeks 2, 4, 6, and 8

• Subjective self-evaluation of therapeutic effects

  week 2, week 4, week 6, week 8, week 20, week 32

Study Arms (2)

Electroacupuncture Added to Pelvic Floor Muscle Training

EXPERIMENTAL

Patients will be in a prone position. Bilateral Zhongliao (BL33) and Huiyangacupoint (BL35) will be identified and punctured by an acupuncturist. The electrodes will be placed on the needle handles, and stimulate for 30 minutes at 50 Hz with a current intensity between 1 to 5 mA. PFMT will be performed 3 sets a day (morning, around noon, and night).

Device: Electroacupuncture group; Behavioral: Pelvic floor muscle training

Sham Electroacupuncture Added to Pelvic Floor Muscle Training

EXPERIMENTAL

The preparation for the patients will be the same as that for the patients who will receive EA. Whereas, instead of using real acupuncture needles, special designed placebo needles (size 0.30 × 25 mm) with the blunt-head will be used in the PFMT+sham EA group to penetrate the fixed pad to the skin surface but without skin penetration. The same procedure for deqi will be performed as in the PFMT+EA group. A special-designed cable (the intermediate wire of the cable is cut off but the appearance is normal) will be used to connect the electrodes to the electroacupuncture machine. Therefore, the electroacupuncture machine appears to work, but does not actually stimulated acupoints. The sham EA treatment will also be maintained for 30 minutes. PFMT will be performed 3 sets a day (morning, around noon, and night),

Device: Sham electroacupuncture group; Behavioral: Pelvic floor muscle training

Interventions

Electroacupuncture group DEVICE

Also known as: SDA-V electroacupuncture apparatus(Huatuo,made in China)

Electroacupuncture Added to Pelvic Floor Muscle Training

Sham electroacupuncture group DEVICE

Also known as: Sham SDZ-V electroacupuncture apparatus(Huatuo,China)

Sham Electroacupuncture Added to Pelvic Floor Muscle Training

Pelvic floor muscle training BEHAVIORAL

Electroacupuncture Added to Pelvic Floor Muscle Training; Sham Electroacupuncture Added to Pelvic Floor Muscle Training

Eligibility Criteria

• Age: 40 Years - 75 Years
• Gender Eligibility Details: Women who are 40-75 years of age
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women who are 40-75 years of age
• Involuntary leakage of urine during increased intra-abdominal pressure in the absence of a bladder contraction, such as coughing, sneezing, or other physical activities
• a 1-hour pad test exceeds 1 g
• no other treatments are administered for urinary incontinence currently

You may not qualify if:

• Subject has urgency and mixed urinary
• Subjects with pelvic organ prolapse, pregnancy, a history of pelvic surgery, chronic respiratory diseases, urinary tract infection, cardiac pacemaker installation, metal allergy, severe needle fear, and currently taking medications for SUI or psychological disorders.

Sponsors & Collaborators

• Shanghai Yueyang Integrated Medicine Hospital: lead

Study Sites (4)

Department of Acupuncture and Moxibustion, Nanjing Hospital of Chinese Medicine, Nanjing University of Chinese Medicine

Nanjing, Jiangsu, 210006, China

Location

Department of Acupuncture and Moxibustion, Shaanxi Hospital of Traditional Chinese Medicine

Xi'an, Shaanxi, 710003, China

Location

Department of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200437, China

Location

Department of Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, Tianjin Municipality, 300193, China

Location

Related Publications (24)

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  BACKGROUND

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MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yuelai Chen, Doctor

  Yueyang Hospital of Integrated Traditional Chinese and Western Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: A central randomized system of clinical research (provided by the Clinical Evaluation Center of the Chinese Academy of Traditional Chinese Medicine) will be used for randomization. When eligible subjects are enrolled, randomized personnel from each center will log on to the central random online system to apply for a randomized number. Then the participants will be randomly assigned to PFMT+EA group or PFMT+sham EA group at a ratio of 1:1 to one of four hospitals. The following individuals in the trial will be blinded: 1) participants, this will be achieved by using sham EA procedure; (2) Evaluators, evaluation and record of measurements will be conducted by the evaluators who do not know the grouping situation; (3) Statisticians, group allocation will not be revealed until the statistical analyses are completed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: September 22, 2021
• Study Start: May 20, 2014
• Primary Completion: June 9, 2017
• Study Completion: November 21, 2017
• Last Updated: September 22, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: one year after the data are published
• Access Criteria: Data are available for the editorial office and other investigators following reasonable requests. A data use agreement needs to be signed.

Locations

CN (4)