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NCT Number: NCT05798403

Efficacy of Electroacupuncture Versus Solifenacin Succinate for Female Overactive Bladder

Through a scientific and standardized multicenter, blinding, double-dummy, randomized controlled, noninferiority clinical trial study method, the investigators evaluated electroacupuncture as a safe and effective non-pharmacological treatment for OAB in women by comparison with Solifenacin Succinate.

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Longhua Hospital Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200032, China

Location status: Recruiting

Location contact

YUELAI CHEN

CONTACT

[email protected]

0086-13020193726

About this study

Epidemiological researches have shown that approximately 500 million people worldwide are affected by OAB, 2 3 with a higher incidence in women than that in men. Pharmacological treatment remains the usual method of clinical treatment. However, some Pharmacologphy has certain side effects, such as blurred consciousness, dry mouth, constipation, and so on, which have limited its widespread clinical use. Therefore, the treatment of OAB needs comprehensive consideration in clinical practice, which deserves our attention and active exploration of other effective treatment methods to relieve patients' pain.Electroacupuncture can effectively improve the clinical symptoms of OAB. As for the comparison between electroacupuncture and medication for the treatment of OAB in women, the results are inconclusive based on the limited research evidence. The aim of the study is to investigate the effectiveness and safety of electroacupuncture compared to Solifenacin Succinate.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Meet the American Urological Association (AUA) diagnostic criteria for adult overactive bladder disorder (non-neurogenic) and the Chinese Urological Association's Guidelines for the Diagnosis and Treatment of Urological Diseases in China (2014 edition) for OAB.
  • Female patients aged 18-75 years.
  • Duration of illness with OAB ≥ 3 months.
  • 3≤OABSS≤11.
  • No abnormality in routine urine tests.
  • Patients had never received acupuncture treatment.
  • No mental or intellectual abnormalities, able to understand the provisions of the scales and complete the assessment.
  • Consent to participate in this study and sign a written informed consent.

Exclusion criteria

  • Combination of more serious heart, liver, kidney and other serious diseases; Or patients with severe liver or kidney insufficiency.
  • Patients with pelvic organ prolapse ≥ Ⅱ degree, urinary system surgery history or pelvic floor surgery history.
  • Patients with other diseases presenting with OAB symptoms.
  • Those with urinary diseases (such as calculi and tuberculosis of the bladder), malignant tumors, and neurological disorders.
  • Patients who are pregnant or breastfeeding.
  • Patients using medication that may affect bladder function one month prior to enrollment or having received behavioural therapy for OAB three months prior to enrolment, etc.
  • Patients with pacemakers.
  • Patients with blood diseases, diabetes mellitus or mental diseases.
  • Infections, ulcers, abscesses, and skin infections at needling sites; metal allergy or extreme needle phobia.
  • Participation in other clinical medical trial studies over the last month.

Treatment and study plan

Electroacupuncture

Device

All acupuncture locations will be sterilized on a routine basis. As acupuncture needles are inserted, all needles will be lifting, twirling, and thrusting to reach de qi, a sensation generally associated with acupuncture, including swelling, soreness, numbness, and heaviness.

An electrical stimulator is applied to ipsilateral BL32 and BL35 (KI12 and ST28) with continuous waves of 30 Hz and currents of 1 to 5.0 mA. During the study, oral Solifenacin Succinate placebo will be used.

Other names: placebo medication

Solifenacin Succinate Tablets

Drug

During the study, participants will take Solifenacin Succinate. The acupuncture points are the same as the electroacupuncture group, without the insertion of needles. The procedures, electrode positions and other treatment settings are the same as the electroacupuncture group, without the skin penetration, power output or needle manipulation of the de qi. At the end of the treatment, the acupuncturist will press the acupuncture point with a dry cotton ball to allow the patient to feel the "needles"being pulled out.

Other names: Sham electroacupuncture

Primary outcomes

  1. the percentage change in the number of voids every 24 hours at week 4.

    Time frame: At week 4 (end of treatment).

    The percentage change in the number of voids every 24 hours at week 4 compared to baseline. It is measured by a three-day voiding diary.

Secondary outcomes

  1. The percentage change in the number of voids every 24 hours.

    Time frame: At week 2, week 8(follow-up) and week 16 (follow-up).

    The percentage change in the number of voids every 24 hours at 2th, 8th and 16th weeks of the trail.It is measured by a three-day voiding diary.

  2. The mean changes of OABSS.

    Time frame: At week 2, 4 (end of treatment), week 8(follow-up) and week 16 (follow-up).

    The OABSS assessed the occurrence of daytime voiding, nocturnal voiding, urgency and urge incontinence in patients during the last week.

  3. The number of urinary incontinence and urgency every 24 hours.

    Time frame: At week 2, 4 (end of treatment), week 8(follow-up) and week 16 (follow-up).

    The number of urinary incontinence and urgency every 24 hours based on a three-day voiding diary.

  4. Overactive Bladder Questionnaire (OAB-q).

    Time frame: At baseline and week 4 (end of treatment).

    The OAB-q is an observation of the severity and frequency of bladder-related symptoms in patients over the past four weeks.

  5. Generalized Anxiety Disorder 7 (GAD-7)

    Time frame: At baseline and week 4 (end of treatment).

    The GAD-7 is used to assess subjects' anxiety.

  6. Health-Related Quality of Life (HRQoL)

    Time frame: At baseline and week 4 (end of treatment).

    The HRQoL will be measured by the King's Health Questionnaire (KHQ).

  7. Participants'self-evaluation of therapeutic effects.

    Time frame: At week 2, 4 (end of treatment), week 8(follow-up) and week 16 (follow-up).

    It will be evaluated using a four-point scale, which is level 0 (not at all helpful), level 1 (a little helpful), level 2 (moderately helpful) and level 3 (very helpful).

Other outcomes

  1. Incidence of adverse events

    Time frame: During 1-4 weeks.

    Observe the incidence of adverse events during the treatment.

  2. Evaluation of discomfort during treatment.

    Time frame: Within 5 minutes after the first, sixth and twelfth acupuncture treatment.

    Visual analog scale (VAS) will be used to evaluate the degree of discomfort during treatment. The scale ranging from 0 to 10cm, with 0cm indicating no discomfort and 10cm indicating severe discomfort. Evaluation time: The average value of the first and ninth acupuncture treatments was taken within 5 minutes after the end of the two treatments. If the VAS value is missing in one of the cases, another is taken as the result.

  3. Patient acceptability evaluation

    Time frame: Within 5 minutes after the first and ninth acupuncture treatment.

    0=very difficult to accept, 1=slightly difficult to accept, 2=acceptable, 3=easy to accept, 4=very easy to accept. Evaluation time: The average value of the first and ninth acupuncture treatments was taken within 5 minutes after the end of the two treatments. If the VAS value is missing in one of the cases, another is taken as the result.

  4. Blinding assessment

    Time frame: At the end of the 12th session of acupuncture treatment

    Six options will be offered by an independent assessor in an interrogative manner: electroacupuncture, sham electroacupuncture and indeterminate; medication, placebo treatment and indeterminate. The patients' answers will be statistically analyzed to assess the success of the blinded implementation.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Yin Ping

Other

Collaborators

  • Longhua Hospital

Registry information

Official study title

Electroacupuncture Versus Solifenacin Succinate for Female Overactive Bladder: A Multicenter, Randomized, Controlled, Noninferiority Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 4, 2023
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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