Acupuncture for Overactive Bladder in Adults

NCT05158361 | Recruiting

• 1 other identifier: 2019S443
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the effectiveness and safety of acupuncture for treating overactive bladder in adults.

Conditions

Overactive Bladder

Keywords

Overactive Bladder; Acupuncture

Outcome Measures

Primary Outcomes (1)

• Change in number of micturition episodes per 24 hours

  Assessed by 72 h bladder diary

  Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up)

Secondary Outcomes (9)

• Number of urinary urgency episodes per 24 hours

  Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up)

• Number of daytime micturition episodes per 24 hours

  Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up)

• Number of nocturia episodes per 24 hours

  Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up)

• Change in mean volume voided per micturition

  Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up)

• Change in OABSS questionnaire

  Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up)

Study Arms (2)

Acupuncture

EXPERIMENTAL

Participants will receive acupuncture.

Other: Acupuncture

Sham acupuncture

SHAM COMPARATOR

Participants will receive sham acupuncture.

Other: Sham acupuncture

Interventions

Acupuncture OTHER

Participants will receive acupuncture, three times per week for eight weeks. The selected acupoints include bilateral BL33, BL35, SP6, and ST36. All acupoints areas have been sterilized before acupuncture. For BL33, a needle (Ф0.40×100mm) will be inserted with an angle of 60° in an inferomedial direction at a depth of 90-100mm. For BL35, the same needle will be inserted with a direction to the ischial rectal fossa at a depth of 60-70 mm deep. For SP6 and ST36, needles (Ф0.30×50mm) will be directly inserted at a depth of 25-30 mm deep. After the needles are inserted, a portable electro-acupuncture machine will be connected to the handles of needles located in BL33 and BL35 to provide the electrical stimulation for 30 minutes with a disperse-dense wave (4/20Hz). All current intensities will be as high as can be tolerated.

Acupuncture

Sham acupuncture OTHER

The sham acupoints will be located at 20 mm outward to BL33, BL35, SP6, and ST36, and the needless will be inserted with a depth of 2 mm. The BL33 and BL35 will not receive any electrical stimulation, though the handles of needles will be connected to the same machine as the acupuncture group, and the parameter setting and course are also the same.

Sham acupuncture

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Present symptoms of urinary frequency and urgency for more than 3 months.
• With a total score of more than 3 points on the overactive Bladder Symptom Score (OABSS) and a score of more than 2 points on question 3 of OABSS.

You may not qualify if:

• With other lower urinary tract disorders (e.g. urinary tract infection, bladder outlet obstruction, neurogenic bladder, interstitial cystitis, etc.)
• With previous pelvic floor surgery or a post-void residual urine volume more than 100 mL.
• With neurological disease or psychiatric illness.
• Taking medications affecting lower urinary tract function.
• With contraindications to acupuncture.
• Pregnant women.

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead

Study Sites (1)

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100053, China

RECRUITING

Related Publications (1)

• Hargreaves E, Baker K, Barry G, Harding C, Zhang Y, Kandala NB, Zhang X, Kernohan A, Clarkson CE. Acupuncture for treating overactive bladder in adults. Cochrane Database Syst Rev. 2022 Sep 23;9(9):CD013519. doi: 10.1002/14651858.CD013519.pub2.

  PMID: 36148895 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; 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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Ran Pang, MD

  Guang'anmen hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ran Pang, MD

CONTACT

+8610-88001040; pangran2002@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: December 15, 2021
• Study Start: March 8, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 4, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)