Acupuncture for Urinary Incontinence

NCT00297427 | Completed Phase 2 Results DMC

• 1 other identifier: R01AT002175-01A1
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

Brief Summary

This research study will evaluate the effectiveness of acupuncture in decreasing urinary incontinence (involuntary urine loss) in women. The study will involve 12 acupuncture sessions over 6 weeks. We will compare the effectiveness of acupuncture and sham (placebo) acupuncture (a procedure in which the needle feels like it penetrates the skin, but is not actually inserted into the body) on the frequency and volume of involuntary (accidental) urine loss after completing the intervention, and again one month later. Individuals participating in this study will be randomly assigned to receive either the actual or sham acupuncture. Randomization means being assigned by chance, similar to flipping a coin. Study participants will not know which group (actual or sham acupuncture) they were assigned to until one month after completing the 6-weeks of treatment. The sham acupuncture needles look similar to the real acupuncture needles and feel like they penetrate the skin, but do not actually do so. If individuals are assigned to the sham acupuncture group, they will be eligible to receive the actual acupuncture one month after completing the sham acupuncture if they wanted to. All individuals will be followed for 6 months after completing the acupuncture treatments.

Conditions

Urinary Incontinence

Keywords

urinary incontinence

Outcome Measures

Primary Outcomes (9)

• Percent Change in Incontinent Episodes

  Percent change in incontinent episodes (measured by self-report electronic bladder diary) at 1 week post-intervention (true or sham acupuncture) relative to baseline.

  Baseline to 1 Week post-intervention

• Percent Change in Incontinent Episodes

  Percent change in incontinent episodes (measured by self-report electronic bladder diary) 4 weeks post true or sham acupuncture

  4 weeks post true or sham acupuncture

• Physical Health-Related Quality of Live

  Percent change in physical health related quality of life measured at 1 week post-intervention (true or sham acupuncture) relative to baseline; measured by the Medical Outcomes Study Short Form-36 (SF-36) Physical Component score. Higher SF-36 Physical Component scores are considered a better outcome.

  1 Week post-intervention

• Physical Health-Related Quality of Life

  Percent change in physical health related quality of life measured at 4 weeks post intervention (true or sham acupuncture) relative to baseline; measured by the Medical Outcomes Study Short Form-36 (SF-36) Physical Component score. Positive change indicates an increase in physical health-related quality of life.

  4-weeks post-intervention

• Mental Health Related Quality of Life

  Percent change in mental health related quality of life measured at 1 week1 post intervention (true or sham acupuncture) relative to baseline; measured by the Medical Outcomes Study Short Form-36 (SF-36) Mental Health Component score. Higher Mental Health Component scores are considered a better outcome.

  1 week post-intervention

• Mental Health Related Quality of Life

  Percent change in mental health related quality of life measured at 4 weeks post intervention (true or sham acupuncture) relative to baseline; measured by the Medical Outcomes Study Short Form-36 (SF-36) Mental Health Component score.

  4 weeks post true or sham acupuncture

• Incontinence-Specific Quality of Life

  Percent change in incontinence specific quality of life at 1 week post intervention (true or sham acupuncture) as measured by the Incontinence Impact Questionnaire. Positive values indicate improvement in incontinence-specific quality of life.

  1 Week post-intervention

• Incontinence-Specific Quality of Life

  Percent change in incontinence-specific quality of life a 4 weeks post-intervention (true or sham acupuncture) measured by the Incontinence Impact Questionnaire. Positive changes indicate improvement in incontinence-specific quality of life.

  4-weeks post-intervention

• Duration of Any Beneficial Effects

  Time to relapse in months of participants who completed true acupuncture initially or who crossed-over following sham (offered to all sham participants)

  monthly during follow-up up to 6 months

Secondary Outcomes (11)

• Change in Bladder Capacity

  Change from baseline to 4 weeks post-intervention

• Urodynamic Diagnostic Impression of Stress Urinary Incontinence

  Baseline and 4 weeks post-treatment

• Urodynamic Impression of Urge Urinary Incontinence

  Baseline and 4 weeks post true or sham acupuncture

• Characteristics of Responders Based on Glasses/Cups Per Day of Non-caffeinated Fluids (Including Water)

  Baseline

• Characteristics of Responders: Duration of Urinary Incontinence (UI) in Years

  Baseline

Study Arms (2)

Acupuncture

EXPERIMENTAL

Subjects will 12 acupuncture treatments over 6 weeks; treatment sessions occur twice a week. A total of 12 acupuncture needles will be inserted bilaterally at two leg points and four back points. Needles are manually inserted through a standard guide tube contained within a fitted sheath and the basal ring secured to the skin by double-sided tape. The needles remain in place for 25 minutes and are manually stimulated twice during each treatment.

Procedure: Acupuncture

Sham acupuncture

SHAM COMPARATOR

Subjects will receive 12 sham acupuncture treatments (delivered twice a week) over 6 weeks. The sham needle is blunted needle whose shaft telescopes into the handle when tapped. While the needle appears to have been inserted, it does not actually penetrate the skin. It is held in place by the same standard guide tube used in the true acupuncture group. The acupuncture points and duration of treatment are the same as for the true acupuncture group.

Other: Sham acupuncture

Interventions

Acupuncture PROCEDURE

Acupuncture twice weekly for 6 weeks.

Acupuncture

Sham acupuncture OTHER

Twice a week for 6 weeks

Sham acupuncture

Eligibility Criteria

• Age: 25 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Urge or stress urinary incontinence at least twice a week on average for at least 3 months

You may not qualify if:

• History of previous acupuncture
• History of a neurologic problem such as Parkinson's disease or multiple sclerosis that could affect bladder function
• Current treatment with overactive bladder medications or medications that relax the bladder
• Urinary catheter
• Pregnancy
• Inability to empty the bladder effectively
• Inability to toilet independently
• Current treatment with steroid
• Interstitial cystitis
• Chronic pelvic pain
• Current treatment with warfarin

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Urinary Incontinence

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Results Point of Contact

• Title: Dr. Sandra Engberg
• Organization: University of Pittsburgh

sje1@pitt.edu

412-624-6616

Study Officials

• Sandra Engberg, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Associate Dean for Graduate Clinical Education

Study Record Dates

• First Submitted: February 24, 2006
• First Posted: February 28, 2006
• Study Start: October 1, 2005
• Primary Completion: May 1, 2011
• Study Completion: July 1, 2011
• Last Updated: October 24, 2016
• Results First Posted: August 1, 2016

Record last verified: 2016-08

Locations

US (1)