N/A
Completed N=500
Effect of Electroacupuncture Versus PFMT Plus Solifenacin for Mixed Urinary Incontinence
Source: ClinicalTrials.gov NCT02047032 ↗Enrolled (actual)
500
Serious AEs
0.2%
Results posted
Jun 2019
Primary outcomePrimary: Percentage of Change From Baseline in 72-hour Incontinence Episode Frequency (IEF) Over Weeks 1-12 — -36.49; -37.83 percent change
Summary
A noninferiority randomized controlled trial aimed at comparing the effect and safety of electroacupuncture versus the pelvic floor muscle training (PFMT) plus solifenacin for mixed urinary incontinence (MUI).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Change From Baseline in 72-hour Incontinence Episode Frequency (IEF) Over Weeks 1-12 |
-36.49; -37.83 | — |
| SECONDARY Percentage of Change From Baseline in Mean 72-hour IEF During Weeks 13-24 and Weeks 25-36 |
-58.20; -56.69; -64.20; -65.48 | — |
| SECONDARY Percentage of Participants With ≥50% Decrease in Average 72-h Incontinence Episode Frequency |
109; 112; 174; 164; 190; 188 | — |
| SECONDARY Change of Episodes From Baseline in Average 72-hour Urgencies/Urination/Nocturia Episodes |
-2.62; -2.99; -4.75; -4.77; -5.55; -5.55 | — |
| SECONDARY Change From Baseline in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Score |
-3.96; -3.73; -6.44; -5.97; -7.06; -6.80 | — |
| SECONDARY Weekly Median Number of Urine Pads Used During Weeks 1-12, 13-24, and 25-36 |
8.0; 9.0; 7.0; 8.0; 8.0; 8.0 | — |
| SECONDARY the Amount of Urine Leakage (Grams) Measured by the 1-hour Pad Test at Weeks 4 and 12 |
-6.74; -6.96; -12.16; -11.49 | — |
| SECONDARY Patient's Treatment Satisfaction Degree |
58; 62; 84; 112; 80; 56 | — |
| SECONDARY Patient Global Impression Improvement |
69; 52; 85; 75; 82; 96 | — |
| SECONDARY Electroacupuncture Acceptance Assessment |
3.0; 3.0; 3.0 | — |
| SECONDARY The Number of Participants Using Urine Pads |
86; 105; 68; 80; 59; 72 | — |
| SECONDARY Change of Episodes From Baseline in Mean 72-h Incontinence Episodes |
-4.56; -4.37; -7.27; -6.95; -8.31; -8.22 | — |
Eligibility Criteria
Inclusion Criteria
- females meet the meet the diagnostic criteria of mixed urinary incontinence
- aged 35-75 years
- moderate and severe urinary incontinence with the urinary incontinence severity index between 3 and 9
- suffering from urinary incontinence at least for 3 months with the 72-h incontinence episode frequency≥2 in the baseline assessment
- voluntarily join the research and sign the informed consent
Exclusion Criteria
- pure stress urinary incontinence, pure urgency urinary incontinence, overflow incontinence and neurogenic bladder
- medicine use for urinary incontinence or may affect the bladder function, or taking any non-drug therapy (such as electric stimulation, bladder training and pelvic floor muscle training) in the last month
- symptomatic urinary tract infection and non-functional urologic disease
- having ever undergone an operation for urinary incontinence or on the pelvic floor (including hysterectomy)
- pelvic organ prolapse degree ≥2
- residual urinary volume (RUV) >30 mL
- maximum flow rate (Qmax) <20 mL/s;
- be allergic to solifenacin or having contradictions for muscarine antagonist (such as urinary retention, gastric retention, myasthenia gravis, ulcerative colitis and angle closure glaucoma)
- diseases affect function of lower urinary tract, such as uncontrolled diabetes, multiple sclerosis, Alzheimer's disease, Parkinson's disease, spinal injury, cauda equina injury and multiple system atrophy.
- serious cardiovascular, pulmonary, cerebral, liver, kidney, hematopoietic system or psychiatric disease and cognitive impairment
- patients with severe renal dysfunction or moderate hepatic dysfunction who are using strong Cyp3a4 Inhibitor like ketoconazole
- unable or limited to walking, up and down stairs and running
- poor compliance with electroacupuncture, pelvic floor muscle training or drug
- pregnancy, lactation or within the 12 months after birth
- having a cardiac pacemaker, a metal allergy, or a severe needle phobia.
- volunteer of other trials
Data sourced from ClinicalTrials.gov (NCT02047032). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.