N/A
N=500
Effect of Electroacupuncture Versus PFMT Plus Solifenacin for Mixed Urinary Incontinence
Urinary Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT02047032 ↗Enrolled (actual)
500
Serious AEs
0.2%
Results posted
Jun 2019
Primary outcome: Primary: Percentage of Change From Baseline in 72-hour Incontinence Episode Frequency (IEF) Over Weeks 1-12 — -36.49; -37.83 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- acupuncture (Procedure); solifenacin (Drug); PFMT (Procedure)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- Female
- Sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Primary completion
- Aug 2016
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 | — |
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).
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.