Trial Outcomes & Findings for Effect of Electroacupuncture Versus PFMT Plus Solifenacin for Mixed Urinary Incontinence (NCT NCT02047032)
NCT ID: NCT02047032
Last Updated: 2019-06-06
Results Overview
The average 72-h IEF is calculated based on a 72-h bladder diary. All relevant time points used in the calculation in the Time Frame (baseline, weeks 1-12)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
500 participants
Primary outcome timeframe
baseline, weeks 1-12
Results posted on
2019-06-06
Participant Flow
Participant milestones
| Measure |
Acupuncture
BL33 and BL35 of both sides are used. Every session will last for 30 minuets and will be given every other day. There are 36 sessions for each participant in all (3 session per week, 12 weeks).
acupuncture: For BL33, the needle (75mm) will be inserted at the point upper and outside of BL33. Insert the needle with a 30-45°angle to a depth of 50-60 mm. The needle will be manipulated with an even lifting, thrusting and twisting method and the sense of soreness and distention will radiate to the perineal region or the anus. For BL35, the needle will be inserted upward and outward slightly with an even lifting, thrusting and twisting method. The sense of soreness and distention will radiate to the perineal region or the anus. The electric stimulator will be put on the two pair of points with a spare-dense wave, 10/50 Hz, 0.1-5.0 mA. The current intensity will be increased until the participant can not stand.
|
Solifenacin Plus PFMT
Both PFMT and solifenacin will be given for 36 weeks. Solifenacin will be taken 5mg once daily, before or after meal. PFMT includes intensive exercises conducted in hospital and home exercises. Intensive exercises will be done once every week for the first 12 weeks and once every four weeks for the 13th to 36th week. Home exercises will be done three times daily for 36 weeks.
solifenacin: Solifenacin used in this trial is produced by Astellas Pharma Europe B.V.(Country medicine accurate character No. J20090109 )
PFMT: Intensity of the PFMT exercises will conform to the guideline of National Institute for Health and Clinical Excellence (NICE).
|
|---|---|---|
|
Overall Study
STARTED
|
250
|
250
|
|
Overall Study
COMPLETED
|
245
|
235
|
|
Overall Study
NOT COMPLETED
|
5
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Electroacupuncture Versus PFMT Plus Solifenacin for Mixed Urinary Incontinence
Baseline characteristics by cohort
| Measure |
Acupuncture
n=250 Participants
BL33 and BL35 of both sides are used. Every session will last for 30 minuets and will be given every other day. There are 36 sessions for each participant in all (3 session per week, 12 weeks).
acupuncture: For BL33, the needle (75mm) will be inserted at the point upper and outside of BL33. Insert the needle with a 30-45°angle to a depth of 50-60 mm. The needle will be manipulated with an even lifting, thrusting and twisting method and the sense of soreness and distention will radiate to the perineal region or the anus. For BL35, the needle will be inserted upward and outward slightly with an even lifting, thrusting and twisting method. The sense of soreness and distention will radiate to the perineal region or the anus. The electric stimulator will be put on the two pair of points with a spare-dense wave, 10/50 Hz, 0.1-5.0 mA. The current intensity will be increased until the participant can not stand.
|
Solifenacin Plus PFMT
n=250 Participants
Both PFMT and solifenacin will be given for 36 weeks. Solifenacin will be taken 5mg once daily, before or after meal. PFMT includes intensive exercises conducted in hospital and home exercises. Intensive exercises will be done once every week for the first 12 weeks and once every four weeks for the 13th to 36th week. Home exercises will be done three times daily for 36 weeks.
solifenacin: Solifenacin used in this trial is produced by Astellas Pharma Europe B.V.(Country medicine accurate character No. J20090109 )
PFMT: Intensity of the PFMT exercises will conform to the guideline of National Institute for Health and Clinical Excellence (NICE).
|
Total
n=500 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.7 years
STANDARD_DEVIATION 10.11 • n=5 Participants
|
53.7 years
STANDARD_DEVIATION 9.38 • n=7 Participants
|
54.2 years
STANDARD_DEVIATION 9.75 • n=5 Participants
|
|
Sex: Female, Male
Female
|
250 Participants
n=5 Participants
|
250 Participants
n=7 Participants
|
500 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, weeks 1-12Population: 1 patient withdrew consent and did not receive electroacupuncture treatment, 2 refused to participate and did not receive PFMT-solifenacin treatment.
The average 72-h IEF is calculated based on a 72-h bladder diary. All relevant time points used in the calculation in the Time Frame (baseline, weeks 1-12)
Outcome measures
| Measure |
Solifenacin Plus PFMT
n=248 Participants
Both PFMT and solifenacin will be given for 36 weeks. Solifenacin will be taken 5mg once daily, before or after meal. PFMT includes intensive exercises conducted in hospital and home exercises. Intensive exercises will be done once every week for the first 12 weeks and once every four weeks for the 13th to 36th week. Home exercises will be done three times daily for 36 weeks.
solifenacin: Solifenacin used in this trial is produced by Astellas Pharma Europe B.V.(Country medicine accurate character No. J20090109 )
PFMT: Intensity of the PFMT exercises will conform to the guideline of National Institute for Health and Clinical Excellence (NICE).
|
Electroacupuncture
n=249 Participants
BL33 and BL35 of both sides are used. Every session will last for 30 minuets and will be given every other day. There are 36 sessions for each participant in all (3 session per week, 12 weeks).
acupuncture: For BL33, the needle (75mm) will be inserted at the point upper and outside of BL33. Insert the needle with a 30-45°angle to a depth of 50-60 mm. The needle will be manipulated with an even lifting, thrusting and twisting method and the sense of soreness and distention will radiate to the perineal region or the anus. For BL35, the needle will be inserted upward and outward slightly with an even lifting, thrusting and twisting method. The sense of soreness and distention will radiate to the perineal region or the anus. The electric stimulator will be put on the two pair of points with a spare-dense wave, 10/50 Hz, 0.1-5.0 mA. The current intensity will be increased until the participant can not stand.
|
|---|---|---|
|
Percentage of Change From Baseline in 72-hour Incontinence Episode Frequency (IEF) Over Weeks 1-12
|
-36.49 percent change
Interval -43.87 to -29.11
|
-37.83 percent change
Interval -41.96 to 33.7
|
SECONDARY outcome
Timeframe: baseline, weeks 13-24, week 25-36Population: 1 patient withdrew consent and did not receive electroacupuncture treatment, 2 refused to participate and did not receive PFMT-solifenacin treatment.
Calculated as the same way as the primary outcome. But this outcome will be assessed at different time point.
Outcome measures
| Measure |
Solifenacin Plus PFMT
n=249 Participants
Both PFMT and solifenacin will be given for 36 weeks. Solifenacin will be taken 5mg once daily, before or after meal. PFMT includes intensive exercises conducted in hospital and home exercises. Intensive exercises will be done once every week for the first 12 weeks and once every four weeks for the 13th to 36th week. Home exercises will be done three times daily for 36 weeks.
solifenacin: Solifenacin used in this trial is produced by Astellas Pharma Europe B.V.(Country medicine accurate character No. J20090109 )
PFMT: Intensity of the PFMT exercises will conform to the guideline of National Institute for Health and Clinical Excellence (NICE).
|
Electroacupuncture
n=248 Participants
BL33 and BL35 of both sides are used. Every session will last for 30 minuets and will be given every other day. There are 36 sessions for each participant in all (3 session per week, 12 weeks).
acupuncture: For BL33, the needle (75mm) will be inserted at the point upper and outside of BL33. Insert the needle with a 30-45°angle to a depth of 50-60 mm. The needle will be manipulated with an even lifting, thrusting and twisting method and the sense of soreness and distention will radiate to the perineal region or the anus. For BL35, the needle will be inserted upward and outward slightly with an even lifting, thrusting and twisting method. The sense of soreness and distention will radiate to the perineal region or the anus. The electric stimulator will be put on the two pair of points with a spare-dense wave, 10/50 Hz, 0.1-5.0 mA. The current intensity will be increased until the participant can not stand.
|
|---|---|---|
|
Percentage of Change From Baseline in Mean 72-hour IEF During Weeks 13-24 and Weeks 25-36
Weeks 13-24
|
-58.20 percent change
Interval -63.19 to -53.22
|
-56.69 percent change
Interval -61.77 to -51.61
|
|
Percentage of Change From Baseline in Mean 72-hour IEF During Weeks 13-24 and Weeks 25-36
Weeks 25-36
|
-64.20 percent change
Interval -68.77 to -59.63
|
-65.48 percent change
Interval -70.14 to -60.82
|
SECONDARY outcome
Timeframe: Weeks 1-12, 13-24, 25-36Population: For various reasons, participants discontinued study.
Count the number of cases with the reduction of average 72-h incontinence episode frequency ≥50% and divide it by the number of participants at baseline.
Outcome measures
| Measure |
Solifenacin Plus PFMT
n=249 Participants
Both PFMT and solifenacin will be given for 36 weeks. Solifenacin will be taken 5mg once daily, before or after meal. PFMT includes intensive exercises conducted in hospital and home exercises. Intensive exercises will be done once every week for the first 12 weeks and once every four weeks for the 13th to 36th week. Home exercises will be done three times daily for 36 weeks.
solifenacin: Solifenacin used in this trial is produced by Astellas Pharma Europe B.V.(Country medicine accurate character No. J20090109 )
PFMT: Intensity of the PFMT exercises will conform to the guideline of National Institute for Health and Clinical Excellence (NICE).
|
Electroacupuncture
n=248 Participants
BL33 and BL35 of both sides are used. Every session will last for 30 minuets and will be given every other day. There are 36 sessions for each participant in all (3 session per week, 12 weeks).
acupuncture: For BL33, the needle (75mm) will be inserted at the point upper and outside of BL33. Insert the needle with a 30-45°angle to a depth of 50-60 mm. The needle will be manipulated with an even lifting, thrusting and twisting method and the sense of soreness and distention will radiate to the perineal region or the anus. For BL35, the needle will be inserted upward and outward slightly with an even lifting, thrusting and twisting method. The sense of soreness and distention will radiate to the perineal region or the anus. The electric stimulator will be put on the two pair of points with a spare-dense wave, 10/50 Hz, 0.1-5.0 mA. The current intensity will be increased until the participant can not stand.
|
|---|---|---|
|
Percentage of Participants With ≥50% Decrease in Average 72-h Incontinence Episode Frequency
Weeks 1-12
|
109 Participants
|
112 Participants
|
|
Percentage of Participants With ≥50% Decrease in Average 72-h Incontinence Episode Frequency
Weeks 13-24
|
174 Participants
|
164 Participants
|
|
Percentage of Participants With ≥50% Decrease in Average 72-h Incontinence Episode Frequency
Weeks 25-36
|
190 Participants
|
188 Participants
|
SECONDARY outcome
Timeframe: Baseline, weeks 1-12, 13-24, 25-36Population: 1 patient withdrew consent and did not receive electroacupuncture treatment, 2 refused to participate and did not receive PFMT-solifenacin treatment.
The average 72-h IEF (urinary incontinence, stress urinary incontinence and urgency urinary incontinence respectively) is calculated based on a 72-h bladder diary. For example, the average 72-h incontinence episodes from the 13th to 36th week equal to the sum of 72-h incontinence episodes of the 16th, 20th, 24th, 28th, 32nd, 36th weeks divided by 6.
Outcome measures
| Measure |
Solifenacin Plus PFMT
n=249 Participants
Both PFMT and solifenacin will be given for 36 weeks. Solifenacin will be taken 5mg once daily, before or after meal. PFMT includes intensive exercises conducted in hospital and home exercises. Intensive exercises will be done once every week for the first 12 weeks and once every four weeks for the 13th to 36th week. Home exercises will be done three times daily for 36 weeks.
solifenacin: Solifenacin used in this trial is produced by Astellas Pharma Europe B.V.(Country medicine accurate character No. J20090109 )
PFMT: Intensity of the PFMT exercises will conform to the guideline of National Institute for Health and Clinical Excellence (NICE).
|
Electroacupuncture
n=248 Participants
BL33 and BL35 of both sides are used. Every session will last for 30 minuets and will be given every other day. There are 36 sessions for each participant in all (3 session per week, 12 weeks).
acupuncture: For BL33, the needle (75mm) will be inserted at the point upper and outside of BL33. Insert the needle with a 30-45°angle to a depth of 50-60 mm. The needle will be manipulated with an even lifting, thrusting and twisting method and the sense of soreness and distention will radiate to the perineal region or the anus. For BL35, the needle will be inserted upward and outward slightly with an even lifting, thrusting and twisting method. The sense of soreness and distention will radiate to the perineal region or the anus. The electric stimulator will be put on the two pair of points with a spare-dense wave, 10/50 Hz, 0.1-5.0 mA. The current intensity will be increased until the participant can not stand.
|
|---|---|---|
|
Change of Episodes From Baseline in Average 72-hour Urgencies/Urination/Nocturia Episodes
Change in the 72-h urgence, Weeks 13-24
|
-4.75 percent change
Interval -5.32 to -4.19
|
-4.77 percent change
Interval -5.35 to -4.19
|
|
Change of Episodes From Baseline in Average 72-hour Urgencies/Urination/Nocturia Episodes
Change in the 72-h urgence, Weeks 25-36
|
-5.55 percent change
Interval -6.12 to -4.97
|
-5.55 percent change
Interval -6.14 to -4.96
|
|
Change of Episodes From Baseline in Average 72-hour Urgencies/Urination/Nocturia Episodes
Change in the 72-h urination, Weeks 1-12
|
-3.23 percent change
Interval -3.93 to -2.53
|
-3.62 percent change
Interval -4.33 to -2.91
|
|
Change of Episodes From Baseline in Average 72-hour Urgencies/Urination/Nocturia Episodes
Change in the 72-h urination, Weeks 13-24
|
-5.96 percent change
Interval -6.7 to -5.22
|
-5.26 percent change
Interval -6.02 to -4.51
|
|
Change of Episodes From Baseline in Average 72-hour Urgencies/Urination/Nocturia Episodes
Change in the 72-h nocturia, Weeks 1-12
|
-0.79 percent change
Interval -1.01 to -0.5
|
-0.87 percent change
Interval -1.08 to -0.65
|
|
Change of Episodes From Baseline in Average 72-hour Urgencies/Urination/Nocturia Episodes
Change in the 72-h nocturia, Weeks 13-24
|
-1.38 percent change
Interval -1.6 to -1.15
|
-1.33 percent change
Interval -1.56 to -1.11
|
|
Change of Episodes From Baseline in Average 72-hour Urgencies/Urination/Nocturia Episodes
Change in the 72-h nocturia, Weeks 25-36
|
-1.58 percent change
Interval -1.79 to -1.36
|
-1.58 percent change
Interval -1.8 to -1.36
|
|
Change of Episodes From Baseline in Average 72-hour Urgencies/Urination/Nocturia Episodes
Change in the 72-h urgence, Weeks 1-12
|
-2.62 percent change
Interval -3.2 to -2.05
|
-2.99 percent change
Interval -3.58 to -2.41
|
|
Change of Episodes From Baseline in Average 72-hour Urgencies/Urination/Nocturia Episodes
Change in the 72-h urination, Weeks 25-36
|
-7.02 percent change
Interval -7.85 to -6.19
|
-6.11 percent change
Interval -6.96 to -5.26
|
SECONDARY outcome
Timeframe: baseline, weeks 12, 24 and 36The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF (range, 0 \[best\]-21 \[worst\] outcomes, and 2.52 as minimal clinically important differences (MCID)) scores.
Outcome measures
| Measure |
Solifenacin Plus PFMT
n=249 Participants
Both PFMT and solifenacin will be given for 36 weeks. Solifenacin will be taken 5mg once daily, before or after meal. PFMT includes intensive exercises conducted in hospital and home exercises. Intensive exercises will be done once every week for the first 12 weeks and once every four weeks for the 13th to 36th week. Home exercises will be done three times daily for 36 weeks.
solifenacin: Solifenacin used in this trial is produced by Astellas Pharma Europe B.V.(Country medicine accurate character No. J20090109 )
PFMT: Intensity of the PFMT exercises will conform to the guideline of National Institute for Health and Clinical Excellence (NICE).
|
Electroacupuncture
n=248 Participants
BL33 and BL35 of both sides are used. Every session will last for 30 minuets and will be given every other day. There are 36 sessions for each participant in all (3 session per week, 12 weeks).
acupuncture: For BL33, the needle (75mm) will be inserted at the point upper and outside of BL33. Insert the needle with a 30-45°angle to a depth of 50-60 mm. The needle will be manipulated with an even lifting, thrusting and twisting method and the sense of soreness and distention will radiate to the perineal region or the anus. For BL35, the needle will be inserted upward and outward slightly with an even lifting, thrusting and twisting method. The sense of soreness and distention will radiate to the perineal region or the anus. The electric stimulator will be put on the two pair of points with a spare-dense wave, 10/50 Hz, 0.1-5.0 mA. The current intensity will be increased until the participant can not stand.
|
|---|---|---|
|
Change From Baseline in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Score
Week 36
|
-7.06 units on a scale
Interval -7.51 to -6.6
|
-6.80 units on a scale
Interval -7.26 to -6.34
|
|
Change From Baseline in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Score
Week 12
|
-3.96 units on a scale
Interval -4.32 to -3.61
|
-3.73 units on a scale
Interval -4.09 to -3.37
|
|
Change From Baseline in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Score
Week 24
|
-6.44 units on a scale
Interval -6.9 to -5.98
|
-5.97 units on a scale
Interval -6.44 to -5.5
|
SECONDARY outcome
Timeframe: Baseline, weeks 1-12, 13-24, 25-36Population: 1 patient withdrew consent and did not receive electroacupuncture treatment, 2 refused to participate and did not receive PFMT-solifenacin treatment.
Outcome measures
| Measure |
Solifenacin Plus PFMT
n=249 Participants
Both PFMT and solifenacin will be given for 36 weeks. Solifenacin will be taken 5mg once daily, before or after meal. PFMT includes intensive exercises conducted in hospital and home exercises. Intensive exercises will be done once every week for the first 12 weeks and once every four weeks for the 13th to 36th week. Home exercises will be done three times daily for 36 weeks.
solifenacin: Solifenacin used in this trial is produced by Astellas Pharma Europe B.V.(Country medicine accurate character No. J20090109 )
PFMT: Intensity of the PFMT exercises will conform to the guideline of National Institute for Health and Clinical Excellence (NICE).
|
Electroacupuncture
n=248 Participants
BL33 and BL35 of both sides are used. Every session will last for 30 minuets and will be given every other day. There are 36 sessions for each participant in all (3 session per week, 12 weeks).
acupuncture: For BL33, the needle (75mm) will be inserted at the point upper and outside of BL33. Insert the needle with a 30-45°angle to a depth of 50-60 mm. The needle will be manipulated with an even lifting, thrusting and twisting method and the sense of soreness and distention will radiate to the perineal region or the anus. For BL35, the needle will be inserted upward and outward slightly with an even lifting, thrusting and twisting method. The sense of soreness and distention will radiate to the perineal region or the anus. The electric stimulator will be put on the two pair of points with a spare-dense wave, 10/50 Hz, 0.1-5.0 mA. The current intensity will be increased until the participant can not stand.
|
|---|---|---|
|
Weekly Median Number of Urine Pads Used During Weeks 1-12, 13-24, and 25-36
Weeks 1-12
|
8.0 urine pads
Interval 5.0 to 11.0
|
9.0 urine pads
Interval 5.0 to 12.0
|
|
Weekly Median Number of Urine Pads Used During Weeks 1-12, 13-24, and 25-36
Weeks 13-24
|
7.0 urine pads
Interval 4.0 to 10.0
|
8.0 urine pads
Interval 5.0 to 12.0
|
|
Weekly Median Number of Urine Pads Used During Weeks 1-12, 13-24, and 25-36
Weeks 25-36
|
8.0 urine pads
Interval 4.0 to 10.0
|
8.0 urine pads
Interval 5.0 to 12.0
|
SECONDARY outcome
Timeframe: Weeks 4 and 12Population: 1 patient withdrew consent and did not receive electroacupuncture treatment, 2 refused to participate and did not receive PFMT-solifenacin treatment.
The performance of 1-hour pad test according to the International Incontinence Society: Participants were instructed to void 2 hours before the pad test. On arrival, they received a pre-weighed pad and were asked to sit and drink 500 ml sodium-free water in 15 minutes. Next, they were instructed to walk for 30 minutes, including going up and down 24 stairs. On returning to the clinic, the participants were instructed to perform several activities, including standing and sitting 10 times, coughing vigorously 10 times, running for 1 minute, picking up a coin from the floor 5 times, and putting their hands under water for 1 minute. After the activities were completed, the pad was reweighed to measure the amount of urinary leakage using a gram sensitive weight scale (Xiangshan, EK3820).
Outcome measures
| Measure |
Solifenacin Plus PFMT
n=249 Participants
Both PFMT and solifenacin will be given for 36 weeks. Solifenacin will be taken 5mg once daily, before or after meal. PFMT includes intensive exercises conducted in hospital and home exercises. Intensive exercises will be done once every week for the first 12 weeks and once every four weeks for the 13th to 36th week. Home exercises will be done three times daily for 36 weeks.
solifenacin: Solifenacin used in this trial is produced by Astellas Pharma Europe B.V.(Country medicine accurate character No. J20090109 )
PFMT: Intensity of the PFMT exercises will conform to the guideline of National Institute for Health and Clinical Excellence (NICE).
|
Electroacupuncture
n=248 Participants
BL33 and BL35 of both sides are used. Every session will last for 30 minuets and will be given every other day. There are 36 sessions for each participant in all (3 session per week, 12 weeks).
acupuncture: For BL33, the needle (75mm) will be inserted at the point upper and outside of BL33. Insert the needle with a 30-45°angle to a depth of 50-60 mm. The needle will be manipulated with an even lifting, thrusting and twisting method and the sense of soreness and distention will radiate to the perineal region or the anus. For BL35, the needle will be inserted upward and outward slightly with an even lifting, thrusting and twisting method. The sense of soreness and distention will radiate to the perineal region or the anus. The electric stimulator will be put on the two pair of points with a spare-dense wave, 10/50 Hz, 0.1-5.0 mA. The current intensity will be increased until the participant can not stand.
|
|---|---|---|
|
the Amount of Urine Leakage (Grams) Measured by the 1-hour Pad Test at Weeks 4 and 12
Week 4
|
-6.74 amount of leakage (grams)
Interval -7.93 to -5.56
|
-6.96 amount of leakage (grams)
Interval -8.17 to -5.76
|
|
the Amount of Urine Leakage (Grams) Measured by the 1-hour Pad Test at Weeks 4 and 12
Week 12
|
-12.16 amount of leakage (grams)
Interval -13.18 to -11.15
|
-11.49 amount of leakage (grams)
Interval -12.52 to -10.46
|
SECONDARY outcome
Timeframe: Weeks 12, 36Population: 1 patient withdrew consent and did not receive electroacupuncture treatment. 2 refused to participate and did not receive PFMT-solifenacin treatment.
The self-assessing satisfaction degree on a 5-point Likert scale (range, 1 \[unsatisfied strongly\] to 5 \[satisfied strongly\]) will be finished by participants to evaluate their satisfaction for the treatment.
Outcome measures
| Measure |
Solifenacin Plus PFMT
n=248 Participants
Both PFMT and solifenacin will be given for 36 weeks. Solifenacin will be taken 5mg once daily, before or after meal. PFMT includes intensive exercises conducted in hospital and home exercises. Intensive exercises will be done once every week for the first 12 weeks and once every four weeks for the 13th to 36th week. Home exercises will be done three times daily for 36 weeks.
solifenacin: Solifenacin used in this trial is produced by Astellas Pharma Europe B.V.(Country medicine accurate character No. J20090109 )
PFMT: Intensity of the PFMT exercises will conform to the guideline of National Institute for Health and Clinical Excellence (NICE).
|
Electroacupuncture
n=249 Participants
BL33 and BL35 of both sides are used. Every session will last for 30 minuets and will be given every other day. There are 36 sessions for each participant in all (3 session per week, 12 weeks).
acupuncture: For BL33, the needle (75mm) will be inserted at the point upper and outside of BL33. Insert the needle with a 30-45°angle to a depth of 50-60 mm. The needle will be manipulated with an even lifting, thrusting and twisting method and the sense of soreness and distention will radiate to the perineal region or the anus. For BL35, the needle will be inserted upward and outward slightly with an even lifting, thrusting and twisting method. The sense of soreness and distention will radiate to the perineal region or the anus. The electric stimulator will be put on the two pair of points with a spare-dense wave, 10/50 Hz, 0.1-5.0 mA. The current intensity will be increased until the participant can not stand.
|
|---|---|---|
|
Patient's Treatment Satisfaction Degree
Week 12 · Marked satisfaction
|
58 Participants
|
62 Participants
|
|
Patient's Treatment Satisfaction Degree
Week 12 · Satisfaction
|
84 Participants
|
112 Participants
|
|
Patient's Treatment Satisfaction Degree
Week 12 · No change
|
80 Participants
|
56 Participants
|
|
Patient's Treatment Satisfaction Degree
Week 12 · Dissatisfaction
|
12 Participants
|
12 Participants
|
|
Patient's Treatment Satisfaction Degree
Week 12 · Marked dissatisfaction
|
0 Participants
|
1 Participants
|
|
Patient's Treatment Satisfaction Degree
Week 36 · Marked satisfaction
|
77 Participants
|
85 Participants
|
|
Patient's Treatment Satisfaction Degree
Week 36 · Satisfaction
|
90 Participants
|
101 Participants
|
|
Patient's Treatment Satisfaction Degree
Week 36 · No change
|
58 Participants
|
47 Participants
|
|
Patient's Treatment Satisfaction Degree
Week 36 · Dissatisfaction
|
9 Participants
|
11 Participants
|
|
Patient's Treatment Satisfaction Degree
Week 36 · Marked dissatisfaction
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Weeks 12, 36Population: 1 patient withdrew consent and did not receive electroacupuncture treatment, 2 refused to participate and did not receive PFMT-solifenacin treatment.
Participants will be asked to finish one item evaluating their present condition.
Outcome measures
| Measure |
Solifenacin Plus PFMT
n=249 Participants
Both PFMT and solifenacin will be given for 36 weeks. Solifenacin will be taken 5mg once daily, before or after meal. PFMT includes intensive exercises conducted in hospital and home exercises. Intensive exercises will be done once every week for the first 12 weeks and once every four weeks for the 13th to 36th week. Home exercises will be done three times daily for 36 weeks.
solifenacin: Solifenacin used in this trial is produced by Astellas Pharma Europe B.V.(Country medicine accurate character No. J20090109 )
PFMT: Intensity of the PFMT exercises will conform to the guideline of National Institute for Health and Clinical Excellence (NICE).
|
Electroacupuncture
n=248 Participants
BL33 and BL35 of both sides are used. Every session will last for 30 minuets and will be given every other day. There are 36 sessions for each participant in all (3 session per week, 12 weeks).
acupuncture: For BL33, the needle (75mm) will be inserted at the point upper and outside of BL33. Insert the needle with a 30-45°angle to a depth of 50-60 mm. The needle will be manipulated with an even lifting, thrusting and twisting method and the sense of soreness and distention will radiate to the perineal region or the anus. For BL35, the needle will be inserted upward and outward slightly with an even lifting, thrusting and twisting method. The sense of soreness and distention will radiate to the perineal region or the anus. The electric stimulator will be put on the two pair of points with a spare-dense wave, 10/50 Hz, 0.1-5.0 mA. The current intensity will be increased until the participant can not stand.
|
|---|---|---|
|
Patient Global Impression Improvement
Week 12 · Marked improvement
|
69 Participants
|
52 Participants
|
|
Patient Global Impression Improvement
Week 12 · Moderate improvement
|
85 Participants
|
75 Participants
|
|
Patient Global Impression Improvement
Week 12 · Slight improvement
|
82 Participants
|
96 Participants
|
|
Patient Global Impression Improvement
Week 12 · No change
|
8 Participants
|
8 Participants
|
|
Patient Global Impression Improvement
Week 12 · Slight worsening
|
0 Participants
|
3 Participants
|
|
Patient Global Impression Improvement
Week 12 · Moderate worsening
|
0 Participants
|
0 Participants
|
|
Patient Global Impression Improvement
Week 12 · Marked worening
|
0 Participants
|
0 Participants
|
|
Patient Global Impression Improvement
Week 36 · Marked improvement
|
87 Participants
|
74 Participants
|
|
Patient Global Impression Improvement
Week 36 · Slight improvement
|
55 Participants
|
59 Participants
|
|
Patient Global Impression Improvement
Week 36 · No change
|
9 Participants
|
9 Participants
|
|
Patient Global Impression Improvement
Week 36 · Slight worsening
|
1 Participants
|
1 Participants
|
|
Patient Global Impression Improvement
Week 36 · Moderate worsening
|
0 Participants
|
0 Participants
|
|
Patient Global Impression Improvement
Week 36 · Marked worening
|
0 Participants
|
0 Participants
|
|
Patient Global Impression Improvement
Week 36 · Moderate improvement
|
93 Participants
|
92 Participants
|
SECONDARY outcome
Timeframe: Weeks 2, 6 and 12Population: 1 patient withdrew consent and did not receive electroacupuncture treatment.
The acceptance of electroacupuncture will be tested within 5 minute with a 5-point scale ('0' means very difficult to accept and '4' means accept easily). Median of scores of the three times will be calculated.
Outcome measures
| Measure |
Solifenacin Plus PFMT
n=249 Participants
Both PFMT and solifenacin will be given for 36 weeks. Solifenacin will be taken 5mg once daily, before or after meal. PFMT includes intensive exercises conducted in hospital and home exercises. Intensive exercises will be done once every week for the first 12 weeks and once every four weeks for the 13th to 36th week. Home exercises will be done three times daily for 36 weeks.
solifenacin: Solifenacin used in this trial is produced by Astellas Pharma Europe B.V.(Country medicine accurate character No. J20090109 )
PFMT: Intensity of the PFMT exercises will conform to the guideline of National Institute for Health and Clinical Excellence (NICE).
|
Electroacupuncture
BL33 and BL35 of both sides are used. Every session will last for 30 minuets and will be given every other day. There are 36 sessions for each participant in all (3 session per week, 12 weeks).
acupuncture: For BL33, the needle (75mm) will be inserted at the point upper and outside of BL33. Insert the needle with a 30-45°angle to a depth of 50-60 mm. The needle will be manipulated with an even lifting, thrusting and twisting method and the sense of soreness and distention will radiate to the perineal region or the anus. For BL35, the needle will be inserted upward and outward slightly with an even lifting, thrusting and twisting method. The sense of soreness and distention will radiate to the perineal region or the anus. The electric stimulator will be put on the two pair of points with a spare-dense wave, 10/50 Hz, 0.1-5.0 mA. The current intensity will be increased until the participant can not stand.
|
|---|---|---|
|
Electroacupuncture Acceptance Assessment
Week 2
|
3.0 units on a scale
Interval 3.0 to 3.0
|
—
|
|
Electroacupuncture Acceptance Assessment
Week 6
|
3.0 units on a scale
Interval 2.0 to 3.0
|
—
|
|
Electroacupuncture Acceptance Assessment
Week 12
|
3.0 units on a scale
Interval 2.0 to 3.0
|
—
|
SECONDARY outcome
Timeframe: Weeks 1-12, 13-24, 25-36Population: For various reasons, the participants discontinued study.
Outcome measures
| Measure |
Solifenacin Plus PFMT
n=249 Participants
Both PFMT and solifenacin will be given for 36 weeks. Solifenacin will be taken 5mg once daily, before or after meal. PFMT includes intensive exercises conducted in hospital and home exercises. Intensive exercises will be done once every week for the first 12 weeks and once every four weeks for the 13th to 36th week. Home exercises will be done three times daily for 36 weeks.
solifenacin: Solifenacin used in this trial is produced by Astellas Pharma Europe B.V.(Country medicine accurate character No. J20090109 )
PFMT: Intensity of the PFMT exercises will conform to the guideline of National Institute for Health and Clinical Excellence (NICE).
|
Electroacupuncture
n=248 Participants
BL33 and BL35 of both sides are used. Every session will last for 30 minuets and will be given every other day. There are 36 sessions for each participant in all (3 session per week, 12 weeks).
acupuncture: For BL33, the needle (75mm) will be inserted at the point upper and outside of BL33. Insert the needle with a 30-45°angle to a depth of 50-60 mm. The needle will be manipulated with an even lifting, thrusting and twisting method and the sense of soreness and distention will radiate to the perineal region or the anus. For BL35, the needle will be inserted upward and outward slightly with an even lifting, thrusting and twisting method. The sense of soreness and distention will radiate to the perineal region or the anus. The electric stimulator will be put on the two pair of points with a spare-dense wave, 10/50 Hz, 0.1-5.0 mA. The current intensity will be increased until the participant can not stand.
|
|---|---|---|
|
The Number of Participants Using Urine Pads
Weeks 25-36
|
59 Participants
|
72 Participants
|
|
The Number of Participants Using Urine Pads
Weeks 1-12
|
86 Participants
|
105 Participants
|
|
The Number of Participants Using Urine Pads
Weeks 13-24
|
68 Participants
|
80 Participants
|
SECONDARY outcome
Timeframe: Weeks 1-12, 13-24, 25-36Population: 1 patient withdrew consent and did not receive electroacupuncture treatment, 2 refused to participate and did not receive PFMT-solifenacin treatment.
Outcome measures
| Measure |
Solifenacin Plus PFMT
n=249 Participants
Both PFMT and solifenacin will be given for 36 weeks. Solifenacin will be taken 5mg once daily, before or after meal. PFMT includes intensive exercises conducted in hospital and home exercises. Intensive exercises will be done once every week for the first 12 weeks and once every four weeks for the 13th to 36th week. Home exercises will be done three times daily for 36 weeks.
solifenacin: Solifenacin used in this trial is produced by Astellas Pharma Europe B.V.(Country medicine accurate character No. J20090109 )
PFMT: Intensity of the PFMT exercises will conform to the guideline of National Institute for Health and Clinical Excellence (NICE).
|
Electroacupuncture
n=248 Participants
BL33 and BL35 of both sides are used. Every session will last for 30 minuets and will be given every other day. There are 36 sessions for each participant in all (3 session per week, 12 weeks).
acupuncture: For BL33, the needle (75mm) will be inserted at the point upper and outside of BL33. Insert the needle with a 30-45°angle to a depth of 50-60 mm. The needle will be manipulated with an even lifting, thrusting and twisting method and the sense of soreness and distention will radiate to the perineal region or the anus. For BL35, the needle will be inserted upward and outward slightly with an even lifting, thrusting and twisting method. The sense of soreness and distention will radiate to the perineal region or the anus. The electric stimulator will be put on the two pair of points with a spare-dense wave, 10/50 Hz, 0.1-5.0 mA. The current intensity will be increased until the participant can not stand.
|
|---|---|---|
|
Change of Episodes From Baseline in Mean 72-h Incontinence Episodes
Weeks 1-12
|
-4.56 episodes
Interval -5.13 to -3.98
|
-4.37 episodes
Interval -4.95 to -3.79
|
|
Change of Episodes From Baseline in Mean 72-h Incontinence Episodes
Weeks 13-24
|
-7.27 episodes
Interval -7.83 to -6.7
|
-6.95 episodes
Interval -7.52 to -6.37
|
|
Change of Episodes From Baseline in Mean 72-h Incontinence Episodes
Weeks 25-36
|
-8.31 episodes
Interval -8.83 to -7.78
|
-8.22 episodes
Interval -8.76 to -7.69
|
Adverse Events
Electroacupuncture
Serious events: 0 serious events
Other events: 41 other events
Deaths: 0 deaths
Solifenacin Plus PFMT
Serious events: 1 serious events
Other events: 90 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Electroacupuncture
n=250 participants at risk
BL33 and BL35 of both sides are used. Every session will last for 30 minuets and will be given every other day. There are 36 sessions for each participant in all (3 session per week, 12 weeks).
acupuncture: For BL33, the needle (75mm) will be inserted at the point upper and outside of BL33. Insert the needle with a 30-45°angle to a depth of 50-60 mm. The needle will be manipulated with an even lifting, thrusting and twisting method and the sense of soreness and distention will radiate to the perineal region or the anus. For BL35, the needle will be inserted upward and outward slightly with an even lifting, thrusting and twisting method. The sense of soreness and distention will radiate to the perineal region or the anus. The electric stimulator will be put on the two pair of points with a spare-dense wave, 10/50 Hz, 0.1-5.0 mA. The current intensity will be increased until the participant can not stand.
|
Solifenacin Plus PFMT
n=250 participants at risk
Both PFMT and solifenacin will be given for 36 weeks. Solifenacin will be taken 5mg once daily, before or after meal. PFMT includes intensive exercises conducted in hospital and home exercises. Intensive exercises will be done once every week for the first 12 weeks and once every four weeks for the 13th to 36th week. Home exercises will be done three times daily for 36 weeks.
solifenacin: Solifenacin used in this trial is produced by Astellas Pharma Europe B.V.(Country medicine accurate character No. J20090109 )
PFMT: Intensity of the PFMT exercises will conform to the guideline of National Institute for Health and Clinical Excellence (NICE).
|
|---|---|---|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/250
|
0.40%
1/250 • Number of events 1
|
Other adverse events
| Measure |
Electroacupuncture
n=250 participants at risk
BL33 and BL35 of both sides are used. Every session will last for 30 minuets and will be given every other day. There are 36 sessions for each participant in all (3 session per week, 12 weeks).
acupuncture: For BL33, the needle (75mm) will be inserted at the point upper and outside of BL33. Insert the needle with a 30-45°angle to a depth of 50-60 mm. The needle will be manipulated with an even lifting, thrusting and twisting method and the sense of soreness and distention will radiate to the perineal region or the anus. For BL35, the needle will be inserted upward and outward slightly with an even lifting, thrusting and twisting method. The sense of soreness and distention will radiate to the perineal region or the anus. The electric stimulator will be put on the two pair of points with a spare-dense wave, 10/50 Hz, 0.1-5.0 mA. The current intensity will be increased until the participant can not stand.
|
Solifenacin Plus PFMT
n=250 participants at risk
Both PFMT and solifenacin will be given for 36 weeks. Solifenacin will be taken 5mg once daily, before or after meal. PFMT includes intensive exercises conducted in hospital and home exercises. Intensive exercises will be done once every week for the first 12 weeks and once every four weeks for the 13th to 36th week. Home exercises will be done three times daily for 36 weeks.
solifenacin: Solifenacin used in this trial is produced by Astellas Pharma Europe B.V.(Country medicine accurate character No. J20090109 )
PFMT: Intensity of the PFMT exercises will conform to the guideline of National Institute for Health and Clinical Excellence (NICE).
|
|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/250
|
24.8%
62/250 • Number of events 62
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/250
|
2.8%
7/250 • Number of events 7
|
|
Gastrointestinal disorders
stomach
|
0.40%
1/250 • Number of events 1
|
2.4%
6/250 • Number of events 6
|
|
Gastrointestinal disorders
diarrhea
|
1.2%
3/250 • Number of events 3
|
0.80%
2/250 • Number of events 2
|
|
Gastrointestinal disorders
dyspepsia
|
0.00%
0/250
|
2.0%
5/250 • Number of events 5
|
|
Gastrointestinal disorders
heartburn
|
0.00%
0/250
|
0.40%
1/250 • Number of events 1
|
|
Reproductive system and breast disorders
upper respiratory infection
|
7.6%
19/250 • Number of events 19
|
4.0%
10/250 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
0.40%
1/250 • Number of events 1
|
0.40%
1/250 • Number of events 1
|
|
Nervous system disorders
dizziness
|
0.80%
2/250 • Number of events 2
|
0.80%
2/250 • Number of events 2
|
|
Nervous system disorders
hypogeusia
|
0.00%
0/250
|
0.80%
2/250 • Number of events 2
|
|
Nervous system disorders
blurred vision
|
0.00%
0/250
|
0.40%
1/250 • Number of events 1
|
|
Nervous system disorders
headache
|
0.40%
1/250 • Number of events 1
|
0.00%
0/250
|
|
Nervous system disorders
herpes zoster
|
0.40%
1/250 • Number of events 1
|
0.00%
0/250
|
|
Nervous system disorders
low back pain
|
0.00%
0/250
|
0.40%
1/250 • Number of events 1
|
|
Nervous system disorders
pruritus
|
0.00%
0/250
|
0.40%
1/250 • Number of events 1
|
|
Nervous system disorders
urinary tract infection
|
0.80%
2/250 • Number of events 2
|
0.00%
0/250
|
|
Nervous system disorders
dysuria
|
0.00%
0/250
|
0.40%
1/250 • Number of events 1
|
|
Eye disorders
dry eye
|
0.00%
0/250
|
0.40%
1/250 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
facial edema
|
0.40%
1/250 • Number of events 1
|
0.00%
0/250
|
|
Injury, poisoning and procedural complications
subcutaneous hematoma
|
4.0%
10/250 • Number of events 10
|
0.00%
0/250
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place