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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).
Participants experiencing mixed urinary incontinence will be recruited from 10 centers. A gynecologist or urologist will make the diagnosis. Central randomization will be performed by the Clinical Evaluation Center of the China Academy of Chinese Medical Sciences in Beijing.
Sample size: Sample size is based on the primary outcome. According to literature, the investigators predict that MUI patient's average 72-h incontinence episode frequency of the week 1-12 will decrease by 60% from the baseline after treatment of PFMT plus solifenacin. The number of the acupuncture group is 57%. For the assessment of noninferiority, 250 participants will be needed for each group allowing for a 15% dropout (α=0.05，β=0.2，δ=15%).
Quality control: A 3-level monitoring system (monitors responsible for one center, monitors responsible for all centers and monitors responsible for the whole trial) will be established to check the performance of the trial in time. Outcome assessment, completion of case report forms and data management will be under strict supervision.
Data management: The Remote Dara Capture (RDC) system will be used for data entering. Both paper and electronic case report form will be reserved. A data verification plan is made.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| acupuncture | Experimental | 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). |
|
| Solifenacin plus PFMT | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acupuncture | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Change From Baseline in 72-hour Incontinence Episode Frequency (IEF) Over Weeks 1-12 | 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) | baseline, weeks 1-12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Change From Baseline in Mean 72-hour IEF During Weeks 13-24 and Weeks 25-36 | Calculated as the same way as the primary outcome. But this outcome will be assessed at different time point. | baseline, weeks 13-24, week 25-36 |
| Percentage of Participants With ≥50% Decrease in Average 72-h Incontinence Episode Frequency |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhishun Liu, doctor | Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences | Beijing | 100053 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36148895 | Derived | 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. | |
| 31919102 | Derived | Sun B, Liu Y, Su T, Sun Y, Liu Z. Electroacupuncture for stress-related urinary incontinence in elderly women: data analysis from two randomised controlled studies. BMJ Support Palliat Care. 2022 May;12(e1):e164-e170. doi: 10.1136/bmjspcare-2019-002034. Epub 2020 Jan 9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Change From Baseline in 72-hour Incontinence Episode Frequency (IEF) Over Weeks 1-12 | 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) | 1 patient withdrew consent and did not receive electroacupuncture treatment, 2 refused to participate and did not receive PFMT-solifenacin treatment. | Posted | Least Squares Mean | 95% Confidence Interval | percent change | baseline, weeks 1-12 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry mouth | Gastrointestinal disorders | Non-systematic Assessment |
The noninferiority margin to PFMT-solifenacin in MUI women was hard to define. PFMT were led by trained research assistants instead of professional therapists, which may dilute the effect of the control group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zhishun Liu | Gunang'anmen Hospital | 86 88002331 | liuzhishun@aliyun.com |
Not provided
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D015671 | Electroacupuncture |
| D000069464 | Solifenacin Succinate |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D003131 | Combined Modality Therapy |
| D004599 | Electric Stimulation Therapy |
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|
|
| solifenacin | Drug | Solifenacin used in this trial is produced by Astellas Pharma Europe B.V.(Country medicine accurate character No. J20090109 ) |
|
|
| PFMT | Procedure | Intensity of the PFMT exercises will conform to the guideline of National Institute for Health and Clinical Excellence (NICE). |
|
|
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. |
| Weeks 1-12, 13-24, 25-36 |
| Change of Episodes From Baseline in Average 72-hour Urgencies/Urination/Nocturia Episodes | 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. | Baseline, weeks 1-12, 13-24, 25-36 |
| Change From Baseline in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Score | The 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. | baseline, weeks 12, 24 and 36 |
| Weekly Median Number of Urine Pads Used During Weeks 1-12, 13-24, and 25-36 | Baseline, weeks 1-12, 13-24, 25-36 |
| the Amount of Urine Leakage (Grams) Measured by the 1-hour Pad Test at Weeks 4 and 12 | 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). | Weeks 4 and 12 |
| Patient's Treatment Satisfaction Degree | 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. | Weeks 12, 36 |
| Patient Global Impression Improvement | Participants will be asked to finish one item evaluating their present condition. | Weeks 12, 36 |
| Electroacupuncture Acceptance Assessment | 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. | Weeks 2, 6 and 12 |
| The Number of Participants Using Urine Pads | Weeks 1-12, 13-24, 25-36 |
| Change of Episodes From Baseline in Mean 72-h Incontinence Episodes | Weeks 1-12, 13-24, 25-36 |
| 30611454 | Derived | Liu B, Liu Y, Qin Z, Zhou K, Xu H, He L, Li N, Su T, Sun J, Yue Z, Zang Z, Zhang W, Zhao J, Zhou Z, Liu L, Wu D, Wu J, Zhou J, Pang R, Wang Y, Liu J, Yu J, Liu Z. Electroacupuncture Versus Pelvic Floor Muscle Training Plus Solifenacin for Women With Mixed Urinary Incontinence: A Randomized Noninferiority Trial. Mayo Clin Proc. 2019 Jan;94(1):54-65. doi: 10.1016/j.mayocp.2018.07.021. |
| 25128002 | Derived | Liu B, Wang Y, Xu H, Chen Y, Wu J, Mo Q, Liu Z. Effect of electroacupuncture versus pelvic floor muscle training plus solifenacin for moderate and severe mixed urinary incontinence in women: a study protocol. BMC Complement Altern Med. 2014 Aug 15;14:301. doi: 10.1186/1472-6882-14-301. |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| Secondary | Percentage of Change From Baseline in Mean 72-hour IEF During Weeks 13-24 and Weeks 25-36 | Calculated as the same way as the primary outcome. But this outcome will be assessed at different time point. | 1 patient withdrew consent and did not receive electroacupuncture treatment, 2 refused to participate and did not receive PFMT-solifenacin treatment. | Posted | Least Squares Mean | 95% Confidence Interval | percent change | baseline, weeks 13-24, week 25-36 |
|
|
|
| Secondary | Percentage of Participants With ≥50% Decrease in Average 72-h Incontinence Episode Frequency | 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. | For various reasons, participants discontinued study. | Posted | Count of Participants | Participants | Weeks 1-12, 13-24, 25-36 |
|
|
|
| Secondary | Change of Episodes From Baseline in Average 72-hour Urgencies/Urination/Nocturia Episodes | 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. | 1 patient withdrew consent and did not receive electroacupuncture treatment, 2 refused to participate and did not receive PFMT-solifenacin treatment. | Posted | Least Squares Mean | 95% Confidence Interval | percent change | Baseline, weeks 1-12, 13-24, 25-36 |
|
|
|
| Secondary | Change From Baseline in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Score | The 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. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | baseline, weeks 12, 24 and 36 |
|
|
|
| Secondary | Weekly Median Number of Urine Pads Used During Weeks 1-12, 13-24, and 25-36 | 1 patient withdrew consent and did not receive electroacupuncture treatment, 2 refused to participate and did not receive PFMT-solifenacin treatment. | Posted | Median | Inter-Quartile Range | urine pads | Baseline, weeks 1-12, 13-24, 25-36 |
|
|
|
| Secondary | the Amount of Urine Leakage (Grams) Measured by the 1-hour Pad Test at Weeks 4 and 12 | 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). | 1 patient withdrew consent and did not receive electroacupuncture treatment, 2 refused to participate and did not receive PFMT-solifenacin treatment. | Posted | Least Squares Mean | 95% Confidence Interval | amount of leakage (grams) | Weeks 4 and 12 |
|
|
|
| Secondary | Patient's Treatment Satisfaction Degree | 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. | 1 patient withdrew consent and did not receive electroacupuncture treatment. 2 refused to participate and did not receive PFMT-solifenacin treatment. | Posted | Count of Participants | Participants | Weeks 12, 36 |
|
|
|
| Secondary | Patient Global Impression Improvement | Participants will be asked to finish one item evaluating their present condition. | 1 patient withdrew consent and did not receive electroacupuncture treatment, 2 refused to participate and did not receive PFMT-solifenacin treatment. | Posted | Count of Participants | Participants | Weeks 12, 36 |
|
|
|
| Secondary | Electroacupuncture Acceptance Assessment | 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. | 1 patient withdrew consent and did not receive electroacupuncture treatment. | Posted | Median | Inter-Quartile Range | units on a scale | Weeks 2, 6 and 12 |
|
|
|
| Secondary | The Number of Participants Using Urine Pads | For various reasons, the participants discontinued study. | Posted | Count of Participants | Participants | Weeks 1-12, 13-24, 25-36 |
|
|
|
| Secondary | Change of Episodes From Baseline in Mean 72-h Incontinence Episodes | 1 patient withdrew consent and did not receive electroacupuncture treatment, 2 refused to participate and did not receive PFMT-solifenacin treatment. | Posted | Least Squares Mean | 95% Confidence Interval | episodes | Weeks 1-12, 13-24, 25-36 |
|
|
|
| 0 |
| 250 |
| 41 |
| 250 |
| EG001 | 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). | 1 | 250 | 90 | 250 |
| constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| stomach | Gastrointestinal disorders | Non-systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
|
| heartburn | Gastrointestinal disorders | Non-systematic Assessment |
|
| upper respiratory infection | Reproductive system and breast disorders | Non-systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| dizziness | Nervous system disorders | Non-systematic Assessment |
|
| hypogeusia | Nervous system disorders | Non-systematic Assessment |
|
| blurred vision | Nervous system disorders | Non-systematic Assessment |
|
| headache | Nervous system disorders | Non-systematic Assessment |
|
| herpes zoster | Nervous system disorders | Non-systematic Assessment |
|
| low back pain | Nervous system disorders | Non-systematic Assessment |
|
| pruritus | Nervous system disorders | Non-systematic Assessment |
|
| urinary tract infection | Nervous system disorders | Non-systematic Assessment |
|
| dysuria | Nervous system disorders | Non-systematic Assessment |
|
| dry eye | Eye disorders | Non-systematic Assessment |
|
| facial edema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| subcutaneous hematoma | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D000758 | Anesthesia |
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Weeks 13-24 |
|
|
| Weeks 25-36 |
|
|
| Change in the 72-h urgence, Weeks 25-36 |
|
| Change in the 72-h urination, Weeks 1-12 |
|
| Change in the 72-h urination, Weeks 13-24 |
|
| Change in the 72-h urination, Weeks 25-36 |
|
| Change in the 72-h nocturia, Weeks 1-12 |
|
| Change in the 72-h nocturia, Weeks 13-24 |
|
| Change in the 72-h nocturia, Weeks 25-36 |
|
| Week 36 |
|
| Weeks 25-36 |
|
| Satisfaction |
|
| No change |
|
| Dissatisfaction |
|
| Marked dissatisfaction |
|
| Week 36 |
|
|
| Moderate improvement |
|
| Slight improvement |
|
| No change |
|
| Slight worsening |
|
| Moderate worsening |
|
| Marked worening |
|
| Week 36 |
|
|
| Title | Measurements |
|---|---|
|
| Weeks 13-24 |
|
|
| Weeks 25-36 |
|
|
| Weeks 25-36 |
|