EUCTR2004-001559-12-DK进行中（未招募）不适用
Measurement of Urethral Function in Women with Stress Urinary Incontinence - Evaluation of the Sensitivity of Urethral Reflectometry compared to Urethral Pressure Profilometry, using [S,S]-Reboxetine to detect Pharmacological Augmentation of Urethral Pressure. - Not Applicable
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Pfizer
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.
- •2. Female outpatients aged 18 to 65 years.
- •3. Clinically significant stress urinary incontinence (SUI) presenting either as pure SUI, or as part of mixed urinary incontinence (MUI) with predominant symptoms of SUI present.
- •4. Objective evidence of SUI (without concomitant evidence of detrusor overactivity associated with urinary incontinence) as shown by either:
- •- previous evidence of urodynamically proven SUI within 12 months of screening.
- •- or during cystometry performed at the screening visit (as described in section
- •7.7 of protocol).
- •5. Subjects must be non-pregnant and non-lactating, and be either postmenopausal (greater than 1 year without menses), surgically sterilized, or using a hormonal contraceptive. (If the subject uses hormonal contraceptives (oral, injected, transdermal or implanted) they must have been using the contraceptive for =3 months prior to the study to ensure effectiveness and must remain on the same treatment regime throughout the entire study).
- •Subjects of childbearing potential must have confirmed negative pregnancy tests prior to randomization.
- •6. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, diary, and other trial procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Symptoms of SUI < 3 months.
- •2. Presence of nocturnal enuresis. (This will be calculated from the self-reported diary data collected prior to randomization).
- •3. History of relevant neurological disease (e.g. multiple sclerosis).
- •4. History of lower urinary tract anatomical anomaly, e.g. clinically significant (grades =2) urogenital prolapse.
- •5. History or evidence of urinary outlet obstruction or urinary retention, including post void residual (PVR) urine volume > 50 ml (on 3 repeated measurements) at Visit 3.
- •6. Chronic persistent local pathology that may cause urinary symptoms, e.g. interstitial cystitis, genitourinary tumor, bladder stone, recurrent urinary tract infection (UTI) - i.e., 3 or more UTI’s over the past 2 years.
- •7. Subjects using any pharmacological agent or device for their urinary incontinence (excluding incontinence pads).
- •8. Subjects with any of the following conditions:
- •i) Indwelling urinary catheters or who perform Intermittent Self Catheterization (ISC).
- •ii) Passive urinary incontinence (eg vesicovaginal fistula).
- •iii) Not capable of independent toileting.
- •9. Subjects who intend to start a bladder-training program or physiotherapy regimen during the study. Subjects on an established regimen for at least 3 months prior to study start may remain on this as long as it remains unchanged for the duration of the study.
- •10. Subjects with a documented and untreated urinary tract infection (UTI) at screening. Subjects with a positive (1+ or greater) leukocyte or nitrite result in their urine dipstick test will be excluded unless a UTI can be ruled out via urine culture (please refer to section 7.12 of protocol). Subjects with a documented UTI at screening can undergo a course of treatment. Following treatment, subjects must be asymptomatic and have a repeat negative urine culture. Further participation in the study must be delayed until at least 2 weeks after successful treatment.
- •11. Subjects with greater than 1+ of haematuria on dipstick test, unless fully investigated prior to randomization to rule out significant urological disease. NB: subjects who are menstruating may be re-screened once menstruation has ceased if they have been found to have haematuria on dipstick testing.
- •12. History of recurrent syncope or evidence of low blood pressure (BP) (<90mmHg systolic or <40mmHg diastolic).
- •13. Evidence of symptomatic postural hypotension. This includes relevant postural symptoms associated with fall in systolic BP of > 20 mmHg or diastolic BP > 10 mmHg on standing (from sitting).
- •14. Subjects with a history of transient ischaemic attacks (TIA’s), stroke, or the presence of a carotid bruit (unless significant carotid stenosis (>70%) has been ruled out by appropriate investigation).
- •15. Narrow angle glaucoma.
- •16. Major depressive disorder (as defined by DSM-IV diagnostic criteria – see Appendix 2 of the protocol).
- •17. Subjects receiving prohibited concomitant medications such as antidepressants, MAOI’s, CYP3A4 inhibitors and antimuscarinics (Further details can be found in section 5.5 of the protocol).
- •18. Subjects who require systemic or topically applied Hormone Replacement Therapy (HRT) must have been using this at a stable dose for at least 3 months prior to study entry. Any change in dose or type of HRT taken during the study will be considered a protocol violation.
- •19. Subjects taking any medication for an unlicensed indication.
- •20. Creatinine clearance = 30 ml/min (see section 7.12 of protoc
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