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

• Conditions: Stress Urinary Incontinence (SUI); MedDRA version: 7.1Level: VTcClassification code 10042213

• Registration Number: EUCTR2004-001559-12-DK
• Lead Sponsor: Pfizer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07-08
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 16

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the utility of urethral reflectometry in the detection of pharmacologically induced pressure changes in the female urethra.<br><br>To compare urethral reflectometry against standard urodynamic assessment of opening and closing urethral pressure using urethral pressure profilometry (UPP) in women with SUI.;Secondary Objective: To assess the effect of [S,S]-Reboxetine on urethral function in women with SUI.;Primary end point(s): Opening urethral pressure (Reflectometry)