Please select the eligibility criteria that correspond to the clinical trial below.
Title: Self-management for Men With Uncomplicated Lower Urinary Tract Symptoms. A Randomised Controlled Trial Against Standard Therapy
Brief Summary: Objective To test the hypothesis that a nurse-led self-management programme is effective for men with uncomplicated lower urinary tract symptoms. This will be achieved by comparing symptom seveirty and the amount of drug therapy used to manage these symptoms in men who attend a self-management programme, compared to those who do not.

Study design This study will use the format of a randomised controlled trial. 200 new patients with uncomplicated LUTS will be randomised to either attend or not attend (standard therapy) a self-management programme. The programme provides education, reassurance, prostate cancer risk, advice on lifestyle modifications (e.g. fluids - type and amount), concurrent medication re-scheduling and behavioural changes (double-voiding, strategies for dribbling, and bladder re-training). These strategies are learnt through group discussion, problem solving and goal setting.

All men start the study with a period of watchful waiting (monitoring symptoms only) and are followed up for a total of 1 year. At each assessment (baseline, 3, 6, and 12 months) symptom severity and the use of drug therapy to control symptoms will be compared between the two groups. The only difference between them is that one group has attended a self-management programme and the other has not.

Potential application of results Self-management focuses on patient involvement in health care by involving them in the day-to-day control of their symptoms. If effective, self-management may provide a long-term method of managing LUTS without using drug therapy, thereby offering considerable health gain and financial savings.

The NHS Modernisation Agency wishes to develop the role of the nurse specialist to manage some patients independently of doctors. Nurse-led LUTS assessment clinics are now well established, perhaps nurses managing these patients with self-management interventions may become part of standard therapy.


Options:
A: Inclusion Criteria:

* Pre-pregnancy body mass index of 28 or more
* 18 years or more
* singleton live fetus at the routine ultrasound scan

Exclusion Criteria:

* high risk for preterm labor or diseases that could interfere with participation
B: Inclusion Criteria:

* aged ≥ 30 years and not institutionalized
* body mass index 25 to 50 kg/m2
* urinary incontinence symptoms for \> 3 months by self-report and record \> 10 incontinent episodes per week on a 7-day urinary diary
* able to complete a behavioral run-in consisting of self-monitoring of food and activity
* report having a primary health care provider
* able to understand and sign informed consent and complete baseline questionnaires
* agree to not initiate new treatment for incontinence or weight reduction, including behavioral, pharmacological or surgical therapies, for the duration of the study

Exclusion Criteria:

* current use, or use within the previous month of medical therapy for incontinence
* currently pregnant or gave birth in the previous 6 months
* current urinary tract infection (dipstick urinalysis positive for leukocyte esterase, nitrites or blood) or report having \> 4 urinary tract infections in the preceding year
* incontinence of neurologic or functional origin (by history)
* self-report of prior anti-incontinence or urethral surgery, pelvic cancer or pelvic irradiation
* self-report of significant medical conditions of the genitourinary tract (genitourinary fistula, interstitial cystitis, symptomatic pelvic organ prolapse)
* report a medical condition that would affect the safety and/or efficacy of a weight management program involving diet and physical activity, including type 2 diabetes requiring medical therapy that may cause hypoglycemia, chronic steroid use or uncontrolled hypertension (systolic blood pressure \>180 mm Hg or diastolic blood pressure \> 100 mm Hg); women with a history of coronary heart disease may participate with written approval from their primary care physician
* currently engaged in an active weight loss program and/or experienced a 10% or greater weight reduction in the past 3 months
* report being unable to walk 2 blocks (1/4 mile) without stopping
* report conditions that, in the judgment of the Clinical Center Principal Investigator, render potential participants unlikely to follow the protocol for 18 months, including illness likely to be terminal within 2 years, plans to move, substance abuse or other significant psychiatric problems, or dementia
* participating in another research study that involves investigational drugs or can potentially confound the results of PRIDE
C: Inclusion Criteria:

* new patients with uncomplicated LUTS (I-PSS score 0-35)
* aged 40 years and over
* referred for the first time by their family doctor (general practitioner) to one of a participating urological outpatient departments

Exclusion Criteria:

* lower urinary tract symptoms due to any urological malignancy
* previous prostatic surgery within the last 10 years or pelvic radiotherapy
* complications of urinary obstruction (acute or chronic urinary retention - post micturition volumes over 300ml, bladder stones, renal failure, recurrent urinary tract infection or haematuria)
* uncontrolled diabetes, dementia and end stage cardiac or respiratory failure
* inability to speak or understand the English language
* severe symptoms where drug therapy or surgical management is indicated or requested by the patient
* medical therapy for lower urinary tract symptoms in the previous 3 months, including alpha-blockers, 5-alpha reductase inhibitors (finasteride) or anti-cholinergics.
D: Inclusion Criteria:

* Women aged 40 years or older who report urinary incontinence for \> 3 months prior to screening
* Self-report at least 7 urinary incontinence episodes per week on a screening 7-day voiding diary
* Self-report urgency-predominant, stress-predominant, or mixed-type incontinence on the screening voiding diary
* Willing to refrain from initiating medical treatments that may affect their incontinence or voiding pattern during the study period
* Capable of understanding study procedures and giving informed consent

Exclusion Criteria:

* Participation in a yoga class or other formal or organized yoga instruction in the past year
* Any prior yoga therapy directed specifically at improving urinary incontinence or pelvic floor dysfunction
* Current use of medical therapy or device (i.e. pessary) for incontinence or use within the previous month
* Currently pregnant, gave birth within the past 6 months, or planning pregnancy during the study period
* Current urinary tract infection or a history or 3 or more urinary tract infections in the preceding year
* Report history of neurologic conditions such as stroke, multiple sclerosis, spinal cord injury, or Parkinson's disease, or a lumbosacral spine condition associated with neurological symptoms
* Unable to walk up a flight of stairs or at least 2 blocks on level ground without assistance
* Unable to get up from a supine to a standing position in 10 seconds or less and without assistance
* Severe obesity, defined as body mass index \> 35 kg/m2 on screening examination
* Report history of interstitial cystitis, fistula or hole in bladder or rectum, or birth defect leading to urine leakage
* Report any history of prior anti-incontinence or urethral surgery (not including urethral dilation), pelvic cancer, or pelvic irradiation for any reason
* Report use of bladder botox, electrostimulation, bladder training, or pelvic floor exercise training (with certified practitioners) in the past 3 months
* Report other surgery to the pelvis (hysterectomy, oophorectomy, vaginal surgery, bladder surgery, colon surgery) within the past 3 months
* Report symptomatic pelvic organ prolapse
* Report history of vulvodynia, chronic pelvic pain, or pain when practicing pelvic floor exercises
* Report conditions that, in the judgment of the investigators, render potential participants unlikely to follow the protocol, including plans to move, substance abuse, significant psychiatric problems, or dementia
* Participation in another research study that involves investigational drugs or devices that could potentially confound the results of this study

Answer: C