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: * Predominant stress urinary incontinence by self-report,examination and test;
* Urethral hypermobility;
* Eligible for both surgical procedures;
* Ambulatory;
* Not pregnant;
* \>12 months post-partum;
* No systemic disease known to affect bladder function;
* No current chemotherapy or radiation therapy;
* No urethral diverticulum, augmentation cytoplasty, or artificial sphincter;
* No recent pelvic surgery;
* Available for follow-up and able to complete study assessments;
* Signed informed consent.
B: 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.
C: Inclusion Criteria:

* Symptoms of overactive bladder
* Capable of independent toileting and completing a micturition diary
* Able to comprehend English and follow study procedures and instructions

Exclusion Criteria:

* Post void residual \> 100ml/sec
* Urine flow rate (Qmax) \<10ml/sec for males only

Other protocol-defined inclusion/exclusion criteria may apply
D: Inclusion Criteria:(For randomized trial)

1. Non-pregnant English-speaking women
2. 18 yo or older
3. Overactive Bladder (OAB) Awareness scores ≥ 8
4. 3 UUI episodes/week for ≥ 3 months

Exclusion Criteria: (For Randomized trial)

1. Women with a history of neurologic diseases such as Multiple Sclerosis, Parkinson's disease, stroke, or dementia
2. History of schizophrenia or untreated bipolar disorder or current drug or alcohol dependence
3. Women who have taken anticholinergic medications for UUI within the last 3 weeks (women who have taken anti-cholinergics for UUI but discontinued them \> than 3 weeks ago may participate in the study) or have a sacral neuromodulator in place to treat UUI or have received Onabotulinum toxin A in the last 12 months to treat UUI
4. Contraindications to anticholinergic medications (untreated narrow angle glaucoma, significant urinary retention or gastric retention)
5. Pregnant women or lactating women, women who plan to become pregnant in the next year, or pre-menopausal women unwilling to use contraception if engaging in sexual relations during the year of study participation (hysterectomy is considered to be a form of contraception)
6. Untreated urinary tract infection
7. Prolapse which extends past the hymen (POP-Q points of ≥ 1+) which may be responsible for UUI symptoms
8. Women who cannot keep the majority of the study therapy appointments or those without reliable contact phone numbers or methods of communication with the study personnel.

Answer: B