A prospective, randomised, open, crossover patient preference study comparing oral immediate release and transdermal oxybutynin in overactive bladder patients

Completed

• Conditions: Subjects with overactive bladder (OAB); Urological and Genital Diseases; Overactive bladder

• Registration Number: ISRCTN03265047
• Lead Sponsor: Johannes Gutenberg-Universität Mainz, Fachbereich Medizin (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-22
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Subjects meeting all of the following criteria will be considered for admission to the trial:
1. Male or female (18 ? 80 years) suffering from OverActive Bladder (OAB)
2. Symptoms of OAB as defined by:
a. Urgency frequency =7 /week
b. Urinary urgency incontinence (> 7 UIE/week)
c. Urodynamically proven detrusor instability
3. Women must be surgically sterile, be postmenopausal or must agree to use effective contraception during treatment phases (i.e. contraceptions with a failure ratio of < 1%/ year are implants, injection preparations, combined oral contraceptives, intrauterine device [e.g. hormone spiral] or vasectomy of the partner)
4. Negative urine pregnancy test for women capable of child-bearing within 24 hours before administration of the first dose medication at V1
5. Signed and dated informed consent of the subject must be available before start of any specific trial procedures
6. Ability of subject to understand character and individual consequences of clinical trial

Exclusion Criteria

Subjects presenting with any of the following criteria will not be included in the trial:
1. Pregnancy and lactation
2. History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product
3. Subjects with significant urinary obstruction as measured during cystometry (e.g. prostatic hyperplasia, stricture of urethra), severe gastro-intestinal condition (e.g. toxic megacolon, severe ulcerative colitis, intestinal atony, bowel obstruction), myasthenia gravis or uncontrolled narrow-angle glaucoma
4. Refractory to antimuscarine treatment: Subjects having experienced no benefit from previous treatment with oral or transdermal oxybutynin
5. Subjects with hiatus hernia and reflux oesophagitis
6. Subjects with acute prostatitis
7. Subjects with urinary frequency or nocturia due to cardiac or renal insufficiency and without urgency
8. Subjects with tachyarrhythmia (pulse > 100/min)
9. Subjects with Parkinsons`s disease or Alzheimer`s disease or other cerebral diseases
10. Subjects with cognitive impairment, not able to understand content and aim of the trial
11. Medical or psychological condition that would not permit completion of the trial or signing of informed consent
12. Participation in other clinical trials and observation period of competing trials, respectively
13. Subjects who have previously been enrolled in the trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary efficacy endpoint will be the personal preference of the subject after both treatment phases. The preference will be checked for its plausibility in an end-of-period satisfaction rating (total of scores of final list of questions: 6 = very satisfied, 0 = very dissatisfied)

Secondary Outcome Measures

Name	Time	Method
1. Cognitive abilities during treatment with orally administered Oxybutynin versus transdermal administration of Oxybutynin measured by CNS tests (Trail Making Test and Wechsler Memorial Scale-Revised)<br>2. Quality of life assessed with ?King´s Health Questionnaire?<br>3. Severity of urinary incontinence episodes estimated in pad test at V1, V3, V4 and V6<br>4. Reports of adverse event (AE)/serious adverse event (SAE) in terms of severity and frequency<br>5. Frequency of micturition assessed in a 3 day diary in every treatment period<br>6. Urinary incontinence episodes assessed in a 3 day diary in every treatment period<br>7. Degree of severity of incontinence episodes estimated in Sandvik Index and documented at subject visits<br>8. Urgency frequency assessed in a 3 day diary in every treatment period<br>9. Treatment satisfaction will be assessed with a satisfaction questionnaire at the end of each treatment period