Clinical trial NCT01971437: Cystoscopy and Cystodistension; Therapeutic and Aetiological Aspect in Overactive Bladder
Official title: A Randomised Study of Cystoscopy and Cystodistension Versus Cystoscopy Alone in Women With Overactive Bladder Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence, Urge
Keywords: Overactive Bladder
OAB
Cystoscopy
Cystodistension
UTI
Cytokines
Lead sponsor: Medway NHS Foundation Trust
Sponsor class: OTHER
First posted: 2013-10-29
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an ethically approved randomised controlled study looking at whether Cystodistension(filling the bladder with fluid under pressure) provides any benefit over cystoscopy alone (looking in the bladder) in women with refractory overactive bladder. Urine samples will also be assessed for underlying infected cause of OAB using urinalysis, microscopy and culture and cytokine assays (In collaboration with the University of Kent). We hypothesize that Cystodistension has a therapeutic benefit to women with refractory OAB and the there is an increase prevalence in chronic urinary infections with raised cytokines in women with refractory OAB.

Detailed description: We aim to measure outcomes initially, 6 weels and 6months follow-up.

1. Resolution measured by Urgency Perception Scale (UPS). Resolution of urgency will be assessed with the UPS. The numbers of women with a Level 3 UPS score (hold and finish task) will be compared using Chi square test in patients treated with cystodistension vs non cystodistension arms.
2. Change in quality of life status determined by quality of life questionnaires will ismilarly be comapred between the 2 arms of the study.
3. Change in urinary symptoms defined by Patient's Perception of Intensity Scale. Change in uregncy scores will be compared between the 2 arms of the study.

Secondary Outcome Measure:1. Prevalence of chronic urinary infection and organisms in patients with refractory OAB 2. To identify whether urinary cytokines are present in a higher proportion of patients with OAB.

Inclusion Criteria

1. Women with only OAB symptoms
2. Women who have failed bladder drill and anticholinergic agents
3. Women who stopped medication due to side-effects or lack of efficacy
4. Currently receiving no treatment

Exclusion Criteria

1. Patient with co-existing urodynamic stress incontinence
2. Patients with neurological diseases
3. Patients with pre-existing voiding dysfunction

Eligibility criteria: Inclusion Criteria

1. Women with only OAB symptoms
2. Women who have failed bladder drill and anticholinergic agents
3. Women who stopped medication due to side-effects or lack of efficacy
4. Currently receiving no treatment

Exclusion Criteria

1. Patients with co-existing urodynamic stress incontinence
2. Patients with neurological diseases
3. Patients with pre-existing voiding dysfunction

   * Free flow rate \<5th centile or equivalent reduced pressure flow rate OR
   * Post-void residual volume greater than 100ml

Primary outcomes:
measure: To assess the presence of urgency and urge incontinence initially, 6 weeks and 6 months
timeFrame: 12-18months
Secondary outcomes:
measure: Improved quality of life.
timeFrame: 12-18 months
Other outcomes:
Locations:
city: Gillingham
country: United Kingdom
facility: Medway Maritime Hospital
state: Kent
Study officials:
affiliation: Medway NHS Foundation Trust
name: Jonathan RA Duckett, FRCOG
role: PRINCIPAL_INVESTIGATOR
References: