Clincosm LogoSign in Get a demo

Cystoscopy and Cystodistension; Therapeutic and Aetiological Aspect in Overactive Bladder

Sponsor
Medway NHS Foundation Trust (Other)
Overall Status
Completed
CT.gov ID
NCT01971437
Collaborator
(none)
70
Enrollment
1
Location
2
Arms
29
Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Cystodistension & Cystoscopy
 N/A

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

Study Design

Study Type:
Interventional
Actual Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomised Study of Cystoscopy and Cystodistension Versus Cystoscopy Alone in Women With Overactive Bladder Syndrome.
Study Start Date :
Oct 1, 2013
Actual Primary Completion Date :
Mar 1, 2016
Actual Study Completion Date :
Mar 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cystodistension & Cystoscopy Arm

This is the Arm receiving cystodistension and cystoscopy due to refractory OAB.

Procedure: Cystodistension & Cystoscopy
Women with refractory OAB receiving Cystoscopy and cystodistension
Other Names:
  • Cystodistension
  • Cystoscopy
  • OAB
  • Treatments

    		•
    Placebo Comparator: Cystoscopy Arm

    This is the arm that receives cystoscopy only in women with refractory OAB.

    Procedure: Cystodistension & Cystoscopy
    Women with refractory OAB receiving Cystoscopy and cystodistension
    Other Names:
  • Cystodistension
  • Cystoscopy
  • OAB
  • Treatments

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To assess the presence of urgency and urge incontinence initially, 6 weeks and 6 months [12-18months]

      Resolution measured by Urgency Perception Scale. Change in quality of life status. Change in urinary symptoms defined by the Patient's Perception of Intensity Scale

    Secondary Outcome Measures

    1. Improved quality of life. [12-18 months]

      Change in quality of life status, Urgency Perception Scale and Patient's Perception of Intensity Scale scoring initially, 6 weeks and 6 months.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medway Maritime Hospital Gillingham Kent United Kingdom Me7 5NY

    Sponsors and Collaborators

    • Medway NHS Foundation Trust

    Investigators

    • Principal Investigator: Jonathan RA Duckett, FRCOG, Medway NHS Foundation Trust

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Professor Jonathan Duckett, Consultant Gynaecologist, Medway NHS Foundation Trust
    ClinicalTrials.gov Identifier:
    NCT01971437
    Other Study ID Numbers:
    • TBC
    First Posted:
    Oct 29, 2013
    Last Update Posted:
    Mar 22, 2016
    Last Verified:
    Mar 1, 2016
    Keywords provided by Professor Jonathan Duckett, Consultant Gynaecologist, Medway NHS Foundation Trust
    Overactive Bladder
    OAB
    Cystoscopy
    Cystodistension
    UTI
    Cytokines
    Additional relevant MeSH terms:
    Urinary Incontinence
    Urinary Bladder, Overactive
    Urinary Incontinence, Urge

    Study Results

    No Results Posted as of Mar 22, 2016