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Completed

NCT Number: NCT01971437

Cystoscopy and Cystodistension; Therapeutic and Aetiological Aspect in Overactive Bladder

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.

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Key information

Conditions

Urinary Incontinence, Urge Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Medway Maritime Hospital

Gillingham, Kent, Me7 5NY, United Kingdom

About this study

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

  • 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.
  • Change in quality of life status determined by quality of life questionnaires will ismilarly be comapred between the 2 arms of the study.
  • 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

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

Exclusion criteria

  • Patient with co-existing urodynamic stress incontinence
  • Patients with neurological diseases
  • Patients with pre-existing voiding dysfunction

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients with co-existing urodynamic stress incontinence
  • Patients with neurological diseases
  • 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

Treatment and study plan

Cystodistension & Cystoscopy

Procedure

Women with refractory OAB receiving Cystoscopy and cystodistension

Other names: Cystodistension, Cystoscopy, OAB, Treatments

Primary outcomes

  1. To assess the presence of urgency and urge incontinence initially, 6 weeks and 6 months

    Time frame: 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 outcomes

  1. Improved quality of life.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medway NHS Foundation Trust

Other

Registry information

Official study title

A Randomised Study of Cystoscopy and Cystodistension Versus Cystoscopy Alone in Women With Overactive Bladder Syndrome.

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 29, 2013
Registry last updated
Mar 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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