Cystoscopy and Cystodistension; Therapeutic and Aetiological Aspect in Overactive Bladder

NCT01971437 | Completed DMC

• 1 other identifier: TBC
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence, Urge

Keywords

Overactive Bladder; OAB; Cystoscopy; Cystodistension; UTI; Cytokines

Outcome Measures

Primary Outcomes (1)

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

  1. Resolution measured by Urgency Perception Scale. 2. Change in quality of life status. 3. Change in urinary symptoms defined by the Patient's Perception of Intensity Scale

  12-18months

Secondary Outcomes (1)

• Improved quality of life.

  12-18 months

Study Arms (2)

Cystodistension & Cystoscopy Arm

EXPERIMENTAL

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

Procedure: Cystodistension & Cystoscopy

Cystoscopy Arm

PLACEBO COMPARATOR

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

Procedure: Cystodistension & Cystoscopy

Interventions

Cystodistension & Cystoscopy PROCEDURE

Women with refractory OAB receiving Cystoscopy and cystodistension

Also known as: Cystodistension, Cystoscopy, OAB, Treatments

Cystodistension & Cystoscopy Arm; Cystoscopy Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medway NHS Foundation Trust: lead

Study Sites (1)

Medway Maritime Hospital

Gillingham, Kent, Me7 5NY, United Kingdom

Location

MeSH Terms

Conditions

Urinary Incontinence, Urge; Urinary Bladder, Overactive

Interventions

Cystoscopy; Therapeutics

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Urological; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Jonathan RA Duckett, FRCOG

  Medway NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Gynaecologist

Study Record Dates

• First Submitted: October 21, 2013
• First Posted: October 29, 2013
• Study Start: October 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 22, 2016

Record last verified: 2016-03

Locations

GB (1)