NCT00839969

Brief Summary

Urethral dilatation is a commonly undertaken intervention for a variety of urinary complaints including overactive bladder symptoms. There is however very little evidence for its efficacy, and no randomized trial evidence. The aim of this study is to ascertain the effect of urethral dilatation on overactive bladder symptoms and on voiding parameters. The null hypothesis is that there will be no difference in symptoms or voiding parameters between the urethral dilatation and sham groups. Eligible women will be assessed initially with a history and examination, a King's Health Questionnaire and Bristol Female Urinary Tract Symptoms (BFLUTS) questionnaire and pressure flow studies. They will be randomized to undergo either cystoscopy alone or cystoscopy and urethral dilatation. Patients will be blinded to the procedure undertaken and randomized using a series of opaque envelopes. Follow up will be at 6 weeks with repeat questionnaires and pressure flow studies. Subjective and objective outcomes will be compared between the two groups.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 10, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

February 10, 2009

Status Verified

February 1, 2009

Enrollment Period

9 months

First QC Date

February 9, 2009

Last Update Submit

February 9, 2009

Conditions

Overactive Bladder SyndromeVoiding Dysfunction

Keywords

overactive bladder syndromevoidingpressure flow studiesurethral dilatation

Outcome Measures

Primary Outcomes (2)

  • Change in pressure flow parameters (voided volume, maximum flow rate, acceleration of flow rate and detrusor pressure at maximum flow) at 6 weeks' post-operatively.

    6 weeks

  • Change in symptoms as measured by the BFLUTS questionnaire and Urgency Perception Scale at 6 weeks' and 6 months' post-operatively.

    6 weeks and 6 months

Secondary Outcomes (1)

  • Change in quality of life status as determined by change in King's Health Questionnaire scoring at 6 weeks and 6 months' post-operatively.

    6 weeks and 6 months

Study Arms (2)

Cystoscopy alone

SHAM COMPARATOR

Women in this arm will undergo saline cystoscopy under general anaesthesia only.

Procedure: Cystoscopy

Cystoscopy and urethral dilatation

ACTIVE COMPARATOR

Women in this group will undergo cystoscopy and urethral dilatation under general anaesthesia

Procedure: Cystoscopy and urethral dilatation

Interventions

CystoscopyPROCEDURE

Saline cystoscopy under general anaesthesia

Cystoscopy alone
Cystoscopy and urethral dilatationPROCEDURE

Saline cystoscopy and urethral dilatation (using Hegar dilators) under general anaesthesia

Cystoscopy and urethral dilatation

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • OAB symptoms (based on relevant domains of BFLUTS questionnaire and Urgency Perception Scale) which have not improved with 2 anticholinergic treatments.
  • Maximum flow rate of less than 15 ml/s on a volume voided of 200mls or more, with a normal or high detrusor pressure at maximum flow on pressure flow studies
  • Patients must be able to give informed consent for the study

You may not qualify if:

  • Presence of concurrent urodynamic stress incontinence
  • Patient unfit or unwilling to undergo a general anaesthetic
  • Patients with bladder pathology or haematuria of unknown origin
  • Patients with neurological disorders (as these may affect voiding)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medway Maritime Hospital

Gillingham, Kent, ME7 5NY, United Kingdom

RECRUITING

Related Publications (1)

  • Basu M, Khullar V, Duckett J. Urethral dilatation: Is there any benefit over cystoscopy and distension? A randomized trial in women with overactive bladder symptoms. Neurourol Urodyn. 2014 Mar;33(3):283-8. doi: 10.1002/nau.22411. Epub 2013 May 1.

    PMID: 23636866DERIVED

MeSH Terms

Interventions

Cystoscopy

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, UrologicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeUrologic Surgical ProceduresUrogenital Surgical Procedures

Study Officials

  • Jonathan Duckett, FRCOG

    Medway NHS Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Duckett, FRCOG

CONTACT

+1634 830000jonathan.duckett@medway.nhs.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 9, 2009

First Posted

February 10, 2009

Study Start

January 1, 2009

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

February 10, 2009

Record last verified: 2009-02

Locations

GB(1)