Condition category
Urological and Genital Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
24/11/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Philip Toozs-Hobson

ORCID ID

Contact details

Birmingham Women's Hospital
Uro-gynaecology Department
Edgbaston
Birmingham
B15 2TG
United Kingdom
+44 (0)121 472 1377 ext 4707

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0047111207

Study information

Scientific title

Acronym

NN/A

Study hypothesis

We propose a randomised, double-bind study to compare both anaesthetic techniques (target-controlled sedation and 'low-dose' spinal anaesthesia).

Ethics approval

Not provided at time of registration

Study design

Randomised double-bind study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Urological and Genital Diseases: Stress incontinence

Intervention

Each volunteer will be studied for the duration of the operation, until completion of the post-operative questionnaire and urodynamic studies, 3 h postoperatively. The average length of the procedure is 45 min. The only additional invasive procedure that would not be part of the routine is the subcutaneous local anaesthetic injection of 2 ml Lignocaine 1% in the back of the volunteers randomised into the propofol target controlled sedation group for the purpose of blinding.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Outcomes will be assessed by indices of patient satisfaction, satisfaction for surgical conditions, perioperative sedation scores, oxygenation, haemodynamic variables and the impact of anaesthetic technique on return of bladder sensation.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/2002

Overall trial end date

30/09/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Patients will be recruited from the clinical gynaelogical practice of Mr P Toozs-Hobson and Mr Emens. Individuals scheduled for suburethral sling surgery will be invited to participate in the investigation. Written consent will be obtained in all cases. We aim to recruit 25 patients to each arm of the study.
Inclusion criteria: first operative procedure for stress incontinence.

Participant type

Patient

Age group

Not Specified

Gender

Female

Target number of participants

50

Participant exclusion criteria

1. Contradiction to spinal anaesthesia
2. Unable/unwilling to give consent
3. Significant respiratory/cardiovascular disease/epilepsy
4. Allergy to propofol, opioids and local anaesthetics

Recruitment start date

01/06/2002

Recruitment end date

30/09/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Birmingham Women's Hospital
Birmingham
B15 2TG
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Birmingham Women's Healthcare NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20701511

Publication citations

  1. Results

    Foon R, Toozs-Hobson P, Cooper G, Anaesthesia for incontinence surgery: spinal anaesthesia or sedation?, J Obstet Gynaecol, 2010, 30, 6, 605-608, doi: 10.3109/01443615.2010.497876.

Additional files

Editorial Notes