Bladder Care Following Laparoscopy for Benign Non-Hysterectomy Gynaecological Conditions – A Randomised Controlled Trial

Not Applicable

Completed

• Conditions: Post-operative bladder care following laparoscopy for benign non-hysterectomy gynaecological conditions; Renal and Urogenital - Other renal and urogenital disorders

• Registration Number: ACTRN12611000414910
• Lead Sponsor: Associate Professor Jason Abbott

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-04-20
• Study Completion: 2020-02-20
• Last Update Posted: 6 December 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 866

Inclusion Criteria

Elective laparoscopy for a benign gynaecological condition
- Patients to be aged >=18 years at time of surgery
- Patients who understand the conditions of the study and are willing to participate for the length of the prescribed term of follow-up
- Patients who are capable of, and have given written informed consent to their participation in the study.
- Patients presenting with benign gynaecological conditions that require surgical intervention as agreed to by the patient and her attending medical team.

Exclusion Criteria

- Concurrent involvement in other research studies
- Past history of incontinence surgery
- Surgery for urinary incontinence or prolapse
- Suspected or confirmed gynaecological malignancy
- Patients scheduled for hysterectomy as part of their surgical procedure
- Patients with long-term bladder catheterisation (intermittent or permanent)
- Suspected or confirmed pregnancy at the time of surgery
- Intermittent flow pattern on uroflowmetry (indicative of pre-existing voiding dysfunction)
- Preoperative PVR >=150 ml

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of post-operative urinary tract infection:<br>At the phone interview 10-14 days postoperatively, and at the 6 week postoperative clinic review, study subjects will be asked whether they have been diagnosed with a urinary tract infection, and whether they have had any unscheduled presentation to a general practitioner, emergency department, or outpatient service (clinic/rooms).[Within 6 weeks post-operative];Incidence and pattern of post-operative voiding dysfunction:<br>At the 6 week postoperative clinic review, study subjects will complete two validated questionnaires regarding lower urinary tract symptoms (ICIQ-FLUTS and ICIQ-LUTSqol).[Within 6 weeks post-operative]