Immediate versus delayed removal of urinary catheters after uncomplicated total abdominal hysterectomy in a tertiary care hospital
| ISRCTN | ISRCTN11843192 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11843192 |
| Sponsor | Pakistan Institute of Medical Sciences |
| Funders | Pakistan Institute of Medical Sciences, Shaheed Zulfiqar Ali Bhutto Medical University |
- Submission date
- 11/08/2026
- Registration date
- 14/08/2026
- Last edited
- 11/08/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Women undergoing a total abdominal hysterectomy (surgical removal of the womb) often have a flexible tube, called a urinary catheter, placed into their bladder to drain urine during the operation. After the surgery, doctors must decide when is the best time to remove this tube. Some prefer to remove it immediately, while others prefer to leave it in for several hours. Leaving it in can increase the risk of an infection, but taking it out too early might mean the patient struggles to pee on their own and needs the tube put back in. This study aims to find out if removing the catheter immediately after surgery is better for patient recovery than waiting 6 hours.
Who can participate?
Women aged 35 to 75 years old who are scheduled to have an uncomplicated abdominal hysterectomy for benign (non-cancerous).
What does the study involve?
Participants are randomly divided into two equal groups after their surgery. For the first group, the urinary catheter is removed immediately as soon as the surgery is finished. For the second group, the catheter is left in place and removed 6 hours after the surgery. Doctors and nurses then closely monitor both groups during their hospital stay. They record if any patients are unable to pass urine on their own, if anyone develops a fever or urinary tract infection, and how many days each patient needs to stay in the hospital before going home.
What are the possible benefits and risks of participating?
The potential benefit of immediate removal is a faster return to normal movement, a lower chance of developing a urinary tract infection, and potentially going home sooner. The possible risk of early removal is that the patient might not be able to empty their bladder naturally, which would require a nurse to temporarily reinsert the catheter.
Where is the study run from?
Pakistan Institute of Medical Sciences, Pakistan.
When is the study starting and how long is it expected to run for?
October 2018 to August 2020.
Who is funding the study?
1. Pakistan Institute of Medical Sciences, Pakistan.
2. Shaheed Zulfiqar Ali Bhutto Medical University, Pakistan.
Who is the main contact?
Dr Ayesha Ahmed, ayesha.ahmed62@nhs.net
Contact information
Public, Scientific, Principal investigator
Nottingham University Hospitals NHS Trust
Nottingham
NG5 1PB
United Kingdom
| Phone | +447591996799 |
|---|---|
| ayesha.ahmed62@nhs.net |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Active |
| Assignment | Parallel |
| Purpose | Prevention, Treatment |
| Scientific title | Immediate and late removal of urinary catheter after total abdominal hysterectomy in middle aged vs old women |
| Study objectives | To evaluate and compare the clinical outcomes of immediate versus delayed (six hours post-operative) removal of urinary catheters in women undergoing uncomplicated total abdominal hysterectomy for benign conditions, specifically focusing on urinary and febrile morbidities and length of hospital stay. |
| Ethics approval(s) |
Approved 15/08/2018, Ethics Review Board, Shaheed Zulfiqar Ali Bhutto Medical University (PIMS, G-8/3., Islamabad, 44000, Pakistan; +92 51 9107679; info@szabmu.edu.pk), ref: F. 1-1/2015/ERB/SZABMU/282 |
| Health condition(s) or problem(s) studied | Post-operative urinary retention and urinary tract complications following uncomplicated total abdominal hysterectomy |
| Intervention | Patients are randomly assigned to one of two parallel care groups following their surgery: Group A (Immediate Removal): The indwelling urinary catheter is removed immediately upon completion of the total abdominal hysterectomy. Group B (Delayed Removal): The indwelling urinary catheter remains in place and is removed 6 hours post-operatively. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 31/08/2020 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 35 Years |
| Upper age limit | 75 Years |
| Sex | Female |
| Target sample size at registration | 140 |
| Total final enrolment | 140 |
| Key inclusion criteria | 1. Female patients undergoing elective, uncomplicated total abdominal hysterectomy for benign gynecological conditions 2. Patients who provided written informed consent to participate in the study 3. Patients with no prior history of voiding dysfunction or urinary tract infections |
| Key exclusion criteria | 1. Anticipated complicated surgical procedure 2. Malignant condition 3. Positive urine cultures or urinary symptoms prior to surgery 4. Comorbid illness requiring strict input and output monitoring |
| Date of first enrolment | 01/10/2018 |
| Date of final enrolment | 31/08/2020 |
Locations
Countries of recruitment
- Pakistan
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
11/08/2026: Study’s existence confirmed by the Ethics Review Board, Shaheed Zulfiqar Ali Bhutto Medical University, Pakistan.
