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Enhanced Recovery After Urogynaecological Surgery - Early Urinary Catheter Removal in an Asian Population

Enhanced Recovery After Urogynaecological Surgery - Early Urinary Catheter Removal in an Asian Population

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07768878
Enrollment
97
Registered
2026-08-17
Start date
2024-04-01
Completion date
2025-10-23
Last updated
2026-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Complications

Keywords

urogynaecology, enhanced recovery, trial off catheter

Brief summary

It is estimated that more than 50% of parous women are impaired by pelvic organ prolapse (POP). By 85 years of age, 11-19% of women will have undergone at least one operation for POP, and this is expected to increase due to Singapore's aging population. Currently, locally, patients remain inpatient for minimum 2 days post-operatively as removal of indwelling catheter (IDC) and trial of void is done on 1st to 2nd post operative day. However, there is a trend towards same-day surgery and same-day removal of IDC in western populations with good success (ranging 40-90% success). Inpatient stays can be prolonged due to voiding dysfunction after removal of IDC which require reinsertion of IDC and another trial of void the next day. Thus, the investigators seek to investigate if removal of IDC is feasible on first post-operative day. If successful, this will change current local practice, improve time to ambulation and reduce length of hospital stay and costs. Early catheter removal after pelvic organ prolapse surgery reduces time to spontaneous void, post-void residual volume, length of admission, and pain score. Aims: 1. To investigate if early catheter removal reduces time to spontaneous void and post-void residual urine volume or risks of urinary retention 2. To determine if early catheter removal results in earlier ambulation and shorter length of admission. 3. To determine if patient satisfaction is improved with early catheter removal.

Detailed description

In Western populations, POP surgery has been shown to be successful as a same-day procedure. However, formal literature is scarce, especially in the Asian context. More research is available for general gynaecology operations. In a published meta-analysis, there was no significant difference in post-operative urinary retention if IDC was removed within 6 hours or after 6 hours post operatively. However, it was clear that earlier IDC removal reduces rates of urinary tract infection. Specifically for urogynaecological operations, a published randomised controlled trial has shown that removal of IDC earlier on post operative day 0 did not prolong catheter use after obliterative and apical suspension procedures, and benefitted patients in enabling them to ambulate sooner and more often. A literature review failed to identify other relevant studies. As the Asian elderly population has traditionally been perceived to hold a more conservative or passive stance towards enhanced recovery and post-operative care, it remains unknown whether early IDC removal will translate into earlier ambulation and discharge. It is also possible that rather than improved satisfaction with earlier IDC removal, the Asian population may be more anxious around their recovery process in the post-operative period. Hence, this study is needed to confirm whether earlier IDC removal will result in improved outcomes and patient satisfaction in the Asian population as has been shown in the Western population. This study intends to evaluate whether earlier IDC removal can improve patient satisfaction and recovery time, reduce hospital cost, without causing complications (mainly re-catheterisation and urinary tract infections). Study design: randomised controlled trial, single centre, healthy population Suitable patients will be identified by urogynaecology surgical team from outpatient clinic and via operative list, using inclusion and exclusion criteria. Participants will be recruited by members of the study team (excluding clinical research coordinator and primary physician) either in outpatient clinic when consented for operation, which is usually around 2-3 weeks before operation. This will give participants ample time to consider their participation in the study. Participants will be randomised in a 1:1 ratio to have their IDC and vaginal pack removed on post operative day 0 or 1. Two arms of the study: * removal of IDC and vaginal pack on post operative day 0 (6 hours after end of operation time) * removal of IDC and vaginal pack on post operative day 1 (IDC removal at 6am, vaginal pack removal at 8am) The clinical research coordinator (CRC) will put participant's allocated group into a sealed envelope and staple in participant's case note pre-operatively. This is to ensure that the other members of the study group do not know as they will likely be involved in the participant's intra-operative and post-operative care. Post-operatively when typing the operative note, the operative team will open the envelope and include into post-operative instructions when the IDC should be removed. It is at this point where the study can no longer be blinded. The nursing team will remove IDC as per the operative note. The ward medical officer will be informed to remove vaginal pack as per the operative note. Pain score and STAI-S score will be quantified at time of recruitment and time of removal of IDC (as part of a printed written questionnaire) and included in daily ward round entry with 0-10 pain scale. The study team will help with administration of questionnaires. These will have been already included in participant's file upon admission. Data collected will be observational. There are no additional visits scheduled. The investigators anticipate to recruit two patients each week - thus expect to complete study recruitment over 18 months, accounting for public holidays. The expected duration of patient participation is from time of listing for operation till 1 month after operation (at one month follow up appointment).

Interventions

OTHEREarly indwelling catheter removal

Early indwelling catheter and vaginal pack removal on same day of operation, 6 hours post-operatively

Sponsors

KK Women's and Children's Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Masking description

Participants, care provider, investigators are blinded to study arm until postoperative care plans are made, during which study is unmasked to determine when patient's indwelling catheter will be removed.

Eligibility

Sex/Gender
FEMALE
Age
21 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* type of operation: vaginal route surgery for the correction of pelvic organ prolapse (vaginal hysterectomy and/or pelvic floor repair and/or vault suspension and/or colpocleisis and/or manchester) * ADL (activities of daily living) independent * Community ambulant * good discharge support * age 21 years old and above (adult) * all ASA scores * all BMI * patients in KK Women's and Children's Hospital (single-centre)

Exclusion criteria

* operations that are traditionally done as same day operation (MUS alone) * non-vaginal route, including laparoscopy/open/ mix of both * recurrent/chronic urinary retention * pre-op UDS (urodynamic studies): high RU (residual urine) \>150ml * current urinary tract infection at time of op * bilateral hydronephrosis * neurological disorders affecting incontinence / neurological bladder

Design outcomes

Primary

MeasureTime frameDescription
Successful spontaneous urine voidFrom removal of indwelling catheter until successful spontaneous void, assessed up to 12 hourstime to spontaneous urine void

Secondary

MeasureTime frameDescription
AmbulationFrom day of operation until day of ambulation, assessed up to 3 daystime to ambulation
Length of admissionFrom day of admission until day of discharge, assessed up to 7 daysTime to discharge
Patient anxiety score - State-Trait Anxiety Inventory (STAI)From time of enrolment until time of removal of indwelling catheter, assessed up to 3 months20 is equivalent to no anxiety and 80 indicates the worst possible anxiety
Patient satisfaction - pain score with Visual Analog ScoreFrom time of enrolment until time of removal of indwelling catheter, assessed up to 3 monthsZero is equivalent to no pain and 10 indicates the worst possible pain.

Countries

Singapore

Contacts

PRINCIPAL_INVESTIGATORXinyi Li, MBBS, MRCOG

KK Women's and Children's Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 18, 2026