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

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).

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