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CompletedNCT07768878Updated Aug 17, 2026

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

An interventional study of Early indwelling catheter removal in Postoperative Complications, sponsored by KK Women's and Children's Hospital. Completed at 1 site in Singapore. Open to female participants aged 21 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-08-17.

Sponsored by KK Women's and Children's Hospital · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
97
Allocation
Randomized
Ages
21 Years to 99 Years
Sex
Female
01

Study 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.
Read the 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).

02

Conditions studied

  • Postoperative Complications

Keywords

  • urogynaecology
  • enhanced recovery
  • trial off catheter
03

Who can participate

Ages eligible
21 Years to 99 Years
Sexes eligible
Female
Accepts 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

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
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
97 participants (actual)

Study arms

  • Active comparator
    Study arm

    Remove indwelling catheter and vaginal pack 6 hours post-operatively on post-operative day 0

    Other: Early indwelling catheter removal

  • No intervention
    Control arm

    Remove indwelling catheter and vaginal pack on post-operative day 1 at 6am

Interventions

  • OtherEarly indwelling catheter removal

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

05

What researchers measure

Primary outcomes

  1. Successful spontaneous urine void

    time to spontaneous urine void

    Time frame: From removal of indwelling catheter until successful spontaneous void, assessed up to 12 hours

Secondary outcomes

  1. Ambulation

    time to ambulation

    Time frame: From day of operation until day of ambulation, assessed up to 3 days

  2. Length of admission

    Time to discharge

    Time frame: From day of admission until day of discharge, assessed up to 7 days

  3. Patient anxiety score - State-Trait Anxiety Inventory (STAI)

    20 is equivalent to no anxiety and 80 indicates the worst possible anxiety

    Time frame: From time of enrolment until time of removal of indwelling catheter, assessed up to 3 months

  4. Patient satisfaction - pain score with Visual Analog Score

    Zero is equivalent to no pain and 10 indicates the worst possible pain.

    Time frame: From time of enrolment until time of removal of indwelling catheter, assessed up to 3 months

06

Study locations

1 site
  • KK Women's and Children's Hospital
    Singapore, Singapore 229899, Singapore
07

References and documents

Publications

  • Carter-Brooks CM, Zyczynski HM, Moalli PA, Brodeur PG, Shepherd JP. Early catheter removal after pelvic floor reconstructive surgery: a randomized trial. Int Urogynecol J. 2018 Aug;29(8):1203-1212. doi: 10.1007/s00192-018-3641-3. Epub 2018 Mar 29. PubMed 29600401 ↗
  • Groth JM, Geisler PP, Glavind K. Same-day surgery for pelvic organ prolapse and hospital contact within 30 days. Int Urogynecol J. 2022 Jan;33(1):123-131. doi: 10.1007/s00192-021-04852-5. Epub 2021 May 27. PubMed 34043047 ↗
  • Courtieu C, Cornille A, Vaast M, Lacombe S, Panel L. Prospective feasability study of ambulatory surgery for pelvic organ prolapse. Eur J Obstet Gynecol Reprod Biol. 2019 May;236:36-40. doi: 10.1016/j.ejogrb.2019.01.019. Epub 2019 Mar 5. PubMed 30878895 ↗

Individual participant data

Plan to share: No — IPD will not be shared with other researchers

08

Registry details

Key details

Study ID
NCT07768878
Lead sponsor
KK Women's and Children's Hospital
Responsible party
Li Xinyi (Consultant, Department of Urogynaecology, Principal Investigator, KK Women's and Children's Hospital) — Principal investigator
First posted
Aug 17, 2026
Start date
Apr 1, 2024
Primary completion
Oct 9, 2025
Completion
Oct 23, 2025
Last update
Aug 17, 2026

Study contacts

Xinyi Li, MBBS, MRCOG
principal investigator · KK Women's and Children's Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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