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

NCT07768878 | Completed DMC

• 1 other identifier: 2022-2758
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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. 1.To investigate if early catheter removal reduces time to spontaneous void and post-void residual urine volume or risks of urinary retention
2. 2.To determine if early catheter removal results in earlier ambulation and shorter length of admission.
3. 3.To determine if patient satisfaction is improved with early catheter removal.

Conditions

Postoperative Complications

Keywords

urogynaecology; enhanced recovery; trial off catheter

Outcome Measures

Primary Outcomes (1)

• Successful spontaneous urine void

  time to spontaneous urine void

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

Secondary Outcomes (4)

• Ambulation

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

• Length of admission

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

• Patient anxiety score - State-Trait Anxiety Inventory (STAI)

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

• Patient satisfaction - pain score with Visual Analog Score

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

Study Arms (2)

Study arm

ACTIVE COMPARATOR

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

Other: Early indwelling catheter removal

Control arm

NO INTERVENTION

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

Interventions

Early indwelling catheter removal OTHER

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

Study arm

Eligibility Criteria

• Age: 21 Years - 99 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead

Study Sites (1)

KK Women's and Children's Hospital

Singapore, Singapore, 229899, Singapore

Location

Related Publications (3)

• 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.

  PMID: 29600401 BACKGROUND

• 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.

  PMID: 34043047 BACKGROUND

• 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.

  PMID: 30878895 BACKGROUND

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xinyi Li, MBBS, MRCOG

  KK Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, Department of Urogynaecology, Principal Investigator

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: August 17, 2026
• Study Start: April 1, 2024
• Primary Completion: October 9, 2025
• Study Completion: October 23, 2025
• Last Updated: August 17, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)