Postoperative ComplicationsNCT07768878
Enhanced Recovery After Urogynaecological Surgery - Early Urinary Catheter Removal in an Asian Population
A study testing Early indwelling catheter removal in people with Postoperative Complications, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 99 years, women only
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- Early indwelling catheter removal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Apr 2024to 23 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Singapore1 site
KK Women's and Children's Hospital
Singapore, Singapore, 229899
About this study
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.
Read more
Aims:
- To investigate if early catheter removal reduces time to spontaneous void and post-void residual urine volume or risks of urinary retention
- To determine if early catheter removal results in earlier ambulation and shorter length of admission.
- 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).
- Conditions
- Postoperative Complications
- Being tested
- Early indwelling catheter removal
- Keywords
- urogynaecology, enhanced recovery, trial off catheter
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early indwelling catheter removalOther
Early indwelling catheter and vaginal pack removal on same day of operation, 6 hours post-operatively
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Active comparator | Remove indwelling catheter and vaginal pack 6 hours post-operatively on post-operative day 0 Receives: Other: Early indwelling catheter removal |
| Control arm | No intervention | Remove indwelling catheter and vaginal pack on post-operative day 1 at 6am |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful spontaneous urine void
time to spontaneous urine void
Measured: From removal of indwelling catheter until successful spontaneous void, assessed up to 12 hours
Secondary outcomes (4)
Ambulation
time to ambulation
Measured: From day of operation until day of ambulation, assessed up to 3 days
Length of admission
Time to discharge
Measured: From day of admission until day of discharge, assessed up to 7 days
Patient anxiety score - State-Trait Anxiety Inventory (STAI)
20 is equivalent to no anxiety and 80 indicates the worst possible anxiety
Measured: From time of enrolment until time of removal of indwelling catheter, assessed up to 3 months
Patient satisfaction - pain score with Visual Analog Score
Zero is equivalent to no pain and 10 indicates the worst possible pain.
Measured: From time of enrolment until time of removal of indwelling catheter, assessed up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start1 Apr 2024
- Primary completion9 Oct 2025
- Study completion23 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Li Xinyi, KK Women's and Children's Hospital
- Investigators
- Xinyi Li, MBBS, MRCOG, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07768878
- Sponsor's protocol ID
- 2022-2758
- Status last verified
- Aug 2026
- First submitted
- 10 Mar 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers
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 29600401Groth 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 34043047Courtieu 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Recovery After Urogynaecological Surgery - Early Urinary Catheter Removal in an Asian Population
- ClinicalTrials.gov ID
- NCT07768878
- Acronym / sponsor ID
- 2022-2758
- Conditions
- Postoperative Complications
- Keywords
- urogynaecology, enhanced recovery, trial off catheter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 9 Oct 2025 (actual)
- Study completion
- 23 Oct 2025 (actual)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To investigate if early catheter removal reduces time to spontaneous void and post-void residual urine volume or risks of urinary retention
- To determine if early catheter removal results in earlier ambulation and shorter length of admission.
- 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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study arm | Active comparator | Other: Early indwelling catheter removalRemove indwelling catheter and vaginal pack 6 hours post-operatively on post-operative day 0 |
| Control arm | No intervention | –Remove indwelling catheter and vaginal pack on post-operative day 1 at 6am |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early indwelling catheter removalEarly indwelling catheter and vaginal pack removal on same day of operation, 6 hours post-operatively | Other | Study arm |
Primary outcome
Successful spontaneous urine void
Time frame: From removal of indwelling catheter until successful spontaneous void, assessed up to 12 hours
time to spontaneous urine void
4 secondary outcomes
Ambulation
Time frame: From day of operation until day of ambulation, assessed up to 3 days
Length of admission
Time frame: From day of admission until day of discharge, assessed up to 7 days
Patient anxiety score - State-Trait Anxiety Inventory (STAI)
Time frame: From time of enrolment until time of removal of indwelling catheter, assessed up to 3 months
Patient satisfaction - pain score with Visual Analog Score
Time frame: From time of enrolment until time of removal of indwelling catheter, assessed up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Background: PubMed 29600401Carter-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.
- Background: PubMed 34043047Groth 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.
- Background: PubMed 30878895Courtieu 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.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xinyi Li, MBBS, MRCOG principal investigator
KK Women's and Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early indwelling catheter removal in people with Postoperative Complications, run by KK Women's and Children's Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful spontaneous urine void (time frame: From removal of indwelling catheter until successful spontaneous void, assessed up to 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07768878, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.