Postoperative Urinary RetentionNCT07293000
Evaluating Two Nursing Interventions to Prevent Urinary Retention After Spinal Anesthesia
A study testing Suprapubic Cold Pack and Sacral Massage in people with Postoperative Urinary Retention and Urinary Retention, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to learn whether two simple nursing methods can help prevent trouble emptying the bladder (acute urinary retention, AUR) after surgery with numbing medicine in the lower back (spinal anesthesia). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Urinary Retention, Urinary Retention
- What is being tested?
- Suprapubic Cold Pack and Sacral Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2026to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: Patients who meet all of the following criteria will be included:
- Age 18 years or older
- No diagnosis of urolithiasis, benign prostatic hyperplasia, neurogenic bladder, cancer, or other malignancy
- No diagnosis of urinary tract infection within the last month
- No history of prior urological surgery or surgery involving the sacral region
- No history of urinary retention
- Not using antidepressants, antipsychotics, muscarinic receptor antagonists, alpha-blockers, or similar medications
- No contraindication for applying cold to the suprapubic area or massage to the sacral area (e.g., no pacemaker, bladder stimulator, or other sensitive electronic medical device in the sacral region)
- No visual, hearing, cognitive, or perceptual impairment
Exclusion Criteria:Patients who meet any of the following criteria will be excluded:
- Duration of surgery longer than 2 hours
- Urinary catheterization performed preoperatively, intraoperatively, or postoperatively
- Blood transfusion performed preoperatively, intraoperatively, or postoperatively
- Development of complications such as hypothermia, bleeding, or other conditions that prevent the application of dry cold or sacral massage in the preoperative, intraoperative, or postoperative period
- Transfer to the intensive care unit after surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa, Institute of Graduate Studies
Istanbul, Avcılar, 34320
Hülya CEYHAN, RN,MSc, +90 545 541 40 29, hulya.ceyhan@ogr.iuc.edu.tr
About this study
Official title: Evaluation of the Effectiveness of Two Different Nursing Interventions in Preventing Urinary Retention in Patients Undergoing Spinal Anesthesia: Randomized Controlled Trial
The goal of this clinical trial is to learn whether two simple nursing methods can help prevent trouble emptying the bladder (acute urinary retention, AUR) after surgery with numbing medicine in the lower back (spinal anesthesia). Adults having surgery in the scrotum (scrotal), groin (inguinal), pelvic area, lower belly (lower abdominal), or bones and joints (orthopedic surgery) with spinal anesthesia will take part. After surgery, participants will be randomly placed into one of three groups: one group will receive a cold pack on the lower belly (suprapubic area), a second group will receive a gentle massage on the lower back over the tailbone (sacral area), and a third group will receive usual care only with no extra procedure. The same nurse researcher will provide the study care for all groups, check how well participants pass urine, use a small painless scan on the lower belly to see how much urine is in the bladder (portable bladder ultrasound), and record whether a tube in the bladder to drain urine (urinary catheter) is needed.
Read the detailed description
Trouble emptying the bladder after surgery (acute urinary retention, AUR) is a common and important problem in adults who receive numbing medicine in the lower back (spinal anesthesia). AUR can cause pain, an overfilled bladder (bladder distension), urinary tract infection, longer hospital stays, and higher health care costs. The usual way to manage AUR is to place a tube into the bladder to drain urine (urinary catheterization). This works, but it is invasive and may lead to infection, injury to the urethra, and discomfort. Because of these risks, there is a need for simple, non-drug, non-invasive nursing methods to help prevent AUR.
Spinal anesthesia can temporarily block normal bladder function and increase the risk of AUR. Nurses are often the first to notice when a person is unable to pass urine and are in a key position to provide early, preventive care. Some studies have looked at different nursing interventions for urinary retention, but there is little evidence about non-invasive methods after spinal anesthesia, and no trial has directly compared a cold pack on the lower belly with a massage over the tailbone in this setting.
This randomized controlled trial will include adult surgical patients who receive spinal anesthesia for operations in the scrotum (scrotal), groin (inguinal), pelvic area, lower belly (lower abdominal), or bones and joints (orthopedic surgery). Participants will be randomly assigned to one of three groups:
- a dry cold pack applied to the lower belly over the bladder (suprapubic area),
- gentle massage over the lower back in the area of the tailbone (sacral area), or
- usual postoperative care without an extra study procedure.
All study procedures in all three groups will be carried out by a single nurse researcher, using the same assessment steps for every participant. The aim is to keep the care consistent and reduce differences that are not related to the study methods.
The main focus of the study is to find out whether these nursing methods can lower the rate of acute urinary retention after spinal anesthesia. Nurses will regularly check how well participants can pass urine on their own and will estimate bladder volume using a small, painless scan placed on the skin over the lower belly (portable bladder ultrasound device). This objective measurement is expected to improve early detection of AUR compared with relying only on symptoms or physical examination.
The study will also look at related outcomes such as time to first spontaneous urination, need for urinary catheterization, bladder fullness and pain, and comfort and satisfaction with nursing care. By providing clear, comparative information on two simple, non-invasive nursing interventions, this trial aims to support evidence-based postoperative nursing protocols, improve patient comfort, and reduce the need for invasive urinary catheterization after spinal anesthesia.
- Conditions
- Postoperative Urinary Retention, Urinary Retention
- Being tested
- Suprapubic Cold Pack, Sacral Massage
- Keywords
- Urinary retention, Postoperative urinary retention, Nursing Interventions, Bladder Volume Measurement Device, Cold Application, Sacral Massage
- Medical subject headings
- Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suprapubic Cold PackOther
A dry cold pack applied externally to the skin over the lower abdomen above the bladder (suprapubic area) in adult patients after surgery with spinal anesthesia. The cold pack is used for a predefined duration in the early postoperative period as a non-pharmacologic, non-invasive nursing intervention to support bladder emptying and patient comfort.
Sacral MassageOther
A gentle manual massage applied externally to the skin over the lower back in the sacral (tailbone) region in adult patients after surgery with spinal anesthesia. The massage is performed for a predefined duration in the early postoperative period as a non-pharmacologic, non-invasive nursing intervention to support bladder function and patient comfort.
| Study group | Role | What they receive |
|---|---|---|
| Suprapubic Cold Pack Group | Experimental | Participants in this arm receive a suprapubic dry cold pack in addition to usual postoperative nursing care after surgery with spinal anesthesia. The cold pack is applied in the early postoperative period according to a standard nursing protocol. Receives: Other: Suprapubic Cold Pack |
| Sacral Massage Group | Experimental | Participants in this arm receive sacral massage in addition to usual postoperative nursing care after surgery with spinal anesthesia. The massage is delivered in the early postoperative period by a nurse researcher following a standard nursing protocol. Receives: Other: Sacral Massage |
| Usual Care Control Group | No intervention | Participants in this arm receive only usual postoperative nursing care after surgery with spinal anesthesia, according to the hospital's standard protocols. They do not receive any additional study-specific intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who develop postoperative acute urinary retention
Proportion of participants who develop postoperative acute urinary retention (AUR) within the first 6 hours after surgery with spinal anesthesia, defined as inability to void spontaneously requiring urinary catheterization and/or elevated bladder volume on bladder ultrasound.
Measured: Within the first 6 hours after surgery with spinal anesthesia (postoperative 0-6 hours).
Secondary outcomes (3)
Proportion of participants requiring urinary catheterization within the first 6 hours after surgery
Proportion of participants requiring insertion of a urinary catheter within the first 6 hours after surgery with spinal anesthesia because of inability to void spontaneously or clinically significant bladder distension.
Measured: Within the first 6 hours after surgery with spinal anesthesia (postoperative 0-6 hours).
Bladder-related discomfort or pain score within the first 6 hours after surgery
Bladder-related discomfort or pain score assessed within the first 6 hours after surgery with spinal anesthesia using a numerical rating scale from 0 to 10, with higher scores indicating greater discomfort or pain.
Measured: Within the first 6 hours after surgery with spinal anesthesia (postoperative 0-6 hours).
Time to first spontaneous voiding within the first 6 hours after surgery
Time to first spontaneous voiding within the first 6 hours after surgery with spinal anesthesia, measured in minutes from the end of surgery to the first spontaneous voiding without urinary catheterization.
Measured: Within the first 6 hours after surgery with spinal anesthesia (postoperative 0-6 hours).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start15 May 2026 (estimated)
- Primary completion15 Nov 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Urinary RetentionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, parallel, three-arm trial comparing suprapubic cold pack application, sacral massage, and usual care in adults undergoing scrotal, inguinal, pelvic, lower abdominal, or orthopedic surgery with spinal anesthesia.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hülya CEYHAN, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07293000
- Sponsor's protocol ID
- HCEYHAN
- Status last verified
- Mar 2026
- First submitted
- 7 Dec 2025
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Two Different Nursing Interventions in Preventing Urinary Retention in Patients Undergoing Spinal Anesthesia: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07293000
- Acronym / sponsor ID
- HCEYHAN
- Conditions
- Postoperative Urinary Retention, Urinary Retention
- Keywords
- Urinary retention, Postoperative urinary retention, Nursing Interventions, Bladder Volume Measurement Device, Cold Application, Sacral Massage
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 18 Dec 2025 (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.
The goal of this clinical trial is to learn whether two simple nursing methods can help prevent trouble emptying the bladder (acute urinary retention, AUR) after surgery with numbing medicine in the lower back (spinal anesthesia). Adults having surgery in the scrotum (scrotal), groin (inguinal), pelvic area, lower belly (lower abdominal), or bones and joints (orthopedic surgery) with spinal anesthesia will take part. After surgery, participants will be randomly placed into one of three groups: one group will receive a cold pack on the lower belly (suprapubic area), a second group will receive a gentle massage on the lower back over the tailbone (sacral area), and a third group will receive usual care only with no extra procedure. The same nurse researcher will provide the study care for all groups, check how well participants pass urine, use a small painless scan on the lower belly to see how much urine is in the bladder (portable bladder ultrasound), and record whether a tube in the bladder to drain urine (urinary catheter) is needed.
Detailed description
Trouble emptying the bladder after surgery (acute urinary retention, AUR) is a common and important problem in adults who receive numbing medicine in the lower back (spinal anesthesia). AUR can cause pain, an overfilled bladder (bladder distension), urinary tract infection, longer hospital stays, and higher health care costs. The usual way to manage AUR is to place a tube into the bladder to drain urine (urinary catheterization). This works, but it is invasive and may lead to infection, injury to the urethra, and discomfort. Because of these risks, there is a need for simple, non-drug, non-invasive nursing methods to help prevent AUR.
Spinal anesthesia can temporarily block normal bladder function and increase the risk of AUR. Nurses are often the first to notice when a person is unable to pass urine and are in a key position to provide early, preventive care. Some studies have looked at different nursing interventions for urinary retention, but there is little evidence about non-invasive methods after spinal anesthesia, and no trial has directly compared a cold pack on the lower belly with a massage over the tailbone in this setting.
This randomized controlled trial will include adult surgical patients who receive spinal anesthesia for operations in the scrotum (scrotal), groin (inguinal), pelvic area, lower belly (lower abdominal), or bones and joints (orthopedic surgery). Participants will be randomly assigned to one of three groups:
- a dry cold pack applied to the lower belly over the bladder (suprapubic area),
- gentle massage over the lower back in the area of the tailbone (sacral area), or
- usual postoperative care without an extra study procedure.
All study procedures in all three groups will be carried out by a single nurse researcher, using the same assessment steps for every participant. The aim is to keep the care consistent and reduce differences that are not related to the study methods.
The main focus of the study is to find out whether these nursing methods can lower the rate of acute urinary retention after spinal anesthesia. Nurses will regularly check how well participants can pass urine on their own and will estimate bladder volume using a small, painless scan placed on the skin over the lower belly (portable bladder ultrasound device). This objective measurement is expected to improve early detection of AUR compared with relying only on symptoms or physical examination.
The study will also look at related outcomes such as time to first spontaneous urination, need for urinary catheterization, bladder fullness and pain, and comfort and satisfaction with nursing care. By providing clear, comparative information on two simple, non-invasive nursing interventions, this trial aims to support evidence-based postoperative nursing protocols, improve patient comfort, and reduce the need for invasive urinary catheterization after spinal anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, parallel, three-arm trial comparing suprapubic cold pack application, sacral massage, and usual care in adults undergoing scrotal, inguinal, pelvic, lower abdominal, or orthopedic surgery with spinal anesthesia.
| Arm | Type | Receives |
|---|---|---|
| Suprapubic Cold Pack Group | Experimental | Other: Suprapubic Cold PackParticipants in this arm receive a suprapubic dry cold pack in addition to usual postoperative nursing care after surgery with spinal anesthesia. The cold pack is applied in the early postoperative period according to a standard nursing protocol. |
| Sacral Massage Group | Experimental | Other: Sacral MassageParticipants in this arm receive sacral massage in addition to usual postoperative nursing care after surgery with spinal anesthesia. The massage is delivered in the early postoperative period by a nurse researcher following a standard nursing protocol. |
| Usual Care Control Group | No intervention | –Participants in this arm receive only usual postoperative nursing care after surgery with spinal anesthesia, according to the hospital's standard protocols. They do not receive any additional study-specific intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Suprapubic Cold PackA dry cold pack applied externally to the skin over the lower abdomen above the bladder (suprapubic area) in adult patients after surgery with spinal anesthesia. The cold pack is used for a predefined duration in the early postoperative period as a non-pharmacologic, non-invasive nursing intervention to support bladder emptying and patient comfort. | Other | Suprapubic Cold Pack Group |
| Sacral MassageA gentle manual massage applied externally to the skin over the lower back in the sacral (tailbone) region in adult patients after surgery with spinal anesthesia. The massage is performed for a predefined duration in the early postoperative period as a non-pharmacologic, non-invasive nursing intervention to support bladder function and patient comfort. | Other | Sacral Massage Group |
Primary outcome
Proportion of participants who develop postoperative acute urinary retention
Time frame: Within the first 6 hours after surgery with spinal anesthesia (postoperative 0-6 hours).
Proportion of participants who develop postoperative acute urinary retention (AUR) within the first 6 hours after surgery with spinal anesthesia, defined as inability to void spontaneously requiring urinary catheterization and/or elevated bladder volume on bladder ultrasound.
3 secondary outcomes
Proportion of participants requiring urinary catheterization within the first 6 hours after surgery
Time frame: Within the first 6 hours after surgery with spinal anesthesia (postoperative 0-6 hours).
Bladder-related discomfort or pain score within the first 6 hours after surgery
Time frame: Within the first 6 hours after surgery with spinal anesthesia (postoperative 0-6 hours).
Time to first spontaneous voiding within the first 6 hours after surgery
Time frame: Within the first 6 hours after surgery with spinal anesthesia (postoperative 0-6 hours).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suprapubic Cold Pack and Sacral Massage in people with Postoperative Urinary Retention and Urinary Retention, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 6 Apr 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hülya CEYHAN, RN, MSc (+90 545 541 40 29, hulya.ceyhan@ogr.iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants who develop postoperative acute urinary retention (time frame: Within the first 6 hours after surgery with spinal anesthesia (postoperative 0-6 hours).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2026.