Evaluating Two Nursing Interventions to Prevent Urinary Retention After Spinal Anesthesia

NCT07293000 | Not Yet Recruiting DMC

• 1 other identifier: HCEYHAN
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Urinary Retention; Postoperative Urinary Retention

Keywords

Urinary retention; Postoperative urinary retention; Nursing Interventions; Bladder Volume Measurement Device; Cold Application; Sacral Massage

Outcome Measures

Primary Outcomes (1)

• Incidence of 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.

  Postoperative 0-6 hours after surgery with spinal anesthesia

Secondary Outcomes (3)

• Need for Urinary Catheterization Within the First 6 Hours

  Within the first 6 hours after surgery with spinal anesthesia (postoperative 0-6 hours)

• Bladder-Related Discomfort/Pain Score During the First 6 Hours

  Within the first 6 hours after surgery with spinal anesthesia (postoperative 0-6 hours)

• Time to First Spontaneous Voiding Within the First 6 Hours

  Within the first 6 hours after surgery with spinal anesthesia (postoperative 0-6 hours)

Study Arms (3)

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.

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.

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.

Interventions

Suprapubic Cold Pack OTHER

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.

Suprapubic Cold Pack Group

Sacral Massage OTHER

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.

Sacral Massage Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa, Institute of Graduate Studies

Istanbul, Avcılar, 34320, Turkey (Türkiye)

Location

Related Links

• Related Info

MeSH Terms

Conditions

Urinary Retention

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Hülya CEYHAN, RN, MSc

CONTACT

+90 545 541 40 29; hulya.ceyhan@ogr.iuc.edu.tr

Yeliz ÇULHA, Associate Professor

CONTACT

+90 544 284 50 80; yeliz.culha@iuc.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants will be randomly assigned to one of three groups using a computer-generated random sequence (Randomizer.org), with group allocation concealed in sealed opaque envelopes until enrollment. All interventions will be delivered by a single nurse researcher, who will be aware of group assignments. However, the data will be analyzed by an independent expert who will be blinded to group allocation and will work with de-identified, coded data only.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Phd candidate of nursing

Model Details: 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.

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: December 18, 2025
• Study Start: January 15, 2026
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)