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CompletedNCT06715202Updated Dec 4, 2024

Effect of Educatıon Gıven To Patıents Wıth Ureteral Stent (Dj) Insertıon On Postoperatıve Symptom Management And Qualıty of Lıfe

An interventional study of Patient Education Booklet in Ureteral Calculi, sponsored by Ataturk University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-04.

Sponsored by Ataturk University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 2 years 7 months after the study started (first participant enrolled Apr 2022, registered Nov 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
162
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The data of the randomized controlled experimental study were collected at the Urology Clinics of Atatürk University Health Practice and Research Hospital between April and November 2022. The study sample consisted of 162 patients (82 in the training group, 80 in the control group) who were selected by simple random sampling method and met the inclusion criteria for the study.

Read the detailed description

Ureteral stents have been widely used in many urological procedures since their use was published by Zimskind in 1967 and Finley's use of the modern double J (DJ) stent in 1978. Ureterorenoscopy (URS) is a popular method used frequently in the diagnosis and treatment of ureteral diseases today. Apart from being performed for diagnostic purposes, URS is most commonly used to treat ureteral stones. The vast majority of ureteral stones are treated endoscopically. A Double-J (DJ) stent is often placed after ureterorenoscopy. The purpose of the stent is to prevent obstruction, renal colic, and deterioration of renal function. The fact that the DJ stent will remain in the patient for a certain period of time (approximately 3-4 weeks) causes anxiety in the patient. However, urinary system symptoms that impair the quality of life are observed in approximately 80% of patients who have a DJ stent. These symptoms include frequent urination (50-60%), urgency (57-60%), pain during urination (40%), incomplete voiding (76%), flank pain (19-32%), suprapubic pain (30%), incontinence and hematuria (25%). In addition, 32% of patients with DJ stents develop sexual dysfunction. 2,3,4 Patients who have DJ stents inserted after ureteroscopy surgery need more information, support, explanation and help to cope with the effects of these symptoms in the clinic and at home. 5 In this context, it is important to provide individualized and comprehensive education that includes the home care process before and after URS. It has been determined in the literature that education given before surgical intervention reduces anxiety, pain level, complication rate and depression rate in the postoperative period and increases patient satisfaction. 6,7,8 However, it is reported that individuals should be discharged with sufficient theory and practice to meet their post-discharge care needs. Although all healthcare personnel are responsible for the discharge education of individuals and their relatives, the most important responsibility belongs to nurses.

02

Conditions studied

  • Ureteral Calculi

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Keywords

  • Ureteral Stent (DJ), Symptom Management, Quality of Life
03

In context

Ureteral Calculi

50 studies on the registry are indexed under Ureteral Calculi; 14 are open to participants now.

This study's enrollment of 162 is above the median of 100 across 42 interventional studies indexed under Ureteral Calculi.

Browse Ureteral Calculi studies →

Lead sponsor

Ataturk University is the lead sponsor of 460 studies on the registry; 126 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Being between the ages of 18-65
  • Volunteering to participate in the study
  • Having URS surgery for the first time due to stones and temporary DJ stent placement

Exclusion criteria

Exclusion Criteria:

  • Having URS surgery for reasons other than stones
  • Having a permanent stent
  • Having major hearing and vision impairment
  • Using antidepressants or anxiolytics
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
162 participants (actual)

Study arms

  • Experimental
    Experimental: Patient Education Booklet

    Patients will be informed about URS, DJ stents and possible problems in the early postoperative period with an education booklet and the patient's questions will be answered.

    Procedure: Patient Education Booklet

Interventions

  • ProcedurePatient Education Booklet

    Before the surgery, a personal information form and the SF-36 Quality of Life Scale will be filled out. The educational content regarding the problems that these patients may encounter with the DJ stent after the surgery until they are discharged will be explained in sections and the patients' questions will be answered. When the patient comes to the hospital for DJ stent removal 4 weeks after discharge, the Ureteral Stent Symptom 1st Questionnaire and the SF-36 Quality of Life Scale will be filled out while the DJ stent is in place. The Ureteral Stent Symptom 2nd Questionnaire and the SF-36 Quality of Life Scale will be applied 4 weeks after the stent is removed. The education booklet will be prepared by the researchers in accordance with the recommendations of the European Association of Urology and the relevant literature.

06

What researchers measure

Primary outcomes

  1. Primary Outcome Measure

    Ureteral Stent Symptom Questionnaire: In 2003, Joshi and colleagues developed a special questionnaire for the assessment of quality of life and stent-related symptoms. The Ureteral Stent Symptoms Questionnaire (USSQ), a validated tool that assesses symptoms and quality of life, was validated in Turkish by Yılören and colleagues in 2017. The USSQ was originally designed as a 38-item questionnaire with 33 Likert-type questions and 5 more descriptive items organized into six main areas. This questionnaire provides a comprehensive assessment of urinary symptoms, general health, pain, sexual health, work performance, and other additional problems related to ureteral stents

    Time frame: The universe of the study, between April and November 2022.

07

Study locations

1 site
  • Muazzez Merve TORAMAN
    Erzurum, 2500, Turkey
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2022 to primary completion in Aug 2022, 4 months.

Of 19 interventional studies with no phase under Ureteral Calculi, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 42. This study's 4 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 28, 2024
First posted
Dec 4, 2024
StartActual
Apr 1, 2022
Primary completionActual
Aug 30, 2022
CompletionActual
Nov 30, 2022
Last update
Dec 4, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06715202
Lead sponsor
Ataturk University
Responsible party
Muazzez Merve TORAMAN (Research Assistant, Ataturk University) — Principal investigator
First posted
Dec 4, 2024
Start date
Apr 1, 2022
Primary completion
Aug 30, 2022
Completion
Nov 30, 2022
Last update
Dec 4, 2024

Oversight

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

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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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