NCT06795256

Brief Summary

To evaluate the effectiveness of this homework on stone clearance rates after retrograde intrarenal surgery (RIRS) by instructing the patient in the home environment and suggesting percussion and movement/position changes to assist in spontaneous stone passage.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

January 21, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 28, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

January 29, 2025

Status Verified

January 1, 2025

Enrollment Period

9 months

First QC Date

January 21, 2025

Last Update Submit

January 27, 2025

Conditions

Retrograde Intrarenal SurgeryStone, Kidney

Outcome Measures

Primary Outcomes (1)

  • stone free rates

    1 month after the intervention/procedure/surgery

Secondary Outcomes (1)

  • Number of Patients with complications and Number of Patients with need for secondary surgery after retrograde intrarenal surgery

    1 month after the intervention/procedure/surgery

Study Arms (2)

Homework to Help with Stone Dissolution in Retrograde Intrarenal Surgery

EXPERIMENTAL
Behavioral: Percussion and position change in retrograde intrarenal surgery

Standard Retrograde Intrarenal Surgery

NO INTERVENTION

Interventions

Percussion and position change in retrograde intrarenal surgeryBEHAVIORAL

To evaluate the effectiveness of this homework on stone clearance rates after RIRC by giving instructions to the patient in the home environment and suggesting percussion (tapping) and movement/position changes to help spontaneous stone passage.

Homework to Help with Stone Dissolution in Retrograde Intrarenal Surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with an indication for RIRC

You may not qualify if:

  • Patients with anatomic abnormalities such as horseshoe kidney, fragments in the calyx diverticulum, infundibular stenosis, pelvi-ureteral junction obstruction or ureteral stenosis.
  • Patients with morbid obesity, uncontrolled hypertension, previous cerebrovascular accident, skeletal deformity such as significant coronary artery disease or symptomatic gastro-esophageal reflux disease.
  • Patients with lumbar disc herniation who have undergone spinal surgery and are unable to undergo behavioral therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adıyaman University

Adıyaman, 02400, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Bedreddin Kalyenci, Doctor

CONTACT

+905554859583bedreddin84@windowslive.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 21, 2025

First Posted

January 28, 2025

Study Start

January 21, 2025

Primary Completion

October 31, 2025

Study Completion

November 30, 2025

Last Updated

January 29, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR

Locations

TU(1)