NCT04851171

Brief Summary

The present study is randomized in nature, comparing the stone free rate and complications rate between semi-rigid ureteroscopy (SR-URS) and Flexible Ureteroscopy (F-URS) for the treatment of Proximal Ureteric stone (PUS), whereby the preoperative assessments, procedure and reporting of outcomes will all be standardized.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

November 26, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 20, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

April 20, 2021

Status Verified

April 1, 2021

Enrollment Period

1.9 years

First QC Date

April 1, 2021

Last Update Submit

April 14, 2021

Conditions

Ureteric StoneStone Ureter

Keywords

UrolithiasisUreteroscopyUreteric stoneFlexible ureteroscopySemi-rigid ureteroscopy

Outcome Measures

Primary Outcomes (1)

  • Stone free rate

    Sone free status will be assessed by doing CT KUB scan 4 weeks postoperative and it is defined as patients with no residual stones or clinically insignificant residual fragments (\< 2 mm).

    Four weeks

Secondary Outcomes (2)

  • Complication rate

    Three Months

  • To compare stone free rate and complications between patients with ureteric stent and patients without ureteric stent

    Three Months

Study Arms (2)

Semi-rigid Ureteroscopy

ACTIVE COMPARATOR

Patient with upper ureteric stone who are randomized in this arm will undergo semi-rigid ureteroscopy for treatment of the stone.

Procedure: Semi-rigid Ureteroscopy

Flexible Ureteroscopy

ACTIVE COMPARATOR

Patient with upper ureteric stone who are randomized in this arm will undergo flexible ureteroscopy for treatment of the stone.

Procedure: Flexible Ureteroscopy

Interventions

Flexible UreteroscopyPROCEDURE

Flexible ureteroscopy is the use of flexible ureteroscope for the treatment of stone in the upper ureter with the aid of laser lithotripsy.

Flexible Ureteroscopy
Semi-rigid UreteroscopyPROCEDURE

Semi-rigid ureteroscopy is the use of the semi-rigid ureteroscope for the treatment of stone in the upper ureter with the aid of laser lithotripsy.

Semi-rigid Ureteroscopy

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 18 years
  • Single proximal ureteric stone indicated for active treatment with ureteroscopy (stented or non-stented)

You may not qualify if:

  • Solitary Kidney
  • Bilateral ureteric stones
  • Ipsilateral multiple simultaneous ureteric stones
  • Ipsilateral kidney stone
  • Active UTI
  • Coagulopathy diseases
  • Ipsilateral ureteral anomalies, ureteral disorder (tumor or stricture) or previous ureteral open surgery.
  • Pregnant patients.
  • Unable to give informed consent.
  • Patient is not agreeing to go through the randomization.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al Wakra Hospital

Al-Wakrah, Baladīyat ad Dawḩah, 0000, Qatar

RECRUITING

Related Publications (7)

  • Wolf JS Jr. Treatment selection and outcomes: ureteral calculi. Urol Clin North Am. 2007 Aug;34(3):421-30. doi: 10.1016/j.ucl.2007.04.010.

    PMID: 17678991BACKGROUND

  • Lee JH, Woo SH, Kim ET, Kim DK, Park J. Comparison of Patient Satisfaction with Treatment Outcomes between Ureteroscopy and Shock Wave Lithotripsy for Proximal Ureteral Stones. Korean J Urol. 2010 Nov;51(11):788-93. doi: 10.4111/kju.2010.51.11.788. Epub 2010 Nov 17.

    PMID: 21165201BACKGROUND

  • Assimos D, Krambeck A, Miller NL, Monga M, Murad MH, Nelson CP, Pace KT, Pais VM Jr, Pearle MS, Preminger GM, Razvi H, Shah O, Matlaga BR. Surgical Management of Stones: American Urological Association/Endourological Society Guideline, PART II. J Urol. 2016 Oct;196(4):1161-9. doi: 10.1016/j.juro.2016.05.091. Epub 2016 May 27.

    PMID: 27238615BACKGROUND

  • Hyams ES, Monga M, Pearle MS, Antonelli JA, Semins MJ, Assimos DG, Lingeman JE, Pais VM Jr, Preminger GM, Lipkin ME, Eisner BH, Shah O, Sur RL, Mufarrij PW, Matlaga BR. A prospective, multi-institutional study of flexible ureteroscopy for proximal ureteral stones smaller than 2 cm. J Urol. 2015 Jan;193(1):165-9. doi: 10.1016/j.juro.2014.07.002. Epub 2014 Jul 9.

    PMID: 25014576BACKGROUND

  • Alkan E, Saribacak A, Ozkanli AO, Basar MM, Acar O, Balbay MD. Flexible Ureteroscopy Can Be More Efficacious in the Treatment of Proximal Ureteral Stones in Select Patients. Adv Urol. 2015;2015:416031. doi: 10.1155/2015/416031. Epub 2015 Nov 4.

    PMID: 26617636BACKGROUND

  • Galal EM, Anwar AZ, El-Bab TK, Abdelhamid AM. Retrospective comparative study of rigid and flexible ureteroscopy for treatment of proximal ureteral stones. Int Braz J Urol. 2016 Sep-Oct;42(5):967-972. doi: 10.1590/S1677-5538.IBJU.2015.0644.

    PMID: 27622276BACKGROUND

  • Karadag MA, Demir A, Cecen K, Bagcioglu M, Kocaaslan R, Altunrende F. Flexible ureterorenoscopy versus semirigid ureteroscopy for the treatment of proximal ureteral stones: a retrospective comparative analysis of 124 patients. Urol J. 2014 Nov 1;11(5):1867-72.

    PMID: 25361706BACKGROUND

MeSH Terms

Conditions

UreterolithiasisUrolithiasis

Condition Hierarchy (Ancestors)

Ureteral DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Ibrahim Al-Nadhari

    Hamad Medical Corporation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ibrahim Alnadhari, MD, FRCS Uro

CONTACT

+974-33403324/ +974-40115093ibrahimah1978@yahoo.com, IAlnadhari@hamad.qa,

Omar Ali, MD

CONTACT

+974- 55175719/ +974-40115441omarisam1972@yahoo.com, oali@hamad.qa

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Consultant- Surgery

Study Record Dates

First Submitted

April 1, 2021

First Posted

April 20, 2021

Study Start

November 26, 2020

Primary Completion

November 1, 2022

Study Completion

January 1, 2023

Last Updated

April 20, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

QA(1)