Trial Outcomes & Findings for Adjunct Inversion for Lower Pole Stone (NCT NCT01852669)

NCT ID: NCT01852669

Last Updated: 2015-04-20

Results Overview

To compare the effectiveness of simultaneous adjunct controlled inversion therapy during extracorporeal shockwave lithotripsy (ESWL) to that of ESWL alone in the treatment of lower pole caliceal stone as measured by stone-free rate(SFR)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 140 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2015-04-20

Participant Flow

Participant milestones

Measure	Inversion, Hydration, ESWL ESWL with hydration and inversion Inversion: Patients inverted 30 degree head down in Trendelenburg position Shock Wave Lithotripsy: Shock wave lithotripsy Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV	ESWL, Hydration ESWL with hydration Shock Wave Lithotripsy: Shock wave lithotripsy Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV
Overall Study STARTED	71	69
Overall Study COMPLETED	71	68
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Adjunct Inversion for Lower Pole Stone

Baseline characteristics by cohort

Measure	Inversion, Hydration, ESWL n=71 Participants ESWL with hydration and inversion Inversion: Patients inverted 30 degree head down in Trendelenburg position Shock Wave Lithotripsy: Shock wave lithotripsy Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV	ESWL, Hydration n=68 Participants ESWL with hydration Shock Wave Lithotripsy: Shock wave lithotripsy Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV	Total n=139 Participants Total of all reporting groups
Age, Continuous	48.3 years STANDARD_DEVIATION 11.1 • n=5 Participants	50.9 years STANDARD_DEVIATION 12.9 • n=7 Participants	49.63 years STANDARD_DEVIATION 12.0 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	21 Participants n=7 Participants	41 Participants n=5 Participants
Sex: Female, Male Male	51 Participants n=5 Participants	47 Participants n=7 Participants	98 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

To compare the effectiveness of simultaneous adjunct controlled inversion therapy during extracorporeal shockwave lithotripsy (ESWL) to that of ESWL alone in the treatment of lower pole caliceal stone as measured by stone-free rate(SFR)

Outcome measures

Measure	Inversion, Hydration, ESWL n=71 Participants ESWL with hydration and inversion Inversion: Patients inverted 30 degree head down in Trendelenburg position Shock Wave Lithotripsy: Shock wave lithotripsy Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV	ESWL, Hydration n=68 Participants ESWL with hydration Shock Wave Lithotripsy: Shock wave lithotripsy Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV
Number of Participants Who Are Stone Free at 3 Months	54 participants	49 participants

Adverse Events

Inversion, Hydration, ESWL

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

ESWL, Hydration

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Inversion, Hydration, ESWL n=71 participants at risk ESWL with hydration and inversion Inversion: Patients inverted 30 degree head down in Trendelenburg position Shock Wave Lithotripsy: Shock wave lithotripsy Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV	ESWL, Hydration n=68 participants at risk ESWL with hydration Shock Wave Lithotripsy: Shock wave lithotripsy Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV
Blood and lymphatic system disorders Haematoma	1.4% 1/71 • Number of events 1	2.9% 2/68 • Number of events 2

Additional Information

Dr Shaun Lee

Monash University

Phone: 55145890

Email: shaun.lee@monash.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place