Trial Outcomes & Findings for Comparison of Two Urostomy Bags (2-piece). (NCT NCT00761748)

Results Overview

Number of participants preferring the SenSura Uro 2 piece product or the reference Convatec 2 piece product. The subjects are asked via the case report form (questionnaire) at the end of the second cross over period, which of the two products they preferred.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

30 participants

Primary outcome timeframe

6 weeks

Results posted on

2013-01-01

Participant Flow

The subjects were recruited by the investigators at multiple sites in Germany.

39 subjects were enrolled in the study, however 9 subjects were excluded from participating in the study.

Participant milestones

Participant milestones
Measure	Sensura Uro 2 Piece First, Then Convatec 2 Piece Sensura is a newly developed two piece product for people with urostomies.	ConvaTec 2 Piece,First, Then Sensura Uro 2 Piece Convatec is the reference product and was chosen because of its similarity with the Sensura appliance.
First Intervention (21 +/- 3 Days) STARTED	20	10
First Intervention (21 +/- 3 Days) COMPLETED	17	7
First Intervention (21 +/- 3 Days) NOT COMPLETED	3	3
Second Intervention (21 +/- 3 Days) STARTED	17	7
Second Intervention (21 +/- 3 Days) COMPLETED	17	7
Second Intervention (21 +/- 3 Days) NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Sensura Uro 2 Piece First, Then Convatec 2 Piece Sensura is a newly developed two piece product for people with urostomies.	ConvaTec 2 Piece,First, Then Sensura Uro 2 Piece Convatec is the reference product and was chosen because of its similarity with the Sensura appliance.
First Intervention (21 +/- 3 Days) Adverse Event	3	0
First Intervention (21 +/- 3 Days) Lost to Follow-up	0	3

Baseline Characteristics

Comparison of Two Urostomy Bags (2-piece).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study Population n=30 Participants Urostomy operated subjects
Age Continuous	68 years n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: The Per protocol (PP) population is analysed. PP-criteria: Subjects fulfill the inclusion and exclusion criteria, do not seriously violate the protocol, are exposed to both products and are evaluable with respect to the primary endpoint (state preference). \*One drop out was evaluable, as the subject tried both products and stated a preference.

Number of participants preferring the SenSura Uro 2 piece product or the reference Convatec 2 piece product. The subjects are asked via the case report form (questionnaire) at the end of the second cross over period, which of the two products they preferred.

Outcome measures

Outcome measures
Measure	Sensura Uro 2 Piece n=25 Participants The new SenSura Uro 2-piece. Is a urostomy bag with the intended use of collecting urine from a stoma. Consist of a base plate and a bag that is attached to the base plate.	Convatec 2 Piece n=25 Participants The reference product Convatec 2 piece is a urostomy bag intended for collecting urin from a stoma.
Preference of the Two Urostomy Products	21 participants	4 participants

Adverse Events

Sensura Uro 2 Piece

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Convatec 2 Piece

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sensura Uro 2 Piece n=30 participants at risk SenSura Uro 2-piece. Is a urostomy bag with the intended use of collecting urine from a stoma. Consist of a base plate and a bag that is attached to the base plate.	Convatec 2 Piece n=30 participants at risk The reference product Convatec 2 piece is a urostomy bag intended for collecting urine from a stoma.
Gastrointestinal disorders Ileus	3.3% 1/30 • Number of events 1	0.00% 0/30

Other adverse events

Other adverse events
Measure	Sensura Uro 2 Piece n=30 participants at risk SenSura Uro 2-piece. Is a urostomy bag with the intended use of collecting urine from a stoma. Consist of a base plate and a bag that is attached to the base plate.	Convatec 2 Piece n=30 participants at risk The reference product Convatec 2 piece is a urostomy bag intended for collecting urine from a stoma.
Skin and subcutaneous tissue disorders Skin irritation	16.7% 5/30 • Number of events 5	0.00% 0/30

Additional Information

Director of Medical Outcome

Coloplast A/S

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60