Trial Outcomes & Findings for Incontinence Ring on Stress Urinary Incontinence (NCT NCT00427778)

NCT ID: NCT00427778

Last Updated: 2017-09-27

Results Overview

number of women who experienced 50% or more reduction in number of incontinence episode per week on diary while using the incontinence ring, compared to baseline period.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 29 participants
• Primary outcome timeframe: baseline and 4 weeks
• Results posted on: 2017-09-27

Participant Flow

87 women were screened for eligibility between June 2006 and February 2008, at an academic specialty center

29 out of 87 were randomised. of those not randomized, 52 declined to participate and 6 did not meet inclusion criteria.

Participant milestones

Measure	Incontinence Ring, Then no Treatment participants first were fitted to an incontinence ring, which they wore for a period of 4 weeks, then it was removed. After a washout period of 2 weeks, they continued evaluation but with no active treatment	No Treatment, Then Incontinence Ring Participants first were assessment while no active treatment was received, for a period of 4 weeks. After a washout period of 2 weeks, they continued evaluation after an incontinence ring was fitted.
First Intervention (4 Weeks) STARTED	14	15
First Intervention (4 Weeks) COMPLETED	10	14
First Intervention (4 Weeks) NOT COMPLETED	4	1
Wash Out (2 Weeks) STARTED	10	14
Wash Out (2 Weeks) COMPLETED	10	14
Wash Out (2 Weeks) NOT COMPLETED	0	0
Second Intervention (4 Weeks) STARTED	10	14
Second Intervention (4 Weeks) COMPLETED	10	14
Second Intervention (4 Weeks) NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Incontinence Ring, Then no Treatment participants first were fitted to an incontinence ring, which they wore for a period of 4 weeks, then it was removed. After a washout period of 2 weeks, they continued evaluation but with no active treatment	No Treatment, Then Incontinence Ring Participants first were assessment while no active treatment was received, for a period of 4 weeks. After a washout period of 2 weeks, they continued evaluation after an incontinence ring was fitted.
First Intervention (4 Weeks) no longer interested	1	0
First Intervention (4 Weeks) Not successfully fitted with ring	2	0
First Intervention (4 Weeks) unable to manipulate ring due to OA	0	1
First Intervention (4 Weeks) anxious about using ring	1	0

Baseline Characteristics

Incontinence Ring on Stress Urinary Incontinence

Baseline characteristics by cohort

Measure	All Study Participants n=26 Participants All participants who were randomised to a treatment sequence group
Age, Continuous	52.2 years STANDARD_DEVIATION 11.2 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
BMI	29 kg/m^2 STANDARD_DEVIATION 6.8 • n=5 Participants
Parity	2 previous vaginal births n=5 Participants
Smoking status	2 Participants n=5 Participants
Menopausal status	8 Participants n=5 Participants
Pop stage stage 0	2 Participants n=5 Participants
Pop stage stage 1	7 Participants n=5 Participants
Pop stage stage 2	17 Participants n=5 Participants
incontinence episodes per week	10 number of incontinence episodes per week n=5 Participants
Score to question #3 on UDI-6	3 units on a scale n=5 Participants
UDI score	1.5 units on a scale n=5 Participants
MCS12	47.9 units on a scale STANDARD_DEVIATION 11.1 • n=5 Participants
PCS12	51.2 units on a scale STANDARD_DEVIATION 8.3 • n=5 Participants
Peak flow rate (ml/sec)	22.9 ml/sec STANDARD_DEVIATION 15.1 • n=5 Participants
Post void residual (ml)	19.6 ml STANDARD_DEVIATION 21 • n=5 Participants

PRIMARY outcome

Timeframe: baseline and 4 weeks

Population: All participants who were randomized and fitted with a ring are included in this intent to treat analysis. Patients for whom a ring could not be successfully fitted were considered failure (\<50%) improvement)

number of women who experienced 50% or more reduction in number of incontinence episode per week on diary while using the incontinence ring, compared to baseline period.

Outcome measures

Measure	Incontinence Ring n=24 Participants participants completed a 1-week diary during the last of 4 weeks of ring use. Women who did not wear the ring were considered failures (\<50% improvement from baseline)	Controls n=24 Participants participants completed a 1-week diary during the last of 4 weeks of the 'no treatment' week. Failure is determined as \<50% improvement from baseline.
Number of Participants With 50% or More Reduction in Number of Incontinence Episode Per Week	14 Participants	10 Participants

SECONDARY outcome

Timeframe: 4 weeks

Score (0-3) of response to question #3 (stress incontinence specific) of Urogenital Distress inventory - short form. The UDI is a 6-question validated questionnaire assessing the urinary tract symptoms and their bothersomeness. Question three asks specifically about "Leakage related to activity, coughing, or sneezing", i.e. stress urinary incontinence. Answer is scored from 0-3 (3 most bothersome).

Outcome measures

Measure	Incontinence Ring n=24 Participants participants completed a 1-week diary during the last of 4 weeks of ring use. Women who did not wear the ring were considered failures (\<50% improvement from baseline)	Controls n=24 Participants participants completed a 1-week diary during the last of 4 weeks of the 'no treatment' week. Failure is determined as \<50% improvement from baseline.
Score on Question 3 of UDI 6	1 units on a scale Interval 0.0 to 2.0	3 units on a scale Interval 2.0 to 3.0

SECONDARY outcome

Timeframe: 4 weeks

Urogenital Distress inventory - short form. The UDI is a 6-question validated questionnaire assessing the urinary tract symptoms and their bothersomeness. Answers are scored from 0-3 (3 most bothersome). An average score is then obtained, ranging from 0-3.

Outcome measures

Measure	Incontinence Ring n=24 Participants participants completed a 1-week diary during the last of 4 weeks of ring use. Women who did not wear the ring were considered failures (\<50% improvement from baseline)	Controls n=24 Participants participants completed a 1-week diary during the last of 4 weeks of the 'no treatment' week. Failure is determined as \<50% improvement from baseline.
UDI Overall Score	0.7 units on a scale Interval 0.1 to 1.2	1.3 units on a scale Interval 1.1 to 1.7

SECONDARY outcome

Timeframe: 4 weeks

Number of Participants Without Urinary Stress Incontinence During Provocation testing during urodynamic studies (UDS). Provocations included valsalva and cough, first at 300 ml while lying then standing, followed, if no leakage was seen, to provocations at maximum cystometric capacity while standing.

Outcome measures

Measure	Incontinence Ring n=24 Participants participants completed a 1-week diary during the last of 4 weeks of ring use. Women who did not wear the ring were considered failures (\<50% improvement from baseline)	Controls n=26 Participants participants completed a 1-week diary during the last of 4 weeks of the 'no treatment' week. Failure is determined as \<50% improvement from baseline.
Objective Cure Rate	0 Participants	0 Participants

SECONDARY outcome

Timeframe: baseline and at 4 weeks of ring use.

Peak flow rate (ml/sec) during uninstrumented uroflow. The 'no treatment' flow rate was obtained during baseline urodynamic studies (UDS) and the 'incontinence ring' flow rate was obtained at the end of the ring period for each participants, while wearing the ring.

Outcome measures

Measure	Incontinence Ring n=24 Participants participants completed a 1-week diary during the last of 4 weeks of ring use. Women who did not wear the ring were considered failures (\<50% improvement from baseline)	Controls n=26 Participants participants completed a 1-week diary during the last of 4 weeks of the 'no treatment' week. Failure is determined as \<50% improvement from baseline.
Urodynamic Effect of the Incontinence Ring on Flow Rate	24.1 ml/sec Standard Deviation 11.6	22.9 ml/sec Standard Deviation 15.1

SECONDARY outcome

Timeframe: 4 weeks

The I-QOL (Incontinence-Quality of Life) is a valid and reproducible self-administered measure for assessing quality of life of patients with urinary incontinence. Items are scored on a 4-point Likert response scale (very much, moderately, a little, not at all). Scoring the I-QOL questionnaire involves summing the responses into a single score. The sum score is transformed to a 0-100 scale, with a higher number representing a better quality of life

Outcome measures

Measure	Incontinence Ring n=24 Participants participants completed a 1-week diary during the last of 4 weeks of ring use. Women who did not wear the ring were considered failures (\<50% improvement from baseline)	Controls n=24 Participants participants completed a 1-week diary during the last of 4 weeks of the 'no treatment' week. Failure is determined as \<50% improvement from baseline.
Impact on I-QOL	89.1 units on a scale Interval 72.3 to 95.5	70.9 units on a scale Interval 56.4 to 84.5

SECONDARY outcome

Timeframe: 4 weeks

Population: Women did not fill out this VAS when not wearing the incontinence ring.

participants completed a 10 cm visual analogue scale at the end of 4 weeks of ring use, rating their pelvic discomfort on a 10 cm scale; 0= none, 10= max.

Outcome measures

Measure	Incontinence Ring n=24 Participants participants completed a 1-week diary during the last of 4 weeks of ring use. Women who did not wear the ring were considered failures (\<50% improvement from baseline)	Controls participants completed a 1-week diary during the last of 4 weeks of the 'no treatment' week. Failure is determined as \<50% improvement from baseline.
Patient Acceptability (10 cm VAS)	0.6 cm Standard Deviation 0.9	—

SECONDARY outcome

Timeframe: The UDS while wearing the ring was done 2-4 weeks into the 'ring' treatment period, at patient's convenience, the UDS done at baseline was considered representative of "no treatment" UDS.

Population: All uroflow were obtained on arrival of the patient in the UDS suite and prior to instrumentation. patients were asked to arrive with a full bladder, but some did not, explaining the lower number of women with available results.

Post void residual measured by catheter after free flow uroflowmetry

Outcome measures

Measure	Incontinence Ring n=23 Participants participants completed a 1-week diary during the last of 4 weeks of ring use. Women who did not wear the ring were considered failures (\<50% improvement from baseline)	Controls n=21 Participants participants completed a 1-week diary during the last of 4 weeks of the 'no treatment' week. Failure is determined as \<50% improvement from baseline.
Post Void Residual	15.9 ml Standard Deviation 19.1	51.5 ml Standard Deviation 67.9

Adverse Events

Incontinence Ring

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Marie-Andree Harvey

Queen's University

Phone: 613-548-6115

Email: harveym@queensu.ca

Results disclosure agreements

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