Urinary Incontinence, Stress
Conditions
Keywords
Urinary Incontinence, Stress, Intrinsic sphincter deficiency, Secondary, Transurethral Resection (TUR), Transurethral Resection of the Prostate (TURP), Radical prostatectomy, Open prostatectomy, Post-suprapubic prostatectomy
Brief summary
The purpose of this study is to obtain surgical technique data for use in physician education and training and to collect early clinical outcomes data for future publication.
Detailed description
A multi-center study conducted under a common implant and follow-up protocol. The study will collect pre-operative urologic testing, medical history and subject quality of life (Incontinence Quality of Life Questionnaire). Intra-operative procedural data will be collected. Pad weight and incontinence severity rating (using the International Consultation on Incontinence Questionnaire (ICIQ)) will be used to characterize continence status. Post-operative complications, urologic testing, and subject quality of life will be collected at six weeks and three, six, 12, and 24 months.
Interventions
DEVICEThe AMS Male Transobturator Sling System
The AMS Male Transobturator Sling System was developed to treat urinary stress incontinence in men resulting from intrinsic sphincter deficiency (ISD) secondary to radical prostatectomy. The Male Transobturator Sling System procedure is minimally invasive and consists of using two single-use needle passers and passing them through two small incisions over the obturator foramen. The needles are pushed in an arc through the tissue and exited at a perineal incision. Once the passers are through the perineal incision, the Sling System mesh arms are attached to the needles which are then pulled back through the needle track to their points of origin over the obturator foramen. The Sling System is subsequently tensioned and all incisions are closed.
DEVICEAdVance Male Sling
A transobturator sling for the treatment of post-prostatectomy incontinence
Sponsors
American Medical Systems
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The subject has agreed to be implanted with the AMS Male Transobturator Sling System. 2. The subject is willing and able to give valid informed consent. 3. The subject is \> 40 years of age. 4. The subject has confirmed stress urinary incontinence for at least 6 months and uses no more than 8 pads per day for incontinence management. 5. The subject has any of the following: an observable degree of incontinence during stress related activities, more than one pad is used in a 24 hour period, has more than two episodes of incontinence per day. 6. Internal sphincter contractility confirmed by endoscopic view. 7. The subject's primary etiology is TUR, TURP, radical prostatectomy, open prostatectomy, or suprapubic prostatectomy 8. Pre-existing urological conditions, other than incontinence have been treated and are under control. 9. The subject is willing and able to return for follow-up evaluations and questionnaire completion according to the study protocol. 10. The subject is a good surgical candidate.
Exclusion criteria
1. The subject has a neurogenic bladder condition that is not treatable or controllable by pharmacological or alternative methods. 2. The subject has an atonic bladder. 3. The subject has a post-void residual \> 75 cc. 4. The subject has detrusor-external sphincter dyssynergia. 5. The subject has a urinary tract infection (UTI). 6. The subject was treated with pelvic radiation within the last 6 months. 7. The subject currently has an inflatable penile prosthesis. 8. The subject self-catheterizes. 9. The subject has symptomatic or unstable bladder neck stricture disease. 10. The subject has a history of urethral strictures that may require repetitive instrumentation. 11. The subject has previously had a urethral Sling System, an AMS Sphincter 800™, or any implanted device for the treatment of urinary incontinence (not including bulking agents). 12. The subject has a history of connective tissue or autoimmune conditions. 13. The subject has a compromised immune system. 14. The subject has renal insufficiency, and upper and/or lower urinary tract relative obstruction. 15. The subject's reading level is judged inadequate for reading and understanding the quality of life questionnaires and other study materials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Endpoint: Procedure Time From First Incision to Closing. | During Procedure, Approximately 60 Minutes | Characterize procedure time from first incision to closing. |
| Procedural Endpoint: Type of Anesthesia Used | During Procedure, Approximately 60 Minutes | Describe the type of anesthesia used. |
| Procedural Endpoint: Rate of Foley Catheter Use - Intraoperative | During Procedure, Approximately 60 Minutes | Number of participants requiring the use of a foley catheter intra-operatively. |
| Procedural Endpoint: Rate of Foley Catheter Use - Post-operative | post-operative to discharge | Number of participants requiring the use of a foley catheter who were able to void prior to discharge. |
| Procedural Endpoint: Rate of Foley Catheter Use - Post-discharge | post discharge | Number of participants requiring the use of a foley catheter post-discharge following Bladder Management instructions. |
| Procedural Endpoint: Descriptive Procedural Parameters - Use of Tack Sutures | During Procedure, Approximately 60 Minutes | Characterize procedural parameters including the use of tack sutures. |
| Procedural Endpoint: Descriptive Procedural Parameters - Muscle Dissection | During Procedure, Approximately 60 Minutes | Characterize procedural parameters, including muscle dissection across all participants. |
| Procedural Endpoint: Descriptive Procedural Parameters - Movement of Urethral Bulb While Tensioning | During Procedure, Approximately 60 Minutes | Characterize procedural parameters, including the movement of urethral bulb while tensioning in all participants. |
| Device Success as Defined as Successful Placement of the Device in Desired Position Peri-operatively | During Procedure, Approximately 60 Minutes | Summarize device success as defined as a successful placement of the device in a desired position, peri-operatively, in participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Satisfaction Endpoint: 1-Hour Pad Weight | Baseline to 24 month | Summarize subject satisfaction of 1-hour pad weight for participants. |
| Procedural and Device Complication Rates | Procedure to 24 Months Post implant | Percentage of participants with serious and non-serious adverse events. |
| Subject Satisfaction Endpoint: 24-Hour Pad Weight | Baseline to 24 month | Summarize subject satisfaction with 24-hour pad weight across participants. |
| Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (1 Hour Pad Weight Test) | Baseline to 24 month | Summarize the percent of subjects that have a decrease of pad weight of 25%, 50%, or 75% at follow-up (1-hour pad weight test used). |
| Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (24 Hour Pad Weight Test) | Baseline to 24 Month | Summarize the percent of subjects that have a decrease of pad weight of 25%, 50%, or 75% at follow-up (24-hour pad weight test used). |
| Subject Satisfaction Endpoint: Pads Per Day Use | Baseline to 24 Months | Summarize the subject satisfaction using pads per day use collected in follow-up in participants. |
| Subject Satisfaction Endpoint: Quality of Life I-QOL Scores | Baseline to 24 Months | The Incontinence Quality of Life (I-QOL) questionnaire contains 22 items, each with a 5-point Likert-type response scale, evaluating a subject's quality of life with respect to his urinary problems or incontinence. A possible total score can be 0-100, with a higher score meaning less problems. |
| Subject Satisfaction Endpoint: Quality of Life International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF) Scores | Baseline to 24 Months | The ICIQ-SF questionnaire evaluates the impact of urinary incontinence on quality of life through four questions that evaluate the frequency, severity and impact of urinary incontinence. A set of eight self-diagnosis items related to the causes or situations of urinary incontinence experienced by the subject are also assessed. Scores may range from 0 to 21. Improvement in the subject's quality of life from baseline to follow-up is indicated by a decrease in the ICIQ-SF score. |
| Subject Satisfaction Endpoint: Quality of Life UCLA (University of California Los Angeles) / RAND (RAND Corporation) Scores | Baseline to 24 Months | Improvement in the subject's quality of life from baseline to follow-up is indicated by an increase in the UCLA/RAND urinary function score. Scores may range from 0 to 100. |
| Subject Satisfaction Endpoint: Physician Evaluation of Subject's Incontinence Status | 6 Weeks post implant to 24 Months | Physician evaluation of subject's incontinence status at 6 weeks and subsequent follow-up evaluations |
Countries
Canada, United States
Participant flow
Recruitment details
10 clinical Sites enrolled and implanted subjects. All subjects gave informed consent prior to enrollment and all implanted subjects met the inclusion / exclusion criteria. Enrollment into the study began in February 2006 and ended April 2007.
Pre-assignment details
Subjects who meet the inclusion / exclusion criteria and were good surgical candidates were enrolled into the single arm study and were eligible to be implanted.
Participants by arm
| Arm | Count |
|---|---|
| Treated Participants Participants in which a device placement was attempted. | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Additional Treatments | 11 |
| Overall Study | Case Aborted; Subject Exited | 1 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Treated Participants |
|---|---|
| Age, Continuous | 64.6 years STANDARD_DEVIATION 8.7 |
| Duration of Incontinence Symptoms | 57.2 months STANDARD_DEVIATION 76.5 |
| Primary etiology of intrinsic sphincter deficiency (ISD) Post-Transurethral Resection of Prostate (TURP) | 3 participants |
| Primary etiology of intrinsic sphincter deficiency (ISD) Radical Prostatectomy | 47 participants |
| Race/Ethnicity, Customized African American | 10 participants |
| Race/Ethnicity, Customized Asian | 1 participants |
| Race/Ethnicity, Customized Caucasian | 39 participants |
| Region of Enrollment Canada | 2 participants |
| Region of Enrollment United States | 48 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 50 Participants |
| Years Since Surgery <=1995 | 7 participants |
| Years Since Surgery 1996 - 2001 | 14 participants |
| Years Since Surgery 2002-2004 | 18 participants |
| Years Since Surgery 2005 | 8 participants |
| Years Since Surgery 2006 | 3 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 25 / 50 |
| serious Total, serious adverse events | 2 / 50 |
Outcome results
Primary
Device Success as Defined as Successful Placement of the Device in Desired Position Peri-operatively
Summarize device success as defined as a successful placement of the device in a desired position, peri-operatively, in participants.
Time frame: During Procedure, Approximately 60 Minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treated Participants | Device Success as Defined as Successful Placement of the Device in Desired Position Peri-operatively | 49 Participants |
Primary
Procedural Endpoint: Descriptive Procedural Parameters - Movement of Urethral Bulb While Tensioning
Characterize procedural parameters, including the movement of urethral bulb while tensioning in all participants.
Time frame: During Procedure, Approximately 60 Minutes
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treated Participants | Procedural Endpoint: Descriptive Procedural Parameters - Movement of Urethral Bulb While Tensioning | 2 cm | 5 Participants |
| Treated Participants | Procedural Endpoint: Descriptive Procedural Parameters - Movement of Urethral Bulb While Tensioning | 3 cm | 34 Participants |
| Treated Participants | Procedural Endpoint: Descriptive Procedural Parameters - Movement of Urethral Bulb While Tensioning | > 3 cm | 11 Participants |
Primary
Procedural Endpoint: Descriptive Procedural Parameters - Muscle Dissection
Characterize procedural parameters, including muscle dissection across all participants.
Time frame: During Procedure, Approximately 60 Minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treated Participants | Procedural Endpoint: Descriptive Procedural Parameters - Muscle Dissection | 50 Participants |
Primary
Procedural Endpoint: Descriptive Procedural Parameters - Use of Tack Sutures
Characterize procedural parameters including the use of tack sutures.
Time frame: During Procedure, Approximately 60 Minutes
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treated Participants | Procedural Endpoint: Descriptive Procedural Parameters - Use of Tack Sutures | Tack suture used | 45 Participants |
| Treated Participants | Procedural Endpoint: Descriptive Procedural Parameters - Use of Tack Sutures | Corpus spongiosum | 37 Participants |
| Treated Participants | Procedural Endpoint: Descriptive Procedural Parameters - Use of Tack Sutures | Perineal body | 16 Participants |
| Treated Participants | Procedural Endpoint: Descriptive Procedural Parameters - Use of Tack Sutures | Other tack suture | 9 Participants |
Primary
Procedural Endpoint: Procedure Time From First Incision to Closing.
Characterize procedure time from first incision to closing.
Time frame: During Procedure, Approximately 60 Minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treated Participants | Procedural Endpoint: Procedure Time From First Incision to Closing. | 61.8 minutes | Standard Deviation 25.4 |
Primary
Procedural Endpoint: Rate of Foley Catheter Use - Intraoperative
Number of participants requiring the use of a foley catheter intra-operatively.
Time frame: During Procedure, Approximately 60 Minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treated Participants | Procedural Endpoint: Rate of Foley Catheter Use - Intraoperative | 44 Participants |
Primary
Procedural Endpoint: Rate of Foley Catheter Use - Post-discharge
Number of participants requiring the use of a foley catheter post-discharge following Bladder Management instructions.
Time frame: post discharge
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treated Participants | Procedural Endpoint: Rate of Foley Catheter Use - Post-discharge | No instructions | 35 Participants |
| Treated Participants | Procedural Endpoint: Rate of Foley Catheter Use - Post-discharge | Intermittent self-catheterization | 5 Participants |
| Treated Participants | Procedural Endpoint: Rate of Foley Catheter Use - Post-discharge | Foley catheter | 10 Participants |
Primary
Procedural Endpoint: Rate of Foley Catheter Use - Post-operative
Number of participants requiring the use of a foley catheter who were able to void prior to discharge.
Time frame: post-operative to discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treated Participants | Procedural Endpoint: Rate of Foley Catheter Use - Post-operative | 39 Participants |
Primary
Procedural Endpoint: Type of Anesthesia Used
Describe the type of anesthesia used.
Time frame: During Procedure, Approximately 60 Minutes
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treated Participants | Procedural Endpoint: Type of Anesthesia Used | General | 41 Participants |
| Treated Participants | Procedural Endpoint: Type of Anesthesia Used | Spinal | 9 Participants |
Secondary
Procedural and Device Complication Rates
Percentage of participants with serious and non-serious adverse events.
Time frame: Procedure to 24 Months Post implant
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treated Participants | Procedural and Device Complication Rates | 54 percentage of participants |
Secondary
Subject Satisfaction Endpoint: 1-Hour Pad Weight
Summarize subject satisfaction of 1-hour pad weight for participants.
Time frame: Baseline to 24 month
Population: Last observation carried forward (LOCF) and worst case scenario (WCS) data are derived from data from the 24 month visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treated Participants | Subject Satisfaction Endpoint: 1-Hour Pad Weight | Baseline | 78.4 grams | Standard Deviation 102.3 |
| Treated Participants | Subject Satisfaction Endpoint: 1-Hour Pad Weight | 3 Month | 8.9 grams | Standard Deviation 24.2 |
| Treated Participants | Subject Satisfaction Endpoint: 1-Hour Pad Weight | 6 Month | 23.6 grams | Standard Deviation 49.5 |
| Treated Participants | Subject Satisfaction Endpoint: 1-Hour Pad Weight | 12 Month | 15.8 grams | Standard Deviation 29.7 |
| Treated Participants | Subject Satisfaction Endpoint: 1-Hour Pad Weight | 24 Month | 21.0 grams | Standard Deviation 67 |
| Treated Participants | Subject Satisfaction Endpoint: 1-Hour Pad Weight | 24 Month LOCF | 22.2 grams | Standard Deviation 59.2 |
| Treated Participants | Subject Satisfaction Endpoint: 1-Hour Pad Weight | 24 Month WCS | 30.5 grams | Standard Deviation 76.1 |
Secondary
Subject Satisfaction Endpoint: 24-Hour Pad Weight
Summarize subject satisfaction with 24-hour pad weight across participants.
Time frame: Baseline to 24 month
Population: LOCF and WCS data are derived from data from the 24 month visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treated Participants | Subject Satisfaction Endpoint: 24-Hour Pad Weight | 24 Month WCS | 110.0 grams | Standard Deviation 244.1 |
| Treated Participants | Subject Satisfaction Endpoint: 24-Hour Pad Weight | Baseline | 377.2 grams | Standard Deviation 657.5 |
| Treated Participants | Subject Satisfaction Endpoint: 24-Hour Pad Weight | 3 Month | 108.0 grams | Standard Deviation 191.7 |
| Treated Participants | Subject Satisfaction Endpoint: 24-Hour Pad Weight | 6 Month | 53.7 grams | Standard Deviation 99.1 |
| Treated Participants | Subject Satisfaction Endpoint: 24-Hour Pad Weight | 12 Month | 42.0 grams | Standard Deviation 92.3 |
| Treated Participants | Subject Satisfaction Endpoint: 24-Hour Pad Weight | 24 Month | 38.3 grams | Standard Deviation 58.8 |
| Treated Participants | Subject Satisfaction Endpoint: 24-Hour Pad Weight | 24 Month LOCF | 73.0 grams | Standard Deviation 131.2 |
Secondary
Subject Satisfaction Endpoint: Pads Per Day Use
Summarize the subject satisfaction using pads per day use collected in follow-up in participants.
Time frame: Baseline to 24 Months
Population: LOCF and WCS data are derived from data from the 24 month visit
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treated Participants | Subject Satisfaction Endpoint: Pads Per Day Use | 24 Month WCS | 25 Participants |
| Treated Participants | Subject Satisfaction Endpoint: Pads Per Day Use | 3 Month | 34 Participants |
| Treated Participants | Subject Satisfaction Endpoint: Pads Per Day Use | 24 Month LOCF | 25 Participants |
| Treated Participants | Subject Satisfaction Endpoint: Pads Per Day Use | Baseline | 7 Participants |
| Treated Participants | Subject Satisfaction Endpoint: Pads Per Day Use | 24 Month | 21 Participants |
| Treated Participants | Subject Satisfaction Endpoint: Pads Per Day Use | 12 Month | 26 Participants |
| Treated Participants | Subject Satisfaction Endpoint: Pads Per Day Use | 6 Month | 32 Participants |
| Treated Participants | Subject Satisfaction Endpoint: Pads Per Day Use | 6 Week | 33 Participants |
| 6 Month | Subject Satisfaction Endpoint: Pads Per Day Use | Baseline | 20 Participants |
| 6 Month | Subject Satisfaction Endpoint: Pads Per Day Use | 6 Week | 8 Participants |
| 6 Month | Subject Satisfaction Endpoint: Pads Per Day Use | 3 Month | 6 Participants |
| 6 Month | Subject Satisfaction Endpoint: Pads Per Day Use | 6 Month | 4 Participants |
| 6 Month | Subject Satisfaction Endpoint: Pads Per Day Use | 12 Month | 7 Participants |
| 6 Month | Subject Satisfaction Endpoint: Pads Per Day Use | 24 Month | 9 Participants |
| 6 Month | Subject Satisfaction Endpoint: Pads Per Day Use | 24 Month LOCF | 15 Participants |
| 6 Month | Subject Satisfaction Endpoint: Pads Per Day Use | 24 Month WCS | 15 Participants |
| 12 Month | Subject Satisfaction Endpoint: Pads Per Day Use | 24 Month LOCF | 3 Participants |
| 12 Month | Subject Satisfaction Endpoint: Pads Per Day Use | Baseline | 13 Participants |
| 12 Month | Subject Satisfaction Endpoint: Pads Per Day Use | 24 Month WCS | 3 Participants |
| 12 Month | Subject Satisfaction Endpoint: Pads Per Day Use | 24 Month | 1 Participants |
| 12 Month | Subject Satisfaction Endpoint: Pads Per Day Use | 6 Month | 3 Participants |
| 12 Month | Subject Satisfaction Endpoint: Pads Per Day Use | 6 Week | 2 Participants |
| 12 Month | Subject Satisfaction Endpoint: Pads Per Day Use | 12 Month | 2 Participants |
| 12 Month | Subject Satisfaction Endpoint: Pads Per Day Use | 3 Month | 2 Participants |
| 24 Month | Subject Satisfaction Endpoint: Pads Per Day Use | 3 Month | 2 Participants |
| 24 Month | Subject Satisfaction Endpoint: Pads Per Day Use | 6 Month | 0 Participants |
| 24 Month | Subject Satisfaction Endpoint: Pads Per Day Use | Baseline | 8 Participants |
| 24 Month | Subject Satisfaction Endpoint: Pads Per Day Use | 12 Month | 1 Participants |
| 24 Month | Subject Satisfaction Endpoint: Pads Per Day Use | 24 Month | 0 Participants |
| 24 Month | Subject Satisfaction Endpoint: Pads Per Day Use | 24 Month WCS | 3 Participants |
| 24 Month | Subject Satisfaction Endpoint: Pads Per Day Use | 24 Month LOCF | 3 Participants |
| 24 Month | Subject Satisfaction Endpoint: Pads Per Day Use | 6 Week | 2 Participants |
| 24 Month LOCF | Subject Satisfaction Endpoint: Pads Per Day Use | 12 Month | 1 Participants |
| 24 Month LOCF | Subject Satisfaction Endpoint: Pads Per Day Use | 3 Month | 0 Participants |
| 24 Month LOCF | Subject Satisfaction Endpoint: Pads Per Day Use | Baseline | 1 Participants |
| 24 Month LOCF | Subject Satisfaction Endpoint: Pads Per Day Use | 6 Week | 3 Participants |
| 24 Month LOCF | Subject Satisfaction Endpoint: Pads Per Day Use | 24 Month WCS | 3 Participants |
| 24 Month LOCF | Subject Satisfaction Endpoint: Pads Per Day Use | 24 Month | 0 Participants |
| 24 Month LOCF | Subject Satisfaction Endpoint: Pads Per Day Use | 6 Month | 0 Participants |
| 24 Month LOCF | Subject Satisfaction Endpoint: Pads Per Day Use | 24 Month LOCF | 3 Participants |
Secondary
Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (1 Hour Pad Weight Test)
Summarize the percent of subjects that have a decrease of pad weight of 25%, 50%, or 75% at follow-up (1-hour pad weight test used).
Time frame: Baseline to 24 month
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treated Participants | Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (1 Hour Pad Weight Test) | 1-Hour ≥ 50% Reduction in Pad Weight | 32 participants |
| Treated Participants | Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (1 Hour Pad Weight Test) | 1-Hour ≥ 25% Reduction in Pad Weight | 34 participants |
| Treated Participants | Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (1 Hour Pad Weight Test) | 1-Hour ≥ 75% Reduction in Pad Weight | 26 participants |
| 6 Month | Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (1 Hour Pad Weight Test) | 1-Hour ≥ 50% Reduction in Pad Weight | 25 participants |
| 6 Month | Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (1 Hour Pad Weight Test) | 1-Hour ≥ 25% Reduction in Pad Weight | 28 participants |
| 6 Month | Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (1 Hour Pad Weight Test) | 1-Hour ≥ 75% Reduction in Pad Weight | 24 participants |
| 12 Month | Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (1 Hour Pad Weight Test) | 1-Hour ≥ 50% Reduction in Pad Weight | 25 participants |
| 12 Month | Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (1 Hour Pad Weight Test) | 1-Hour ≥ 25% Reduction in Pad Weight | 29 participants |
| 12 Month | Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (1 Hour Pad Weight Test) | 1-Hour ≥ 75% Reduction in Pad Weight | 23 participants |
| 24 Month | Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (1 Hour Pad Weight Test) | 1-Hour ≥ 50% Reduction in Pad Weight | 24 participants |
| 24 Month | Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (1 Hour Pad Weight Test) | 1-Hour ≥ 25% Reduction in Pad Weight | 25 participants |
| 24 Month | Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (1 Hour Pad Weight Test) | 1-Hour ≥ 75% Reduction in Pad Weight | 20 participants |
| 24 Month LOCF | Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (1 Hour Pad Weight Test) | 1-Hour ≥ 50% Reduction in Pad Weight | 31 participants |
| 24 Month LOCF | Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (1 Hour Pad Weight Test) | 1-Hour ≥ 25% Reduction in Pad Weight | 34 participants |
| 24 Month LOCF | Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (1 Hour Pad Weight Test) | 1-Hour ≥ 75% Reduction in Pad Weight | 26 participants |
| 24 Month WCS | Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (1 Hour Pad Weight Test) | 1-Hour ≥ 25% Reduction in Pad Weight | 34 participants |
| 24 Month WCS | Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (1 Hour Pad Weight Test) | 1-Hour ≥ 75% Reduction in Pad Weight | 26 participants |
| 24 Month WCS | Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (1 Hour Pad Weight Test) | 1-Hour ≥ 50% Reduction in Pad Weight | 31 participants |
Secondary
Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (24 Hour Pad Weight Test)
Summarize the percent of subjects that have a decrease of pad weight of 25%, 50%, or 75% at follow-up (24-hour pad weight test used).
Time frame: Baseline to 24 Month
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treated Participants | Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (24 Hour Pad Weight Test) | 24-Hour ≥ 75% Reduction in Pad Weight | 20 participants |
| Treated Participants | Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (24 Hour Pad Weight Test) | 24-Hour ≥ 25% Reduction in Pad Weight | 26 participants |
| Treated Participants | Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (24 Hour Pad Weight Test) | 24-Hour ≥ 50% Reduction in Pad Weight | 24 participants |
| 6 Month | Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (24 Hour Pad Weight Test) | 24-Hour ≥ 50% Reduction in Pad Weight | 24 participants |
| 6 Month | Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (24 Hour Pad Weight Test) | 24-Hour ≥ 25% Reduction in Pad Weight | 28 participants |
| 6 Month | Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (24 Hour Pad Weight Test) | 24-Hour ≥ 75% Reduction in Pad Weight | 22 participants |
| 12 Month | Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (24 Hour Pad Weight Test) | 24-Hour ≥ 50% Reduction in Pad Weight | 27 participants |
| 12 Month | Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (24 Hour Pad Weight Test) | 24-Hour ≥ 25% Reduction in Pad Weight | 29 participants |
| 12 Month | Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (24 Hour Pad Weight Test) | 24-Hour ≥ 75% Reduction in Pad Weight | 25 participants |
| 24 Month | Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (24 Hour Pad Weight Test) | 24-Hour ≥ 25% Reduction in Pad Weight | 26 participants |
| 24 Month | Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (24 Hour Pad Weight Test) | 24-Hour ≥ 50% Reduction in Pad Weight | 26 participants |
| 24 Month | Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (24 Hour Pad Weight Test) | 24-Hour ≥ 75% Reduction in Pad Weight | 20 participants |
| 24 Month LOCF | Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (24 Hour Pad Weight Test) | 24-Hour ≥ 50% Reduction in Pad Weight | 34 participants |
| 24 Month LOCF | Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (24 Hour Pad Weight Test) | 24-Hour ≥ 75% Reduction in Pad Weight | 26 participants |
| 24 Month LOCF | Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (24 Hour Pad Weight Test) | 24-Hour ≥ 25% Reduction in Pad Weight | 36 participants |
| 24 Month WCS | Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (24 Hour Pad Weight Test) | 24-Hour ≥ 75% Reduction in Pad Weight | 26 participants |
| 24 Month WCS | Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (24 Hour Pad Weight Test) | 24-Hour ≥ 25% Reduction in Pad Weight | 36 participants |
| 24 Month WCS | Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (24 Hour Pad Weight Test) | 24-Hour ≥ 50% Reduction in Pad Weight | 34 participants |
Secondary
Subject Satisfaction Endpoint: Physician Evaluation of Subject's Incontinence Status
Physician evaluation of subject's incontinence status at 6 weeks and subsequent follow-up evaluations
Time frame: 6 Weeks post implant to 24 Months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treated Participants | Subject Satisfaction Endpoint: Physician Evaluation of Subject's Incontinence Status | 6 Month | 12 Participants |
| Treated Participants | Subject Satisfaction Endpoint: Physician Evaluation of Subject's Incontinence Status | 12 Month | 9 Participants |
| Treated Participants | Subject Satisfaction Endpoint: Physician Evaluation of Subject's Incontinence Status | 24 Month | 7 Participants |
| Treated Participants | Subject Satisfaction Endpoint: Physician Evaluation of Subject's Incontinence Status | 3 Month | 12 Participants |
| Treated Participants | Subject Satisfaction Endpoint: Physician Evaluation of Subject's Incontinence Status | 6 Week | 12 Participants |
| 6 Month | Subject Satisfaction Endpoint: Physician Evaluation of Subject's Incontinence Status | 3 Month | 14 Participants |
| 6 Month | Subject Satisfaction Endpoint: Physician Evaluation of Subject's Incontinence Status | 6 Month | 11 Participants |
| 6 Month | Subject Satisfaction Endpoint: Physician Evaluation of Subject's Incontinence Status | 6 Week | 17 Participants |
| 6 Month | Subject Satisfaction Endpoint: Physician Evaluation of Subject's Incontinence Status | 12 Month | 15 Participants |
| 6 Month | Subject Satisfaction Endpoint: Physician Evaluation of Subject's Incontinence Status | 24 Month | 12 Participants |
| 12 Month | Subject Satisfaction Endpoint: Physician Evaluation of Subject's Incontinence Status | 12 Month | 9 Participants |
| 12 Month | Subject Satisfaction Endpoint: Physician Evaluation of Subject's Incontinence Status | 6 Week | 12 Participants |
| 12 Month | Subject Satisfaction Endpoint: Physician Evaluation of Subject's Incontinence Status | 3 Month | 15 Participants |
| 12 Month | Subject Satisfaction Endpoint: Physician Evaluation of Subject's Incontinence Status | 6 Month | 14 Participants |
| 12 Month | Subject Satisfaction Endpoint: Physician Evaluation of Subject's Incontinence Status | 24 Month | 11 Participants |
| 24 Month | Subject Satisfaction Endpoint: Physician Evaluation of Subject's Incontinence Status | 3 Month | 3 Participants |
| 24 Month | Subject Satisfaction Endpoint: Physician Evaluation of Subject's Incontinence Status | 6 Week | 7 Participants |
| 24 Month | Subject Satisfaction Endpoint: Physician Evaluation of Subject's Incontinence Status | 12 Month | 4 Participants |
| 24 Month | Subject Satisfaction Endpoint: Physician Evaluation of Subject's Incontinence Status | 24 Month | 1 Participants |
| 24 Month | Subject Satisfaction Endpoint: Physician Evaluation of Subject's Incontinence Status | 6 Month | 2 Participants |
Secondary
Subject Satisfaction Endpoint: Quality of Life International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF) Scores
The ICIQ-SF questionnaire evaluates the impact of urinary incontinence on quality of life through four questions that evaluate the frequency, severity and impact of urinary incontinence. A set of eight self-diagnosis items related to the causes or situations of urinary incontinence experienced by the subject are also assessed. Scores may range from 0 to 21. Improvement in the subject's quality of life from baseline to follow-up is indicated by a decrease in the ICIQ-SF score.
Time frame: Baseline to 24 Months
Population: Number of subjects that did not have test performed at follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treated Participants | Subject Satisfaction Endpoint: Quality of Life International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF) Scores | Baseline | 15.7 score | Standard Deviation 4.1 |
| Treated Participants | Subject Satisfaction Endpoint: Quality of Life International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF) Scores | 3 Month | 7.6 score | Standard Deviation 5.6 |
| Treated Participants | Subject Satisfaction Endpoint: Quality of Life International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF) Scores | 6 Month | 7.6 score | Standard Deviation 5.7 |
| Treated Participants | Subject Satisfaction Endpoint: Quality of Life International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF) Scores | 12 Month | 7.3 score | Standard Deviation 5.8 |
| Treated Participants | Subject Satisfaction Endpoint: Quality of Life International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF) Scores | 24 Month | 7.5 score | Standard Deviation 5.5 |
Secondary
Subject Satisfaction Endpoint: Quality of Life I-QOL Scores
The Incontinence Quality of Life (I-QOL) questionnaire contains 22 items, each with a 5-point Likert-type response scale, evaluating a subject's quality of life with respect to his urinary problems or incontinence. A possible total score can be 0-100, with a higher score meaning less problems.
Time frame: Baseline to 24 Months
Population: Number of subjects that did not have test performed at follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treated Participants | Subject Satisfaction Endpoint: Quality of Life I-QOL Scores | Baseline | 50.3 score | Standard Deviation 22.4 |
| Treated Participants | Subject Satisfaction Endpoint: Quality of Life I-QOL Scores | 3 Month | 79.2 score | Standard Deviation 20.9 |
| Treated Participants | Subject Satisfaction Endpoint: Quality of Life I-QOL Scores | 6 Month | 79.4 score | Standard Deviation 21.6 |
| Treated Participants | Subject Satisfaction Endpoint: Quality of Life I-QOL Scores | 12 Month | 79.9 score | Standard Deviation 22.9 |
| Treated Participants | Subject Satisfaction Endpoint: Quality of Life I-QOL Scores | 24 Month | 82.4 score | Standard Deviation 18.3 |
Secondary
Subject Satisfaction Endpoint: Quality of Life UCLA (University of California Los Angeles) / RAND (RAND Corporation) Scores
Improvement in the subject's quality of life from baseline to follow-up is indicated by an increase in the UCLA/RAND urinary function score. Scores may range from 0 to 100.
Time frame: Baseline to 24 Months
Population: Number of subjects that did not have test performed at follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treated Participants | Subject Satisfaction Endpoint: Quality of Life UCLA (University of California Los Angeles) / RAND (RAND Corporation) Scores | Baseline | 20.1 score | Standard Deviation 14.3 |
| Treated Participants | Subject Satisfaction Endpoint: Quality of Life UCLA (University of California Los Angeles) / RAND (RAND Corporation) Scores | 3 Month | 54.7 score | Standard Deviation 28.7 |
| Treated Participants | Subject Satisfaction Endpoint: Quality of Life UCLA (University of California Los Angeles) / RAND (RAND Corporation) Scores | 6 Month | 55.9 score | Standard Deviation 28.8 |
| Treated Participants | Subject Satisfaction Endpoint: Quality of Life UCLA (University of California Los Angeles) / RAND (RAND Corporation) Scores | 12 Month | 57.4 score | Standard Deviation 29.1 |
| Treated Participants | Subject Satisfaction Endpoint: Quality of Life UCLA (University of California Los Angeles) / RAND (RAND Corporation) Scores | 24 Month | 57.3 score | Standard Deviation 27.1 |
Post Hoc
Urodynamic Results: Abdominal Leak Point Pressure
Abdominal leak point pressure (ALPP) is one indicator of improvement in continence symptoms. Abdominal leak point pressure was collected at baseline and 6-month follow-up as part of the urodynamic assessment.
Time frame: Baseline and 6 Months Post Implant
Population: 18 participants did not have 6-month follow-up data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treated Participants | Urodynamic Results: Abdominal Leak Point Pressure | Unchanged: leaked same at baseline and 6 months | 1 participants |
| Treated Participants | Urodynamic Results: Abdominal Leak Point Pressure | Improved: leaked @ baseline, improved @ 6 months | 10 participants |
| Treated Participants | Urodynamic Results: Abdominal Leak Point Pressure | Improved: leaked @ baseline, no leak @ 6 months | 14 participants |
| Treated Participants | Urodynamic Results: Abdominal Leak Point Pressure | Unchanged: no leak @ baseline, no leak @ 6 months | 1 participants |
| Treated Participants | Urodynamic Results: Abdominal Leak Point Pressure | Worsened: leaked @ baseline, leaked more at 6 mo | 4 participants |
| Treated Participants | Urodynamic Results: Abdominal Leak Point Pressure | Worsened: no leak @ baseline, leak @ 6 months | 1 participants |
Post Hoc
Urodynamic Results: Bladder Capacity
Baseline urodynamic measurements including bladder capacity, maximum detrusor pressure, detrusor pressure at maximum flow, and detrusor instability were measured at baseline and at 6-month follow-up.
Time frame: Baseline and 6 Months Post implant
Population: Number of subjects that did not have test performed at follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treated Participants | Urodynamic Results: Bladder Capacity | Baseline | 323.5 ml | Standard Deviation 130.8 |
| Treated Participants | Urodynamic Results: Bladder Capacity | 6 Month | 349.4 ml | Standard Deviation 136.7 |
Post Hoc
Urodynamics Results: Abnormal Cystometrogram, Abnormal End Fill Pressure
Baseline urodynamic measurements including bladder capacity, maximum detrusor pressure, detrusor pressure at maximum flow, and detrusor instability were measured at baseline and at 6-month follow-up. Abnormal graphical representation of bladder pressure during urodynamics testing which is when the bladder is filled with saline water.
Time frame: Baseline and 6 Months Post Implant
Population: Number of subjects that did not have test performed at follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treated Participants | Urodynamics Results: Abnormal Cystometrogram, Abnormal End Fill Pressure | Baseline | 10.0 cm H2O | Standard Deviation 8.3 |
| Treated Participants | Urodynamics Results: Abnormal Cystometrogram, Abnormal End Fill Pressure | 6 Month | 6.0 cm H2O | Standard Deviation 0 |
Post Hoc
Urodynamics Results: Detrusor Instability, Max Pdet
Baseline urodynamic measurements including bladder capacity, maximum detrusor pressure, detrusor pressure at maximum flow, and detrusor instability were measured at baseline and at 6-month follow-up. Maximum detrusor pressure is measured during a urodynamic study when tension is applied to the bladder wall (detrusor muscles) by filling the bladder to capacity with saline water and observing the detrusor muscle during filling of the bladder and voiding of the saline water. Pdet at Qmax is the detrusor pressure at maximal flow rate when the bladder is full and the patient begins voiding. Detrusor instability occurs when the detrusor muscle is unstable and spontaneously contracts the bladder. The outcome measure data table shows the Pdet for patients with detrusor instability.
Time frame: Baseline and 6 Months Post Implant
Population: Number of subjects that did not have test performed at follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treated Participants | Urodynamics Results: Detrusor Instability, Max Pdet | Baseline | 31.5 cm H2O | Standard Deviation 31.3 |
| Treated Participants | Urodynamics Results: Detrusor Instability, Max Pdet | 6 Month | 41.0 cm H2O | Standard Deviation 37.8 |
Post Hoc
Urodynamics Results: Detrusor Instability, Started at Filling Volume
Baseline urodynamic measurements including bladder capacity, maximum detrusor pressure, detrusor pressure at maximum flow, and detrusor instability were measured at baseline and at 6-month follow-up. Detrusor instability occurs when the detrusor muscle is unstable and spontaneously contracts the bladder. The measure data table shows the mean volume at the start of the urodynamic measurement study for patients with detrusor instability.
Time frame: Baseline and 6 Months Post Implant
Population: Number of subjects that did not have test performed at follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treated Participants | Urodynamics Results: Detrusor Instability, Started at Filling Volume | Baseline | 225.8 ml | Standard Deviation 159.9 |
| Treated Participants | Urodynamics Results: Detrusor Instability, Started at Filling Volume | 6 Month | 170.8 ml | Standard Deviation 32.1 |
Post Hoc
Urodynamics Results: Maximum Detrusor Pressure
Baseline urodynamic measurements including bladder capacity, maximum detrusor pressure, detrusor pressure at maximum flow, and detrusor instability were measured at baseline and at 6-month follow-up. Maximum detrusor pressure is measured during a urodynamic study when tension is applied to the bladder wall (detrusor muscles) by filling the bladder to capacity with saline water and observing the detrusor muscle during filling of the bladder and voiding of the saline water.
Time frame: Baseline and 6 Months Post Implant
Population: Number of subjects that did not have test performed at follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treated Participants | Urodynamics Results: Maximum Detrusor Pressure | Baseline | 35.9 cm H2O | Standard Deviation 27.4 |
| Treated Participants | Urodynamics Results: Maximum Detrusor Pressure | 6 Months | 32.3 cm H2O | Standard Deviation 21.3 |
Post Hoc
Urodynamics Results: Pdet at Qmax
Baseline urodynamic measurements including bladder capacity, maximum detrusor pressure, detrusor pressure at maximum flow, and detrusor instability were measured at baseline and at 6-month follow-up. Maximum detrusor pressure is measured during a urodynamic study when tension is applied to the bladder wall (detrusor muscles) by filling the bladder to capacity with saline water and observing the detrusor muscle during filling of the bladder and voiding of the saline water. Pdet at Qmax is the detrusor pressure at maximal flow rate when the bladder is full and the patient begins voiding.
Time frame: Baseline and 6 Months Post Implant
Population: Number of subjects that did not have test performed at follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treated Participants | Urodynamics Results: Pdet at Qmax | Baseline | 26.2 cm H20 | Standard Deviation 19.3 |
| Treated Participants | Urodynamics Results: Pdet at Qmax | 6 Months | 30.2 cm H20 | Standard Deviation 17.1 |
Post Hoc
Uroflow Studies: Average Flow Rates
Baseline uroflow measurements including peak flow rates, average flow rates, voided volume, and post-void residual were compared to follow-up results at 3, 6, 12, and 24 months.
Time frame: Baseline to 24 Month
Population: Number of subjects that did not have test performed at follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treated Participants | Uroflow Studies: Average Flow Rates | Baseline | 12.0 ml/sec | Standard Deviation 6 |
| Treated Participants | Uroflow Studies: Average Flow Rates | 3 Month | 11.1 ml/sec | Standard Deviation 7 |
| Treated Participants | Uroflow Studies: Average Flow Rates | 6 Month | 11.3 ml/sec | Standard Deviation 9.8 |
| Treated Participants | Uroflow Studies: Average Flow Rates | 12 Month | 10.9 ml/sec | Standard Deviation 4.9 |
| Treated Participants | Uroflow Studies: Average Flow Rates | 24 Month | 11.5 ml/sec | Standard Deviation 5.8 |
Post Hoc
Uroflow Studies: Peak Flow Rate
Baseline uroflow measurements including peak flow rates, average flow rates, voided volume, and post-void residual were compared to follow-up results at 3, 6, 12, and 24 months.
Time frame: Baseline to 24 month
Population: Number of subjects that did not have test performed at follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treated Participants | Uroflow Studies: Peak Flow Rate | Baseline | 20.8 ml/sec | Standard Deviation 11.3 |
| Treated Participants | Uroflow Studies: Peak Flow Rate | 3 Month | 20.9 ml/sec | Standard Deviation 13.5 |
| Treated Participants | Uroflow Studies: Peak Flow Rate | 6 Month | 19.8 ml/sec | Standard Deviation 13.8 |
| Treated Participants | Uroflow Studies: Peak Flow Rate | 12 Month | 19.4 ml/sec | Standard Deviation 8.4 |
| Treated Participants | Uroflow Studies: Peak Flow Rate | 24 Month | 20.1 ml/sec | Standard Deviation 8.5 |
Post Hoc
Uroflow Studies: Post-Void Residual
Baseline uroflow measurements including peak flow rates, average flow rates, voided volume, and post-void residual were compared to follow-up results at 3, 6, 12, and 24 months.
Time frame: Baseline to 24 Months
Population: Number of subjects that did not have test performed at follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treated Participants | Uroflow Studies: Post-Void Residual | 24 Month | 18.2 ml | Standard Deviation 28.8 |
| Treated Participants | Uroflow Studies: Post-Void Residual | Baseline | 17.0 ml | Standard Deviation 27.8 |
| Treated Participants | Uroflow Studies: Post-Void Residual | 3 Month | 17.7 ml | Standard Deviation 31.1 |
| Treated Participants | Uroflow Studies: Post-Void Residual | 6 Month | 23.8 ml | Standard Deviation 41.7 |
| Treated Participants | Uroflow Studies: Post-Void Residual | 12 Month | 13.1 ml | Standard Deviation 30 |
Post Hoc
Uroflow Studies: Voided Volume
Baseline uroflow measurements including peak flow rates, average flow rates, voided volume, and post-void residual were compared to follow-up results at 3, 6, 12, and 24 months.
Time frame: Baseline to 24 Months
Population: Number of subjects that did not have test performed at follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treated Participants | Uroflow Studies: Voided Volume | Baseline | 280.8 ml | Standard Deviation 112.4 |
| Treated Participants | Uroflow Studies: Voided Volume | 3 Month | 263.0 ml | Standard Deviation 142.6 |
| Treated Participants | Uroflow Studies: Voided Volume | 6 Month | 244.2 ml | Standard Deviation 114.3 |
| Treated Participants | Uroflow Studies: Voided Volume | 12 Month | 248.7 ml | Standard Deviation 134.4 |
| Treated Participants | Uroflow Studies: Voided Volume | 24 Month | 298.6 ml | Standard Deviation 147.4 |