UDI-LF Total Score Change From Baseline
| Group | Value (units on a scale) |
|---|---|
| Botox A | -82.2 |
| Mid-Urethral Sling | -84.6 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataShort name MUSA
This trial does not test a peptide that PepBank tracks.
United States
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The primary aim is to compare the effectiveness of intradetrusor injection of 100 unit injection of Botulinum toxin A to mid-urethral sling for change in MUI symptoms 6 months following treatment.
Active comparator
Botox A® injection
A dose of 100 units of Botulinum toxin A will be injected into the bladder. Follow up visits at 2 weeks, 3 and 6 months post intervention to collect clinical and patient-reported outcomes.
Active comparator
Mid-urethral sling
Mid-urethral Sling Procedure includes retropubic as well as transobturator full length slings. Follow up visits at 2 weeks, 3 and 6 months post intervention to collect clinical and patient-reported outcomes.
Outcomes the sponsor listed as primary.
UDI-LF Total Score Change From Baseline
Time frame · 3, 6, 9, and 12 Months
The Urogenital Distress Inventory is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI scale has a range from 0 to 300 with higher scores indicating greater distress. The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
UDI-LF Stress Score Change From Baseline
Time frame · 3, 6, 9, and 12 Months
The Urogenital Distress Inventory is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI Stress subscale has a range from 0 to 100 with higher scores indicating greater distress. The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
UDI-LF Irritative Score Change From Baseline
Time frame · 3, 6, 9, and 12 Months
The Urogenital Distress Inventory is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI Irritative subscale has a range from 0 to 100 with higher scores indicating greater distress. The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (units on a scale) |
|---|---|
| Botox A | -82.2 |
| Mid-Urethral Sling | -84.6 |
| Group | Value (units on a scale) |
|---|---|
| Botox A | -27.9 |
| Mid-Urethral Sling | -46.4 |
| Group | Value (units on a scale) |
|---|---|
| Botox A | -40.8 |
| Mid-Urethral Sling | -28.1 |
| Group | Value (units on a scale) |
|---|---|
| Botox A | -13.5 |
| Mid-Urethral Sling | -10.1 |
| Group | Value (incontinence episodes/day) |
|---|---|
| Botox A | -0.4 |
| Mid-Urethral Sling | -0.4 |
| Group | Value (incontinence episodes/day) |
|---|---|
| Botox A | -4 |
| Mid-Urethral Sling | -3.9 |
| Group | Value (diurnal voids/day) |
|---|---|
| Botox A | -1.2 |
| Mid-Urethral Sling | 0 |
| Group | Value (nocturnal voids/day) |
|---|---|
| Botox A | -0.5 |
| Mid-Urethral Sling | -0.5 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Botox AUp to 2 administrations of Botulinum Toxin A | 0 / 71 | 3 / 71 | 40 / 71 |
| Mid-Urethral SlingMid-Urethral Sling for treatment of urinary incont | 0 / 69 | 8 / 69 | 41 / 69 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
No study cites this trial.
References listed at the registry that are not in PepBank. They link to PubMed.
Who could join, as posted.
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