Urinary Incontinence
Conditions
Keywords
Stress urinary incontinence, Mixed, Urge
Brief summary
The purpose of this study is to compare treatment outcomes for patients with mixed urinary incontinence (MUI) for whom therapy is initiated with surgery to those for whom therapy is initiated with non-surgical treatment. Women who are bothered by symptoms of both stress and urge incontinence will be randomly assigned to initiate treatment with a surgical (surgery for stress incontinence) vs. a non-surgical (drug and behavioral therapy) approach. Follow-up will be a minimum of 12 Months.
Detailed description
The purpose of this study is to compare treatment outcomes for patients with mixed urinary incontinence (MUI) for whom therapy is initiated with surgery to those for whom therapy is initiated with non-surgical treatment. Women who are bothered by symptoms of both stress and urge incontinence will be randomly assigned to initiate treatment with a surgical (surgery for stress incontinence) vs. a non-surgical (drug and behavioral therapy) approach. Follow-up will be a minimum of 12 Months.
Interventions
Both oral urge incontinence medication and behavioral treatment
PROCEDURESurgical
Initial surgical (stress incontinence surgery) treatment approach.
Sponsors
University of Alabama at Birmingham
University of California, San Diego
University of Maryland
University of Pittsburgh
University of Texas
The University of Texas at San Antonio
University of Utah
Beaumont Hospital
Loyola University
Carelon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Female 2. Mixed UI as evidenced by stress and urge symptoms reported on MESA (either percent of urge-type symptoms ≥ the percent of stress-type symptoms or urge symptom score ≥7 if stress predominant) followed by report of moderately or greatly/quite a bit bothered to questions 2 and 3 of the 6-item Urinary Distress Index (UDI-6) or questions 16 and 17 of the 20-item Pelvic Fl;oor Distress Index (PFDI-20), respectively (See Appendix C) 3. Moderate or severe UI as evidenced by the corresponding response on the Patient Global Impression of Severity (PGI-S) 4. Incontinence symptoms present for at least (3) months\* 5. Bladder capacity \> 200cc (by any method) 6. Urodynamic Stress Incontinence 7. Eligible for both treatment interventions 8. Available to start intervention within 6 weeks 9. Negative urine dipstick (negative result = trace or less for leukocytes & nitrites) 10. Available for 12 months of follow-up and able to complete study assessments as per clinician judgment 11. Signed consent form
Exclusion criteria
1. Age \<21 years\* 2. Currently undergoing or recommended to undergo treatment of pelvic organ prolapse 3. Other indicated/planned concomitant surgery 4. Pregnant or has not completed child bearing\* 5. \<12 months post-partum\*† 6. Active malignancy of cervix, uterus, fallopian tube(s) or ovary \> Stage I, or bladder of any Stage 7. Current catheter use 8. Unevaluated hematuria 9. Participation in another trial that may influence the results of this study * Patient can be rescreened after respective time interval has been met. †Partum is defined as a delivery or other termination that occurs after 20 weeks gestation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Optimal Outcome of Treatment at 6 Months | 6 Months | Composite measure defined as much better or very much better on Patient Global Impression of Improvement (PGI-I) and normal or mild on Patient Global Impression of Symptoms (PGI-S). PGI-I is a single item: Circle the one answer that best describes your urinary tract condition now, compared to how it was before your incontinence treatment with responses ranging from 1= Very much better to 7= Very much worse. The PGI-S is a single item:; Circle the one number that best describes how your urinary tract condition is now with responses ranging from 1 = Normal to 4 Severe. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Optimal Outcome of Treatment at 3 Months | 3 months | Composite measure defined as much better or very much better om PGI-I and normal or mild on PGI-S. PGI-I is a single item: Circle the one answer that best describes how your urinary tract condition is now, compared with how it was before your incontinence treatment with responses ranging from 1=Very much better to 7=Very much worse. PGI-S is a single items: Circle the one number that best describes how your urinary tract condition is now with responses ranging from 1=Normal to 4=Severe. |
Countries
United States
Participant flow
Recruitment details
40 women were screened, 29 met eligibility criteria and 27 were enrolled between November, 2008 and March, 2009. The trial was terminated in March 2009 due to inadequate enrollment.
Pre-assignment details
All enrolled participants were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Surgical Treatment Surgical treatment will consist of the following evidence-based stress incontinence procedures: mid-urethral slings (TVT, TOT, TVT-O), fascial slings, and Burch colposuspension. | 13 |
| Non Surgical Treatment The non-surgical treatment will include two components:
1. Pharmacological therapy with any FDA approved OAB drug in approved doses; and
2. Behavioral therapy. | 14 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 2 |
Baseline characteristics
| Characteristic | Non Surgical Treatment | Surgical Treatment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 5 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 8 Participants | 19 Participants |
| Age Continuous | 59 years STANDARD_DEVIATION 14 | 53 years STANDARD_DEVIATION 14 | 56 years STANDARD_DEVIATION 14 |
| Region of Enrollment United States | 14 participants | 13 participants | 27 participants |
| Sex: Female, Male Female | 14 Participants | 13 Participants | 27 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 14 | 1 / 13 |
| serious Total, serious adverse events | 0 / 14 | 0 / 13 |
Outcome results
Primary
Optimal Outcome of Treatment at 6 Months
Composite measure defined as much better or very much better on Patient Global Impression of Improvement (PGI-I) and normal or mild on Patient Global Impression of Symptoms (PGI-S). PGI-I is a single item: Circle the one answer that best describes your urinary tract condition now, compared to how it was before your incontinence treatment with responses ranging from 1= Very much better to 7= Very much worse. The PGI-S is a single item:; Circle the one number that best describes how your urinary tract condition is now with responses ranging from 1 = Normal to 4 Severe.
Time frame: 6 Months
Population: Participants who attended 6 month follow-up visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Surgical Treatment | Optimal Outcome of Treatment at 6 Months | 9 participants |
| Non Surgical Treatment | Optimal Outcome of Treatment at 6 Months | 8 participants |
p-value: 0.9995% CI: [-0.28, 0.44]Fisher Exact
Secondary
Optimal Outcome of Treatment at 3 Months
Composite measure defined as much better or very much better om PGI-I and normal or mild on PGI-S. PGI-I is a single item: Circle the one answer that best describes how your urinary tract condition is now, compared with how it was before your incontinence treatment with responses ranging from 1=Very much better to 7=Very much worse. PGI-S is a single items: Circle the one number that best describes how your urinary tract condition is now with responses ranging from 1=Normal to 4=Severe.
Time frame: 3 months
Population: Participants who attended 3 month follow-up visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Surgical Treatment | Optimal Outcome of Treatment at 3 Months | 7 participants |
| Non Surgical Treatment | Optimal Outcome of Treatment at 3 Months | 3 participants |
p-value: 0.0895% CI: [0.03, 0.87]Fisher Exact