Stress Urinary Incontinence, Urinary Incontinence
Conditions
Keywords
Stress urinary incontinence
Brief summary
Stress urinary incontinence is the uncontrollable leakage of urine with physical effort or stress, such as coughing, sneezing, or exercise. Treatment for stress incontinence can be surgical or non-surgical. Different non-surgical treatments include pelvic muscle exercises and pessary use. Pelvic muscle exercises (often known as Kegel exercises) train and strengthen the pelvic muscles and improve incontinence. A pessary is a medical device that fits inside the vagina to give the urethra and bladder extra support and prevent or reduce urinary incontinence. Exercises and pessary use can help women with stress incontinence but it is not known which treatment is better, or if a combination of the two treatments at the same time is best. This study will determine whether pelvic muscle training and exercises, pessary use, or a combination of both exercises and pessary is most effective at improving incontinence in women. The study's primary hypothesis is that pessary use is more effective than pelvic muscle exercises after 3 months of treatment.
Detailed description
Women commonly have symptoms of stress urinary incontinence (leakage with physical stress such as coughing or sneezing) and urinary urgency or urge incontinence (leakage associated with the overwhelming urge to urinate). Non-surgical treatment is usually offered as first-line therapy, such as pelvic muscle exercises (Kegel exercises) or pessary use. A pessary is a small ring that fits inside the vagina. Pelvic muscle training and exercises may help incontinence by increased awareness and strength of the muscles that are used in holding the urethra closed. Pessary use may help incontinence by providing more support to the bladder and urethra. Both treatments can be helpful in reducing or eliminating incontinence, but it is not known which treatment is better. The study will compare the level of improvement with pelvic muscle exercises, pessary use, and a combination of both exercises and pessary. Women with stress or mixed urinary incontinence will be randomly assigned to 1 of 3 groups: (1) pelvic muscle training and exercises; (2) pessary use; and (3) both exercises and pessary. Women in the exercises groups will have 4 visits over 8 weeks with a specially trained therapist for pelvic muscle training and exercises. Women in the pessary group will be fitted with a pessary to be worn continuously. Assessments will include questionnaires, bladder diary, and physical examination. Follow-up evaluations occur at 3 months, 6 months (by telephone only), and 1 year after initial treatment. Comparisons: The level of improvement after treatment will be compared in the 3 groups. In addition, women in the 3 groups will record the number of accidental leakage episodes by bladder diary; and the frequency of those episodes will be compared in the 3 groups. Other aspects of health, including health-related quality of life, will be compared in the 3 groups.
Interventions
BEHAVIORALBehavioral Therapy
Pelvic muscle training and exercises
DEVICEIntravaginal Pessary
Intravaginal pessary
DEVICEPessary combined with behavioral therapy
Intravaginal pessary and behavioral therapy
Sponsors
NICHD Pelvic Floor Disorders Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Stress urinary incontinence or stress-predominant mixed urinary incontinence, with at least 2 episodes of stress incontinence on 7-day bladder diary and the number of stress incontinence episodes exceeding the number of urge incontinence episodes. * Urinary incontinence for at least three months. * Ambulatory adult women. * Stage 0-I-II pelvic organ prolapse.
Exclusion criteria
* Continual urine leakage. * Pregnancy or planning pregnancy within 1 year. * Active urinary tract infection. * Urinary retention. * Currently on medication for incontinence. * Currently using a pessary. * Neurologic condition that affects bladder function.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Much Better or Very Much Better on PGI-I at 3 Months | Outcome was measured at three months following randomization. | PGI-I, Patient Global Impression of Improvement, is a five-point scale that ranges from not at all to very much better. Participants were considered a success if they responded much better or very much better, or a failure if they responded otherwise. |
| No Bothersome Stress Incontinence Symptoms at 3 Months | Outcome was measured at three months following randomization. | Success if participants answer either no or yes with a bother component of not at all or somewhat to all seven Urogenital Distress Inventory-Stress Incontinence Subscale items of the Pelvic Floor Distress Inventory, or a failure if they responded otherwise. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 75% Reduction in Weekly Urinary Incontinence Episodes at 3 Months | Outcome was measured at three months following randomization. | Success if participants reported at least 75% reduction in frequency of incontinence episodes on 7-day bladder diary, a failure if they reported otherwise. |
| 75% Reduction in Weekly Urinary Incontinence Episodes at 12 Months | Outcome was measured at 12 months following randomization. | Success if participants reported at least 75% reduction in frequency of incontinence episodes on 7-day bladder diary, a failure if they reported otherwise. |
| Much Better or Very Much Better on PGI-I at 12 Months | Outcome was measured at 12 months following randomization. | PGI-I, Patient Global Impression of Improvement, is a five-point scale that ranges from not at all to very much better. Participants were considered a success if they responded much better or very much better, or a failure if they responded otherwise. |
| Satisfaction With Treatment at 12 Months | Outcome was measured at 12 months following randomization. | Success if participant reported being satisfied on Patient Satisfaction Question (PSQ), a failure if they reported otherwise. |
| Satisfaction With Treatment at 3 Months | Outcome was measured at three months following randomization. | Success if participant reported being satisfied on Patient Satisfaction Question (PSQ), a failure if they reported otherwise. |
| No Bothersome Stress Incontinence Symptoms at 12 Months. | Outcome was measured at 12 months following randomization. | Success if participants answer either no or yes with a bother component of not at all or somewhat to all seven Urogenital Distress Inventory-Stress Incontinence Subscale items of the Pelvic Floor Distress Inventory, or a failure if they responded otherwise. |
Countries
United States
Participant flow
Recruitment details
740 women were screened for symptoms of stress only or mixed incontinence symptoms and age of at least 18 years old. 294 did not meet inclusion criteria, one refused to participate and 445 were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Pessary Intravaginal pessary | 149 |
| Behavioral Therapy Pelvic muscle training and exercises | 146 |
| Combination of Pessary and Behavioral Therapy Treatment includes a combination of both pessary and pelvic muscle exercises | 150 |
| Total | 445 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| 12 Month Follow-up | Lack of Efficacy | 5 | 4 | 3 |
| 12 Month Follow-up | Personal/family health | 0 | 5 | 1 |
| 12 Month Follow-up | Pessary did not fit | 1 | 0 | 0 |
| 12 Month Follow-up | Received/desired alternate treatment | 1 | 4 | 1 |
| 12 Month Follow-up | Withdrawal by Subject | 7 | 12 | 16 |
| 3 Month Follow-up | Adverse Event | 1 | 0 | 0 |
| 3 Month Follow-up | Lack of Efficacy | 1 | 2 | 1 |
| 3 Month Follow-up | Personal/family health | 1 | 1 | 0 |
| 3 Month Follow-up | Pessary did not fit | 12 | 0 | 0 |
| 3 Month Follow-up | Received/desired alternate treatment | 13 | 5 | 2 |
| 3 Month Follow-up | Withdrawal by Subject | 11 | 14 | 15 |
Baseline characteristics
| Characteristic | Total | Pessary | Combination of Pessary and Behavioral Therapy | Behavioral Therapy |
|---|---|---|---|---|
| Age, Continuous | 49.8 years STANDARD_DEVIATION 11.9 | 50.2 years STANDARD_DEVIATION 11 | 49.5 years STANDARD_DEVIATION 11.8 | 49.6 years STANDARD_DEVIATION 13 |
| Currently Receiving Estrogen Therapy | 67 Participants | 27 Participants | 16 Participants | 24 Participants |
| Hysterectomy | 110 Participants | 39 Participants | 32 Participants | 39 Participants |
| Incontinence Frequency 14 or more episodes per wk | 202 Participants | 68 Participants | 67 Participants | 67 Participants |
| Incontinence Frequency Fewer than 14 episodes per wk | 243 Participants | 81 Participants | 83 Participants | 79 Participants |
| Incontinence Type Mixed | 241 Participants | 80 Participants | 80 Participants | 81 Participants |
| Incontinence Type Stress Only | 204 Participants | 69 Participants | 70 Participants | 65 Participants |
| Menstrual Status Not sure | 43 Participants | 14 Participants | 16 Participants | 13 Participants |
| Menstrual Status Post-menopausal | 188 Participants | 60 Participants | 66 Participants | 62 Participants |
| Menstrual Status Pre-menopausal | 214 Participants | 75 Participants | 68 Participants | 71 Participants |
| Prior Nonsurgical UI | 92 Participants | 30 Participants | 27 Participants | 35 Participants |
| Prior UI Surgery | 27 Participants | 10 Participants | 10 Participants | 7 Participants |
| Race/Ethnicity, Customized Black or African American | 45 Participants | 15 Participants | 20 Participants | 10 Participants |
| Race/Ethnicity, Customized Other | 20 Participants | 8 Participants | 8 Participants | 4 Participants |
| Race/Ethnicity, Customized White or Caucasian | 380 Participants | 126 Participants | 122 Participants | 132 Participants |
| Sex/Gender, Customized Female | 445 Participants | 149 Participants | 150 Participants | 146 Participants |
| Vaginal Deliveries | 2 deliveries | 2 deliveries | 2 deliveries | 2 deliveries |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 149 | 0 / 146 | 0 / 150 |
| serious Total, serious adverse events | 7 / 149 | 4 / 146 | 6 / 150 |
Outcome results
Primary
Much Better or Very Much Better on PGI-I at 3 Months
PGI-I, Patient Global Impression of Improvement, is a five-point scale that ranges from not at all to very much better. Participants were considered a success if they responded much better or very much better, or a failure if they responded otherwise.
Time frame: Outcome was measured at three months following randomization.
Population: If participant did not attend the three-month follow-up, missing values were imputed by either the value from the next available follow-up or if the participant was lost to follow-up the participant was treated as a failure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pessary | Much Better or Very Much Better on PGI-I at 3 Months | 80 Participants |
| Behavioral Therapy | Much Better or Very Much Better on PGI-I at 3 Months | 72 Participants |
| Combination of Pessary and Behavioral Therapy | Much Better or Very Much Better on PGI-I at 3 Months | 59 Participants |
Comparison: A priori, the combination treatment was considered superior (75% success rate) to either single-modality therapy (60% success rate) at 80% power with 150 participants per group.p-value: <0.0492Regression, Logistic
Comparison: A priori, the combination treatment was considered superior (75% success rate) to either single-modality therapy (60% success rate) at 80% power with 150 participants per group.p-value: 0.02Regression, Logistic
Comparison: A priori, the combination treatment was considered superior (75% success rate) to either single-modality therapy (60% success rate) at 80% power with 150 participants per group.p-value: 0.49Regression, Logistic
Primary
No Bothersome Stress Incontinence Symptoms at 3 Months
Success if participants answer either no or yes with a bother component of not at all or somewhat to all seven Urogenital Distress Inventory-Stress Incontinence Subscale items of the Pelvic Floor Distress Inventory, or a failure if they responded otherwise.
Time frame: Outcome was measured at three months following randomization.
Population: If participant did not attend the three-month follow-up, missing values were imputed by either the value from the next available follow-up or if the participant was lost to follow-up the participant was treated as a failure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pessary | No Bothersome Stress Incontinence Symptoms at 3 Months | 66 Participants |
| Behavioral Therapy | No Bothersome Stress Incontinence Symptoms at 3 Months | 71 Participants |
| Combination of Pessary and Behavioral Therapy | No Bothersome Stress Incontinence Symptoms at 3 Months | 49 Participants |
p-value: 0.006Regression, Logistic
p-value: 0.048Regression, Logistic
p-value: 0.42Regression, Logistic
Secondary
75% Reduction in Weekly Urinary Incontinence Episodes at 12 Months
Success if participants reported at least 75% reduction in frequency of incontinence episodes on 7-day bladder diary, a failure if they reported otherwise.
Time frame: Outcome was measured at 12 months following randomization.
Population: If participant did not attend the 12-month follow-up, missing values were imputed as a failure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pessary | 75% Reduction in Weekly Urinary Incontinence Episodes at 12 Months | 52 Participants |
| Behavioral Therapy | 75% Reduction in Weekly Urinary Incontinence Episodes at 12 Months | 54 Participants |
| Combination of Pessary and Behavioral Therapy | 75% Reduction in Weekly Urinary Incontinence Episodes at 12 Months | 51 Participants |
p-value: <0.0492Regression, Logistic
p-value: <0.0492Regression, Logistic
p-value: <0.0492Regression, Logistic
Secondary
75% Reduction in Weekly Urinary Incontinence Episodes at 3 Months
Success if participants reported at least 75% reduction in frequency of incontinence episodes on 7-day bladder diary, a failure if they reported otherwise.
Time frame: Outcome was measured at three months following randomization.
Population: If participant did not attend the three-month follow-up, missing values were imputed by either the value from the next available follow-up or if the participant was lost to follow-up the participant was treated as a failure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pessary | 75% Reduction in Weekly Urinary Incontinence Episodes at 3 Months | 80 Participants |
| Behavioral Therapy | 75% Reduction in Weekly Urinary Incontinence Episodes at 3 Months | 68 Participants |
| Combination of Pessary and Behavioral Therapy | 75% Reduction in Weekly Urinary Incontinence Episodes at 3 Months | 69 Participants |
p-value: <0.0492Regression, Logistic
p-value: <0.0492Regression, Logistic
p-value: <0.0492Regression, Logistic
Secondary
Much Better or Very Much Better on PGI-I at 12 Months
PGI-I, Patient Global Impression of Improvement, is a five-point scale that ranges from not at all to very much better. Participants were considered a success if they responded much better or very much better, or a failure if they responded otherwise.
Time frame: Outcome was measured at 12 months following randomization.
Population: If participant did not attend the 12-month follow-up, missing values were imputed as a failure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pessary | Much Better or Very Much Better on PGI-I at 12 Months | 49 Participants |
| Behavioral Therapy | Much Better or Very Much Better on PGI-I at 12 Months | 48 Participants |
| Combination of Pessary and Behavioral Therapy | Much Better or Very Much Better on PGI-I at 12 Months | 47 Participants |
p-value: <0.0492Regression, Logistic
p-value: <0.0492Regression, Logistic
p-value: <0.0492Regression, Logistic
Secondary
No Bothersome Stress Incontinence Symptoms at 12 Months.
Success if participants answer either no or yes with a bother component of not at all or somewhat to all seven Urogenital Distress Inventory-Stress Incontinence Subscale items of the Pelvic Floor Distress Inventory, or a failure if they responded otherwise.
Time frame: Outcome was measured at 12 months following randomization.
Population: If participant did not attend the 12-month follow-up, missing values were imputed as a failure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pessary | No Bothersome Stress Incontinence Symptoms at 12 Months. | 49 Participants |
| Behavioral Therapy | No Bothersome Stress Incontinence Symptoms at 12 Months. | 59 Participants |
| Combination of Pessary and Behavioral Therapy | No Bothersome Stress Incontinence Symptoms at 12 Months. | 52 Participants |
p-value: <0.0492Regression, Logistic
p-value: <0.0492Regression, Logistic
p-value: <0.0492Regression, Logistic
Secondary
Satisfaction With Treatment at 12 Months
Success if participant reported being satisfied on Patient Satisfaction Question (PSQ), a failure if they reported otherwise.
Time frame: Outcome was measured at 12 months following randomization.
Population: If participant did not attend the 12-month follow-up, missing values were imputed as a failure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pessary | Satisfaction With Treatment at 12 Months | 81 Participants |
| Behavioral Therapy | Satisfaction With Treatment at 12 Months | 79 Participants |
| Combination of Pessary and Behavioral Therapy | Satisfaction With Treatment at 12 Months | 75 Participants |
p-value: <0.0492Regression, Logistic
p-value: <0.0492Regression, Logistic
p-value: <0.0492Regression, Logistic
Secondary
Satisfaction With Treatment at 3 Months
Success if participant reported being satisfied on Patient Satisfaction Question (PSQ), a failure if they reported otherwise.
Time frame: Outcome was measured at three months following randomization.
Population: If participant did not attend the three-month follow-up, missing values were imputed by either the value from the next available follow-up or if the participant was lost to follow-up the participant was treated as a failure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pessary | Satisfaction With Treatment at 3 Months | 118 Participants |
| Behavioral Therapy | Satisfaction With Treatment at 3 Months | 110 Participants |
| Combination of Pessary and Behavioral Therapy | Satisfaction With Treatment at 3 Months | 94 Participants |
p-value: 0.03Regression, Logistic
p-value: 0.048Regression, Logistic
p-value: <0.0492Regression, Logistic