Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravaginal Pessary | Experimental | Pessary restores continence by stabilization of the proximal urethra and urethrovesical junction, facilitating pressure transmission to the proximal urethra. |
|
| Behavioral Therapy | Experimental | Pelvic floor muscle training and exercise which includes strong contraction of the pelvic floor muscles to prevent incontinence by occluding the urethra and regular practice can improve pelvic muscle support. |
|
| Pessary combined with behavioral therapy | Experimental | Combination of the explanations above. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Therapy | Behavioral | Pelvic muscle training and exercises |
| |
| Measure | Description | Time Frame |
|---|---|---|
| "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. | Outcome was measured at three months following randomization. |
| 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. | Outcome was measured at three months following randomization. |
| Measure | Description | Time Frame |
|---|---|---|
| "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. | Outcome was measured at 12 months following randomization. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Holly E Richter, PhD, MD | University of Alabama at Birmingham | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35249 | United States | ||
| University of California, San Diego Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17327249 | Background | Richter HE, Burgio KL, Goode PS, Borello-France D, Bradley CS, Brubaker L, Handa VL, Fine PM, Visco AG, Zyczynski HM, Wei JT, Weber AM; Pelvic Foor Desorders Network. Non-surgical management of stress urinary incontinence: ambulatory treatments for leakage associated with stress (ATLAS) trial. Clin Trials. 2007;4(1):92-101. doi: 10.1177/1740774506075237. | |
| 20177294 |
| Label | URL |
|---|---|
| Website of the National Institute of Child Health and Human Development, which funds the Pelvic Floor Disorders Network | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Pessary | Intravaginal incontinence pessary |
| FG001 | Behavioral Therapy | Pelvic muscle training and exercises |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| 3 Month Follow-up |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Intravaginal Pessary |
| Device |
Intravaginal pessary |
|
| Pessary combined with behavioral therapy | Device | Intravaginal pessary and behavioral therapy |
|
| 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. | Outcome was measured at 12 months following randomization. |
| 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. | Outcome was measured at three months following randomization. |
| 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. | Outcome was measured at 12 months following randomization. |
| Satisfaction With Treatment at 3 Months | Success if participant reported being "satisfied" on Patient Satisfaction Question (PSQ), a failure if they reported otherwise. | Outcome was measured at three months following randomization. |
| Satisfaction With Treatment at 12 Months | Success if participant reported being "satisfied" on Patient Satisfaction Question (PSQ), a failure if they reported otherwise. | Outcome was measured at 12 months following randomization. |
| La Jolla |
| California |
| 92037 |
| United States |
| Loyola University | Maywood | Illinois | 60153 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| University of Texas Southwestern | Dallas | Texas | 75390 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| Richter HE, Burgio KL, Brubaker L, Nygaard IE, Ye W, Weidner A, Bradley CS, Handa VL, Borello-France D, Goode PS, Zyczynski H, Lukacz ES, Schaffer J, Barber M, Meikle S, Spino C; Pelvic Floor Disorders Network. Continence pessary compared with behavioral therapy or combined therapy for stress incontinence: a randomized controlled trial. Obstet Gynecol. 2010 Mar;115(3):609-617. doi: 10.1097/AOG.0b013e3181d055d4. |
| 23431210 | Derived | Borello-France D, Burgio KL, Goode PS, Ye W, Weidner AC, Lukacz ES, Jelovsek JE, Bradley CS, Schaffer J, Hsu Y, Kenton K, Spino C; Pelvic Floor Disorders Network. Adherence to behavioral interventions for stress incontinence: rates, barriers, and predictors. Phys Ther. 2013 Jun;93(6):757-73. doi: 10.2522/ptj.20120072. Epub 2013 Feb 21. |
| 22914396 | Derived | Schaffer J, Nager CW, Xiang F, Borello-France D, Bradley CS, Wu JM, Mueller E, Norton P, Paraiso MF, Zyczynski H, Richter HE. Predictors of success and satisfaction of nonsurgical therapy for stress urinary incontinence. Obstet Gynecol. 2012 Jul;120(1):91-7. doi: 10.1097/AOG.0b013e31825a6de7. |
| 22453323 | Derived | Kenton K, Barber M, Wang L, Hsu Y, Rahn D, Whitcomb E, Amundsen C, Bradley CS, Zyczynski H, Richter HE; Pelvic Floor Disorders Network. Pelvic floor symptoms improve similarly after pessary and behavioral treatment for stress incontinence. Female Pelvic Med Reconstr Surg. 2012 Mar-Apr;18(2):118-21. doi: 10.1097/SPV.0b013e31824a021d. |
| 21344495 | Derived | Barber MD, Chen Z, Lukacz E, Markland A, Wai C, Brubaker L, Nygaard I, Weidner A, Janz NK, Spino C. Further validation of the short form versions of the Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ). Neurourol Urodyn. 2011 Apr;30(4):541-6. doi: 10.1002/nau.20934. Epub 2011 Feb 22. |
| 19375574 | Derived | Barber MD, Spino C, Janz NK, Brubaker L, Nygaard I, Nager CW, Wheeler TL; Pelvic Floor Disorders Network. The minimum important differences for the urinary scales of the Pelvic Floor Distress Inventory and Pelvic Floor Impact Questionnaire. Am J Obstet Gynecol. 2009 May;200(5):580.e1-7. doi: 10.1016/j.ajog.2009.02.007. |
| FG002 |
| Combination of Pessary and Behavioral Therapy |
Treatment is a combination of both pessary and pelvic muscle exercises |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| 12 Month Follow-up |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pessary | Intravaginal pessary |
| BG001 | Behavioral Therapy | Pelvic muscle training and exercises |
| BG002 | Combination of Pessary and Behavioral Therapy | Treatment includes a combination of both pessary and pelvic muscle exercises |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex/Gender, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Vaginal Deliveries | Median | Inter-Quartile Range | deliveries |
| |||||||||||||||
| Menstrual Status | Count of Participants | Participants |
| ||||||||||||||||
| Prior Nonsurgical UI | Count of Participants | Participants |
| ||||||||||||||||
| Prior UI Surgery | Count of Participants | Participants |
| ||||||||||||||||
| Hysterectomy | Count of Participants | Participants |
| ||||||||||||||||
| Incontinence Type | Count of Participants | Participants |
| ||||||||||||||||
| Incontinence Frequency | Count of Participants | Participants |
| ||||||||||||||||
| Currently Receiving Estrogen Therapy | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | Outcome was measured at three months following randomization. |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Count of Participants | Participants | Outcome was measured at three months following randomization. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | If participant did not attend the 12-month follow-up, missing values were imputed as a failure. | Posted | Count of Participants | Participants | Outcome was measured at 12 months following randomization. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | If participant did not attend the 12-month follow-up, missing values were imputed as a failure. | Posted | Count of Participants | Participants | Outcome was measured at 12 months following randomization. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Count of Participants | Participants | Outcome was measured at three months following randomization. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | If participant did not attend the 12-month follow-up, missing values were imputed as a failure. | Posted | Count of Participants | Participants | Outcome was measured at 12 months following randomization. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Satisfaction With Treatment at 3 Months | Success if participant reported being "satisfied" on Patient Satisfaction Question (PSQ), a failure if they reported otherwise. | 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. | Posted | Count of Participants | Participants | Outcome was measured at three months following randomization. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Satisfaction With Treatment at 12 Months | Success if participant reported being "satisfied" on Patient Satisfaction Question (PSQ), a failure if they reported otherwise. | If participant did not attend the 12-month follow-up, missing values were imputed as a failure. | Posted | Count of Participants | Participants | Outcome was measured at 12 months following randomization. |
|
|
Adverse events were collected during treatment visits over an 8-week treatment period.
As no other adverse events, those that don't meet the definition of a SAE, occurred in at least 5% of participants in any one of the three arms for the ATLAS trial, no table was generated as it is not required by law.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pessary | Intravaginal incontinence pessary | 7 | 149 | 0 | 149 | ||
| EG001 | Behavioral Therapy | Pelvic muscle training and exercises | 4 | 146 | 0 | 146 | ||
| EG002 | Combination of Pessary and Behavioral Therapy | Treatment is a combination of both pessary and pelvic muscle exercises | 6 | 150 | 0 | 150 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary incontinence surgery | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Cholecystectomy | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Angioplasty of heart | Cardiac disorders | Non-systematic Assessment |
| ||
| Deep vein thrombosis | Vascular disorders | Non-systematic Assessment |
| ||
| Hiatal hernia repair | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Left femoral hernia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Left eye surgery for cancer | Nervous system disorders | Non-systematic Assessment |
| ||
| Non-cardiac chest pain and anxiety | Nervous system disorders | Non-systematic Assessment |
| ||
| Oophorectomy | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Fractured right leg and ankle | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Lumbar decompression surgery | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Right knee surgery | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Kidney surgery | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Uterine cancer | Renal and urinary disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marie Gantz | RTI International | 919-597-5110 | mgantz@rti.org |
| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
| Pessary did not fit |
|
| Personal/family health |
|
| Received/desired alternate treatment |
|
| Black or African American |
|
| Other |
|
| Post-menopausal |
|
| Not sure |
|
| Mixed |
|
| Fewer than 14 episodes per wk |
|
| 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. | Regression, Logistic | 0.02 | A priori threshold for statistical significance set at p = 0.0492 to account for interim analysis | Non-Inferiority | Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made. |
| 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. | Regression, Logistic | 0.49 | A priori threshold for statistical significance set at p = 0.0492 to account for interim analysis | Non-Inferiority | Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made. |
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|