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| ID | Type | Description | Link |
|---|---|---|---|
| 2U01HD041249 | U.S. NIH Grant/Contract | View source | |
| 2U10HD041250 | U.S. NIH Grant/Contract | View source | |
| 2U10HD041261 | U.S. NIH Grant/Contract | View source | |
| 2U10HD041267 | U.S. NIH Grant/Contract | View source | |
| 1U10HD054136 | U.S. NIH Grant/Contract | View source | |
| 1U10HD054214 | U.S. NIH Grant/Contract | View source | |
| 1U10HD054215 | U.S. NIH Grant/Contract | View source | |
| 1U10HD054241 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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Pelvic organ prolapse is common among women with a prevalence that has been estimated to be as high as 30%. Pelvic organ prolapse often involves a combination of support defects involving the anterior, posterior and/or apical vaginal segments. While the anterior vaginal wall is the segment most likely to demonstrate recurrent prolapse after reconstructive surgery, reoperations are highest among those who require apical suspension procedures with or without repair of other vaginal segments (12%-33%). Despite the substantial health impact, there is a paucity of high quality evidence to support different practices in the management of prolapse, particularly surgery. Thus, the objectives of the Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL) Trial are:
Many women develop pelvic organ prolapse over the course of their lives. Pelvic organ prolapse is the downward descent of the pelvic organs (which include the uterus, bladder and bowel) into the vagina. Researchers estimate that between 7-10% of women will require surgery for prolapse sometime in their lifetime. Many will have more than one operation for the prolapse. Because this is such a common problem, the investigators in the Pelvic Floor Disorders Network strive to offer women the best treatment options. However, there were not enough carefully designed and conducted research studies to help guide them in this direction.
Women who are planning surgery for apical vaginal prolapse often experience bladder and bowel symptoms, as well as pressure and a bulge. These symptoms might include urinary leakage (urinary incontinence), urinary urgency (a sudden strong desire to urinate with fear that leakage may occur) or frequent urination, difficulty starting to urinate or perhaps a slow weak urinary stream, as well as accidental bowel leakage (fecal incontinence). After surgery, bladder and bowel symptoms may get better, get worse, or stay the same as before surgery. Sometimes new symptoms can start after surgery even if they weren't present before surgery.
The OPTIMAL study was designed to compare two commonly performed vaginal surgeries for pelvic organ prolapse. One is the sacrospinous ligament fixation, called SSLF for short. The other is the uterosacral ligament suspension, called ULS. Both surgeries involve attaching the top of the vagina, which has fallen down, to internal ligaments in the pelvis in order to resuspend the vagina and correct the prolapse.
The investigators were also interested in studying how the surgeries altered bladder and bowel symptoms. They had seen in other studies that behavioral and pelvic floor muscle therapy (PMT) is an effective therapy for stress and urge urinary incontinence, fecal incontinence, and other pelvic floor disorders. It is relatively easy to perform, and has rare side effects. They wondered if PMT around the time of surgery might further improve these symptoms.
The OPTIMAL study has two main purposes:
Four Hundred women were enrolled into the OPTIMAL study, from January 2008 to May 2011. These women were randomly assigned to receive either the SSLF or the ULS surgery. They were randomly assigned to either receive the PMT training with a therapist before and after surgery or to not receive this therapy. So women fell into one of four groups:
Women in this study were followed closely at regular intervals for two years after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SSLF and PMT | Experimental | Sacrospinous Ligament Fixation (SSLF) and Pelvic Muscle Training & Exercises (PMT) |
|
| ULS and PMT | Experimental | Uterosacral Vaginal Vault Ligament Suspension (ULS) and Pelvic Muscle Training & Exercises (PMT) |
|
| SSLF without PMT | Experimental | Sacrospinous Ligament Fixation (SSLF) without Pelvic Muscle Training & Exercises (PMT) |
|
| ULS without PMT | Experimental | Uterosacral Vaginal Vault Ligament Suspension (ULS) without Pelvic Muscle Training & Exercises (PMT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SSLF | Procedure | sacrospinous ligament fixation (SSLF) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical Success | The absence of the following: (1) descent of the vaginal apex more than one-third into the vaginal canal; (2) anterior or posterior vaginal wall descent beyond the hymen; (3) bothersome vaginal bulge symptoms as indicated by an affirmative response to either 'Do you usually have a sensation of bulging or protrusion from the vaginal area?' or 'Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?' in the Pelvic Floor Distress Inventory and any response other than 'not at all' to the question 'How much does this bother you?'; or (4) re-treatment for prolapse by either surgery or pessary. | 24 months |
| Anatomic Failure | Anatomic failure is defined by one of the following: descent of the vaginal apex more than one-third into the vaginal canal, anterior or posterior vaginal wall descent beyond the hymen, or re-treatment for prolapse. | 24 months |
| Urinary Distress Inventory at 6 Months | The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (POPDI, with 3 subscales), 2. Colorectal Anal Distress Inventory (CRADI, with 4 subscales), and 3. Urinary Distress Inventory (UDI, with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of responses for the UDI is: 0-300 with 0 (least distress) to 300 (most distress). Lower scores indicate better function / fewer symptoms. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline: Urinary Distress Inventory | The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (POPDI, with 3 subscales), 2. Colorectal Anal Distress Inventory (CRADI, with 4 subscales), and 3. Urinary Distress Inventory (UDI, with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of responses for the UDI is: 0-300 with 0 (least distress) to 300 (most distress). Change = (24 Month Score - Baseline Score). Lower scores indicate better function / fewer symptoms. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Barber, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Alabama at Birmingham | Birmingham | Alabama | 35233-7333 | United States | ||
| Kaiser Permanente Bellflower |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19130903 | Background | Barber MD, Brubaker L, Menefee S, Norton P, Borello-France D, Varner E, Schaffer J, Weidner A, Xu X, Spino C, Weber A; Pelvic Floor Disorders Network. Operations and pelvic muscle training in the management of apical support loss (OPTIMAL) trial: design and methods. Contemp Clin Trials. 2009 Mar;30(2):178-89. doi: 10.1016/j.cct.2008.12.001. Epub 2008 Dec 16. | |
| 37318279 | Derived | Borello-France D, Newman DK, Markland AD, Propst K, Jelovsek JE, Cichowski S, Gantz MG, Balgobin S, Jakus-Waldman S, Korbly N, Mazloomdoost D, Burgio KL; NICHD Pelvic Floor Disorders Network. Adherence to Perioperative Behavioral Therapy With Pelvic Floor Muscle Training in Women Receiving Vaginal Reconstructive Surgery for Pelvic Organ Prolapse. Phys Ther. 2023 Sep 1;103(9):pzad059. doi: 10.1093/ptj/pzad059. |
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| ID | Title | Description |
|---|---|---|
| FG000 | SSLF+BPMT | Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training |
| FG001 | SSLF+USUAL | Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Randomized to Surgical and BPMT Arms |
|
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| ULS |
| Procedure |
uterosacral vaginal vault ligament suspension (ULS) |
|
| PMT | Behavioral | Pelvic muscle training and exercises (PMT) |
|
| Baseline and 24 months |
| Change From Baseline: Pelvic Organ Prolapse Distress Inventory | The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (POPDI, with 3 subscales), 2. Colorectal Anal Distress Inventory (CRADI, with 4 subscales), and 3. Urinary Distress Inventory (UDI, with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of responses for the POPDI is: 0-300 with 0 (least distress) to 300 (most distress). Change = (24 Month Score - Baseline Score). Lower scores indicate better function / fewer symptoms. | Baseline and 24 months |
| Change From Baseline: Colorectal Anal Distress Inventory | The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (POPDI, with 3 subscales), 2. Colorectal Anal Distress Inventory (CRADI, with 4 subscales), and 3. Urinary Distress Inventory (UDI, with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of responses for the CRADI is: 0-400 with 0 (least distress) to 400 (most distress). Change = (24 Month Score - Baseline Score). Lower scores indicate better function / fewer symptoms. | Baseline and 24 months |
| Urinary Impact Questionnaire Change From Baseline to 24 Months | The Pelvic Floor Impact Questionnaire measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales: the Urinary Impact Questionnaire (UIQ; 4 subscales, range 0-400), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; 4 subscales, range 0-400), and the Colorectal-Anal Impact Questionnaire (CRAIQ; 4 subscales, range 0-400). Scores are calculated by multiplying the mean value of all answered questions for a subscale by 100 divided by 3. The subscales are then added together. The range of responses is: 0-400 with 0 (least negative impact) to 400 (most negative impact). Change = (24 Month Score - Baseline Score). Lower scores indicate better function / fewer symptoms. | Baseline and 24 months |
| Pelvic Organ Prolapse Impact Questionnaire Change From Baseline to 24 Months | The Pelvic Floor Impact Questionnaire measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales: the Urinary Impact Questionnaire (UIQ; 4 subscales, range 0-400), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; 4 subscales, range 0-400), and the Colorectal-Anal Impact Questionnaire (CRAIQ; 4 subscales, range 0-400). Scores are calculated by multiplying the mean value of all answered questions for a subscale by 100 divided by 3. The subscales are then added together. The range of responses is: 0-400 with 0 (least negative impact) to 400 (most negative impact). Change = (Year 2 Score - Baseline Score). Lower scores indicate better function / fewer symptoms. | Baseline and 24 months |
| Colorectal-Anal Impact Questionnaire Change From Baseline to 24 Months | The Pelvic Floor Impact Questionnaire measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales: the Urinary Impact Questionnaire (UIQ; 4 subscales, range 0-400), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; 4 subscales, range 0-400), and the Colorectal-Anal Impact Questionnaire (CRAIQ; 4 subscales, range 0-400). Scores are calculated by multiplying the mean value of all answered questions for a subscale by 100 divided by 3. The subscales are then added together. The range of responses is: 0-400 with 0 (least negative impact) to 400 (most negative impact). Change = (Year 2 Score - Baseline Score). Lower scores indicate better function / fewer symptoms. | Baseline and 24 months |
| Sexual Function 36 - Physical Health Component Score Change From Baseline to 24 Months | Sexual Function 36 (SF36) - Physical Health Component Score is the physical health component of the Sexual Function 36 survey with scores ranging from 0 to 100 with higher scores meaning a better health state. Scales are scored according to the algorithm that describes the handling of the various types of questions included in the questionnaire. Several steps are involved in the scoring process: recoding items that require it; summing over items; and transforming raw scale scores to a 0 to 100 scale. This physical health component is a function of several constructs measured under the SF36: physical functioning, physical role, bodily pain, general health, and vitality. | Baseline and 24 months |
| Sexual Function 36 - Mental Health Component Score Change From Baseline to 24 Months | Sexual Function 36 (SF36) - Mental Health Component Score is the mental health component of the Sexual Function 36 survey with scores ranging from 0 to 100 with higher scores meaning a better health state. Scales are scored according to the algorithm that describes the handling of the various types of questions included in the questionnaire. Several steps are involved in the scoring process: recoding items that require it; summing over items; and transforming raw scale scores to a 0 to 100 scale. | Baseline and 24 months |
| Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire Change From Baseline to 24 Months | Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ) is a survey of sexual functioning with scores ranging from 0 to 48 with higher scores meaning better sexual functioning. Patients were asked to answer 31 questions about their sexuality in the past 6 months. | Baseline and 24 months |
| Bellflower |
| California |
| 90706 |
| United States |
| University of California, San Diego Medical Center | La Jolla | California | 92037 | United States |
| Kaiser Permanente | San Diego | California | 92120 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | 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 |
| 33030871 | Derived | Jakus-Waldman S, Brubaker L, Jelovsek JE, Schaffer JI, Ellington DR, Mazloomdoost D, Whitworth R, Gantz MG; NICHD Pelvic Floor Disorders Network (PFDN). Risk Factors for Surgical Failure and Worsening Pelvic Floor Symptoms Within 5 Years After Vaginal Prolapse Repair. Obstet Gynecol. 2020 Nov;136(5):933-941. doi: 10.1097/AOG.0000000000004092. |
| 32769645 | Derived | Lukacz ES, Sridhar A, Chermansky CJ, Rahn DD, Harvie HS, Gantz MG, Varner RE, Korbly NB, Mazloomdoost D; Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network (PFDN). Sexual Activity and Dyspareunia 1 Year After Surgical Repair of Pelvic Organ Prolapse. Obstet Gynecol. 2020 Sep;136(3):492-500. doi: 10.1097/AOG.0000000000003992. |
| 31449806 | Derived | Sutkin G, Zyczynski HM, Sridhar A, Jelovsek JE, Rardin CR, Mazloomdoost D, Rahn DD, Nguyen JN, Andy UU, Meyer I, Gantz MG; NICHD Pelvic Floor Disorders Network. Association between adjuvant posterior repair and success of native tissue apical suspension. Am J Obstet Gynecol. 2020 Feb;222(2):161.e1-161.e8. doi: 10.1016/j.ajog.2019.08.024. Epub 2019 Aug 23. |
| 27159758 | Derived | Lukacz ES, Warren LK, Richter HE, Brubaker L, Barber MD, Norton P, Weidner AC, Nguyen JN, Gantz MG. Quality of Life and Sexual Function 2 Years After Vaginal Surgery for Prolapse. Obstet Gynecol. 2016 Jun;127(6):1071-1079. doi: 10.1097/AOG.0000000000001442. |
| 24618964 | Derived | Barber MD, Brubaker L, Burgio KL, Richter HE, Nygaard I, Weidner AC, Menefee SA, Lukacz ES, Norton P, Schaffer J, Nguyen JN, Borello-France D, Goode PS, Jakus-Waldman S, Spino C, Warren LK, Gantz MG, Meikle SF; Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Comparison of 2 transvaginal surgical approaches and perioperative behavioral therapy for apical vaginal prolapse: the OPTIMAL randomized trial. JAMA. 2014 Mar 12;311(10):1023-34. doi: 10.1001/jama.2014.1719. |
| 22777368 | Derived | Barber MD, Kenton K, Janz NK, Hsu Y, Dyer KY, Greer WJ, White A, Meikle S, Ye W. Validation of the activities assessment scale in women undergoing pelvic reconstructive surgery. Female Pelvic Med Reconstr Surg. 2012 Jul-Aug;18(4):205-10. doi: 10.1097/SPV.0b013e31825e6422. |
| 22777367 | Derived | Barber MD, Janz N, Kenton K, Hsu Y, Greer WJ, Dyer K, White A, Meikle S, Ye W. Validation of the surgical pain scales in women undergoing pelvic reconstructive surgery. Female Pelvic Med Reconstr Surg. 2012 Jul-Aug;18(4):198-204. doi: 10.1097/SPV.0b013e31825d65aa. |
| FG002 | ULS+BPMT | Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training |
| FG003 | ULS+USUAL | Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training |
| COMPLETED |
|
| NOT COMPLETED |
|
| Baseline to 6-Months |
|
| 6-Months to 24-Months |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SSLF+BPMT | Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training |
| BG001 | SSLF+USUAL | Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training |
| BG002 | ULS+BPMT | Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training |
| BG003 | ULS+USUAL | Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Insurance: Private/HMO | Count of Participants | Participants |
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| Insurance: Medicare or Medicaid | Count of Participants | Participants |
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| Insurance: Self-pay | Count of Participants | Participants |
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| Insurance: Other | Count of Participants | Participants |
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| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
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| Current Smoker | Count of Participants | Participants |
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| Diabetes | Count of Participants | Participants |
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| Connective tissue disease | Count of Participants | Participants |
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| Number of Vaginal Deliveries | Median | Full Range | Number of deliveries |
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| Number of Cesarean Deliveries | Median | Full Range | Number of deliveries |
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| Estrogen Use: Oral or patch | Count of Participants | Participants |
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| Estrogen Use: Vaginal | Count of Participants | Participants |
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| Menstrual Status | Count of Participants | Participants |
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| Hysterectomy | Count of Participants | Participants |
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| Prior Stress Urinary Incontinence Surgery | Count of Participants | Participants |
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| Prior Pelvic Organ Prolapse Surgery | Count of Participants | Participants |
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| Pelvic Organ Prolapse-Q stage | The POP-Q assessment is a tool that measure the severity of prolapse. It measures nine points in the vagina with the hymen being the reference point. The distance to the reference point (in cm) is measured for the prolapsed and the severity stage is calculated. Higher stages indicate worse prolapse. | Count of Participants | Participants |
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| 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 | Surgical Success | The absence of the following: (1) descent of the vaginal apex more than one-third into the vaginal canal; (2) anterior or posterior vaginal wall descent beyond the hymen; (3) bothersome vaginal bulge symptoms as indicated by an affirmative response to either 'Do you usually have a sensation of bulging or protrusion from the vaginal area?' or 'Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?' in the Pelvic Floor Distress Inventory and any response other than 'not at all' to the question 'How much does this bother you?'; or (4) re-treatment for prolapse by either surgery or pessary. | This outcome is analyzed in participants randomized to both surgical and behavioral interventions who had non-missing data for this 24-month outcome. There are minor differences between the Number of Participants Analyzed and the 24-month numbers in the Participant Flow module because of missing data. | Posted | Count of Participants | Participants | 24 months |
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| Primary | Anatomic Failure | Anatomic failure is defined by one of the following: descent of the vaginal apex more than one-third into the vaginal canal, anterior or posterior vaginal wall descent beyond the hymen, or re-treatment for prolapse. | This outcome is analyzed in participants randomized to both surgical and behavioral interventions and who were in the study at 24 months. | Posted | Count of Participants | Participants | 24 months |
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| Primary | Urinary Distress Inventory at 6 Months | The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (POPDI, with 3 subscales), 2. Colorectal Anal Distress Inventory (CRADI, with 4 subscales), and 3. Urinary Distress Inventory (UDI, with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of responses for the UDI is: 0-300 with 0 (least distress) to 300 (most distress). Lower scores indicate better function / fewer symptoms. | This outcome is analyzed in participants randomized to both surgical and behavioral interventions who had non-missing data for this 6-month outcome. There are minor differences between the Number of Participants Analyzed and the 6-month numbers in the Participant Flow module because of missing data. | Posted | Mean | 95% Confidence Interval | units on a scale | 6 months |
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| Secondary | Change From Baseline: Urinary Distress Inventory | The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (POPDI, with 3 subscales), 2. Colorectal Anal Distress Inventory (CRADI, with 4 subscales), and 3. Urinary Distress Inventory (UDI, with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of responses for the UDI is: 0-300 with 0 (least distress) to 300 (most distress). Change = (24 Month Score - Baseline Score). Lower scores indicate better function / fewer symptoms. | This outcome is analyzed in participants randomized to both surgical and behavioral interventions who had non-missing data for this 24-month outcome. There are differences between the Number of Participants Analyzed and the 24-month numbers in the Participant Flow module because of missing data. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 24 months |
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| Secondary | Change From Baseline: Pelvic Organ Prolapse Distress Inventory | The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (POPDI, with 3 subscales), 2. Colorectal Anal Distress Inventory (CRADI, with 4 subscales), and 3. Urinary Distress Inventory (UDI, with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of responses for the POPDI is: 0-300 with 0 (least distress) to 300 (most distress). Change = (24 Month Score - Baseline Score). Lower scores indicate better function / fewer symptoms. | This outcome is analyzed in participants randomized to both surgical and behavioral interventions who had non-missing data for this 24-month outcome. There are differences between the Number of Participants Analyzed and the 24-month numbers in the Participant Flow module because of missing data. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 24 months |
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| Secondary | Change From Baseline: Colorectal Anal Distress Inventory | The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (POPDI, with 3 subscales), 2. Colorectal Anal Distress Inventory (CRADI, with 4 subscales), and 3. Urinary Distress Inventory (UDI, with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of responses for the CRADI is: 0-400 with 0 (least distress) to 400 (most distress). Change = (24 Month Score - Baseline Score). Lower scores indicate better function / fewer symptoms. | This outcome is analyzed in participants randomized to both surgical and behavioral interventions who had non-missing data for this 24-month outcome. There are differences between the Number of Participants Analyzed and the 24-month numbers in the Participant Flow module because of missing data. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 24 months |
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| Secondary | Urinary Impact Questionnaire Change From Baseline to 24 Months | The Pelvic Floor Impact Questionnaire measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales: the Urinary Impact Questionnaire (UIQ; 4 subscales, range 0-400), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; 4 subscales, range 0-400), and the Colorectal-Anal Impact Questionnaire (CRAIQ; 4 subscales, range 0-400). Scores are calculated by multiplying the mean value of all answered questions for a subscale by 100 divided by 3. The subscales are then added together. The range of responses is: 0-400 with 0 (least negative impact) to 400 (most negative impact). Change = (24 Month Score - Baseline Score). Lower scores indicate better function / fewer symptoms. | This outcome is analyzed in participants randomized to both surgical and behavioral interventions who had non-missing data for this 24-month outcome. There are differences between the Number of Participants Analyzed and the 24-month numbers in the Participant Flow module because of missing data. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 24 months |
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| Secondary | Pelvic Organ Prolapse Impact Questionnaire Change From Baseline to 24 Months | The Pelvic Floor Impact Questionnaire measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales: the Urinary Impact Questionnaire (UIQ; 4 subscales, range 0-400), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; 4 subscales, range 0-400), and the Colorectal-Anal Impact Questionnaire (CRAIQ; 4 subscales, range 0-400). Scores are calculated by multiplying the mean value of all answered questions for a subscale by 100 divided by 3. The subscales are then added together. The range of responses is: 0-400 with 0 (least negative impact) to 400 (most negative impact). Change = (Year 2 Score - Baseline Score). Lower scores indicate better function / fewer symptoms. | This outcome is analyzed in participants randomized to both surgical and behavioral interventions who had non-missing data for this 24-month outcome. There are differences between the Number of Participants Analyzed and the 24-month numbers in the Participant Flow module because of missing data. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 24 months |
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| Secondary | Colorectal-Anal Impact Questionnaire Change From Baseline to 24 Months | The Pelvic Floor Impact Questionnaire measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales: the Urinary Impact Questionnaire (UIQ; 4 subscales, range 0-400), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; 4 subscales, range 0-400), and the Colorectal-Anal Impact Questionnaire (CRAIQ; 4 subscales, range 0-400). Scores are calculated by multiplying the mean value of all answered questions for a subscale by 100 divided by 3. The subscales are then added together. The range of responses is: 0-400 with 0 (least negative impact) to 400 (most negative impact). Change = (Year 2 Score - Baseline Score). Lower scores indicate better function / fewer symptoms. | This outcome is analyzed in participants randomized to both surgical and behavioral interventions who had non-missing data for this 24-month outcome. There are differences between the Number of Participants Analyzed and the 24-month numbers in the Participant Flow module because of missing data. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 24 months |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Sexual Function 36 - Physical Health Component Score Change From Baseline to 24 Months | Sexual Function 36 (SF36) - Physical Health Component Score is the physical health component of the Sexual Function 36 survey with scores ranging from 0 to 100 with higher scores meaning a better health state. Scales are scored according to the algorithm that describes the handling of the various types of questions included in the questionnaire. Several steps are involved in the scoring process: recoding items that require it; summing over items; and transforming raw scale scores to a 0 to 100 scale. This physical health component is a function of several constructs measured under the SF36: physical functioning, physical role, bodily pain, general health, and vitality. | This outcome is analyzed in participants randomized to both surgical and behavioral interventions who had non-missing data for this 24-month outcome. There are differences between the Number of Participants Analyzed and the 24-month numbers in the Participant Flow module because of missing data. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 24 months |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Sexual Function 36 - Mental Health Component Score Change From Baseline to 24 Months | Sexual Function 36 (SF36) - Mental Health Component Score is the mental health component of the Sexual Function 36 survey with scores ranging from 0 to 100 with higher scores meaning a better health state. Scales are scored according to the algorithm that describes the handling of the various types of questions included in the questionnaire. Several steps are involved in the scoring process: recoding items that require it; summing over items; and transforming raw scale scores to a 0 to 100 scale. | This outcome is analyzed in participants randomized to both surgical and behavioral interventions who had non-missing data for this 24-month outcome. There are differences between the Number of Participants Analyzed and the 24-month numbers in the Participant Flow module because of missing data. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 24 months |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire Change From Baseline to 24 Months | Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ) is a survey of sexual functioning with scores ranging from 0 to 48 with higher scores meaning better sexual functioning. Patients were asked to answer 31 questions about their sexuality in the past 6 months. | This outcome is analyzed in participants randomized to both surgical and behavioral interventions who had non-missing data for this 24-month outcome. There are differences between the Number of Participants Analyzed and the 24-month numbers in the Participant Flow module because of missing data. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 24 months |
|
24 Months
Not provided
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 | ULS+BPMT | Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training | 15 | 91 | 62 | 91 | ||
| EG001 | SSLF+BPMT | Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training | 15 | 95 | 69 | 95 | ||
| EG002 | ULS+USUAL | Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training | 16 | 97 | 73 | 97 | ||
| EG003 | SSLF+USUAL | Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training | 16 | 91 | 62 | 91 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Myocardial Infarction | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hiatal Hernia | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Oesophageal achalasia | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Fever | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Suprapubic pain | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Unable to determine Preferred Term | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Biliary cholic | Hepatobiliary disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Non-alcoholic steatohepatitis | Hepatobiliary disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Allergic Reaction | Immune system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Cholecystitis infective | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| DIVERTICULITIS | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pelvic abscess | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Unable to determine Preferred Term | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Vaginal Abscess | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Anaemia postoperative | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
| |
| Bladder injury | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
| |
| Procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| PO2 decreased | Investigations | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pain in Leg | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Non-systematic Assessment |
| |
| Endometrial cancer stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Non-systematic Assessment |
| |
| Transitonal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Non-systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pudenal canal syndrome | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Sciatic nerve neuropathy | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Depression Suicidal | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Breast enlargement | Reproductive system and breast disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Haemorrhage | Reproductive system and breast disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Ovarian vein thrombosis | Reproductive system and breast disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pelvic prolapse | Reproductive system and breast disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Vulvovaginal Pain | Reproductive system and breast disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| Hiatus hernia | Surgical and medical procedures | MedDRA 20.1 | Non-systematic Assessment |
| |
| Knee arthroplasty | Surgical and medical procedures | MedDRA 20.1 | Non-systematic Assessment |
| |
| Nephrectomy | Surgical and medical procedures | MedDRA 20.1 | Non-systematic Assessment |
| |
| Prolapse repair | Surgical and medical procedures | MedDRA 20.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| OTHER ADVERSE EVENTS | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| MESH EROSION/EXPOSURE AT 4 WEEKS TO 24 MONTHS | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| SUTURE EXPOSURE AT 6 TO 24 MONTHS | General disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| BLADDER INJURY | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
| |
| BLOOD TRANSFUSION | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
| |
| INTRAOPERTIVE URETERAL INJURY | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
| |
| RECTAL INJURY | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
| |
| TREATMENT - STENT PLACEMENT | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
| |
| TREATMENT - SUTURE REMOVED INTRAOPERATIVELY | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
| |
| URETERAL INJURY - DELAYED RECOGNITION | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
| |
| NEUROLOGIC PAIN REQUIRING TREATMENT | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
| |
| VAGINAL GRANULATION TISSUE AT 6 TO 24 MONTHS | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marie Gantz | RTI International | 919-597-5110 | mgantz@rti.org |
| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| D011391 | Prolapse |
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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 |
Not provided
Not provided
| Asian |
|
| Black or African American |
|
| Other |
|
| White |
|
| Not Hispanic/Latina |
|
| Yes |
|
| Yes |
|
| Yes |
|
| Yes |
|
| Yes |
|
| No |
|
| Yes |
|
| No |
|
| Yes |
|
| Yes |
|
| Yes |
|
| Postmenopausal |
|
| Premenopausal |
|
| Yes |
|
| Yes |
|
| Yes |
|
| 3 |
|
| 4 |
|
| Success |
|
|
|
Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training |
| OG003 | ULS+USUAL | Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training |
|
|
| ULS+BPMT |
Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training |
| OG003 | ULS+USUAL | Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training |
|
|
| ULS+BPMT |
Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training |
| OG003 | ULS+USUAL | Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training |
|
|
| ULS+BPMT |
Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training |
| OG003 | ULS+USUAL | Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training |
|
|
| OG002 | ULS+BPMT | Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training |
| OG003 | ULS+USUAL | Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training |
|
|
| OG002 | ULS+BPMT | Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training |
| OG003 | ULS+USUAL | Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training |
|
|
| OG002 | ULS+BPMT | Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training |
| OG003 | ULS+USUAL | Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training |
|
|
| OG002 |
| ULS+BPMT |
Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training |
| OG003 | ULS+USUAL | Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training |
|
|
Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training
| OG003 | ULS+USUAL | Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training |
|
|
| OG003 |
| ULS+USUAL |
Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training |
|
|