Operations and Pelvic Muscle Training in the Management of Apical Support Loss: The OPTIMAL Trial

Operations and Pelvic Muscle Training in the Management of Apical Support Loss: The OPTIMAL Trial: A Randomized Trial of Sacrospinous Ligament Fixation (SSLF) Versus Uterosacral Ligament Suspension (ULS) With and Without Perioperative Behavioral Therapy/Pelvic Muscle Training

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00597935

Acronym

OPTIMAL

Enrollment

374

Registered

2008-01-18

Start date

2008-02-29

Completion date

2013-07-31

Last updated

2020-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Organ Prolapse (POP)

Keywords

prolapse, urinary incontinence, uterosacral vaginal vault ligament suspension, sacrospinous ligament fixation, behavioral therapy, pelvic muscle training

Brief summary

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: 1. to compare sacrospinous ligament fixation (SSLF) to uterosacral vaginal vault ligament suspension (ULS); and 2. to assess the role of perioperative behavioral therapy/pelvic muscle training (PMT) in women undergoing vaginal surgery for apical or uterine prolapse and stress urinary incontinence.

Detailed description

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: 1. To find out which type of surgery, SSLF or ULS, has better results when used to repair prolapse of the top of the vagina, 2. To find out whether or not doing pelvic muscle exercises and behavioral changes around the time of surgery will affect both bladder and bowel symptoms after surgery, and the success of the prolapse repair. 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: 1. SSLF plus PMT 2. ULS plus PMT 3. SSLF without PMT 4. ULS without PMT Women in this study were followed closely at regular intervals for two years after surgery.

Interventions

PROCEDURESSLF

sacrospinous ligament fixation (SSLF)

PROCEDUREULS

uterosacral vaginal vault ligament suspension (ULS)

BEHAVIORALPMT

Pelvic muscle training and exercises (PMT)

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Stage 2 to 4 prolapse * Prolapse of the vaginal apex or cervix to at least half way into the vaginal canal (POPQ Point C \> -TVL/2) \[TVL stands for total vaginal length\] * Vaginal bulge symptoms as indicated by an affirmative response to either questions on the Pelvic Floor Distress Inventory (PFDI) * Vaginal surgery for prolapse is planned, including a vaginal apical suspension procedure. * Stress incontinence symptoms as indicated by an affirmative response to the PFDI Stress incontinence subscale * Documentation of transurethral stress leakage on an office stress test or urodynamics with or without prolapse reduction within the previous 12 months * A tension free vaginal tape (TVT) is planned to treat stress urinary incontinence. * A pelvic muscle training (PMT) visit can be performed at least 2 weeks and not more than 4 weeks before surgery. * Available for 24-months of follow-up. * Able to complete study assessments, per clinician judgment * Able and willing to provide written informed consent

Exclusion criteria

* Contraindication to sacrospinous ligament fixation (SSLF), uterosacral vaginal vault ligament suspension (ULS), or TVT in the opinion of the treating surgeon. * History of previous surgery that included a SSLF or ULS. (Previous vaginal vault suspensions using other techniques or in which the previous technique is unknown are eligible.) * Pelvic pain or dyspareunia due to levator ani spasm that would preclude a PMT program. * History of previous synthetic sling procedure for stress incontinence. * Previous adverse reaction to synthetic mesh. * Urethral diverticulum, current or previous (i.e., repaired) * History of femoral to femoral bypass. * Current cytotoxic chemotherapy or current or history of pelvic radiation therapy. * History of two inpatient hospitalizations for medical comorbidities in the previous 12 months. * Subject wishes to retain her uterus. \[Both ULS and SLS include removal of the uterus, if not previously removed\]

Design outcomes

Primary

Measure	Time frame	Description
Surgical Success	24 months	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.
Anatomic Failure	24 months	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.
Urinary Distress Inventory at 6 Months	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.

Secondary

Measure	Time frame	Description
Urinary Impact Questionnaire Change From Baseline to 24 Months	Baseline and 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.
Pelvic Organ Prolapse Impact Questionnaire Change From Baseline to 24 Months	Baseline and 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.
Colorectal-Anal Impact Questionnaire Change From Baseline to 24 Months	Baseline and 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.
Change From Baseline: Urinary Distress Inventory	Baseline and 24 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). Change = (24 Month Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
Sexual Function 36 - Mental Health Component Score Change From Baseline to 24 Months	Baseline and 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.
Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire Change From Baseline to 24 Months	Baseline and 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.
Sexual Function 36 - Physical Health Component Score Change From Baseline to 24 Months	Baseline and 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.
Change From Baseline: Pelvic Organ Prolapse Distress Inventory	Baseline and 24 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 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.
Change From Baseline: Colorectal Anal Distress Inventory	Baseline and 24 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 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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
SSLF+BPMT Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training	95
SSLF+USUAL Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training	91
ULS+BPMT Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training	91
ULS+USUAL Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training	97
Total	374

Baseline characteristics

Characteristic	SSLF+BPMT	SSLF+USUAL	ULS+BPMT	ULS+USUAL	Total
Age, Continuous	56.3 years STANDARD_DEVIATION 11.2	58.1 years STANDARD_DEVIATION 10.7	58.7 years STANDARD_DEVIATION 10.5	55.8 years STANDARD_DEVIATION 11	57.2 years STANDARD_DEVIATION 10.9
Body Mass Index	30 kg/m^2 STANDARD_DEVIATION 6.2	28 kg/m^2 STANDARD_DEVIATION 5.1	28.6 kg/m^2 STANDARD_DEVIATION 4.9	28.8 kg/m^2 STANDARD_DEVIATION 5.5	28.8 kg/m^2 STANDARD_DEVIATION 5.5
Connective tissue disease .	1 Participants	1 Participants	0 Participants	3 Participants	5 Participants
Connective tissue disease No	93 Participants	90 Participants	90 Participants	91 Participants	364 Participants
Connective tissue disease Yes	1 Participants	0 Participants	1 Participants	3 Participants	5 Participants
Current Smoker No	84 Participants	83 Participants	83 Participants	91 Participants	341 Participants
Current Smoker Yes	11 Participants	8 Participants	8 Participants	6 Participants	33 Participants
Diabetes .	5 Participants	2 Participants	0 Participants	1 Participants	8 Participants
Diabetes No	78 Participants	81 Participants	76 Participants	87 Participants	322 Participants
Diabetes Yes	12 Participants	8 Participants	15 Participants	9 Participants	44 Participants
Estrogen Use: Oral or patch No	84 Participants	76 Participants	80 Participants	88 Participants	328 Participants
Estrogen Use: Oral or patch Yes	11 Participants	15 Participants	11 Participants	9 Participants	46 Participants
Estrogen Use: Vaginal No	77 Participants	70 Participants	67 Participants	72 Participants	286 Participants
Estrogen Use: Vaginal Yes	18 Participants	21 Participants	24 Participants	25 Participants	88 Participants
Hysterectomy No	73 Participants	61 Participants	68 Participants	72 Participants	274 Participants
Hysterectomy Yes	22 Participants	30 Participants	23 Participants	25 Participants	100 Participants
Insurance: Medicare or Medicaid No	68 Participants	65 Participants	62 Participants	70 Participants	265 Participants
Insurance: Medicare or Medicaid Yes	27 Participants	26 Participants	29 Participants	27 Participants	109 Participants
Insurance: Other No	77 Participants	74 Participants	76 Participants	75 Participants	302 Participants
Insurance: Other Yes	18 Participants	17 Participants	15 Participants	22 Participants	72 Participants
Insurance: Private/HMO No	33 Participants	30 Participants	28 Participants	32 Participants	123 Participants
Insurance: Private/HMO Yes	62 Participants	61 Participants	63 Participants	65 Participants	251 Participants
Insurance: Self-pay No	93 Participants	90 Participants	90 Participants	95 Participants	368 Participants
Insurance: Self-pay Yes	2 Participants	1 Participants	1 Participants	2 Participants	6 Participants
Menstrual Status Not sure	7 Participants	4 Participants	6 Participants	5 Participants	22 Participants
Menstrual Status Postmenopausal	59 Participants	64 Participants	64 Participants	59 Participants	246 Participants
Menstrual Status Premenopausal	29 Participants	23 Participants	21 Participants	33 Participants	106 Participants
Number of Cesarean Deliveries	0 Number of deliveries	0 Number of deliveries	0 Number of deliveries	0 Number of deliveries	0 Number of deliveries
Number of Vaginal Deliveries	3 Number of deliveries	2 Number of deliveries	3 Number of deliveries	3 Number of deliveries	3 Number of deliveries
Pelvic Organ Prolapse-Q stage 2	37 Participants	36 Participants	35 Participants	36 Participants	144 Participants
Pelvic Organ Prolapse-Q stage 3	54 Participants	48 Participants	51 Participants	59 Participants	212 Participants
Pelvic Organ Prolapse-Q stage 4	4 Participants	7 Participants	5 Participants	2 Participants	18 Participants
Prior Pelvic Organ Prolapse Surgery No	89 Participants	80 Participants	88 Participants	91 Participants	348 Participants
Prior Pelvic Organ Prolapse Surgery Yes	6 Participants	11 Participants	3 Participants	6 Participants	26 Participants
Prior Stress Urinary Incontinence Surgery No	93 Participants	87 Participants	87 Participants	94 Participants	361 Participants
Prior Stress Urinary Incontinence Surgery Yes	2 Participants	4 Participants	4 Participants	3 Participants	13 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants	1 Participants	0 Participants	0 Participants	2 Participants
Race/Ethnicity, Customized Asian	1 Participants	3 Participants	0 Participants	0 Participants	4 Participants
Race/Ethnicity, Customized Black or African American	7 Participants	3 Participants	8 Participants	4 Participants	22 Participants
Race/Ethnicity, Customized Hispanic/Latina	19 Participants	15 Participants	19 Participants	22 Participants	75 Participants
Race/Ethnicity, Customized Not Hispanic/Latina	76 Participants	76 Participants	72 Participants	75 Participants	299 Participants
Race/Ethnicity, Customized Other	6 Participants	7 Participants	9 Participants	9 Participants	31 Participants
Race/Ethnicity, Customized White	80 Participants	77 Participants	74 Participants	84 Participants	315 Participants
Sex/Gender, Customized Female	95 Participants	91 Participants	91 Participants	97 Participants	374 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —
other Total, other adverse events	62 / 91	69 / 95	73 / 97	62 / 91
serious Total, serious adverse events	15 / 91	15 / 95	16 / 97	16 / 91

Outcome results

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.

Time frame: 24 months

Population: This outcome is analyzed in participants randomized to both surgical and behavioral interventions and who were in the study at 24 months.

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
SSLF+BPMT	Anatomic Failure	Failure	18 Participants
SSLF+BPMT	Anatomic Failure	Non-failure	58 Participants
SSLF+USUAL	Anatomic Failure	Non-failure	56 Participants
SSLF+USUAL	Anatomic Failure	Failure	23 Participants
ULS+BPMT	Anatomic Failure	Failure	19 Participants
ULS+BPMT	Anatomic Failure	Non-failure	58 Participants
ULS+USUAL	Anatomic Failure	Failure	19 Participants
ULS+USUAL	Anatomic Failure	Non-failure	66 Participants

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.

Time frame: 24 months

Population: 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.

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
SSLF+BPMT	Surgical Success	Success	47 Participants
SSLF+BPMT	Surgical Success	Failure	25 Participants
SSLF+USUAL	Surgical Success	Success	47 Participants
SSLF+USUAL	Surgical Success	Failure	30 Participants
ULS+BPMT	Surgical Success	Success	45 Participants
ULS+BPMT	Surgical Success	Failure	28 Participants
ULS+USUAL	Surgical Success	Success	55 Participants
ULS+USUAL	Surgical Success	Failure	27 Participants

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.

Time frame: 6 months

Population: 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.

Arm	Measure	Value (MEAN)
SSLF+BPMT	Urinary Distress Inventory at 6 Months	30.6 units on a scale
SSLF+USUAL	Urinary Distress Inventory at 6 Months	37.9 units on a scale
ULS+BPMT	Urinary Distress Inventory at 6 Months	27.4 units on a scale
ULS+USUAL	Urinary Distress Inventory at 6 Months	29.7 units on a scale

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.