The Extended Operations And Pelvic Muscle Training In The Management Of Apical Support Loss Study

Pelvic Organ Prolapse Clinical Trial

— E-OPTIMAL  

Official title:

Long-Term Effectiveness Of Sacrospinous Ligament Fixation vs Uterosacral Ligament Suspension With and Without Perioperative Behavioral Therapy/Pelvic Muscle Training: Extended Operations & Pelvic Muscle Training Of Apical Support Loss Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01166373
• Other study ID #: 16P01S
• Status: Completed
• Phase: N/A
• Start date: April 2010
• Est. completion date: July 2016

Study information

• Verified date: September 2020
• Source: NICHD Pelvic Floor Disorders Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Women will be invited to participate in E-OPTIMAL at their last clinical follow-up visit for OPTIMAL (at 24 months post surgery). E-OPTIMAL is an extension of the ongoing OPTIMAL study and no new study treatment interventions will be given. Rather an enrollment intervention will be investigated with potential E-OPTIMAL participants randomly assigned to watch a standardized video prior to consent or undergo the standard informed consent process. The standardized video will review the rationale for women's health research, the importance of long-term follow-up and a detailed invitation to participate in E-OPTIMAL. The video has undergone review by potential subjects, coordinators and physician researchers to ensure that the relevance and importance of issues potentially impacting on long-term participation in studies such as E-OPTIMAL are covered. Participation in E-OPTIMAL will occur up to three additional years. Women will be strongly encouraged to participate in annual examinations and annual telephone surveys but may participate in only one of these study parts if needed.

We propose to test the following null hypotheses:

1. There will be no difference in time to surgical failure between uterosacral vaginal vault ligament suspension (ULS) and sacrospinous ligament fixation (SSLF) up to 5 years after surgery.

2. The addition of a standardized video detailing the importance of long-term follow-up studies for POP to the informed consent process will not improve enrollment or retention in E-OPTIMAL.

Description:

The goal of this long-term follow-up study is to extend the follow-up of women in the OPTIMAL study up to 5 years from the time of surgery and to compare the success and complication rates of the two surgical treatment groups over this extended time period. The Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL) study is a randomized trial designed to compare sacrospinous ligament fixation (SSLF) to uterosacral vaginal vault ligament suspension (ULS) and 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 (SUI).

The OPTIMAL study includes a two-year follow up from the time of surgery, which is too short to evaluate the long-term sequelae of the surgical procedures. A further goal of E-OPTIMAL is to investigate a strategy for improving enrollment and retention in long-term studies of women undergoing surgery for pelvic organ prolapse and SUI, by randomizing subjects to two different recruitment methods.

The primary aims of this extension study are to compare SSLF and ULS for the following outcomes up to 5 years after surgery in women with Stage 2-4 prolapse involving the vaginal apex or uterus and stress urinary incontinence:

1. time to surgical failure;

2. the long-term functional and health-related quality of life (QOL), adjusted for PMT treatment group;

3. the annual and cumulative incidence, resolution, and persistence of pelvic floor symptoms (urinary, bowel, and prolapse), adjusted for PMT treatment group.

An additional primary aim (aim 4) is to determine whether exposure to a standardized video detailing the importance of long-term follow-up studies for pelvic organ prolapse prior to the informed consent process will improve enrollment and/or retention in E-OPTIMAL. We will utilize a conceptual framework that assesses three concepts (motivation, barriers and pragmatic issues) at two levels (study level and personal/individual level). This conceptual framework was developed following a review of the scant available literature on the topic, as well as during discussions with investigators who are experienced in recruiting and retaining participants in pelvic floor disorders studies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 285
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Completion of the Year 2 OPTIMAL in-person visit

Exclusion Criteria:

1. Inability to provide informed consent.

2. Subjects who are long-term residents of a skilled nursing facility (that is, residency is not limited to short-term rehabilitation) at the time of enrollment into E-OPTIMAL. Note: Subjects unable to return for annual visits are not excluded as they can participate in the telephone interview. However, every attempt will be made to encourage in-person participation.

Criteria for termination of participation:

(Due to evidence or likelihood that the subject can no longer consent for herself)

1. Subjects 75 years and older that fail the telephone mini-mental status examination. If the participant gets 5 or more of the 10 items "incorrect" the interviewer says "thank you very much for your time, that completes the interview for today." In other words, the interviewer in no way implies to the participant that they did not "pass" a test to continue. The interviewer contacts the appropriate site coordinator immediately after the interview to let them know of the outcome.

2. Subjects younger than 75 who appear to have cognitive deficits during the quality of life telephone interview will be administered the mini-mental status examination; those who fail will be excluded from further participation. (Proxy respondents will not be used.) Subjects who appear to have cognitive deficits during the in-person visit or site telephone interview will be withdrawn from the study by the study coordinator.

3. Subjects who become long-term residents of a skilled nursing facility.

4. Withdrawal of consent. Verbal assent will be obtained prior to each telephone interview and each in-person visit.

Note: Subjects that are unable to complete telephone interviews (for example, because of hearing loss) may complete the interview portion of the survey in person, either at the site or in the home.

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Behavioral:
• Enrollment video
Standardized video detailing the importance of long-term follow-up studies for pelvic organ prolapse prior to the informed consent process

Procedure:
• SSLF
sacrospinous ligament fixation to suspend the vaginal apex
• ULS
uterosacral ligament suspension to suspend the vaginal apex

Behavioral:
• PMT
perioperative behavioral therapy / pelvic muscle training with formal individualized PMT program that begins two to four weeks prior to surgery and continues for three months after surgery

Other:
• Usual Care
usual care both before and after prolapse surgery with respect to pelvic muscle training

Locations

Country	Name	City	State
United States	University of Alabama	Birmingham	Alabama
United States	Cleveland Clinic	Cleveland	Ohio
United States	University of Texas Southwestern	Dallas	Texas
United States	Duke University	Durham	North Carolina
United States	University of California, San Diego Medical Center	La Jolla	California
United States	Loyola University Medical Center	Maywood	Illinois
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
NICHD Pelvic Floor Disorders Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Granulation Tissue	Cumulative number of participants with granulation tissue. Granulation tissue was reported on the adverse event log.	2, 3, 4, and 5 years
Other	Number of Participants With Suture Exposure	Cumulative number of participants with suture exposure. Suture exposure was reported on the adverse event log.	2, 3, 4, and 5 years
Other	Number of Participants With Midurethral Sling Erosion or Exposure	Cumulative number of participants with mesh erosion or exposure. Mesh erosion and exposure was reported on the adverse event log.	2, 3, 4, and 5 years
Other	Number of Participants With Pelvic Organ Prolapse Surgery	Cumulative number of participants with pelvic organ prolapse. Pelvic organ prolapse was reported on the adverse event log.	2, 3, 4, and 5 years
Other	PGI-I	The Patient Global Impression of Improvement (PGI-I) is a patient-reported measure of perceived improvement with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse).This outcome measure is shows results from the original OPTIMAL trial as well as results from the E-OPTIMAL trial (for those that consented to the extended follow-up)	6 months, and 1, 2, 3, 4, and 5 years
Other	Change From Baseline CRAIQ Score	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 [0.5, 1, 2, 3, 4, 5] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.	6 months, and 1, 2, 3, 4, and 5 years
Other	Change From Baseline POPIQ Score	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 [0.5, 1, 2, 3, 4, 5] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.	6 months, and 1, 2, 3, 4, and 5 years
Other	Change From Baseline UIQ Score	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 [0.5, 1, 2, 3, 4, 5] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.	6 months, and 1, 2, 3, 4, and 5 years
Other	Change From Baseline CRADI Score	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 (with 3 subscales), 2. Colorectal Anal Distress Inventory (with 4 subscales), and 3. Urinary Distress Inventory (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 = (Year [0.5, 1, 2, 3, 4, 5] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.	6 months, and 1, 2, 3, 4, and 5 years
Other	Change From Baseline POPDI Score	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 (with 3 subscales), 2. Colorectal Anal Distress Inventory (with 4 subscales), and 3. Urinary Distress Inventory (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 POPDI responses is: 0-300 with 0 (least distress) to 300 (most distress). Change = (Year [0.5, 1, 2, 3, 4, 5] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.	6 months, and 1, 2, 3, 4, and 5 years
Other	Change From Baseline UDI Score	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 (with 3 subscales), 2. Colorectal Anal Distress Inventory (with 4 subscales), and 3. Urinary Distress Inventory (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 UDI responses is: 0-300 with 0 (least distress) to 300 (most distress). Change = (Year [0.5, 1, 2, 3, 4, 5] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.	6 months, and 1, 2, 3, 4, and 5 years
Other	Change From Baseline Hunskaar Score	The Hunskaar Urinary Incontinence assessment measures the severity of a participant's urinary incontinence. Scores range from 1 to 8 with higher score indicating more severe incontinence. Change = (Year [0.5, 1, 2, 3, 4, 5] Score - Baseline Score).	6 months, and 1, 2, 3, 4, and 5 years
Other	Change From Baseline SF-36 Physical Health Score	The health assessment questionnaire Short Form 36 Version (SF-36) determines participants' overall quality of life by assessing 1. limitations in physical functioning due to health problems; 2. limitations in usual role because of physical health problems; 3. bodily pain; 4. general health perceptions; 5. vitality; 6. limitations in social functioning because of physical or emotional problems; 7. limitations in usual role due to emotional problems; and 8. general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 "worst" - 100 "best"). Change = (Year [0.5, 1, 2, 3, 4, 5] Score - Baseline Score).	6 months, and 1, 2, 3, 4, and 5 years
Other	Change From Baseline SF-36 Mental Health Score	The health assessment questionnaire Short Form 36 Version (SF-36) determines participants' overall quality of life by assessing 1. limitations in physical functioning due to health problems; 2. limitations in usual role because of physical health problems; 3. bodily pain; 4. general health perceptions; 5. vitality; 6. limitations in social functioning because of physical or emotional problems; 7. limitations in usual role due to emotional problems; and 8. general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 "worst" - 100 "best"). Change = (Year [0.5, 1, 2, 3, 4, 5] Score - Baseline Score).	6 months, and 1, 2, 3, 4, and 5 years
Other	Change From Baseline Brink Score	The Brink scale considers three pelvic floor muscle contraction variables: vaginal pressure or muscle force, elevation or vertical displacement of the examiner fingers, and duration of contraction. The score ranges from 3 to 12 with higher scores indicating greater PFM function. Change = (Year [0.5, 2, 3, 4, 5] Score - Baseline Score).	6 months, and 2, 3, 4, and 5 years
Other	POP-Q Point Ba	POPQ Point Ba represents the most distal (i.e. most dependent) position of any part of the upper anterior vaginal wall (between the vaginal cuff or anterior vaginal fornix and Point Aa). The range for point Ba is -3 to total vaginal length (TVL). Point Ba coincides with Point Aa (-3 cm) in a woman who has no anterior POP. In a woman with severe POP, Ba coincides with Point C. For Point Ba, better vaginal support is assigned a negative value (ie, if there is no prolapse, point Ba is -3 cm by definition). Vaginal prolapse beyond the hymen, indicating worse vaginal support, is assigned a positive value (this may be equal to the total vaginal length at the maximum).	6 months, and 1, 2, 3, 4, and 5 years
Other	POP-Q Point Bp	POP-Q Point Bp represents the most distal position of any part of the upper posterior vaginal wall (between the vaginal cuff or posterior vaginal fornix and Point Ap). It ranges from -3 to total vaginal length (TVL). Negative values indicate vaginal support above the hymen, so the more negative number the closer to normal/perfect support; positive values show prolapse beyond the hymen, so larger positive numbers are worse prolapse.	6 months, and 1, 2, 3, 4, and 5 years
Other	POP-Q Point C	POP-Q Point C is measured in cm relative to the hymen with negative values being proximal to the hymen and positive values distal to the hymen. Point C represents either the most distal edge of the cervix or the leading edge of the vaginal cuff after total hysterectomy. It ranges from -TVL to +TVL. Negative values indicate vaginal support above the hymen, so the more negative number the closer to normal/perfect support; positive values show prolapse beyond the hymen, so larger positive numbers are worse prolapse.	6 months, and 1 2, 3, 4, and 5 years
Primary	Surgical Failure	Surgical failure was defined as Pelvic Organ Prolapse Quantification (POP-Q) point C descended more than one-third of total vaginal length; POPQ points Aa, Ba, Ap, or Bp were beyond the hymen; bothersome vaginal bulge symptoms were reported by the participant; or the participant received retreatment. The apex is point C (cervix), and posteriorly is point D (pouch of Douglas). In women after hysterectomy, point C is the vaginal cuff and point D is omitted. This outcome measure is cumulatively across the original OPTIMAL trial and continued through the E-OPTIMAL follow-up with non-failures tracked either until failure or until study completion/dropping out of the study (lost to follow-up, withdrawal, etc.)	6 months and 1, 2, 3, 4, and 5 years
Primary	Recruitment Into E-OPTIMAL	Eligible OPTIMAL participants were to receive a video (or no video) about the importance of follow-up in clinical trials. The outcome is measured as the number of OPTIMAL participants that consented to participate in E-OPTIMAL.	At 24 Months post OPTIMAL Treatment
Primary	Retention in E-OPTIMAL	Retention is defined as those participants who consented to participate in E-OPTIMAL that remained in the E-OPTIMAL study (i.e. completed follow-up visits and were not otherwise dropped from the study).	3, 4, and 5 Years Post OPTIMAL Treatment
Secondary	Anatomic Failure	Anatomic failure was defined as POPQ system point C descended more than one-third of total vaginal length; POPQ points Aa, Ba, Ap, or Bp were beyond the hymen; or the participant received retreatment during follow-up. This outcome measure is cumulative across the original OPTIMAL trial and continued through the E-OPTIMAL follow-up with non-failures tracked either until failure or until study completion/dropping out of the study (lost to follow-up, withdrawal, etc.)	6 months and 1, 2, 3, 4, and 5 years
Secondary	Bothersome Bulge Symptoms	Bothersome bulge symptoms were reported by the participant in response to the questions, '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?' on the Pelvic Floor Disorders Inventory. An answer of "Yes" to either question indicates a failure while an answer to "No" for both questions indicates a non-failure.This outcome measure is cumulative across the original OPTIMAL trial and continued through the E-OPTIMAL follow-up with non-failures tracked either until failure or until study completion/dropping out of the study (lost to follow-up, withdrawal, etc.)	6 months and 1, 2, 3, 4, and 5 years
Secondary	Retreatment for Pelvic Organ Prolapse	Retreatment is defined as any additional POP surgery or the use of pessary. This outcome measure is cumulative across the original OPTIMAL trial and continued through the E-OPTIMAL follow-up with non-retreatments tracked either until retreatment or until study completion/dropping out of the study (lost to follow-up, withdrawal, etc.)	6 months and 1, 2, 3, 4, and 5 years