Postoperative Pain
Conditions
Keywords
Buttock pain, Thigh pain, Sacrospinous ligament fixation
Brief summary
Sacrospinous ligament fixation is a common method of repairing apical support for pelvic organ prolapse but it currently suffers from a high rate of postoperative buttock and posterior thigh pain. Anchorsure® is a relatively new FDA-approved device that uses an anchor instead of the widely-used suture capturing mechanism to perform sacrospinous ligament fixation. The study hypothesis is that Anchorsure® will reduce the degree and rate of buttock and posterior thigh pain compared to the widely used Capio™ Slim suturing capturing Device.
Detailed description
Sacrospinous ligament fixation is a common method of repairing apical support for pelvic organ prolapse but it currently suffers from a high rate of postoperative buttock and posterior thigh pain. Rates of buttock and thigh pain 6 weeks after sacrospinous ligament fixation with the widely used Capio™ Slim device (Boston Scientific) are about 15-16% with immediate postoperative pain occurring in 55-84% of patients. This study is a randomized controlled single-blind study with the primary goal of investigating if there is an improvement in the intensity and rate of buttock and posterior thigh pain 1 day, 7 days, 6 weeks, and minimum 12 months after sacrospinous ligament fixation with a new device, the Anchorsure® Suture Anchoring System (Neomedic) compared to the widely utilized Capio™ Slim (Boston Scientific) device. 60 patients will be enrolled to undergo sacrospinous ligament fixation for treatment of pelvic organ prolapse. The patients will be randomized into two study groups; one will have sacrospinous ligament fixation using the Capio™ Slim device and the other with the Anchorsure® device. The patient's pain will be recorded via the numerical rating scale (NRS), a validated pain evaluation tool. The study is powered to detect a 2.5 point difference in pain between the two groups, a value that has been shown in studies to be clinically significant to acute pain patients. Secondary outcomes of surgeon satisfaction and efficiency with the devices will be assessed via surgeon questionnaires.
Interventions
DEVICECapio Slim Device
Participants who have been assigned to sacrospinous ligament fixation for pelvic organ prolapse will have sacrospinous ligament fixation performed with the Capio Slim Device.
DEVICEAnchorsure Device
Participants who have been assigned to sacrospinous ligament fixation for pelvic organ prolapse will have sacrospinous ligament fixation performed with the Anchorsure Device.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
Participants and research staff will be masked during the study as much as possible, however there will be a description of the type of sacrospinous ligament fixation device used within the body of the operative note for each patient that research staff could gain access to
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female patients * At least 21 years of age * Surgical plan that includes a native tissue vaginal repair with apical support via sacrospinous ligament fixation. We will permit both hysteropexy and post-hysterectomy sacrospinous ligament suspension * Understanding and acceptance of the need to return for the 6 week follow-up visit * English speaking and able to give informed consent * Willing and able to complete all study questionnaires * Ambulatory
Exclusion criteria
* Prior sacrospinous ligament fixation procedure. * Any serious disease or chronic condition that could interfere with the study compliance * Inability to give informed consent * Pregnancy or planning pregnancy prior to the 6 week postoperative visit * Prior pelvic radiation * Incarcerated * Prior augmented (synthetic mesh, autologous graft, xenograft, allograft) prolapse repair * History of significant buttock or leg pain in the past 3 months * History of fibromyalgia, polymyositis, dermatomyositis, systemic lupus erythematosus, or other auto-immune myalgic conditions * Current regular opioid drug therapy for any chronic pain condition * History of loss of motor or sensory function of the lower extremities * History of sacral decubitus ulcers * Planned concomitant levatorplasty; anal sphincteroplasty, anal fissurectomy, rectopexy, or hemorrhoidectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Buttock and Posterior Thigh Pain | postoperative 12 month | This will be assessed using the numeric rating scale (NRS). The score is 0-10, with higher scores denoting a greater degree of pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| POP-Q Stage Score | at 12 MONTHS | The stage is assigned as follows: 0 if there is no prolapse at all, 1 if there is prolapse but the leading point is not within 1cm of the hymen, 2 if the leading point is within 1 cm of the hymen (from 1cm within the hymen to 1cm beyond the hymen), 3 if the leading point is more than 1cm from the hymen but less than 2cm from being completely prolapsed, and 4 if the leading point is within 2cm of being complete prolapsed. Therefore higher POP-Q stages correlate to a worse degree of prolapse than lower POP-Q stages. |
| Change in Pelvic Flore Disability Index - 20 (PFDI-20) Scores From Baseline to 12 Months | Baseline and Month 12 | Symptomatic success was assessed by the pelvic floor disability index (PFDI-20) questionnaire. The PFDI-20 has 20 items within 3 sub-scales of symptoms (total of 20 items). Each item produces a response of 0 to 4, the average response in each sub-scale is multiplied by 25 to obtain the sub-scale score (range 0 to 100). The total score is the sum of the three sub-scale scores with a range of 0-300. Higher value for a time-point score indicates a greater degree of symptom bother. The difference in scores across the study time-points was calculated by subtracting the total score at baseline from the score at 12 months post-operation. A negative value for the difference in scores from baseline to 12 months indicates symptom improvement, where the more negative the difference in score is the greater the improvement in symptoms. |
| Change in Symptomatic Success - PFIQ-7 Scores | Baseline and Month 12 | Symptomatic success will be assessed by the Pelvic Floor Impact Questionnaire - 7 (PFIQ-7). The PFIQ-7 has 7 items for each of 3 sub-scales (total of 21 items). Each item produces a response of 0 to 3, the average response in each sub-scale is multiplied by 100/3 to obtain the total scale score (range 0 to 100). The total score is the sum of the three sub-scale scores with a range of 0-300. Higher value for a time-point score indicates a greater degree of symptom bother. The difference in scores across the study time-points was calculated by subtracting the total score at baseline from the score at 12 months post-operation. A negative value for the difference in scores from baseline to 12 months indicates symptom improvement, where the more negative the difference in score is the greater the improvement in symptoms. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Capio Slim Device Participants will be randomized to the sacrospinous ligament fixation with use of Capio Slim Device
Capio Slim Device: Participants who have been assigned to sacrospinous ligament fixation for pelvic organ prolapse will have sacrospinous ligament fixation performed with the Capio Slim Device. | 22 |
| Anchorsure Device Participants will be randomized to the sacrospinous ligament fixation with use of Anchorsure Device
Anchorsure Device: Participants who have been assigned to sacrospinous ligament fixation for pelvic organ prolapse will have sacrospinous ligament fixation performed with the Anchorsure Device. | 21 |
| Total | 43 |
Baseline characteristics
| Characteristic | Anchorsure Device | Total | Capio Slim Device |
|---|---|---|---|
| Age, Continuous | 68.7 years STANDARD_DEVIATION 8.8 | 69.4 years STANDARD_DEVIATION 9.7 | 70.1 years STANDARD_DEVIATION 10.7 |
| Body Mass Index | 29.9 kg/m^2 STANDARD_DEVIATION 6.6 | 30.0 kg/m^2 STANDARD_DEVIATION 6.4 | 30.1 kg/m^2 STANDARD_DEVIATION 6.4 |
| POP-Q Stage Score | 2.8 Units on a scale STANDARD_DEVIATION 0.8 | 2.7 Units on a scale STANDARD_DEVIATION 0.7 | 2.7 Units on a scale STANDARD_DEVIATION 0.6 |
| Race/Ethnicity, Customized Black | 2 Participants | 5 Participants | 3 Participants |
| Race/Ethnicity, Customized Caucasian | 19 Participants | 38 Participants | 19 Participants |
| Sex: Female, Male Female | 21 Participants | 43 Participants | 22 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 21 |
| other Total, other adverse events | 0 / 22 | 0 / 21 |
| serious Total, serious adverse events | 0 / 22 | 0 / 21 |
Outcome results
Primary
Change in Buttock and Posterior Thigh Pain
This will be assessed using the numeric rating scale (NRS). The score is 0-10, with higher scores denoting a greater degree of pain.
Time frame: postoperative 12 month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Capio Slim Device | Change in Buttock and Posterior Thigh Pain | Sacrospinous ligament fixation site Pain compared to preop | -0.5 score on a scale | Standard Deviation 1.6 |
| Capio Slim Device | Change in Buttock and Posterior Thigh Pain | Worst pain compared to preop | -1.8 score on a scale | Standard Deviation 3.1 |
| Anchorsure Device | Change in Buttock and Posterior Thigh Pain | Worst pain compared to preop | -1.5 score on a scale | Standard Deviation 2.8 |
| Anchorsure Device | Change in Buttock and Posterior Thigh Pain | Sacrospinous ligament fixation site Pain compared to preop | -0.2 score on a scale | Standard Deviation 0.9 |
Secondary
Change in Pelvic Flore Disability Index - 20 (PFDI-20) Scores From Baseline to 12 Months
Symptomatic success was assessed by the pelvic floor disability index (PFDI-20) questionnaire. The PFDI-20 has 20 items within 3 sub-scales of symptoms (total of 20 items). Each item produces a response of 0 to 4, the average response in each sub-scale is multiplied by 25 to obtain the sub-scale score (range 0 to 100). The total score is the sum of the three sub-scale scores with a range of 0-300. Higher value for a time-point score indicates a greater degree of symptom bother. The difference in scores across the study time-points was calculated by subtracting the total score at baseline from the score at 12 months post-operation. A negative value for the difference in scores from baseline to 12 months indicates symptom improvement, where the more negative the difference in score is the greater the improvement in symptoms.
Time frame: Baseline and Month 12
Population: These are the two study groups where patients were randomized to either have the Anchorsure or Capio Slim device used for their sacrospinous ligament fixation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Capio Slim Device | Change in Pelvic Flore Disability Index - 20 (PFDI-20) Scores From Baseline to 12 Months | -66.3 score on a scale | Standard Deviation 64.4 |
| Anchorsure Device | Change in Pelvic Flore Disability Index - 20 (PFDI-20) Scores From Baseline to 12 Months | -71.0 score on a scale | Standard Deviation 45.5 |
Secondary
Change in Symptomatic Success - PFIQ-7 Scores
Symptomatic success will be assessed by the Pelvic Floor Impact Questionnaire - 7 (PFIQ-7). The PFIQ-7 has 7 items for each of 3 sub-scales (total of 21 items). Each item produces a response of 0 to 3, the average response in each sub-scale is multiplied by 100/3 to obtain the total scale score (range 0 to 100). The total score is the sum of the three sub-scale scores with a range of 0-300. Higher value for a time-point score indicates a greater degree of symptom bother. The difference in scores across the study time-points was calculated by subtracting the total score at baseline from the score at 12 months post-operation. A negative value for the difference in scores from baseline to 12 months indicates symptom improvement, where the more negative the difference in score is the greater the improvement in symptoms.
Time frame: Baseline and Month 12
Population: These are the two study groups where patients were randomized to either have the Anchorsure or Capio Slim device used for their sacrospinous ligament fixation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Capio Slim Device | Change in Symptomatic Success - PFIQ-7 Scores | -26.4 score on a scale | Standard Deviation 65.7 |
| Anchorsure Device | Change in Symptomatic Success - PFIQ-7 Scores | -40.6 score on a scale | Standard Deviation 62.4 |
Secondary
POP-Q Stage Score
The stage is assigned as follows: 0 if there is no prolapse at all, 1 if there is prolapse but the leading point is not within 1cm of the hymen, 2 if the leading point is within 1 cm of the hymen (from 1cm within the hymen to 1cm beyond the hymen), 3 if the leading point is more than 1cm from the hymen but less than 2cm from being completely prolapsed, and 4 if the leading point is within 2cm of being complete prolapsed. Therefore higher POP-Q stages correlate to a worse degree of prolapse than lower POP-Q stages.
Time frame: at 12 MONTHS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Capio Slim Device | POP-Q Stage Score | 0.8 Units on a scale | Standard Deviation 0.9 |
| Anchorsure Device | POP-Q Stage Score | 0.9 Units on a scale | Standard Deviation 0.8 |