Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06258785
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-15
First Post:
2024-02-06
Brief Title:
Effect of Tizanidine on Postoperative Urinary Retention After Sacrospinous Suspension
Sponsor:
NorthShore University HealthSystem
Organization:
NorthShore University HealthSystem
Study Overview
Official Title:
Effect of Pre-operative Tizanidine on Postoperative Urinary Retention After Sacrospinous Vaginal Vault Suspension a Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Postoperative urinary retention has been defined as the inability to void despite having fluid in the bladder during the postoperative period Urinary retention after pelvic reconstructive surgery requiring indwelling catheter or self-catheterization usage occurs in approximately 30-60 of patients postoperatively Our prior retrospective chart review reviewing postoperative urinary retention rates after pelvic reconstructive surgery demonstrated postoperative urinary retention after a sacrospinous vaginal vault suspension to be approximately 789 Many women consider being discharged home with a Foley catheter to be a surgical complication and describe catheter use as the worst aspect of their surgery Indwelling catheters are the leading cause of hospital-acquired urinary tract infections UTIs are often a source of embarrassment and inconvenience for patients and often require additional office visits and healthcare utilization Tizanidine is a muscle relaxant which can work to alleviate this spasm and theoretically prevent postoperative urinary retention Tizanidine also works as an alpha-adrenergic receptor blocker which can increase smooth muscle relaxation around the urethra specifically and theoretically improve urine flow Postoperative urinary retention is extremely common after pelvic reconstructive surgery involving a sacrospinous vaginal vault suspension and is extremely bothersome to patients Tizanidine is a low-risk well tolerated cost-effective medication No study to date has evaluated preoperative administration of tizanidine for postoperative urinary retention
Detailed Description:
Postoperative urinary retention has been defined as the inability to void despite having fluid in the bladder during the postoperative period Urinary retention after pelvic reconstructive surgery requiring indwelling catheter or self-catheterization usage occurs in approximately 30-60 of patients postoperatively Our prior retrospective chart review reviewing postoperative urinary retention rates after pelvic reconstructive surgery demonstrated postoperative urinary retention after a sacrospinous vaginal vault suspension to be approximately 789
Each patient after surgery undergoes a voiding trial where their voided volume is compared to their post-void residual volume Passing a voiding trial has traditionally been defined as voiding a greater volume than the post-void residual volume If the patient does not pass the voiding trial the patient is characterized as having postoperative urinary retention and is discharged home with an indwelling catheter to prevent detrusor injury from bladder over-distention pain and urinary tract infection
Many women consider being discharged home with a Foley catheter to be a surgical complication and describe catheter use as the worst aspect of their surgery Indwelling catheters are the leading cause of hospital-acquired urinary tract infections UTIs are often a source of embarrassment and inconvenience for patients and often require additional office visits and healthcare utilization
The leading hypotheses regarding the incidence of postoperative urinary retention after sacrospinous ligament suspension includes postoperative pain and pelvic floor muscle spasm leading to retention The sacrospinous suspension includes a suture that is passed through the sacrospinous ligament and therefore through the coccygeus muscle with irritation of the pudendal nerve The pelvic floor is a synergistic team of muscles that work together to support the pelvic organs and spasm of the coccygeus muscle rather than an isolated muscle can cause spasm of the entirety of the pelvic floor leading to retention Tizanidine is a muscle relaxant which can work to alleviate this spasm and theoretically prevent postoperative urinary retention Tizanidine also works as an alpha-adrenergic receptor blocker which can increase smooth muscle relaxation around the urethra specifically and theoretically improve urine flow
Tizanidine is also frequently given for postoperative pain after sacrospinous ligament suspension and may act as an adjunct to a non-narcotic pain regimen to improve postoperative pain while reducing narcotic use after surgery Postoperative buttock and posterior thigh pain are common symptoms after SSLF with immediate pain reported in 6-84 of patients and persistent pain at 6 weeks occurring in 1-15 Untreated acute postoperative pain has been shown to lead to increased morbidity and mortality Pain is the most common reason for a postoperative unplanned hospital admission and poor postoperative pain control can lead to decreased ambulation increased incidence of thromboembolism and decreased inspiratory effort leading to postoperative pneumonia therefore postoperative pain control is critical In a country with rising narcotic-use and dependence it is critical that we continue to explore non-narcotic alternatives for patients after surgery
Postoperative urinary retention is extremely common after pelvic reconstructive surgery involving a sacrospinous vaginal vault suspension and is extremely bothersome to patients Tizanidine is a low-risk well tolerated cost-effective medication No study to date has evaluated preoperative administration of tizanidine for postoperative urinary retention
Each patient after surgery undergoes a voiding trial where their voided volume is compared to their post-void residual volume Passing a voiding trial has traditionally been defined as voiding a greater volume than the post-void residual volume If the patient does not pass the voiding trial the patient is characterized as having postoperative urinary retention and is discharged home with an indwelling catheter to prevent detrusor injury from bladder over-distention pain and urinary tract infection
Many women consider being discharged home with a Foley catheter to be a surgical complication and describe catheter use as the worst aspect of their surgery Indwelling catheters are the leading cause of hospital-acquired urinary tract infections UTIs are often a source of embarrassment and inconvenience for patients and often require additional office visits and healthcare utilization
The leading hypotheses regarding the incidence of postoperative urinary retention after sacrospinous ligament suspension includes postoperative pain and pelvic floor muscle spasm leading to retention The sacrospinous suspension includes a suture that is passed through the sacrospinous ligament and therefore through the coccygeus muscle with irritation of the pudendal nerve The pelvic floor is a synergistic team of muscles that work together to support the pelvic organs and spasm of the coccygeus muscle rather than an isolated muscle can cause spasm of the entirety of the pelvic floor leading to retention Tizanidine is a muscle relaxant which can work to alleviate this spasm and theoretically prevent postoperative urinary retention Tizanidine also works as an alpha-adrenergic receptor blocker which can increase smooth muscle relaxation around the urethra specifically and theoretically improve urine flow
Tizanidine is also frequently given for postoperative pain after sacrospinous ligament suspension and may act as an adjunct to a non-narcotic pain regimen to improve postoperative pain while reducing narcotic use after surgery Postoperative buttock and posterior thigh pain are common symptoms after SSLF with immediate pain reported in 6-84 of patients and persistent pain at 6 weeks occurring in 1-15 Untreated acute postoperative pain has been shown to lead to increased morbidity and mortality Pain is the most common reason for a postoperative unplanned hospital admission and poor postoperative pain control can lead to decreased ambulation increased incidence of thromboembolism and decreased inspiratory effort leading to postoperative pneumonia therefore postoperative pain control is critical In a country with rising narcotic-use and dependence it is critical that we continue to explore non-narcotic alternatives for patients after surgery
Postoperative urinary retention is extremely common after pelvic reconstructive surgery involving a sacrospinous vaginal vault suspension and is extremely bothersome to patients Tizanidine is a low-risk well tolerated cost-effective medication No study to date has evaluated preoperative administration of tizanidine for postoperative urinary retention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None