Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06521450
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-12
Brief Title:
Concurrent Surgery for Prolapse and Stress Urinary Incontinence to Reduce Further Surgery for Incontinence
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Concurrent Surgery for Prolapse Repair and Stress Urinary Incontinence to Reduce the Risk of Postoperative Surgical Intervention for Incontinence
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Urinary incontinence is a common and distressing medical condition which affects 26 of women in developing countriesGlobally upto 54 women suffer from pelvic organ prolapse and stress urinary incontinence concomitantlyWomen with coexisting stress incontinence have a 40 risk of undergoing subsequent surgery for postoperative stress incontinence and woem with occult incontinence have a 15 riskOverallthere is sufficient evidence that for women who are symptomatic of stress incontinence and prolapseconcomitant vaginal surgery for both problems is beneficial for reducing postoperative incontinenceHoweverit must be borne in mind that in woen undergoing vaginal prolapse surgery alonealmost 13 may experience cure of incontinence symptoms and despite concomitant continence surgerystress urinary incontinence persist in approximately 13 of womenThis study will be conducted to assess whether women with polpase and stress urinary incontinence could benefit from combined surgery in regards of requiring further surgery for stress incontinence
Detailed Description:
INTRODUCTION
Urinary incontinence UI is a common and distressing medical condition which affects 26 of women in developing countries and stress urinary incontinence SUI 126 is the most common type1 One of the important risk factors for SUI is pelvic organ prolapse2 Pelvic organ prolapsePOP is descent of pelvic organs resulting in protrusion of pelvic structures including bladder rectum and uterus beyond their anatomical confines In low and middle-income countries the prevalence of pelvic organ prolapse is 197 estimated range is 34-5643 In a study the prevalence of prolapse in Pakistan was 1034 Globally in up to 54 of women pelvic organ prolapse and stress incontinence coexists5 In Pakistan 125 women will suffer with both prolapse and urinary incontinence2
Patients showing no improvement with conservative measures are offered surgery The surgical methods used for SUI include Burch colposuspension BC tension-free vaginal tape TVTand trans obturator tape TOT6 For prolapse the route of repair can be abdominal or vaginal and surgical methods include reconstructive procedures preserving uterus or vaginal hysterectomy7 The uterus preserving surgeries include Sacrohysteropexy ASC sacrospinous ligament fixation ventrosuspension and Manchester repair89
Many women undergoing surgery for pelvic organ prolapse POP will experience incontinence after prolapse repair Developing incontinence after prolapse repair is even more common among women with urinary incontinence before the surgery10 In a recent study women with coexisting SUI have a 40 risk of undergoing subsequent surgery for postoperative SUI and women with occult SUI have a 15 risk 10 It is shown in some studies that women could have lower risk of subsequent continence surgery for SUI after combination surgery than after prolapse surgery only11 However another study showed that about a third of women with POP and SUI will experience resolution of SUI symptoms following isolated POP repair1213 Van der Ploeg et al conducted a large multicentre RCT and results showed a significant reduction in postoperative SUI rates in the combined surgery group as compared to POP repair only 22 versus 61 Despite 61 of women reporting postoperative SUI in the POP repair-only group only 17 went on to receive surgical treatment for SUI within 12 months of follow-up Potential explanations include the use of alternative non-surgical treatments the SUI not being severe enough to warrant surgery or the womans desire to avoid further surgery and operative risks 14 Costantini et al evaluated concomitant colposuspension at the time of abdominal sacrocolpopexy surgery versus sacrocolpopexy alone and showed no significant benefit in adding Burch colposuspension15 Overall there is sufficient evidence that for women who are symptomatic of SUI and POP concomitant vaginal POP repair and anti-incontinence surgery is beneficial for reducing postoperative SUI However it must be borne in mind that in women undergoing vaginal POP surgery alone almost one-third may experience cure of SUI symptoms and despite concomitant continence surgery SUI can still persist in approximately one-third of women16 So we aim to compare the risk of surgical intervention for stress urinary incontinence after combined prolapse and anti-incontinence surgery and prolapse surgery alone
RATIONALE
Urinary incontinence UI is a common and distressing medical condition which affects 26 of women in developing countries1Globally in up to 54 of women pelvic organ prolapse and stress incontinence coexists2 Women with coexisting SUI have a 40 risk of undergoing subsequent surgery for postoperative SUI and women with occult SUI have a 15 risk Overall there is sufficient evidence that for women who are symptomatic of SUI and POP concomitant vaginal POP repair and anti-incontinence surgery is beneficial for reducing postoperative SUI However it must be borne in mind that in women undergoing vaginal POP surgery alone almost one-third may experience cure of SUI symptoms and despite concomitant continence surgery SUI can still persist in approximately one-third of women16
OBJECTIVE
This study will assess whether women with POP and stress urinary incontinence could benefit from combined surgery in regards of requiring further surgery for SUI
OPERATIONAL DEFINITIONS Stress Urinary IncontinenceSUI Involuntary leakage of urine when there is raised intraabdominal pressure such as during coughing weight lifting etc1 Pelvic organ prolapse POP Uterine prolapse occurs when pelvic floor muscles and ligaments stretch and weaken until they no longer provide enough support for the uterus resulting in protrusion of pelvic organs beyond their anatomical position26 Pelvic organ prolapse quantification system POP-Q It is used to subjectively quantify the stage of prolapse6 Paralytic ileus It is a condition in which there is a functional motor paralysis of the digestive tract secondary to neuromuscular failure resulting in abdominal distension absent bowel sounds and electrolyte imbalance6 Urinary retention Inability to pass urine despite persistent effort resulting in painful and palpable bladder or chronic high post void residual urine 300ml as defined by international continence society
Dysuria Sensation of pain burning stinging or itching of the urethra associated with urination234 Wound infection It is the presence of replicating microorganisms within a wound leading to tissue injury resulting in either purulent discharge pain tenderness localised swelling or redness234 Blood loss 500ml Blood loss will be quantified by using gravimetric method which is measuring irrigation fluid and weighing surgical sponges and subtracting the dry weight to obtain a blood volume measurement17
MATERIAL AND METHODS Settings Department of Urogynaecology Shalamar Hospital Lahore Study design Randomized controlled trial Study Population Adult females 41-83 years age presenting with pelvic organ prolapse and stress urinary incontinence
Duration of study The duration of study will be six months after ethical approval
Sampling Technique Simple random sampling
Sample size CalculationStatistical power
nZ2 x p x 1-pE2 n is sample size Z is Z value the number of standard deviation from the mean for the desired confidence level for 95 Z is 196 P is the estimated proportion of the population that has the characteristic of interest in this case 40 or 040 E is the margin of error 5 or 005 p 040 E 005 Z 196 n 1962 x 040 x 1-0400052 1962 38416
First we calculate the numerator
040x 1-040 040x060024 Now multiply these together 38416x0240921984
Next we calculate the denominator
005200025
Finally we divide the numerator by the denominator to get the sample size
n 092198400025 3687936 n n 1n-1 N where n is the adjusted sample size for the finite population n is the initial sample size calculated using the formula for an infinite population N is the total population size
Given
n369initial sample size N200total population size n 369 1369-1 200 n 36928412993 since the sample size must be a whole number we round up to the nearest whole number n 130
Inclusion Criteria Adult females 41-83 years age presenting with concurrent prolapse and stress urinary incontinence willing to participate in the study
Exclusion criteria Study exclusion criteria will be urge incontinence according to questionnaire urinary tract infection unwilling for surgery unfit for surgery urogenital malignancy urolithiasis
Proceduremethods in detail
A total of 130 patients between ages of 41 and 83 years fulfilling the selection criteria will be included in the study It will be a randomised controlled study of prolapse surgery with or without anti-incontinence surgery Patients presenting with stress urinary incontinence and prolapse will be enrolled in the study Patients will be randomly assigned to either combined surgery group or POP alone group each group will have 65 patients All patients will give written informed consent for study participation and approval for the study will be obtained from the ethical committee of our hospital All women will undergo preoperative assessments involving detailed medical and surgical histories Baseline characteristics will be recorded on specially designed proforma Participation in the study will be voluntary and all patients will have free choice to withdraw from the study at any stage which will not affect their management In all patients SUI will be visualized after performing physical examination with cough stress test and prolapse will be staged by using pelvic organ prolapse quantification systemPOP-Q A cough stress test will be performed in the supine position with the bladder comfortably filled with about 250mL of urine Severity of stress urinary incontinence will be assessed by a severity index score Severity index will be created by multiplying the reported frequency four levels by the amount of leakage two levels annexure I The resulting index value 1-8 will be further categorised into slight 1-2 moderate 3-4 and severe 6-818
The operation will be performed under spinal or general anaesthesia according to patients and surgeon preference The same surgeon will perform all the surgeries Cystoscopy will be performed for all patients at the end of procedure to identify any bladder injury Any intra-operative complications like blood loss 500 ml and visceral injury ureter bowel bladder will be noted and managed accordingly Routine post-operative care will be provided and any complications like paralytic ileus urinary retention dysuria and wound infection will be noted and treated
The primary outcome will be symptomatic stress urinary incontinence SUI requiring continence surgery at 6 months Secondary outcome measures will be quality of life parameters Quality of life QOL will be assessed with the International Consultation on Incontinence Questionnaire short form ICIQ-UI SF The questionnaire will be filled before and after surgery for all patients Total score range will be 0-21slight 1-5 moderate 6-12 severe 13-18 very severe 19-21 They will be examined and questioned about their satisfaction with the surgery at each follow up visit Patient follow-up will take place at 1 week 6 weeks and 6 months In the visits 1 week and 6 weeks after surgery wound healing will be checked In the visit 6 months after surgery a cough stress test will be performed for objective assessment Objective cure will be defined as a negative cough stress test Failure will be defined as a positive cough stress test
Data analysis
All data will be analysed using SPSS version 21 Continuous variables including age BMI parity duration of surgery blood loss during surgery and days of hospital stay will be presented as mean SD Categorical variables including prolapse stage complications injury to ureter bowel bladder paralytic ileus urinary retention dysuria wound infection and patients satisfaction with the results of procedure will be presented as frequencies and percentages Pre-and postoperative questionnaire data will be analysed with Students t test A p value 005 will be considered significant
Urinary incontinence UI is a common and distressing medical condition which affects 26 of women in developing countries and stress urinary incontinence SUI 126 is the most common type1 One of the important risk factors for SUI is pelvic organ prolapse2 Pelvic organ prolapsePOP is descent of pelvic organs resulting in protrusion of pelvic structures including bladder rectum and uterus beyond their anatomical confines In low and middle-income countries the prevalence of pelvic organ prolapse is 197 estimated range is 34-5643 In a study the prevalence of prolapse in Pakistan was 1034 Globally in up to 54 of women pelvic organ prolapse and stress incontinence coexists5 In Pakistan 125 women will suffer with both prolapse and urinary incontinence2
Patients showing no improvement with conservative measures are offered surgery The surgical methods used for SUI include Burch colposuspension BC tension-free vaginal tape TVTand trans obturator tape TOT6 For prolapse the route of repair can be abdominal or vaginal and surgical methods include reconstructive procedures preserving uterus or vaginal hysterectomy7 The uterus preserving surgeries include Sacrohysteropexy ASC sacrospinous ligament fixation ventrosuspension and Manchester repair89
Many women undergoing surgery for pelvic organ prolapse POP will experience incontinence after prolapse repair Developing incontinence after prolapse repair is even more common among women with urinary incontinence before the surgery10 In a recent study women with coexisting SUI have a 40 risk of undergoing subsequent surgery for postoperative SUI and women with occult SUI have a 15 risk 10 It is shown in some studies that women could have lower risk of subsequent continence surgery for SUI after combination surgery than after prolapse surgery only11 However another study showed that about a third of women with POP and SUI will experience resolution of SUI symptoms following isolated POP repair1213 Van der Ploeg et al conducted a large multicentre RCT and results showed a significant reduction in postoperative SUI rates in the combined surgery group as compared to POP repair only 22 versus 61 Despite 61 of women reporting postoperative SUI in the POP repair-only group only 17 went on to receive surgical treatment for SUI within 12 months of follow-up Potential explanations include the use of alternative non-surgical treatments the SUI not being severe enough to warrant surgery or the womans desire to avoid further surgery and operative risks 14 Costantini et al evaluated concomitant colposuspension at the time of abdominal sacrocolpopexy surgery versus sacrocolpopexy alone and showed no significant benefit in adding Burch colposuspension15 Overall there is sufficient evidence that for women who are symptomatic of SUI and POP concomitant vaginal POP repair and anti-incontinence surgery is beneficial for reducing postoperative SUI However it must be borne in mind that in women undergoing vaginal POP surgery alone almost one-third may experience cure of SUI symptoms and despite concomitant continence surgery SUI can still persist in approximately one-third of women16 So we aim to compare the risk of surgical intervention for stress urinary incontinence after combined prolapse and anti-incontinence surgery and prolapse surgery alone
RATIONALE
Urinary incontinence UI is a common and distressing medical condition which affects 26 of women in developing countries1Globally in up to 54 of women pelvic organ prolapse and stress incontinence coexists2 Women with coexisting SUI have a 40 risk of undergoing subsequent surgery for postoperative SUI and women with occult SUI have a 15 risk Overall there is sufficient evidence that for women who are symptomatic of SUI and POP concomitant vaginal POP repair and anti-incontinence surgery is beneficial for reducing postoperative SUI However it must be borne in mind that in women undergoing vaginal POP surgery alone almost one-third may experience cure of SUI symptoms and despite concomitant continence surgery SUI can still persist in approximately one-third of women16
OBJECTIVE
This study will assess whether women with POP and stress urinary incontinence could benefit from combined surgery in regards of requiring further surgery for SUI
OPERATIONAL DEFINITIONS Stress Urinary IncontinenceSUI Involuntary leakage of urine when there is raised intraabdominal pressure such as during coughing weight lifting etc1 Pelvic organ prolapse POP Uterine prolapse occurs when pelvic floor muscles and ligaments stretch and weaken until they no longer provide enough support for the uterus resulting in protrusion of pelvic organs beyond their anatomical position26 Pelvic organ prolapse quantification system POP-Q It is used to subjectively quantify the stage of prolapse6 Paralytic ileus It is a condition in which there is a functional motor paralysis of the digestive tract secondary to neuromuscular failure resulting in abdominal distension absent bowel sounds and electrolyte imbalance6 Urinary retention Inability to pass urine despite persistent effort resulting in painful and palpable bladder or chronic high post void residual urine 300ml as defined by international continence society
Dysuria Sensation of pain burning stinging or itching of the urethra associated with urination234 Wound infection It is the presence of replicating microorganisms within a wound leading to tissue injury resulting in either purulent discharge pain tenderness localised swelling or redness234 Blood loss 500ml Blood loss will be quantified by using gravimetric method which is measuring irrigation fluid and weighing surgical sponges and subtracting the dry weight to obtain a blood volume measurement17
MATERIAL AND METHODS Settings Department of Urogynaecology Shalamar Hospital Lahore Study design Randomized controlled trial Study Population Adult females 41-83 years age presenting with pelvic organ prolapse and stress urinary incontinence
Duration of study The duration of study will be six months after ethical approval
Sampling Technique Simple random sampling
Sample size CalculationStatistical power
nZ2 x p x 1-pE2 n is sample size Z is Z value the number of standard deviation from the mean for the desired confidence level for 95 Z is 196 P is the estimated proportion of the population that has the characteristic of interest in this case 40 or 040 E is the margin of error 5 or 005 p 040 E 005 Z 196 n 1962 x 040 x 1-0400052 1962 38416
First we calculate the numerator
040x 1-040 040x060024 Now multiply these together 38416x0240921984
Next we calculate the denominator
005200025
Finally we divide the numerator by the denominator to get the sample size
n 092198400025 3687936 n n 1n-1 N where n is the adjusted sample size for the finite population n is the initial sample size calculated using the formula for an infinite population N is the total population size
Given
n369initial sample size N200total population size n 369 1369-1 200 n 36928412993 since the sample size must be a whole number we round up to the nearest whole number n 130
Inclusion Criteria Adult females 41-83 years age presenting with concurrent prolapse and stress urinary incontinence willing to participate in the study
Exclusion criteria Study exclusion criteria will be urge incontinence according to questionnaire urinary tract infection unwilling for surgery unfit for surgery urogenital malignancy urolithiasis
Proceduremethods in detail
A total of 130 patients between ages of 41 and 83 years fulfilling the selection criteria will be included in the study It will be a randomised controlled study of prolapse surgery with or without anti-incontinence surgery Patients presenting with stress urinary incontinence and prolapse will be enrolled in the study Patients will be randomly assigned to either combined surgery group or POP alone group each group will have 65 patients All patients will give written informed consent for study participation and approval for the study will be obtained from the ethical committee of our hospital All women will undergo preoperative assessments involving detailed medical and surgical histories Baseline characteristics will be recorded on specially designed proforma Participation in the study will be voluntary and all patients will have free choice to withdraw from the study at any stage which will not affect their management In all patients SUI will be visualized after performing physical examination with cough stress test and prolapse will be staged by using pelvic organ prolapse quantification systemPOP-Q A cough stress test will be performed in the supine position with the bladder comfortably filled with about 250mL of urine Severity of stress urinary incontinence will be assessed by a severity index score Severity index will be created by multiplying the reported frequency four levels by the amount of leakage two levels annexure I The resulting index value 1-8 will be further categorised into slight 1-2 moderate 3-4 and severe 6-818
The operation will be performed under spinal or general anaesthesia according to patients and surgeon preference The same surgeon will perform all the surgeries Cystoscopy will be performed for all patients at the end of procedure to identify any bladder injury Any intra-operative complications like blood loss 500 ml and visceral injury ureter bowel bladder will be noted and managed accordingly Routine post-operative care will be provided and any complications like paralytic ileus urinary retention dysuria and wound infection will be noted and treated
The primary outcome will be symptomatic stress urinary incontinence SUI requiring continence surgery at 6 months Secondary outcome measures will be quality of life parameters Quality of life QOL will be assessed with the International Consultation on Incontinence Questionnaire short form ICIQ-UI SF The questionnaire will be filled before and after surgery for all patients Total score range will be 0-21slight 1-5 moderate 6-12 severe 13-18 very severe 19-21 They will be examined and questioned about their satisfaction with the surgery at each follow up visit Patient follow-up will take place at 1 week 6 weeks and 6 months In the visits 1 week and 6 weeks after surgery wound healing will be checked In the visit 6 months after surgery a cough stress test will be performed for objective assessment Objective cure will be defined as a negative cough stress test Failure will be defined as a positive cough stress test
Data analysis
All data will be analysed using SPSS version 21 Continuous variables including age BMI parity duration of surgery blood loss during surgery and days of hospital stay will be presented as mean SD Categorical variables including prolapse stage complications injury to ureter bowel bladder paralytic ileus urinary retention dysuria wound infection and patients satisfaction with the results of procedure will be presented as frequencies and percentages Pre-and postoperative questionnaire data will be analysed with Students t test A p value 005 will be considered significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None