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| Name | Class |
|---|---|
| Kaiser Permanente | OTHER |
| Duke University | OTHER |
| Patient-Centered Outcomes Research Institute | OTHER |
| University of California, San Diego |
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The goal of this clinical trial is to learn if retropubic midurethral sling (RP-MUS) or bulkamide injection (PAHG) at the time of pelvic organ prolapse repair is better from the patient's perspective. The main questions it aims to answer are:
What is the average difference in the urogenital distress inventory (UDI) long form score 24 months after surgery for each procedure? Which procedure has the fewest complications and lowest short- and long-term morbidity profile?
Participants will:
Be blinded and randomized to one of two procedures for the duration of the study, 24 months.
Complete 6 total visits for the clinical trial including validated questionnaires.
Few participants will be selected to complete a qualitative interview at 3 timepoints over 24 month duration of the study.
This will be a double-blinded, non-inferiority, controlled trial utilizing a 1:1 randomization scheme to assign patients to each treatment arm (PAHG vs. RP-MUS). Patients undergoing PAHG will be given sham incisions in order to mask the type of SUI procedure they underwent. This will consist of two "earring-hole" sized superficial scratches in the epidermis and fibrin glue applied to the expected suprapubic exit sites for the RP-MUS. Sham incisions are not associated with an increased risk of infection and are considered low risk. Validated symptom questionnaires will be administered to the patient by a study investigator prior to surgery and at 1, 6, 12, and 24 months. At the final study visit, patients will be un-blinded and provided information on which SUI procedure they underwent. Unless it is necessary for subsequent care, as in the case of a procedure specific complication like a mesh erosion, patients who might require additional intervention for recurrent SUI during the study period will remain blinded to their initial treatment assignment. If patients request this information, they will be informed that they would need to exit the study, however their data would still be analyzed as part of the intention to treat protocol. Data of patients who dropout will be analyzed in the same manner. Pelvic organ prolapse procedures will be limited to native tissue repairs only and may include either or both apical and non-apical repair procedures; selection of appropriate POP repair procedure will be at the surgeon's discretion. All randomized patients will complete surveys at 12 and 24 months will assess patient recovery, satisfaction with care, and calibrating surveyed and clinically assessed outcomes to their daily life experiences. Based on prior similar studies, this number is sufficient to ensure saturation of themes83. Between 8 to 20 participants in each arm will be randomly selected from across all sites to participate in individual semi-structured telephone interviews preoperatively, at 12 months and at 24 months after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retropubic Midurethral Sling (RP-MUS) | Active Comparator | A minimally invasive surgical procedure that treats stress urinary incontinence (SUI) in women by placing a small strip of tape passed through the retropubic space, with entry and exit points in the lower abdomen or groin. |
|
| Urethral Bulking with polyacrylamide hydrogel (PAHG) | Active Comparator | PAHG will be performed using the standard 2 mL dose injection order and number will be at the discretion of the surgeon. Patients undergoing PAHG will be given sham incisions consisting of superficial suprapubic epidermal scratches with a needle and fibrin glue at expected sling exit sites. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RP-MUS | Device | a standard urethral sling placement for treatment of stress urinary incontinence |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bothersome stress urinary incontinence symptoms as measured by urogenital distress inventory long form (UDI) | a questionnaire used to assess the severity of lower urinary tract symptoms like incontinence, particularly in women, by measuring the impact of these symptoms on their quality of life. Scores range from 0 to 100, higher number indicates worse symptoms. | 24 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Change in bothersome stress urinary incontinence symptoms as measured by urogenital distress inventory long form (UDI) | a questionnaire used to assess the severity of lower urinary tract symptoms like incontinence, particularly in women, by measuring the impact of these symptoms on their quality of life. Scores range from 0 to 100, higher number indicates worse symptoms. | 1, 6 and 12 months postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
Gender assigned female at birth
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elisar Khawam | Contact | 216-844-2493 | Elisar.Khawam@UHhospitals.org |
| Name | Affiliation | Role |
|---|---|---|
| David Sheyn, MD | University Hospitals Cleveland Medical Center | Principal Investigator |
| Cecile Ferrando, MD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center | Recruiting | Cleveland | Ohio | 44106 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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IPD will not be shared with other researchers to ensure participant privacy is maintained and avoid any risk of invalid analyses.
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| OTHER |
| University of California, Irvine | OTHER |
| MetroHealth Medical Center | OTHER |
| Ohio State University | OTHER |
| Northwestern University | OTHER |
| University of New Mexico | OTHER |
| Medstar Health Research Institute | OTHER |
| University of Michigan | OTHER |
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| PAHG | Procedure | A standard 2 mL dose injection of bulkamid (order and number will be at the discretion of the surgeon) will be given. Patients undergoing PAHG will be given sham incisions consisting of superficial suprapubic epidermal scratches with a needle and fibrin glue at expected sling exit sites. |
|
| Change in patient assessment of improvement as measured by the Patient Global Impression of Improvement (PGI-I) | Patient Global Impression of Improvement (PGI-I) score is a rating on a scale from 1 to 7 that measures a patient's perception of how their condition has changed in response to treatment | 1 month, 6 months, 12 months and 24 months postoperatively |
| Number of retreatment for SUI as measured by medical record review/patient report | up to 24 months post operatively |
| Change in Lower urinary tract dysfunction research network symptom index-29 (LURN-SI-29) | A patient-centric questionnaire developed to provide a comprehensive assessment of lower urinary tract symptoms including symptoms of overactive bladder and voiding dysfunction. Scoring ranges from 0 (least severe) to 100 (most severe). | preoperatively, 1, 6, 12 and 24 months postoperatively |
| Change in Female Sexual Function Inventory (FSFI) | This 19 item questionnaire will assess sexual function and body image. It has a scoring range from 2 to 36 with higher scores indicating better sexual functioning. | preoperatively, 1, 6, 12 and 24 months postoperatively |
| Average of Perioperative morbidity | Perioperative morbidity will be assessed using the Clavien-Dindo classification. The classification is a system for grading the severity of postoperative complications based on the level of intervention required to treat them. The CD classification uses five grades of severity, with Grade I being low and Grade V being death. | Up 24 months postoperatively |
| Pelvic organ prolapse recurrence (POP-Q) | Recurrence of pelvic organ prolapse is assessed utilizing the POP-Q system classifies pelvic organ prolapse into four stages. It ranges from Stage I (most distal part of the prolapse is more than 1 cm above the hymen) to Stage IV (Complete procidentia or vault eversion) | preoperatively, 1, 6, 12 and 24 months postoperatively |
| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| D014596 | Uterine Prolapse |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D000091662 | Genital Diseases |
| D056887 | Pelvic Organ Prolapse |
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
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