An interventional study of RP-MUS and PAHG in Stress Urinary Incontinence and Vaginal Prolapse, sponsored by University Hospitals Cleveland Medical Center. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-01.
Sponsored by University Hospitals Cleveland Medical Center · Not applicable, Interventional, and Treatment
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.
651 studies on the registry are indexed under Urinary Incontinence, Stress; 120 are open to participants now.
This study's planned enrollment of 476 is above the median of 68 across 506 interventional studies indexed under Urinary Incontinence, Stress.
Browse Urinary Incontinence, Stress studies →University Hospitals Cleveland Medical Center is the lead sponsor of 295 studies on the registry; 45 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 30 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: RP-MUS
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.
Procedure: PAHG
a standard urethral sling placement for treatment of stress urinary incontinence
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.
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.
Time frame: 24 months postoperatively
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.
Time frame: 1, 6 and 12 months postoperatively
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
Time frame: 1 month, 6 months, 12 months and 24 months postoperatively
Number of retreatment for SUI as measured by medical record review/patient report
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: preoperatively, 1, 6, 12 and 24 months postoperatively
Plan to share: No — IPD will not be shared with other researchers to ensure participant privacy is maintained and avoid any risk of invalid analyses.
Started May 2025 (actual). Primary completion is estimated for Apr 2029, 47 months after the start.
Of 225 non-industry interventional studies with no phase under Urinary Incontinence, Stress, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 47 months is above that.
Counting every sponsor, half of 266 studies reached it within 19 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
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