female stress urinary incontinence
Conditions
Interventions
Urolastic ® or Bulkamid ®
Sponsors
Urogyn B.V
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: a. Female is at least 18 years old b. Moderate to severe incontinence according to the Sandvik Score incontinence scale with a duration of at least 12 months c. Written informed consent d. No contra-indications for Urolastic/Bulkamid injection at the site of the bladder neck or external urethral sphincter e. Patient is mentally competent and able to understand all study requirements and agrees to be available for the follow-up evaluations as required by the protocol f. Patient should not be on anticholinergic treatment unless they have been on stable treatment during the previous month and will continue treatment during protocol g. Patient has good bladder function (bladder capacity at least 300 ml and post void residual
Exclusion criteria
Exclusion criteria: a. Women with history of vesicoureteral reflux, predominantly urgency incontinence b. Women who used indwelling catheters for a long period of time and have fibrosis of the tissue at the injection sites c. Women with a psychiatric or progressive neurological or muscular disease or other diseases with life expectancy of less than 1 year d. Women with a previous implantation of an artificial urinary sphincter e. Women who are pregnant, lactating or planning to become pregnant in the 2 years after treatment with Urolastic®/Bulkamid® f. Women who underwent radiotherapy of the pelvis and/or perineum and have fibrosis at the likely injection sites g. Patients having pelvic floor exercises, bladder training or other treatment for their urinary incontinence programmed during the study h. Women with stage 2 or more genital prolapse, according to the ICS-Classification i. Women who are not capable of giving informed consent j. Women diagnosed with a urinary tract infection: cystitis (bacteriuria >100.000cfu/ml) or urethritis k. Women with a bladder capacity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The subjective cure rate of stress incontinence after either Urolastic® or Bulkamid ® procedure performed under local anesthesia | — |
Secondary
| Measure | Time frame |
|---|---|
| Subjective cure rate of stress incontinence at 6 weeks, 3 months, 1 and 2 years after the treatment with either Urolastic ® of Bulkamid® Objective cure rate of stress incontinence at 6 weeks, 3 months, 1 and 2 years after the treatment with either Urolastic ® of Bulkamid® Complications after the procedure Postoperative pain score Patient satisfaction | — |
Countries
Netherlands
Outcome results
None listed