Retrospective observational study of the safety and performance of the DynaMesh® PRM implant for the treatment of male stress urinary incontinence

• Conditions: N39.4; Other specified urinary incontinence

• Registration Number: DRKS00031544
• Lead Sponsor: FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH

Brief Summary

In total, 30 patients received the PVDF sling for stress urinary incontinence/ post-prostatectomy incontinence (PPI) during the study period. On average, patients were 72 years old at the time of the surgery. All patients had previously undergone prostatectomy and 17 % had perviously received radiation in the surgical area. Almost all patients (97 %) had severe incontinence based on their 24-h pad test (> 75 g) according to the classification published by O'Sullivan and colleagues. After a mean follow-up duration of 24.5 months, 53 % of patients were considered completely cured, with no urine leakage during the 24-h pad test. Moreover, 73 % showed improved incontinence as evidenced by a reduced severity level. More than 90 % of patients indicated that their quality of life improved and that they would undergo the same surgery again. Only 10 % of patients underwent reoperation due to recurring or persisting incontinence. There were no intraoperative complications such as lesions or hemorrhages. Moreover, no postoperative complications were recorded, including mesh erosion, infection, pain and de novo voiding dysfunction.

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-10-17
• Study Start: 2023-03-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

All patients who underwent surgical treatment of stress incontinence using a DynaMesh®-PRM/ -PRM visible mesh implant at the Vivantes Klinikum am Urban between July 2017 and October 2020 are included.

Exclusion Criteria

Since this is an observational study within the framework of usual treatment practice, there are no study-related exclusion criteria.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
This observational study primarily serves to assess the performance of the product DynaMesh-PRM (visible)<br>Recurrent incontinence and reoperation if recurrence to assess product performance

Secondary Outcome Measures

Name	Time	Method
The secondary endpoints serve to assess the safety of the product DynaMesh-PRM (visible).<br>Peri- and postoperative complications and follow-up data to assess safety