Prospective registry study to evaluate recurrences and complications after surgical treatment of male stress incontinence with DynaMesh®-PRM mesh implants

Prospective registry study to evaluate recurrences and complications after surgical treatment of male stress incontinence with DynaMesh®-PRM mesh implants - Pro-PRM-Register

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00032228

Enrollment

Registered

2023-07-06

Start date

2023-08-01

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

N39.3

Interventions

Group 1: -Adult male patients of legal age who are to have a DynaMesh® PRM (visible) mesh implant due to stress incontinence. -Light to moderate incontinence (guideline-compliant) Description of all p

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: The informed consent form has been signed by the patient after verbal and written explanation for participation in the registry study.

Exclusion criteria

Exclusion criteria: Pre-operated patients with surgical incontinence therapies. Since this is an observation of routine clinical practice, no further exclusion criteria are defined.

Design outcomes

Primary

Measure	Time frame
The primary purpose of this registry study is to assess the performance of the product. Performance parameter here is: • Reoperation for recurrent or persistent incontinence. • Correction of incontinence (based on daily use of pads, urine leakage 24h pad test) • improvement of incontinence severity (according to ICS classification: light/medium/severe) • the question: "I would have the operation again". • the question: has the quality of life improved with regard to incontinence symptoms? light: 1.3-20 g, moderate: 21-74 g, heavy: > 75 g in the 24-h pad test (https://pubmed.ncbi.nlm.nih.gov/15270937/) The primary endpoint is the frequency of recurrent or persistent stress urinary incontinence. For this purpose, the patients will carry out a pad test/24h and fill out QoL questionnaires. The times of the pad test and the completion of the questionnaires are before the operation and after 6-8 weeks, 6 months and after 1, 3, 5, 10, 15 years	—

Measure

Time frame

The primary purpose of this registry study is to assess the performance of the product. Performance parameter here is: • Reoperation for recurrent or persistent incontinence. • Correction of incontinence (based on daily use of pads, urine leakage 24h pad test) • improvement of incontinence severity (according to ICS classification: light/medium/severe*) • the question: "I would have the operation again". • the question: has the quality of life improved with regard to incontinence symptoms? * light: 1.3-20 g, moderate: 21-74 g, heavy: > 75 g in the 24-h pad test (https://pubmed.ncbi.nlm.nih.gov/15270937/) The primary endpoint is the frequency of recurrent or persistent stress urinary incontinence. For this purpose, the patients will carry out a pad test/24h and fill out QoL questionnaires. The times of the pad test and the completion of the questionnaires are before the operation and after 6-8 weeks, 6 months and after 1, 3, 5, 10, 15 years

—

Secondary

Measure	Time frame
The secondary endpoints are used to assess the safety of the product: • Intraoperative complications • Bleeding (> 200 ml) • Lesion of adjacent structures • Postoperative complications • Hematuria • Hematoma • Erosion • Fistula formation • Dislocation • Pain- postoperative ( 3 months) • de novo micturition disorders • de novo urge incontinence • Infection of the wound • Infection of the implant • urinary tract infections • paresthesia • Re-operation due to complications • Position of the implant (centric alignment, fold-free adaptation to the bulb, fixation) as well as the associated positional correction of related anatomical structures (urethra) (MRI sub-study only)	—

Measure

Time frame

The secondary endpoints are used to assess the safety of the product: • Intraoperative complications • Bleeding (> 200 ml) • Lesion of adjacent structures • Postoperative complications • Hematuria • Hematoma • Erosion • Fistula formation • Dislocation • Pain- postoperative ( 3 months) • de novo micturition disorders • de novo urge incontinence • Infection of the wound • Infection of the implant • urinary tract infections • paresthesia • Re-operation due to complications • Position of the implant (centric alignment, fold-free adaptation to the bulb, fixation) as well as the associated positional correction of related anatomical structures (urethra) (MRI sub-study only)

—

Countries

Austria, Germany, Switzerland

Contacts

Public ContactKarl Dietrich Sievert

Klinikum Lippe

karl-dietrich.sievert@klinikum-lippe.de+49 (0)5231721491

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Apr 4, 2026