A clinical study to evaluate the Safety and Effectiveness of a Urine Leak Capture Device Compared to Standard Care with Pelvic Floor Exercises for males with Urinary Incontinence.

A Clinical Study to Evaluate the Performance and Safety of the Urine Leak Capture, Flow Capture Device in Comparison to standard medical practice administered along with Pelvic Floor Exercises among Males requiring Urinary Incontinence management-A Randomized Controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/11/076710

Enrollment

135

Registered

2024-11-12

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

Health Condition 1: N33- Bladder disorders in diseases classified elsewhere

Interventions

Intervention1: Leak Capture Device and Flow Capture Device: Capury Urine Leak Capture Device (LCD)is a Single use, non-sterile, non-reflux, externally worn, urine drainage & capturing device intended

Eligibility

Inclusion criteria

Inclusion criteria: 1.Male subjects aged above 18 years. 2.Subjects with history of urine incontinence. 3.Subjects with UI (7 episodes/week) and frequency (8 micturition/day). 4.Subjects must be Ambulatory. 5.Subjects who are able to practice the intervention as per the guideline. 6.Subjects who are likely to come for follow up 7.Subjects willing to give their informed consent.

Exclusion criteria

Exclusion criteria: 1.Current urinary tract infection or history of more than 3 urinary tract infections per year 2.Incontinence due to fistula (bladder or rectum) 3.Symptomatic pelvic organ prolapse. 4.BMI greater than 35 kg/m2 5.Congenital defects leading to incontinence. 6.Already engaged in any clinical trial 7.Subjects with bladder outlet obstruction 8.Subjects with latex allergy

Design outcomes

Primary

Measure	Time frame
Performance of the product like security, confidence, ease of use, leak prevention, and application difficulty will be analyzed using a 2-point scale validated questionnaireTimepoint: six months	—

Secondary

Measure	Time frame
The performance of the product like ease of wearing and removing the product, comfort, ease of attaching the device to a leg bag, ease of following instructions, and tracking the overall opinion will be analyzed using 3 -point scale validated questionnaireTimepoint: Six months	—

Countries

India

Contacts

Public ContactMelarkode Krishnan Ramkumar

KEM Hospital Research Centre

chakurkarvipul@gmail.com9102066037335

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 28, 2026