Safety and Efficacy Study of Regen Sling to Treatment SUI

NCT02106299 | Unknown Phase 3

• 1 other identifier: MP201303
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the treatment safety and efficacy of Regen Sling developed by medprin Regenerative Medical Technologies Co., Ltd. for female patients with stress urinary incontinence

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (2)

• pressure test (subjective indicator)

  After patients in lithotomy position during bladder filling period continuously vigorously cough, we can observe whether urine leaks from the urethral orifice; if urine leakage does not occur in supine position, the patients shall stand with feet separated in shoulder width and continuously cough for several times, then we shall observe whether urine leakage occurs or not.

  1 year

• one-hour pad test(objective indicator)

  * The bladder shall be full for one hour and patient shall not urinate after the test starts; * Place accurately weighed urine pad in advance (such as sanitary napkin); * The patient drinks 500ml of water within 15 minutes after the test starts and then rests in bed; * The patient shall walk and walk up and down the stairs of one floor during the subsequent 30 minutes; * During the last 15 minutes, the patient shall stand up and sit down for 10 times, cough heavily for 10 times, run for 1 minute, pick up 5 items on the floor and use tap water to wash hands for 1 minute.

  1 year

Secondary Outcomes (2)

• Urinary Incontinence Impact Questionnaire - Table 7.(IIQ-7)

  1 year

• Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire - Table 12. (PISQ-12)

  1 year

Study Arms (2)

Regen Sling

EXPERIMENTAL

Subjects of this group were submitted to surgical treatment of stress urinary incontinence with a Regen Sling (medprin).

Device: Regen sling

tension-free vaginal tape-obturator

ACTIVE COMPARATOR

Subjects of this group were submitted to surgical treatment of stress urinary incontinence with a transobturator sling TVT-O™ (gynecare™, USA).

Device: tension-free vaginal tape-obturator(TVT-O)

Interventions

Regen sling DEVICE

Subjects of this group were submitted to surgical treatment of stress urinary incontinence with a Regen sling (medprin).

Regen Sling

tension-free vaginal tape-obturator(TVT-O) DEVICE

Subjects of this group were submitted to surgical treatment of stress urinary incontinence with a transobturator sling TVT-O™ (gynecare™, USA).

tension-free vaginal tape-obturator

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old female patients without fertility requirements;
• patients with at least 36-month expected survival time;
• patients meeting the diagnostic criteria of moderate or severe SUI;
• patients meeting follow-up conditions;
• patients having signed the Informed Consent Form.

You may not qualify if:

• patients with urinary infections or reproductive tract infections;
• patients with significant symptoms of dysuria or other urinary tract obstruction;
• patients with weak detrusor of bladder;
• patients with medical history of neurological diseases, urogenital cancer, fistula and pelvic radiotherapy or patients having received anti-urinary incontinence surgery;
• patients with urge urinary incontinence;
• patients with combined symptomatic POP-Q Ⅱ or severer pelvic organ prolapse or patients with combined overactive bladder syndrome;
• patients with scar constitution or allergic constitution;
• patients with uterine diseases or double adnexal diseases that need surgical treatment proved by pelvic B ultrasonic inspection.

Sponsors & Collaborators

• Medprin Regenerative Medical Technologies Co., Ltd.: lead

Study Sites (1)

China

Shenzhen, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhu Lan, professor

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tian Quan

CONTACT

13580397264; tianquan@medprin.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2014
• First Posted: April 8, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: April 8, 2014

Record last verified: 2014-04

Locations

CN (1)