Bulkamid Treatment of Stress Incontinence in Women With Urinary Stress Incontinence and Not Suitable to TVT-procedure

NCT00984958 | Completed DMC

• 1 other identifier: Bulkamid ISD2009 04
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this prospective, randomized study of Bulkamid treatment is to investigate the efficacy of Bulkamid treatment in women with urinary stress incontinence not suitable to TVT-procedure because of suspected ISD.

Conditions

Urinary Stress Incontinence; Treatment

Outcome Measures

Primary Outcomes (1)

• After 2 months a scheduled visit with a new pad-test will be performed and the questionnaires UDI-6 (lover urinary tract symptoms) and IIQ-7 (quality of life) will be filled in.

  less intcontines

  2 month

Secondary Outcomes (1)

• After 12 months a scheduled visit with new pad-test will be performed and the questionnaires UDI-6 (lover urinary tract symptoms) and IIQ-7 (quality of life) will be filled in.

  12 month

Study Arms (2)

Bulkamid

OTHER

Injection with Bulkamid

Device: Bulkamid

expectance

OTHER

The expectance arm will after 2 month have the same treatment as the treatment arm

Device: Bulkamid expectation

Interventions

Bulkamid DEVICE

injection of Bulkamid in the urethra

Bulkamid

Bulkamid expectation DEVICE

expectance

Also known as: after 2 month the patient can be treated

expectance

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand the information and to give informed consent.
• At least 50 years of age
• History of urinary leakage during low grade physical activity. A woman with genuine stress incontinence has urinary incontinence during running or jumping. Women with suspected ISD have incontinence at much lower grade of physical activity such as slow walking or standing up and just coughing. Walking, standing up from a chair, and coughing are regarded as low grade of physical activity.
• A positive pad-test (after coughing 10 times) with increase of minimum of 10 grams of urine with 300 ml in the bladder or a 24 h pad-test of more than 100 mg of urine
• No hypermobility of the urethra during cough test.
• Low pressure of the urethra (optional?)
• With a of average miction volume of minimum 150 ml and at least one volume of more than 250

You may not qualify if:

• Women with hypermobility of the urethra during coughing and positive Bonney's test
• Women suitable for a TVT procedure.
• Positive urinary culture
• Urge incontinence

Sponsors & Collaborators

• Skaraborg Hospital: lead

Study Sites (1)

Deprtm Ob/Gyn

Skövde, SE54185, Sweden

Location

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

• P-G Larsson, professor

  Departm Ob/Gyn Kärnsjukhuset, 541 85 SKövde, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: Group 1 will get treatment and Group 2 will have no treatment for 2 month

Study Record Dates

• First Submitted: September 24, 2009
• First Posted: September 25, 2009
• Study Start: October 1, 2009
• Primary Completion: July 1, 2015
• Study Completion: December 1, 2016
• Last Updated: August 30, 2019

Record last verified: 2019-08

Locations

SE (1)