Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

TVT Versus Bulkamid®-Injections in Treatment of Stress Urinary Incontinence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02538991
Recruitment Status : Active, not recruiting
First Posted : September 2, 2015
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Anna-Maija Itkonen, Helsinki University Central Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

One out of three adult females suffer from daily urinary incontinence. Two thirds of urinary incontinence is physical activity-related stress urinary incontinence (SUI). If the first-line treatment for SUI, training of pelvic floor muscles, is insufficient, treatment options are suburethral sling operation or transurethral bulking injection. Randomized studies between TVT and Bulkamid® and the knowledge about cost-effectiveness and patient satisfaction is missing.

This prospective randomized study compares TVT and Bulkamid®-injections in treatment of SUI. Main outcome measures are patient satisfaction, complications and effectiveness of the treatment in reducing urinary leakage. Secondary outcome measures are cost-effectiveness, pain during and after treatment and changes in Quality of Life and symptoms.


Condition or disease Intervention/treatment Phase
Urinary Stress Incontinence Device: Bulkamid Device: Tension-free Vaginal Tape Not Applicable

  Show Detailed Description

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TVT Versus Bulkamid®-Injections in Treatment of Stress Urinary Incontinence - Patient Satisfaction and Complications of the Treatment
Actual Study Start Date : September 2015
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Bulkamid Device: Bulkamid

Urethral injections will be performed policlinically under local anesthesia (10 ml lidocain, two injections on both sides of the urethra). The Bulkamid-injections will be transurethral four injections (0.2 - 1ml) in locations "ten, two and five and seven o'clock" within 0.5 to 1 cm from the bladder - urethra junction.

Additional injections will be avoided and can be injected only if the first injections fail. After the operation the patient urinates to empty the bladder. The PVR is checked after the treatment with ultrasound simultaneously with evaluation of stability of the Bulkamid-injections. The treatment will be photographed as before and after still pictures for later evaluation.
Active Comparator: Tension-free Vaginal Tape Device: Tension-free Vaginal Tape
TVT will be performed under local anesthesia (70 - 100 ml 0.25% prilocain cum epinephrine) with i.v. pain medication phentanyl two doses and more on request. Operation will be performed with TVT-Exact® kit. Operation can be performed policlinically or in an operation theatre depending on the patient's medical condition. Cystoscopy will be performed after the set of tapes. A cough stress test with 250 to 300 ml bladder fulfillment will show the right tension of the tape. Before the operation a prophylactic antibiotic of Cefuroxime 1.5 g i.v will be given (Dalacin 900 mg i.v in cases of allergy to penicillin). The patient can go home after 2 to 4 hours follow-up, when PVR is under 150 ml. A sick leave of 5 days is recommended.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Patient satisfaction to treatment [ Time Frame: Up to 5 years after treatment ]
    Patient satisfaction measured on VAS scale of 0 (extremely unsatisfied) to 100 (extremely satisfied). VAS ≥80 was defined as a good level of satisfaction. Patient satisfaction is measured on follow-up visits (3 months, 1 year, 3 years, 5 years).

  2. Complications of the treatment [ Time Frame: Up to 5 years after treatment ]
    Possible complications are listed after treatment and on follow-up visits.

  3. Effectiveness of the treatment in reducing urinary leakage [ Time Frame: Up to 5 years after treatment ]
    A stress pad test (Pad weighing after 20 jumping jacks on the spot and three forceful coughs in the standing position with 300 ml bladder volume. To women unable to perform the test it was modified version to 10 coughs in the standing position) performed before treatment and on follow-up visits (3 months, 1 year, 3 years, 5 years).


Secondary Outcome Measures :
  1. Cost-effectiveness of the treatment [ Time Frame: Up to 5 years after treatment ]
    Questionnaires including UDI-6, IIQ-7,RAND-36, PISQ-12

  2. Pain during and after treatment [ Time Frame: Up to 5 years after treatment ]
    VAS scale 0-10 used.

  3. Changes in Quality of Life and symptoms [ Time Frame: Up to 5 years after treatment ]
    Questionnaires including UDI-6, IIQ-7,RAND-36, PISQ-12


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • No previous stress urinary incontinence operation
  • Positive cough stress test without urge-type urine leakage
  • Post-void residual urine volume (PVR) <100ml
  • Urine bladder capacity >3dl in 3-day micturition diary.

Exclusion Criteria:

  • BMI >35 kg/m2
  • Neurogenic disease which can be associated with bladder disorders
  • Use of anticholinergics or mirabegrone
  • Illness or condition causing even a relative risk for complications in TVT operation (e.g. lower urinary tract anomaly, previous radiation therapy of the pelvis, anticoagulation or haemophilia)
  • Active malignancy
  • Current UTI or recurrent UTI (over 3 episodes within the past year)
  • Urogenital prolapse of more than second degree
  • Pregnancy or future plans of pregnancy
  • Inability to understand purpose of the study
  • Uterine myoma requiring operational treatment
  • Autoimmune or connective tissue disease contraindicating operation
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02538991


Locations
Layout table for location information
Finland
Helsinki Women's Hospital
Helsinki, Finland
Sponsors and Collaborators
Helsinki University Central Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Anna-Maija Itkonen, M.D., Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT02538991     History of Changes
Other Study ID Numbers: 19/13/03/03/2015
First Posted: September 2, 2015    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
Keywords provided by Anna-Maija Itkonen, Helsinki University Central Hospital:
Bulkamid
Tension-Free Vaginal Tape
Women
Additional relevant MeSH terms:
Layout table for MeSH terms
Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
 Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders