Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00984958
Other study ID # Bulkamid ISD2009 04
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2009
Est. completion date December 2016

Study information

Verified date August 2019
Source Skaraborg Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The aim of this prospective, randomized study is to investigate the effect of Bulkamid injection for women with urinary stress incontinence and not suitable to TVT-procedure because of suspected ISD and compare this treatment with no or traditional treatment. The primary endpoint for efficacy will be reduction of leakage during pad-test at 2 months compared with pad- test before injection.

Secondary endpoints will be patient satisfaction measured at both 2 and 12 months using a questionnaire and the number of side effects.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date December 2016
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender Female
Age group 50 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Women with hypermobility of the urethra during coughing and positive Bonney's test

- Women suitable for a TVT procedure.

- Positive urinary culture

- Urge incontinence

Study Design


Intervention

Device:
Bulkamid
injection of Bulkamid in the urethra
Bulkamid expectation
expectance

Locations

Country Name City State
Sweden Deprtm Ob/Gyn Skövde

Sponsors (1)

Lead Sponsor Collaborator
Skaraborg Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. less inkontinens 12 month
See also
  Status Clinical Trial Phase
Recruiting NCT05243134 - The Influence of Anatomic Deformities on the Clinical Efficacy in the Patients With Patellar Dislocation
Completed NCT02486874 - Clinical Evaluation of PoreSkin Phase 1
Active, not recruiting NCT04592640 - Stem Cells for Uremic Calciphylaxis Patients N/A
Recruiting NCT04599686 - Stereotactic Body Radiotherapy (SBRT) for Oligometastatic Prostate Cancer N/A
Recruiting NCT03351842 - Surgery With or Without Chemotherapy for Stage I NSCLC With Micropapillary Component ≥ 20% Phase 2
Completed NCT02782442 - Cognitive Training Delivered Remotely to Individuals With Psychosis (ROAM) N/A
Completed NCT03439930 - The Effect of Balance Training on Neuromuscular Control in Subjects With CAI N/A
Not yet recruiting NCT05537155 - Buccal Acupuncture for Delirium Treatment in Older Patients Recovering From Orthopedic Surgery N/A
Recruiting NCT02971982 - PCD Versus RCD for the Treatment of Patients With Waldenstrom's Macroglobulinemia Phase 1/Phase 2
Completed NCT02820272 - Water for Reducing Pain in Negative Pressure Wound Therapy Phase 2
Completed NCT00575224 - Pegasys and Copegus for Asian Patients With Treatment-naive Hepatitis C Genotypes 6, 7, 8, 9 Phase 4
Completed NCT00164528 - Intervening With Children/Adolescents With FAS/ARND Phase 1/Phase 2
Completed NCT00164307 - Assisting Children With Prenatal Alcohol Exposure in Developing Peer Friendships Phase 1/Phase 2
Recruiting NCT04603586 - Stereotactic Radiotherapy in Locally Advanced Pancreatic Cancer With Different Biological Effective Doses N/A
Recruiting NCT03375424 - Vedolizumab Study With Inflammatory Bowel Disease Patients in Germany N/A
Not yet recruiting NCT04062370 - Ranibizumab Treatment for Macular Edema Secondary to Retinal Vein Occlusion Phase 4
Not yet recruiting NCT02931136 - Early Diagnosis and Early Treatment of Alzheimer's Disease Based on Senile Plaque Imaging Phase 4
Completed NCT04661228 - Diagnostic Survey of Mental and Substance Use Disorders in HUNT (PsykHUNT)
Recruiting NCT03365141 - Efficacy of Intralesional Triamcinolone Injection in the Treatment of Vitiligo N/A
Recruiting NCT04599699 - Integrated Boost to the Dominant Intraprostatic Nodule Based on Ga-68 PSMA PET/MR Study of SBRT With Prostate Cancer N/A