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

NCT02538991 | Active Not Recruiting

• 1 other identifier: 19/13/03/03/2015
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Stress Incontinence

Keywords

Bulkamid; Tension-Free Vaginal Tape; Women

Outcome Measures

Primary Outcomes (3)

• Patient satisfaction to 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).

  Up to 5 years after treatment

• Complications of the treatment

  Possible complications are listed after treatment and on follow-up visits.

  Up to 5 years after treatment

• Effectiveness of the treatment in reducing urinary leakage

  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).

  Up to 5 years after treatment

Secondary Outcomes (3)

• Cost-effectiveness of the treatment

  Up to 5 years after treatment

• Pain during and after treatment

  Up to 5 years after treatment

• Changes in Quality of Life and symptoms

  Up to 5 years after treatment

Study Arms (2)

Bulkamid

EXPERIMENTAL

Device: Bulkamid

Tension-free Vaginal Tape

ACTIVE COMPARATOR

Device: Tension-free Vaginal Tape

Interventions

Bulkamid DEVICE

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.

Bulkamid

Tension-free Vaginal Tape DEVICE

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.

Tension-free Vaginal Tape

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (1)

Helsinki Women's Hospital

Helsinki, Finland

Location

Related Publications (20)

• Bezerra CA, Bruschini H, Cody DJ. Traditional suburethral sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2005 Jul 20;(3):CD001754. doi: 10.1002/14651858.CD001754.pub2.

  PMID: 16034866 BACKGROUND

• Rehman H, Bezerra CC, Bruschini H, Cody JD. Traditional suburethral sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2011 Jan 19;(1):CD001754. doi: 10.1002/14651858.CD001754.pub3.

  PMID: 21249648 BACKGROUND

• Nilsson CG, Palva K, Aarnio R, Morcos E, Falconer C. Seventeen years' follow-up of the tension-free vaginal tape procedure for female stress urinary incontinence. Int Urogynecol J. 2013 Aug;24(8):1265-9. doi: 10.1007/s00192-013-2090-2. Epub 2013 Apr 6.

  PMID: 23563892 BACKGROUND

• Laurikainen E, Valpas A, Aukee P, Kivela A, Rinne K, Takala T, Nilsson CG. Five-year results of a randomized trial comparing retropubic and transobturator midurethral slings for stress incontinence. Eur Urol. 2014 Jun;65(6):1109-14. doi: 10.1016/j.eururo.2014.01.031. Epub 2014 Jan 31.

  PMID: 24508070 BACKGROUND

• Kuuva N, Nilsson CG. A nationwide analysis of complications associated with the tension-free vaginal tape (TVT) procedure. Acta Obstet Gynecol Scand. 2002 Jan;81(1):72-7. doi: 10.1034/j.1600-0412.2002.810113.x.

  PMID: 11942891 BACKGROUND

• Abbott S, Unger CA, Evans JM, Jallad K, Mishra K, Karram MM, Iglesia CB, Rardin CR, Barber MD. Evaluation and management of complications from synthetic mesh after pelvic reconstructive surgery: a multicenter study. Am J Obstet Gynecol. 2014 Feb;210(2):163.e1-8. doi: 10.1016/j.ajog.2013.10.012. Epub 2013 Oct 11.

  PMID: 24126300 BACKGROUND

• Kerr LA. Bulking agents in the treatment of stress urinary incontinence: history, outcomes, patient populations, and reimbursement profile. Rev Urol. 2005;7 Suppl 1(Suppl 1):S3-S11.

  PMID: 16985874 BACKGROUND

• Kuhn A, Stadlmayr W, Lengsfeld D, Mueller MD. Where should bulking agents for female urodynamic stress incontinence be injected? Int Urogynecol J Pelvic Floor Dysfunct. 2008 Jun;19(6):817-21. doi: 10.1007/s00192-007-0535-1.

  PMID: 18157642 BACKGROUND

• Klarskov N, Lose G. Urethral injection therapy: what is the mechanism of action? Neurourol Urodyn. 2008;27(8):789-92. doi: 10.1002/nau.20602.

  PMID: 18642372 BACKGROUND

• Kirchin V, Page T, Keegan PE, Atiemo K, Cody JD, McClinton S. Urethral injection therapy for urinary incontinence in women. Cochrane Database Syst Rev. 2012 Feb 15;(2):CD003881. doi: 10.1002/14651858.CD003881.pub3.

  PMID: 22336797 BACKGROUND

• Lose G, Sorensen HC, Axelsen SM, Falconer C, Lobodasch K, Safwat T. An open multicenter study of polyacrylamide hydrogel (Bulkamid(R)) for female stress and mixed urinary incontinence. Int Urogynecol J. 2010 Dec;21(12):1471-7. doi: 10.1007/s00192-010-1214-1. Epub 2010 Jul 20.

  PMID: 20645077 BACKGROUND

• Leone Roberti Maggiore U, Alessandri F, Medica M, Gabelli M, Venturini PL, Ferrero S. Outpatient periurethral injections of polyacrylamide hydrogel for the treatment of female stress urinary incontinence: effectiveness and safety. Arch Gynecol Obstet. 2013 Jul;288(1):131-7. doi: 10.1007/s00404-013-2718-y. Epub 2013 Feb 1.

  PMID: 23371485 BACKGROUND

• Toozs-Hobson P, Al-Singary W, Fynes M, Tegerstedt G, Lose G. Two-year follow-up of an open-label multicenter study of polyacrylamide hydrogel (Bulkamid(R)) for female stress and stress-predominant mixed incontinence. Int Urogynecol J. 2012 Oct;23(10):1373-8. doi: 10.1007/s00192-012-1761-8. Epub 2012 Apr 25.

  PMID: 22531952 BACKGROUND

• Sokol ER, Karram MM, Dmochowski R. Efficacy and safety of polyacrylamide hydrogel for the treatment of female stress incontinence: a randomized, prospective, multicenter North American study. J Urol. 2014 Sep;192(3):843-9. doi: 10.1016/j.juro.2014.03.109. Epub 2014 Apr 2.

  PMID: 24704117 BACKGROUND

• Mouritsen L, Lose G, Moller-Bek K. Long-term follow-up after urethral injection with polyacrylamide hydrogel for female stress incontinence. Acta Obstet Gynecol Scand. 2014 Feb;93(2):209-12. doi: 10.1111/aogs.12283. Epub 2013 Dec 24.

  PMID: 24372312 BACKGROUND

• Koski ME, Enemchukwu EA, Padmanabhan P, Kaufman MR, Scarpero HM, Dmochowski RR. Safety and efficacy of sling for persistent stress urinary incontinence after bulking injection. Urology. 2011 May;77(5):1076-80. doi: 10.1016/j.urology.2010.10.010. Epub 2011 Jan 8.

  PMID: 21216448 BACKGROUND

• Corcos J, Collet JP, Shapiro S, Herschorn S, Radomski SB, Schick E, Gajewski JB, Benedetti A, MacRamallah E, Hyams B. Multicenter randomized clinical trial comparing surgery and collagen injections for treatment of female stress urinary incontinence. Urology. 2005 May;65(5):898-904. doi: 10.1016/j.urology.2004.11.054.

  PMID: 15882720 BACKGROUND

• Svenningsen R, Staff AC, Schiotz HA, Western K, Kulseng-Hanssen S. Long-term follow-up of the retropubic tension-free vaginal tape procedure. Int Urogynecol J. 2013 Aug;24(8):1271-8. doi: 10.1007/s00192-013-2058-2. Epub 2013 Feb 16.

  PMID: 23417313 BACKGROUND

• Freitas AI, Isaksson C, Rahkola-Soisalo P, Mentula M, Mikkola TS. Tension-Free Vaginal Tape versus Polyacrylamide Hydrogel Injection for Stress Urinary Incontinence - 5-Year Follow-Up. NEJM Evid. 2025 May;4(5):EVIDoa2400216. doi: 10.1056/EVIDoa2400216. Epub 2025 Apr 22.

  PMID: 40261117 DERIVED

• Itkonen Freitas AM, Isaksson C, Rahkola-Soisalo P, Tulokas S, Mentula M, Mikkola TS. Tension-Free Vaginal Tape and Polyacrylamide Hydrogel Injection for Primary Stress Urinary Incontinence: 3-Year Followup from a Randomized Clinical Trial. J Urol. 2022 Sep;208(3):658-667. doi: 10.1097/JU.0000000000002720. Epub 2022 Aug 5.

  PMID: 35942796 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Suburethral Slings

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

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Design

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

Study Record Dates

• First Submitted: August 31, 2015
• First Posted: September 2, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2024
• Last Updated: March 26, 2024

Record last verified: 2024-03

Locations

FI (1)