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NCT Number: NCT01148290

Tension-free Vaginal Tape (TVT) Versus Bulking Agent for the Treatment of Post Vulvectomy Urinary Incontinence

The surgical treatment of vulvar cancer is characterized by a radical approach as standard, often associated to an important rate of functional complications. This surgery often includes the partial excision of urethra, resulting in a reduction of urethral closure pressure. The radiotherapy-induced fibrosis in addiction leads to a reduction of urethral mobility. As consequence women treated for vulvar cancer may develop urinary incontinence. The incidence of this complication has been differently reported, but seems to reach the 100%. Poor data are available regarding the treatment of post vulvectomy urinary incontinence and no clear indication may be given at regards.

Based on these considerations the aim of this trial will be to compare tension free vaginal tape and bulking agent injection in women with urinary stress incontinence developed after radical surgery for vulvar cancer.

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Key information

Conditions

Urinary Incontinence, Stress Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Lower Urinary Tract Symptoms Male Urogenital Diseases Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urological Manifestations Vulvar Diseases Vulvar Neoplasms

Age range

18 year–95 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Pugliese Hospital

Catanzaro, 88100, Italy

About this study

Women with urinary stress incontinence developed after radical vulvectomy will be enrolled and randomized in two groups (arm 1 and arm 2). Patients of group 1 will be treated with the tension free vaginal tape, whereas in patients of arm 2 will be used the bulking agent injection.

All eligible patients will undergo baseline assessment consisting of anthropometric, clinical, and urodynamic evaluations. During the study, the surgical outcomes, the clinical subjective and objective efficacy data, and the adverse experiences will be evaluated in each patient.

Data will be analyzed using the intention-to-treat principle and a P value of 0.05 or less will be considered significant.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Stress urinary incontinence by self report, examination and test
  • History of radical vulvectomy

Exclusion criteria

  • Systemic disease and/or drugs known to affect bladder function
  • Current chemotherapy or radiation therapy
  • Detrusor instability

Treatment and study plan

tension free vaginal tape

Procedure

Small incision sites in the vagina and suprapubically. Bilateral retropubic insertion of the sling by means of needles

Bulking agent injection

Procedure

Three Periurethral injections of Bulkamid ® (Ethicon,Somerville, NJ, USA)

Primary outcomes

  1. Cure rate

    Time frame: 12 months

Secondary outcomes

  1. Intra-operative complication rate

    Time frame: 1 day

  2. Postoperative complication rate

    Time frame: 12 months

  3. Recurrence rate

    Time frame: 12 months

  4. Second surgery for stress urinary incontinence (SUI)

    Time frame: 12 months

  5. Quality of life

    Time frame: 12 months

  6. Satisfaction

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

University Magna Graecia

Other

Registry information

Official study title

A Comparison Between Tension-free Vaginal Tape and Bulking Agent for the Treatment of Post-vulvectomy Urinary Incontinence: a Randomized Controlled Trial

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Jun 22, 2010
Registry last updated
Apr 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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