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A prospective randomised controlled trial comparing vaginal prolapse repair with and without Tensionfree Vaginal Tape (TVT) in women with severe genital prolapse and occult stress incontinence

A prospective randomised controlled trial comparing vaginal prolapse repair with and without Tensionfree Vaginal Tape (TVT) in women with severe genital prolapse and occult stress incontinence: Long term follow up

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611000844943
Enrollment
80
Registered
2011-08-10
Start date
2003-05-02
Completion date
2009-08-28
Last updated
2021-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Genital prolapse is a common condition with at least 1 woman in 10 undergoing surgery for this condition. It may be associated with urinary stress incontinence. Paradoxically, women suffering of severe genital prolapse may be continent. By reducing the prolapse during urodynamic assessment (barrier test), one can unmask urinary stress incontinence, called occult stress incontinence (OSI). Reducing the prolapse during urodynamic testing aims at mimicking the postoperative state. It is however unclear from the literature whether a positive barrier test is an indication for anti-incontinence surgery performed at the same time as prolapse surgery. Tensionfree Vaginal Tape (TVT) is an efficient anti-incontinence procedure and can be easily performed at the same time as prolapse surgery. Our study intends to randomise patients undergoing surgery for severe prolapse in two groups, one with usual prolapse surgery without any anti-incontinence procedure, the second with prolapse surgery and TVT. Urodynamics studies on patients with severe prolapse describe 36 to 80% of OSI. Our hypothesis is that 50% of patients operated for prolapse with a positive barrier test will develop urinary stress incontinence. TVT cures or improves stress incontinence in about 90% of patients. Combining TVT with prolapse surgery may therefore reduce the post-operative rate of stress incontinence from 50% to 10%. However, systematic use of TVT may expose patients to complications like voiding difficulties or de novo detrusor instability. The other option is to operate patients for prolapse and perform TVT under local anaesthesia only in those who develop distressing stress incontinence post-operatively.

Interventions

Insertion of TVT suburethral sling at time of prolapse repair. The TVT procedure (Gynecare, Ethicon Inc., Somerville, NJ) was performed as previously described by Ulmsten. The tape is passed from the vagina retropubically without tension. The tape is a permanent synthetic mesh. The procedure takes 10-15 min including cystoscopy to excluded any bladder perforation.

Sponsors

Mercy Hospital for Women
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

pelvic organ prolapse = / > Grade 2, requiring surgical correction in absence of SUI and with urodynamically demonstrated OSI. Ability to give informed consent and willingness to participate are required

Exclusion criteria

Contraindication to surgery in general such as being medically unfit for surgery, the presence of pelvic infection, malignancy, fistula, congenital or neurogenic bladder disorder, and inability to give informed consent.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026