Outcomes of Pelvic Surgery With and Without Anti-incontinence Procedure in Occult Stress Urinary Incontinence Patients

Improved Reconstruction Pelvic Surgery With and Without Tension-free Vaginal Tape-obturator in Women With Occult Stress Urinary Incontinence(PTOS): a Randomized Controlled Trial

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02193607

Acronym

PTOS

Enrollment

196

Registered

2014-07-17

Start date

2014-01-31

Completion date

2017-01-31

Last updated

2014-07-17

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

Conditions

Other Specified Urinary Incontinence, Pelvic Organ Prolapse, Stress Urinary Incontinence

Keywords

Occult stress incontinence, Pelvic Organ Prolapse, Surgical Intervention, TVT-O(Tension-free vaginal tape-obturator), Improved Reconstructive Pelvic Surgery, Combined Surgery, Two-step Approach, Prophylactic Incontinence Procedure, Randomized Controlled Trial

Brief summary

1. To evaluate whether a standardized tension-free vaginal tape-obturator(TVT-O) procedure, when added to a planned improved reconstruction pelvic surgery, improves the rate of urinary stress continence in subjects with occult stress incontinence. 2. Observe the immediate and short-term complications, overall urinary tract function, and other aspects of pelvic health between subjects with and without a TVT-O procedure.

Detailed description

The primary aim of this randomized study is evaluate whether a standardized TVT-O procedure, when added to a planned improved reconstruction pelvic surgery for the treatment of pelvic organ prolapse, improves the rate of urinary stress continence in subjects with occult stress incontinence. Secondary aims include comparison of immediate and short-term complications, overall urinary tract function, and other aspects of pelvic health between subjects with and without a TVT-O procedure. The value of preoperative urodynamic testing with prolapse reduction and 1 hour pad test will also be compared between subjects with and without a concomitant TVT-O procedure.

Interventions

PROCEDURETVT-O

Artificial mesh belt is placed in the middle urethra to provide support to remain no leak

PROCEDUREImproved reconstruction pelvic surgery

Repair of severe pelvic organ prolapse with mesh.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

55 Years to No maximum

Healthy volunteers

Inclusion criteria

* In the absence of medical contraindications for improved pelvic floor reconstruction surgery and the TVT-O surgery * Bulge of paries anterior vaginas stage III-IV * Uterine prolapse stage II-II * Without symptoms of stress urinary incontinence * Screening tests of occult stress urinary incontinence(OSUI) should be positive * ≥55 years old.

Exclusion criteria

* Pregnancy * Illegible to follow up after surgery * Previous surgery for stress urinary incontinence * Unfinished data collection before surgery

Design outcomes

Primary

Measure	Time frame	Description
Stress incontinence	3 months to 2 years post-operation	Urine loss from physical activity such as coughing, sneezing or laughing.

Secondary

Measure	Time frame	Description
Immediate and short-term complications	Intraoperative and 2 years post-opeartion	Immediate and short-term complications such as hemorrhage, bladder perforation and infection.
Overall urinary tract function	3 months, 12 months and 2 years post-operation	Overall urinary tract function: two validated questionnaires, standardized POP-Q measurements, urodynamic testing with prolapse reduction and 1 hour pad test.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026