NCT02263534

Brief Summary

Based on previous studies the single incision minisling is an easy less invasive procedure with fewer complications and cure rate similar to conventional midurethral slings in the treatment of female stress urinary incontinence. The aim of this study is to test the hypothesis that the single incision mini-sling placed in the "U" position is not inferior to TVT in this patient population.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2014

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 13, 2014

Completed
28 days until next milestone

Study Start

First participant enrolled

November 10, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

September 19, 2018

Status Verified

September 1, 2018

Enrollment Period

2.6 years

First QC Date

August 20, 2014

Last Update Submit

September 18, 2018

Conditions

Stress Urinary Incontinence

Keywords

stress urinary incontinencetension free vaginal tapesingle incision minislingmidurethral sling

Outcome Measures

Primary Outcomes (2)

  • objective cure rate of urinary incontinence at 12 months after surgery

    Objective cure is indicated by a negative stress test and the absence of any additional surgical or nonsurgical treatment for stress urinary incontinence

    12 months

  • subjective cure rate of urinary incontinence at 12 months after surgery

    subjective cure is indicated by an Incontinence Severity Index score of 0 and the absence of any additional surgical or nonsurgical treatment for stress urinary incontinence

    12 months

Secondary Outcomes (2)

  • Number of participants with short- term complications

    12 months

  • Number of participants with long-term complications

    12 months

Study Arms (2)

minisling

EXPERIMENTAL

patients in this arm will undergo single incision minisling

Procedure: single incision minisling

tension free vaginal tape

SHAM COMPARATOR

patients in this arm will undergo tension free vaginal tape

Procedure: tension free vaginal tape

Interventions

single incision minislingPROCEDURE

midline incision of the vagina at midurethral level dissection of the vagina from perivesical fascia insertion of the tape (polypropylene macropore mesh tape) in the retropubic direction with its end grasped with an artery forceps till level of perineal membrane closure of the vagina 2 sham incisions if the skin only will be made at suprapubic to maintain blindness posterior colpoperneorraphy will be carried out if needed

minisling
tension free vaginal tapePROCEDURE

midline incision of the vagina at midurethral level dissection of the vagina from perivesical fascia insertion of the tape (polypropylene macropore mesh tape) with the applicators in the retropubic direction and 2 skin incision will be made supra pubic through which the applicators will be passed and removed and the tape will be cut at level just below the skin closure of the vagina posterior colpoperneorraphy will be carried out if needed

Also known as: TVT
tension free vaginal tape

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with urodynamic stress urinary incontinence, with or without pelvic organ prolapse

You may not qualify if:

  • Patients with overactive bladder on urodynamic study.
  • Patients with voiding dysfunction.
  • Patients with intrinsic sphincteric deficiency.
  • Patients with previous anti-incontinence surgery.
  • Patients on anti-coagulant therapy.
  • Immune-compromised patients (DM, patients on corticosteroids treatment).
  • Refusal of surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University, Maternity Hospital

Cairo, Egypt

Location

Related Publications (1)

  • Carter E, Johnson EE, Still M, Al-Assaf AS, Bryant A, Aluko P, Jeffery ST, Nambiar A. Single-incision sling operations for urinary incontinence in women. Cochrane Database Syst Rev. 2023 Oct 27;10(10):CD008709. doi: 10.1002/14651858.CD008709.pub4.

    PMID: 37888839DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Suburethral Slings

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Study Officials

  • ahmed reda, M.Sc

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
specialist obstetrics and gynecology

Study Record Dates

First Submitted

August 20, 2014

First Posted

October 13, 2014

Study Start

November 10, 2014

Primary Completion

June 1, 2017

Study Completion

October 1, 2017

Last Updated

September 19, 2018

Record last verified: 2018-09

Locations

EG(1)