N39.3
Conditions
Interventions
Group 1: Patients with a need for surgical treatment of stress urinary incontinence will be supplied with an suburethral tape (TVT technique). In this observational study the NEOMEDIC KIM tape is used
Sponsors
Neomedic International
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) patients with complicated and non- complicated stress incontinence, who need surgical treatment 2) patients from age of 18 years 3) fullfilled family planing 4) cooperation for data collection, therapy and follow-up investigations 5) patient information was delivered and written consent is present 6) urodynamics are obligatory in case of complicated stress incontinence (e.g. previous incontinence operation, neurologic symptoms, mixed incontinence) 7) obligatory single shot antibiotics pre-/ peroperatively
Exclusion criteria
Exclusion criteria: 1) pregnancy 2) simultaneous prolapse surgery 3) prolapse of uterus or vagina > POP-Q II 4) known imcompatibility of the implant 5) immobile urethra 6) no previous urodynamic investigation in case of complicated stress incontinence (see inclusion criterion) 7) state after radiation in true pelvis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| extension of knowledge concerning success rate and follow-up of therapy with an adjustable suburethral tape Final point: Review of compatibiliy, quality of life and complications after surgical insertion of Neomedic KIM tape suburethral. Review preoperatively, before discharge and after 6 and 12 months. Review with clinical examination, ultrasound and questionnaires. The parameters are: preoperatively: age, weight, height, urogynecological operations in history, intake of spasmolytic drugs, criterions of stress incontinence (Ingelmann- Sundberg, mixed incontinence, hypotone urethra, bladder emptying problems), quality of life, validated incontinence questionnaire ICIQ-SF. At discharge: follow-up of operation (aquadissection), intra- and postoperative complications, adjustment of tape, pain, cough test, other complaints. After 6- 12 months: revision of operation, pain, recurrence of stress incontinence, cough test, intake of spasmolytic drug, residual volume, tape erosion, infection at insertion point of tape/suture, satisfaction, question for repeat operation, other complaints, quality of life, validated incontinence questionnaire ICIQ-SF | — |
Secondary
| Measure | Time frame |
|---|---|
| influence of adjustable tape on subjective complaints, quality of life and satisfaction with the operation frequency of intra- and postoperative complications (erosion, bladder lesion, hematoma, pain). Review with clinical examination, ultrasound and questionnaire (incontinence questionnaire ICIQ-SF) preoperatively, before discharge, after 6 and 12 months. | — |
Countries
Germany, Switzerland
Contacts
Public ContactAchim Niesel
Klinik Preetz
Outcome results
None listed