Vaginal Prolapse Surgery Accompanied by Mid Urethral Sling Versus no Sling for Reduction of Postoperative Incontinence
Vaginal Prolapse Surgery Accompanied by Mid Urethral Sling Versus no Sling for Reduction of Postoperative Incontinence: a Randomized Controlled Trial
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Aim: To de termine the effect of mid urethral sling in reducing postoperative incontinence after vaginal prolapse surgery.
General Objectives: To compare the risk of de novo postoperative incontinence between prolapsed surgery with mid urethral sling versus no sling.
Specific Objectives: to compare the change in score of BFLUTS-SF (Bristol Female lower urinary tract symptoms- sexual function) and UDI-6 (Urinary distress inventory-6) pre and post surgery between the two groups.
Research Hypothesis: The use of mid urethral sling after vaginal prolapse surgery has role in reduction of postoperative incontinence.
Materials & Methods:
- Whether study involves humans/animals or both : Humans
- Population/ participants: Patients with pelvic organ prolapse who are planned for vaginal prolapse surgery in BPKIHS (BP Koirala Institute of Health and Sciences).
- Type of study design: a randomized controlled trial
(e) Expected sample size: 54 Sample size calculation: Previous study done by Control groups: Patient undergoing vaginal prolapse surgery only without mid urethral sling. There will be small incision in the suprapubic region that mimics the TVT incision.
(f) Probable duration of study: one and half year (g) Setting: BPKIHS, Department of Obstetrics and Gynecology (h) Parameter/Variables to be applied/ measured: Age, BMI, POPQ (Pelvic organ prolapse quantification) stage, menopause, ESST (Empty supine stress test).
(i) Outcome measures: LUTS score, UDI-6 score, SUI (stress urinary incontinence), Voiding dysfunction, dyspareunia, satisfaction, Complications like bladder injury, hemorrhage.
(j) Rationale for statistical methods to be employed: attached (k) Ethical clearance: Study will be started after getting clearance from the IRC (Institutional review committee) of BPKIHS .
(l) Permission to use copyright questionnaire/Proforma: Pre designed Proforma and questionnaire will be used to collect the data. The internationally valid questionnaire in English will be validated in Nepali language first and then it will be used.
(m) Maintain the confidentiality of subject: The confidentiality of the patients will be maintained throughout the research.
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 2
- Fase 3
Contactos y Ubicaciones
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Clinical POP-Q stage 3 or more
- Must have cell phone
Exclusion Criteria:
- Patient with POPQ stage less than stage 3
- Patient not giving consent
- Patient with previous pelvic and spine surgery
- Patient having positive cough stress test on examination
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: vagianl prolapse surgery accompanied with TVT sling
patients will undergo vaginal hysterectomy with McCall's culdoplasty and anterior repair with or without posterior repair according to the need.
Patient who falls in Group will undergo mid urethral sling with tension free vaginal tape (TVT) using TVT mid urethral sling.
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patient after hysterectomy will undergo retropubic sling surgery in the same setting.
Retropubic sling will be inserted vaginally in the retropubic area following standard protocol.
Otros nombres:
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Sin intervención: vaginal prolapse surgery not accompanied with sling
patients will undergo vaginal hysterectomy with McCall's culdoplasty and anterior repair with or without posterior repair according to the need.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Stress urinary incontinence
Periodo de tiempo: 3 months
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The primary outcome of the study will be the presence of stress urinary incontinence in post operative at 3 months follow up.
During follow up patient will be asked about the urinary incontinence on coughing, sneezing, heavy work and will examined in comfortably full bladder and cough stress test will be done to confirm the diagnosis of stress urinary incontinence.
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3 months
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stress urinary incontinence
Periodo de tiempo: 6 months
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The primary outcome of the study will be the presence of stress urinary incontinence in post operative at 6 months follow up.
During follow up patient will be asked about the urinary incontinence on coughing, sneezing, heavy work and will examined in comfortably full bladder and cough stress test will be done to confirm the diagnosis of stress urinary incontinence.
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6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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1) BFLUTS-FS (frequency symptoms), VS(voiding symptoms), IS (Irritable symptoms), Sex symptoms , QoL (Quality of life) score 2) UDI-6 (Urinary distress inventory-6) score 3) Complications during surgery 4) Dyspareunia 5) Pelvic pain
Periodo de tiempo: 3 months
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The main two questionnaires used in this study are BFLUTS-SF and UDI-6. BFLUTS-SF has five different section
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3 months
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1) BFLUTS-FS (frequency symptoms), VS(voiding symptoms), IS (Irritable symptoms), Sex symptoms , QoL (Quality of life) score 2) UDI-6 (Urinary distress inventory-6) score 3) Complications during surgery 4) Dyspareunia 5) Pelvic pain
Periodo de tiempo: 6 months
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The main two questionnaires used in this study are BFLUTS-SF and UDI-6. BFLUTS-SF has five different section
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6 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Mohan ch Regmi, Professor, BPKIHS
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRC/1536/019
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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