Clinical Trials Logo
  1. Home
  2. Overactive Bladder
  3. NCT04429360
  4. Details
NCT04429360 Clinical Trial

What is the Effect of Prolapse Surgery on Voiding?

Overactive Bladder Clinical Trial

— PROVOID  

Official title:
What is the Effect of Prolapse Surgery on Voiding?

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04429360
Other study ID # EDGE000835
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 8, 2020
Est. completion date June 8, 2023

Study information
Verified date June 2020
Source Universiteit Antwerpen
Contact Sascha Vereeck, Dr.
Phone 003238215945
Email saschavereeck@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of our study is to examine the effect of prolapse surgery on voiding. Our study is the very first one to combine several innovative low-invasive and low-cost methods to analyse the amelioration or deterioration of voiding function after surgery for pelvic organ prolapse using 3D/4D translabial ultrasound, home-uroflowmetry and patient reported quality of life outcomes.

Recruitment information / eligibility
Status Recruiting
Enrollment 453
Est. completion date June 8, 2023
Est. primary completion date June 8, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- age =18 years

- Dutch, French or English- speaking women

- symptoms of pelvic organ prolapse

- preoperatively pelvic floor surgery.

Exclusion Criteria:

- history of neurological disease

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• pelvic reconstructive surgery
Pelvic reconstructive surgery

Locations
Country Name City State
Belgium University Hospital of Antwerp Edegem Antwerp

Sponsors (1)
Lead Sponsor Collaborator
Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in lower urinary tract symptoms pre- postoperatively Voiding diary 1 year follow-up
Primary Change in lower urinary tract symptoms pre- postoperatively Questionnaire: PFDI-20 1 year follow-up
Secondary Change in clinical outcome measures POP-Q 1 year follow-up
Secondary Change in clinical outcome measures Transperineal ultrasound (TPUS) 1 year follow-up
Secondary Change in voiding home-uroflowmetry 1 year follow-up
Secondary Change in QoL Questionnaire: PFIQ-7 1 year follow-up
Secondary Change in QoL Questionnaire: PISQ-12 1 year follow-up
See also
  Status Clinical Trial Phase
Recruiting NCT04578899 - "The Effectiveness of Transvertebral Magnetic Neuromodulation in Patients With Detrusor Overactivity" N/A
Active, not recruiting NCT03556891 - Pivotal Study of eCoin for Overactive Bladder With Urgency Urinary Incontinence N/A
Not yet recruiting NCT05977634 - Transcutaneous Tibial Nerve Stimulation for Idiopathic Overactive Bladder N/A
Completed NCT01955408 - Severity of Overactive Bladder Symptoms in Patients After Synergo Treatment N/A
Recruiting NCT06201013 - Efficacy and Safety of Vitamin D in the Treatment of OAB-wet in Children N/A
Recruiting NCT03727711 - TPTNS: Home vs Hospital Treatment for Overactive Bladder N/A
Completed NCT00768521 - A Study to Test the Effects of Tolterodine Tartrate in Patients With Overactive Bladder (0000-107) Phase 1
Completed NCT03625843 - Mindfulness Exercises to Reduce Anxiety and Pain During Urodynamic Testing N/A
Completed NCT02211846 - A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron OCAS (Oral Controlled Absorption System) in Pediatric Subjects With Neurogenic Detrusor Overactivity or Overactive Bladder Phase 1
Completed NCT02857816 - PRospective Study to Evaluate EffectivenesS With the NURO™ PErcutaneous Tibial Neuromodulation System in Patients With OAB N/A
Completed NCT02835846 - Investigation of the Effect of the Female Urinary Microbiome on Incontinence Phase 4
Withdrawn NCT02320201 - Foot Neuromodulation for Overactive Bladder in Children N/A
Completed NCT02202031 - Controlling Urgency Through Relaxation Exercises N/A
Not yet recruiting NCT01409512 - Evaluation of Autonomic System Before and After Anticholinergic Treatment in Women With Overactive Bladder N/A
Completed NCT01458197 - A Phase 2 Study to Compare the Efficacy and Tolerability of Tarafenacin 0.2 mg and Tarafenacin 0.4 mg to Placebo in Patients Suffering From Overactive Bladder. Phase 2
Completed NCT01437670 - Observational Study to Estimate the Dry Mouth in OAB Patients With Solifenacin N/A
Not yet recruiting NCT01423838 - Comparison of Solifenacin and Oxybutynin in the Treatment of Overactive Bladder Phase 4
Terminated NCT01758848 - Physical Therapy for Overactive Bladder N/A
Withdrawn NCT01210859 - Effects of Antimuscarinic Drugs on Overactive Bladder (OAB) Symptoms After Insertion of Ureteral Stents N/A
Completed NCT00928070 - A Study Of Efficacy And Safety Of Fesoterodine In Vulnerable Elderly Subjects With Overactive Bladder Phase 4