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Urinary Incontinence, Stress clinical trials

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NCT ID: NCT05464316 Recruiting - Clinical trials for Urinary Incontinence

Prospective Pilot ATOMS vs AUS

Start date: January 13, 2022
Phase: N/A
Study type: Interventional

Post-Prostatectomy Incontinence (PPI) is a common complication affecting 1% to 40% of patients after surgery. When conservative treatments fail, the installation of an artificial urinary sphincter (AUS) has been the treatment of choice for PPI since its introduction more than 50 years ago. Although small studies suggest inferior success rate of male slings compare to the AUS in moderate to severe male incontinence; recent studies, one prospective and one Canadian multicenter cohort study, have demonstrated adjustable transobturator male sling (ATOMS) as a safe and efficient alternative to treat PPI. Interestingly, the ATOMS does not required any operation manipulation from the user in order to void and it causes potentially less urethral erosion and less urethral atrophy than the AUS; although those findings were never compared head to head with the AUS. Therefore, we believe that a thorough prospective non-inferiority study comparing the outcomes and effectiveness of the ATOMS device versus the AUS in treating moderate to severe PPI could prove itself useful in guiding urologists and patients to choose their best treatment of male incontinence. The null hypothesis posed for the present study is that ATOMS is non inferior to AUS for the treatment of moderate to severe PPI using the non-inferiority margin of 15% to be of acceptable lower effectiveness. With regards to study methods, this will be a pilot prospective, randomized controlled trial, non-blinded with a non-inferiority design. This pilot study will take place at the CIUSSS de l'Estrie, in Sherbrooke, Quebec, Canada, with two surgeons. All male patients with moderate to severe incontinence after their prostate surgery, who are suitable for incontinence surgery will be screened for study eligibility respecting the exclusion and inclusion criteria. After written informed consent, enrolled patients will be randomized assigned (1:1) to one of the two interventions' arms (AUS or ATOMS). Sixty patients are estimated to be randomized in the two arms the day of their surgery with a computer-based algorithm sequence. By completing this pilot prospective study, we hope to provide concrete and scientifically significant evidence on the effectiveness of ATOMS in the treatment of moderate to severe PPI comparing with the AUS. Although both treatments are commonly used today, there has been little evidence comparing both devices side by side with more severe PPI. We therefore hope to make a global impact with said project.

NCT ID: NCT05449639 Recruiting - Clinical trials for Urinary Incontinence

Study for a Magnetic Endourethral Sphincter Against Stress Urinary Incontinence

RELIEF-2
Start date: August 17, 2022
Phase: N/A
Study type: Interventional

A second no-random open interventional pilot study sponsored by Relief srl

NCT ID: NCT05448482 Recruiting - Clinical trials for Female Stress Incontinence

Hybrid Versus Synthetic TOT for Treatment of SUI

Start date: January 5, 2021
Phase: N/A
Study type: Interventional

This prospective study is conducted on female patients presenting with SUI at Alexandria main university hospital. Patients with neurogenic voiding dysfunction, history of anti-incontinence surgery, urge-predominant MUI, urogenital cancer, pelvic irradiation, body mass index more than 40 kg/m2 and more than stage 1 POP are excluded. Patients are randomized into 2 groups, one group will be subjected to h_TOT, and the second group to conventional TOT. Patients are subjected to PGI and UDI-6 questionnaires and a urodynamic study before and 6 months after the both surgery. Success is defined as: no subjective complaint of SUI, negative cough stress test and no leakage on UDS.

NCT ID: NCT05366426 Recruiting - Clinical trials for Stress Urinary Incontinence

Effect of EMG Biofeedback in Female Patients With Stress Urinary Incontinence

1
Start date: August 19, 2022
Phase: N/A
Study type: Interventional

The aim of this randomized controlled study was to compare the EMG biofeedback method with pelvic floor muscle (PTC) exercises and Sham EMG biofeedback group in women with stress urinary incontinence (SUI) on pelvic floor muscle strength, trunk endurance, subjective perception of improvement, severity of complaints, pad test and quality of life. to determine its effectiveness.

NCT ID: NCT05342090 Recruiting - Surgery Clinical Trials

Postoperative Return to Sexual Activity

PoRS
Start date: April 5, 2022
Phase: N/A
Study type: Interventional

To determine if standardized counselling regarding first sexual encounter after pelvic reconstructive surgery for pelvic organ prolapse and / or urinary incontinence improves postoperative preparedness to return to sexual activity and sexual function.

NCT ID: NCT05337813 Recruiting - Overactive Bladder Clinical Trials

Effects of Low-intensity Excoporeal Shock Wave Therapy (LiESWT) on Women With Pelvic Floor Dysfunction

Start date: April 10, 2020
Phase: N/A
Study type: Interventional

1. This study needles female reproductive urinary tract, likely bladder hyperactivity, active urinary incontinence and interstitial cystitis, observation use of low-capacity seismic wave (LiESWT) therapy combined with combined platelet plasma (PRP), improved bone basin pain and female Urinary incontinence. 2. LiESWT to arousal the clitoris angiogenesis to prevent female sexual dysfunction.

NCT ID: NCT05304312 Recruiting - Clinical trials for Stress Urinary Incontinence

The Role of Kegel Exercises Book to Improve Treatment in Stress Urinary Incontinence Women

ROSEBOOK-SUI
Start date: September 21, 2020
Phase: N/A
Study type: Interventional

This research aims to evaluate a Kegel Exercises guidebook to treat stress urinary incontinence (SUI) in female patients. The Kegel Exercises guidebook had been made and evaluated before, this was a clinical trial to test out the book in clinical settings. In measuring the effectiveness of the book, the investigators used some examinations and questionnaires such as UDI-6, IIQ-7, perineometer, and 1-hour pad test improvement. Investigators followed up the patient's symptoms subjectively with UDI-6 and IIQ-7 and objectively with a perineometer and 1-hour pad test every four weeks.

NCT ID: NCT05272644 Recruiting - Clinical trials for Stress Urinary Incontinence

Efficacy of Biofeedback-Assisted Pelvic Muscle Floor Training and Electrical Stimulation on Women With Stress Urinary Incontinence

Start date: September 16, 2022
Phase: N/A
Study type: Interventional

The pathophysiological mechanism of stress urinary incontinence divides stress urinary incontinence into urethral hypermobility and intrinsic sphincter deficiency. Pelvic floor muscle exercise as first line therapy has been found to be extremely helpful in patients with mild to moderate forms of incontinence. Biofeedback uses an instrument to record the biological signals ( electrical activity) during a voluntary pelvic floor muscle contraction and present this information back to the woman in auditory or visual form. Electrical stimulation can aid in detecting pelvic floor muscles, and also promote the contraction of the pelvic floor muscles and strengthen the muscles. This study assumes that urinary incontinence women with different pathophysiological classifications receiving a pelvic floor muscle training with surface electromyographic biofeedback and electrical stimulation show differences in the strength of pelvic muscle and degree of symptoms improvement.

NCT ID: NCT05255289 Recruiting - Clinical trials for Stress Urinary Incontinence

Efficacy/Safety of Midurethral Sling

Start date: March 8, 2021
Phase: N/A
Study type: Interventional

The trans-obturator tape (TOT), which exhibits a satisfactory cure rate and a relatively diminished invasiveness, has been increasingly accepted as a surgical treatment of stress urinary incontinence (SUI) patients. Nevertheless, in contrast to the well-recognized therapeutic benefit of the enhanced resistance to the bladder continence during urine storage, if the voiding function of the bladder adapts to the TOT-enhanced outlet resistance has not been adequately investigated. This study retrospectively assayed the voiding efficacy of each voiding cycle, to clarify if the thermodynamic efficacy of the bladder was modified in response to the TOT surgery.

NCT ID: NCT05224024 Recruiting - Clinical trials for Prostate Adenocarcinoma

Retzius-sparing Technique in Robotic-assisted Radical Prostatectomy

Start date: February 15, 2022
Phase: N/A
Study type: Interventional

The objective of this study is to compare the short-term and 1-yr follow-up functional outcomes of retzius-repairing robot-assisted radical prostatectomy (RR-RARP) with retzius-sparing (RS) RARP. This study is a single-centre, single-surgeon and a prospective randomized study.