The Effectiveness of Transvaginal Radiofrequency in Women With Stress Urinary Incontinence

Summary

The following clinical trial investigates the efficacy of transvaginal radiofrequency in the physiotherapy treatment of stress urinary incontinence (SUI). The treatment compares transvaginal radiofrequency with pelvic floor muscle training (PFMT) and PFMT alone.

The present study is a randomized controlled trial with double blinding (evaluator and patients).

The objective is to evaluate what radiofrequency can provide in the improving of the quality of life, symptoms and pelvic floor muscle strength of patients with SUI.

The reason for the combination with PFMT, is that it is the golden standard treatment in pelvic floor rehabilitation and SUI improvement.

Conditions

• Urinary Incontinence,Stress
• Pelvic Floor Disorders
• Urinary Incontinence
• Pelvic Floor Muscle Weakness

Interventions

DEVICE

RF + PFMT

During each session the patient is lying face up, with knees bent and feet resting on the stretcher. Then, the vaginal probe is introduced into the cavity using a lubricant suitable for intracavitary use and radiofrequency. The device is started at 15% intensity and adapting to a 10-point Likert scale, at point 3 or 4 of intensity. At the same time that the radiofrequency is applied, pelvic floor contractions are performed guided by the physiotherapist, and these contractions are three: * 10 fast contractions of one second each, with 10 seconds of rest. * 5 seconds of sustained contraction and 10 seconds of rest. * 10 seconds of contraction maintained with 10 seconds of rest. The contraction maintenance time will be adapted to what each woman can keep the pelvic floor contracted, with a view to the goal being to complete these exercises cyclically during the entire session.

OTHER

PFMT + Placebo RF

The intervention is exactly the same as the group RF + PFMT, unlike the non-functioning of the RF in the patients belonging to this group. The patient is lying face up, with knees bent and feet resting on the stretcher. Then, the vaginal probe is introduced into the cavity using a lubricant suitable for intracavitary use and radiofrequency, the device is started at 15% intensity, but in this case, the program does not work or apply radiofrequency to the patients. At the same time, that the radiofrequency's probe is applied, pelvic floor contractions are performed guided by the physiotherapist, and these contractions are the three named in the Radiofrequency + PFMT. The contraction maintenance time will be adapted to what each woman can keep the pelvic floor contracted, with a view to the goal being to complete these exercises cyclically during the entire session.

Sponsors & Collaborators

• University of Alcalá. Physiotherapy in Women's Health (FPSM) Research Group.

  collaborator UNKNOWN

• José Casaña Granell

  lead OTHER

Principal Investigators

• Yasmin Er Rabiai Boudallaa, Phd Student · University of Valencia (Spain)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

FACTORIAL

Eligibility

Min Age

20 Years

Max Age

75 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-09

Primary Completion

2023-07-27

Completion

2023-07-27

Countries

• Spain

Study Locations