RF in the Treatment OAB in UUI- a Prospective Randomized Placebo Controlled Study

NCT06080217 | Unknown

• 1 other identifier: ginek dr franic
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

Until now, OAB with or without UUI has been treated mainly in two ways: with behavioral methods and/or patient education or using antimuscarinic drugs and/or beta 3 adrenergic receptor agonists. Unfortunately, the drugs might cause side effects in some women or were insufficiently effective, so the patients abandoned them. Methods In prospective, randomized, placebo controlled study, 80 women were enrolled, using radiofrequency in treating OAB and UUI. Based on ICIQ-OAB, ICIQ-OAB QoL, and ICIQ-FLUTSsex questionnaires, severity of OAB symptoms, QoL and detailed evaluation of female sexual matters associated with their lower urinary tract symptoms. RF was applied 4 times for 20 minutes, once a week. Two week after the completion of the treatment,as well as 3, 6 and 12 months, the level of OAB and UUI was reassessed and processed it statistically and evaluated the treatment effect.

Conditions

Overactive Bladder Syndrome; Urge Incontinence

Keywords

radiofrequency-overactive bladder-urge incontinence

Outcome Measures

Primary Outcomes (1)

• changed symptoms specific for OAB

  frequency of urination, nocturia, urgency, incontinence

  2 weeks, 3 months, 6 months, 12 months

Study Arms (2)

study group

EXPERIMENTAL

The patients were lying in the lithotomy position with the streTched lower extremities. Probes are placed on the lower part of the abdomen in the area of the bladder (active probe) and on the lumbar spine (passive probe). A capacitive probe in the "free treatment" / "power control" program was used, where high frequency electricity was released to the bladder for 20 minutes with a frequency of 1.0 MHz and energy to maximum 410 C. Initialy, maximum energy of 75% and a frequency of 0.8 MHz was applied, which was reduced depending on the heat that was pleasant for the patient. Then, the power was reduced to 50% and increased the frequency to 1.0 MHz, which also meant moderate energy absorption. The procedure with this energy was continued until the end, and the patients absorbed 18-19 kJ of energy in average.

Device: study group

placebo group

SHAM COMPARATOR

The patients were lying in the lithotomy position with the streched lower extremities. Probes are placed on the lower part of the abdomen in the area of the bladder (active probe) and on the lumbar spine (passive probe) . A capacitive probe in the "free treatment" / "power control" program was used, with NO electricity was released to the bladder for 20 minutes

Device: study group; Device: placebo (sham control)

Interventions

study group DEVICE

The patients were lying in the lithotomy position with the stretched lower extremities. Probes are placed on the lower part of the abdomen in the area of the bladder (active probe) and on the lumbar spine (passive probe). A capacitive probe in the "free treatment" / "power control" program was used, where high frequency electricity was released to the bladder for 20 minutes with a frequency of 1.0 MHz and energy to maximum 410 C. Initialy, maximum energy of 75% and a frequency of 0.8 MHz was applied, which was reduced depending on the heat that was pleasant for the patient. Then, the power was reduced to 50% and increased the frequency to 1.0 MHz, which also meant moderate energy absorption. The procedure with this energy was continued until the end, and the patients absorbed 18-19 kJ of energy in average.

Also known as: Capenergy C100 (ref. 533001) with upgrade to C500 (ref. 533005)

placebo group; study group

placebo (sham control) DEVICE

The patients were lying in the lithotomy position with the stretched lower extremities. Probes are placed on the lower part of the abdomen in the area of the bladder (active probe) and on the lumbar spine (passive probe). A capacitive probe in the "free treatment" / "power control" program was used, but without any energy transferred through the probe,

Also known as: Capenergy C100 (ref. 533001) with upgrade to C500 (ref. 533005)

placebo group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clear signs of OAB
• did not use drugs for the treatment of OAB (antimuscarinics/beta-3 agonists)
• women who have taken drugs for the treatment of OAB in the past, but stopped at least 3 months prior the entering the study.

You may not qualify if:

• Inserted heart pacemaker,
• unexplained bleeding from the vagina,
• inflammation of the vagina and/or uterus or uterine appendages.
• Bacterial or viral infection,
• weakened immune system,
• sclerodermia,
• radiation treatment,
• burns in the treatment area,
• stress urinary incontinence (SUI) or mixed urinary incontinence

Sponsors & Collaborators

• Ginekologija Dr. Franić, D.O.O.: lead

Study Sites (2)

Damir Franić

Rogaška Slatina, 3250, Slovenia

Location

Outpatient Clinic Ob&Gyn

Rogaška Slatina, 3250, Slovenia

Location

MeSH Terms

Conditions

Urinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• damir franić, MD PhD

  Ginekologija Dr. Franić, D.O.O.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: October 12, 2023
• Study Start: July 10, 2023
• Primary Completion: December 30, 2023
• Study Completion: March 31, 2024
• Last Updated: December 1, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: after completed the study together with 12 months follow-up
• Access Criteria: e-mail adress: damir.franic@guest.arnes.si; ginekologija.drfranic@siol.net

Locations

SL (2)