Effect of Knack Pelvic Floor Contraction on Sexual Dysfunction

NCT07145216 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/005672
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the effect of knack pelvic floor contraction on sexual dysfunction in females with stress urinary incontinence.

Conditions

Stress Urinary Incontinence (SUI); Sexual Dysfunction

Outcome Measures

Primary Outcomes (2)

• Assessment of pelvic floor muscle strength

  PortablE biofeedback device will be used to assess pelvic floor muscle contraction. Each woman in both groups will be asked to count from 0 to 10 for 5 sets to achieve mental relaxation. Then, the area of the perineum will be cleaned with a disinfectant solution. The participant will insert the probe, which was covered with a condom and lubricated with hypoallergenic gel, into her vaginal cavity. The internal probe promotes proprioception and aids muscle awareness. The participants will be instructed to place the probe inside the vagina to a location where 0.5-1.0 cm of the probe is visible from the outside of the introitus. PFM strength will then be evaluated by a maximum voluntary contraction, as will be measured by squeeze pressure. Vaginal pressure testing will be performed with three repetitions of maximum voluntary contractions that each will be lasted for 3 s, with a 3-s rest between contractions. 2-minute rest break will then be taken, and the average score will be recorded.

  8 weeks

• Assessment of sexual function

  The Arabic version of female sexual function Index score (FSFI) will be used to assess sexual function for all participating women in both groups before and after treatment program. All women in both groups will be asked to fill 5 domains of the questionnaire after explanation of them. The scoring system has a range of 2 to 36. According to Anis et al. (2011), a score above 28.1 indicated a good sexual life, whereas a score below 28.1 indicated reduced sexual function. The five categories of the questionnaire are severe (2-7.2), moderate (7.3-14.4), mild to moderate (14.5-21.6), mild (21.7-28.1 "cutoff point"), and no FSD (28.2-36)

  8 weeks

Secondary Outcomes (2)

• Assessment of symptoms of SUI

  8 weeks

• Assessment of quality of life

  8 weeks

Study Arms (2)

Interferential stimulation

ACTIVE COMPARATOR

It will include 20 participants suffering from SUI associated with sexual dysfunction who will receive interferential stimulation for 20 minutes, 3 days per week for 8 weeks.

Other: Interfrential stimulation

Interferential stimulation + Knack pelvic floor exercise

EXPERIMENTAL

It will include 20 participants suffering from SUI with sexual dysfunction who will receive interferential stimulation for 20 minutes in addition to the knack maneuver for 15 minutes, 3 days per week for 8 weeks.

Other: Interfrential stimulation; Other: Knack pelvic floor training

Interventions

Interfrential stimulation OTHER

The participant will be positioned in semi-Fowler's position. Interferential therapy was given using the quadripolar method. Two electrodes were placed on the lower abdomen just above the outer half of the inguinal ligament, and another two on the inner aspect of the thigh near the origin of the adductor muscle. At the first treatment session, every participant will be examined for pelvic floor contraction by the finger palpation method using sterilized gloves to ensure the correct position of the electrodes. It will be set with intensity up to the tolerable limit of subjects, carrier frequency of 2000Hz, vector 900, rhythmic sweep frequency of 10-100Hz, and duration 20 minutes. Interferential therapy will be applied for the treatment procedure of all women in both groups for 20 minutes, 3days per week for 8 weeks.

Interferential stimulation; Interferential stimulation + Knack pelvic floor exercise

Knack pelvic floor training OTHER

The knack technique (Fitz et al., 2021): * The patient will be instructed to lie in supine lying position with flexed knees. * Ask the patient to contract the pelvic floor muscles for 2-4 seconds and relax for 4 seconds for 15 repetitions with 3 sets before and during coughing or sneezing . * Contract the PFM before and during all daily activities involving effort, before and during coughing, sneezing, laughing, walking up and down stairs, jumping, running, bending, lifting a weight from the floor, holding a child, pushing furniture to prevent urine leakage. * Contract PFM and hold for 2-4 seconds, relax 4 seconds, with 3 sets of 15 repetitions.

Interferential stimulation + Knack pelvic floor exercise

Eligibility Criteria

• Age: 25 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Females with mild and moderate degrees of SUI according to Incontinence Severity Index score (mild: 1-2; and moderate: 3-4 scoring).
• Their ages will range from 25 to 45 years old.
• Their body mass index (BMI) will be less than 30 kg/m2.
• They are multiparous women.
• Females complain of sexual disorders related to SUI, identified by an FSFI score of less than 28.1
• They have a sedentary lifestyle.

You may not qualify if:

• Severe degree of SUI.
• Other types of urinary incontinence, such as urge urinary incontinence and mixed urinary incontinence.
• Other neurological diseases such as myasthenia gravis and Parkinsonism.
• History of pelvic fractures.
• Menopausal women.
• Females with pelvic organ prolapse (POP).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy

Giza, Egypt

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress; Sexual Dysfunction, Physiological

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; Genital Diseases

Study Officials

• Doaa A. Osman, PHD

  Department of Women's Health, Faculty of Physical Therapy, Cairo University

  STUDY CHAIR

Central Study Contacts

Wafaa I. Hussein, B.Sc

CONTACT

01005660816; wafaaibraheem1801@gmail.com

Manal A. El-Shafei, PHD

CONTACT

01220664518; manal.ahmed@pt.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: August 28, 2025
• Study Start: September 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 30, 2026
• Last Updated: August 28, 2025

Record last verified: 2025-08

Locations

EG (1)