TITLE: Kegel exercise and Psychosexual counselling for ED in SCI
AUTHORS: K M Amran Hossain, Ahamadullah Hil Galeb, Md. Abu Khayer Hasnat

[DESCRIPTION]
The protocol describes the intervention provided in both "Kegel exercise and psychosexual counselling", and "usual counselling" for the study titled "Effectiveness of Kegel exercise and psychosexual counselling versus usual counselling for managing erectile dysfunction in incomplete spinal cord injury"

This study was approved by International Review Board (IRB), BHPI, and CRP and the reference number is CRP/BHPI/IRB/06/2020/394.

The study has also been registered to Clinical Trial Registry India (CTRI) and the registration number for this trial is CTRI/2020/07/026395

[GUIDELINES]
The study has also been registered to Clinical Trial Registry India (CTRI) and the registration number for this trial is CTRI/2020/07/026395

[STEPS]
SECTION: Study process
1. Screening
SECTION: Study process
2. Randomization
SECTION: Study process
3. Baseline assessment
SECTION: Study process
4. Intervention
SECTION: Study process
4.1. Usual counselling
The counselling department follows the PLISSIT MODEL developed by Annon, in 1976. 
P = Permission (verbal)
LI= Limited Information
SS= Specific Suggestions
IT= Intensive Therapy
Session -1
Given general information about sex in a group. If some feel interested or motivated then assess the need well as verbal consent. Assist the problems and counseling to the couple about facts regarding sex and problems after SCI. After that arrange a single room focusing intimation.
Session-2
In this session, find out the outcome of the previous session and find out the leading problem as well as give specific Suggestions/interventions.
Session-3
In this session, find out the outcome of a previous specific intervention. Any type of limitation in sexual activities they try to motivate to use alternatives. In some cases are referred to a doctor for medication.
Session-4
In this session, find out the outcome of the previous intervention by using feedback from the couple and evaluation. 
Session-5
Arrange telephone conversations after discharge from the hospital regarding the continuation of sexual activities in the community.
SECTION: Study process
4.2. Psychosexual counselling
 
       Contents          Description          Professionals involved             C1 -  Psychosexual Counseling          A counselor   is the main educator and tutor for improving and modifying the thoughts,   fantasies, desires, beliefs, attitudes, values, behaviors practices, roles   and relationships, and Interaction of biological, psychological, social,   economic, cultural, historical, religious, and spiritual factors.          A clinical psychologist and a   Senior Counselor at the spinal cord injury (SCI) unit at Centre for the   Rehabilitation of the Paralysed (CRP), Savar, Dhaka, Bangladesh.                 C2 –   Behavioral Therapy         Behavioral   techniques are mainly used for erectile dysfunction and premature   ejaculation. They also have provided some techniques for penile stimulation.   ·           Start-stop- Approach climax and stop to reduce   stimulation   ·           Pull-out- Approach climax, vaginal withdrawal   to reduce stimulation   ·           Pull-out and squeeze - Approach climax,   vaginal withdrawal and squeeze penis tip to reduce stimulation   ·           Mind distraction- A couple or individual   thinks about unrelated subjects to reduce stimulation   ·           Sex education- Couple learns ways to reduce   stimulation and delay climax   ·           Masturbation daily- for ED as behavior   techniques   ·           Medication- for ED   ·           Penile Ring- Local for PE as well as ED   ·           Vibrator- locally and AE behavior techniques   ·           Relaxation/ exercise and Psycho-education  for – Anxiety/ depression             A clinical psychologist and a Senior Counselor at the spinal cord   injury (SCI) unit at Centre for the Rehabilitation of the Paralysed (CRP),   Savar, Dhaka, Bangladesh.       A neurologist   and a physician working at CRP   One male peer   counselor having SCI             C3 – Peer   Counseling          A peer   counselor who is a person with a disability is a critical source of   information and support. They are the experts on what their bodies   experience. They also have experience accessing different resources in the   community and can share suggestions on what has or hasn’t worked for   themselves or other clients.   Persons with   disabilities themselves are critical sources of information and support. They   are the experts on what their bodies experience. They also have experience   accessing different resources in the community and can share suggestions on   what has or hasn’t worked for themselves or other clients.                C4 – Video   Show         It is an   important method where the patients can learn from the teaching video about sexual   life, sexuality, the importance of sex, method of sex. The patient can learn   different techniques for penile erection.          Counselling   psychologist and a male peer counselor       
 
SECTION: Study process
4.3. Kegel exercise
Kegel exercise is a strengthening process that helps to strengthen the pelvic floor muscles. These muscles provide support to the uterus, bladder, small intestine, and rectum. Among pelvic floor muscles, Bulbocavernosus and Ischiocavernosus muscles are directly attached to the basement of the penis which helps to erect the penis and maintain the erection for intercourse. 
Kegel exercises can be performed in different positions such as prone lying, crook lying, sitting, and standing. But the patient is in a supine lying position on the bed because the participants were spinal cord lesion patients. Patients were instructed to tighten the pelvic floor muscles like hold and stop the urine & stool passing. The pelvic floor muscle strengthening protocol was followed based on different studies related to erectile dysfunction.The patient was provided an intervention protocol leaflet with a picture, description of treatment based on FITT approach. 
 
 
       Variables         Values            Frequency         5 sessions in   a week, total of 12 weeks             Intensity          10 rep with   10 sec hold in each pelvic muscle contraction            Time          3 times/day   (self-exercise)             Type of   exercise         Pelvic muscle   contraction      

 
 
SECTION: Study process
4.4. Doses and Progression: 
Kegel exercise: Intervention for 12 weeks (Exercise 5 sessions/week) 
Psychosexual Counselling: Intervention for 12 weeks (2 sessions/week) 
Usual Counselling: Intervention for 12 weeks (2 sessions/week) 
SECTION: Study process
5. Post Test evaluation
SECTION: Evaluation process
6. Statistical evaluation and result preparation